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Sample records for counselling randomized intervention

  1. Effects of Telephone Counseling Intervention by Pharmacists (TelCIP) on Medication Adherence; Results of a Cluster Randomized Trial

    PubMed Central

    Kooij, Marcel J.; Heerdink, Eibert R.; van Dijk, Liset; van Geffen, Erica C. G.; Belitser, Svetlana V.; Bouvy, Marcel L.

    2016-01-01

    Objectives: To assess the effect of a pharmacist telephone counseling intervention on patients' medication adherence. Design: Pragmatic cluster randomized controlled trial. Setting: 53 Community pharmacies in The Netherlands. Participants: Patients ≥18 years initiating treatment with antidepressants, bisphosphonates, Renin-Angiotensin System (RAS)-inhibitors, or statins (lipid lowering drugs). Pharmacies in arm A provided the intervention for antidepressants and bisphosphonates and usual care for RAS-inhibitors and statins. Pharmacies in arm B provided the intervention for RAS-inhibitors and statins and usual care for antidepressants and bisphosphonates. Intervention: Intervention consisted of a telephone counseling intervention 7–21 days after the start of therapy. Counseling included assessment of practical and perceptual barriers and provision of information and motivation. Main outcome measure: Primary outcome was refill adherence measured over 1 year expressed as continuous outcome and dichotomous (refill rate≥80%). Secondary outcome was discontinuation within 1 year. Results: In the control arms 3627 patients were eligible and in the intervention arms 3094 patients. Of the latter, 1054 patients (34%) received the intervention. Intention to treat analysis showed no difference in adherence rates between the intervention and the usual care arm (74.7%, SD 37.5 respectively 74.5%, 37.9). More patients starting with RAS-inhibitors had a refill ratio ≥80% in the intervention arm compared to usual care (81.4 vs. 74.9% with odds ratio (OR) 1.43, 95%CI 1.11–1.99). Comparing patients with counseling to patients with usual care (per protocol analysis), adherence was statistically significant higher for patients starting with RAS-inhibitors, statins and bisphosphonates. Patients initiating antidepressants did not benefit from the intervention. Conclusions: Telephone counseling at start of therapy improved adherence in patients initiating RAS-inhibitors. The per

  2. Efficacy of a randomized cell phone-based counseling intervention in postponing subsequent pregnancy among teen mothers.

    PubMed

    Katz, Kathy S; Rodan, Margaret; Milligan, Renee; Tan, Sylvia; Courtney, Lauren; Gantz, Marie; Blake, Susan M; McClain, Lenora; Davis, Maurice; Kiely, Michele; Subramanian, Siva

    2011-12-01

    Adolescent mothers in Washington, DC have a high rate of subsequent teen pregnancies, often within 24 months. Children of teen mothers are at risk for adverse psychosocial outcomes. When adolescents are strongly attached to parents, schools, and positive peers, they may be less likely to repeat a pregnancy. This study tested the efficacy of a counseling intervention delivered by cell phone and focused on postponing subsequent teen pregnancies by strengthening healthy relationships, reproductive practices, and positive youth assets. The objective of this study was to compare time to a repeat pregnancy between the intervention and usual care groups, and, secondarily, to determine whether treatment intensity influenced time to subsequent conception. Primiparous pregnant teens ages 15-19, were recruited in Washington, DC. Of 849 teens screened, 29.3% (n = 249) met inclusion criteria, consented to participate, and completed baseline measures. They were then randomized to the intervention (N = 124) or to usual care (N = 125). Intervention group teens received cell phones for 18 months of counseling sessions, and quarterly group sessions. Follow-up measures assessed subsequent pregnancy through 24 months post-delivery. A survival analysis compared time to subsequent conception in the two treatment groups. Additional models examined the effect of treatment intensity. By 24 months, 31% of the intervention and 36% of usual care group teens had a subsequent pregnancy. Group differences were not statistically significant in intent-to-treat analysis. Because there was variability in the degree of exposure of teens to the curriculum, a survival analysis accounting for treatment intensity was performed and a significant interaction with age was detected. Participants who were aged 15-17 years at delivery showed a significant reduction in subsequent pregnancy with increased levels of intervention exposure (P < 0.01), but not those ≥ 18 years. Adolescents ≥ 18 years faced

  3. Nondirective counseling interventions with schizophrenics.

    PubMed

    Gerwood, J B

    1993-12-01

    Counseling interventions with paranoid schizophrenics can be daunting. While chemical, directive, and behavioral controls often are considered important, nondirective counseling techniques used by the therapeutic staff may help schizophrenic patients explore their thoughts and feelings. Several nondirective concepts pioneered by Carl Rogers are examined. These methods, which represent basic concepts of the person-centered approach, are empathy, unconditional positive regard, and congruence. A brief illustration of an interaction with a patient diagnosed as paranoid schizophrenic is presented to suggest the effectiveness of Rogerian counseling.

  4. Randomized controlled trial evaluating the effect of an interactive group counseling intervention for HIV-positive women on prenatal depression and disclosure of HIV status.

    PubMed

    Kaaya, Sylvia F; Blander, Jeffrey; Antelman, Gretchen; Cyprian, Fileuka; Emmons, Karen M; Matsumoto, Kenji; Chopyak, Elena; Levine, Michelle; Smith Fawzi, Mary C

    2013-01-01

    The objective of the study was to assess the effectiveness of group counseling, using a problem-solving therapy approach, on reducing depressive symptoms and increasing prenatal disclosure rates of HIV status among HIV-positive pregnant women living in Dar es Salaam, Tanzania. A randomized controlled trial was performed comparing a six-week structured nurse-midwife facilitated psychosocial support group with the standard of care. Sixty percent of women in the intervention group were depressed post-intervention, versus 73% in the control group [Relative Risk (RR) = 0.82, 95% confidence interval (CI): 0.67-1.01, p=0.066]. HIV disclosure rates did not differ across the two study arms. However, among those women who disclosed, there was a significantly higher level of overall personal satisfaction with the response to disclosure from family and friends among women in the treatment (88%) compared to the control group (62%; p=0.004). The results indicate reductions in the level of depressive symptoms comparable with major depressive disorder (MDD) for HIV-positive pregnant women participating in a group counseling intervention. Although the psychosocial group counseling did not significantly increase disclosure rates, an improvement in the level of personal satisfaction resulting from disclosure was associated with the intervention. This suggests that the counseling sessions have likely reduced the burden of depression and helped clients better manage partner reactions to disclosure. Public agencies and non-governmental organizations working in Tanzania and similar settings should consider offering structured psychosocial support groups to HIV-positive pregnant women to prevent poor mental health outcomes, promote early childhood development, and potentially impact HIV-related disease outcomes in the long term.

  5. Feasibility and Acceptability of a Wearable Technology Physical Activity Intervention With Telephone Counseling for Mid-Aged and Older Adults: A Randomized Controlled Pilot Trial

    PubMed Central

    Swartz, Maria C; Lewis, Zakkoyya H; Martinez, Eloisa; Jennings, Kristofer

    2017-01-01

    Background As adults age, their physical activity decreases and sedentary behavior increases, leading to increased risk of negative health outcomes. Wearable electronic activity monitors have shown promise for delivering effective behavior change techniques. However, little is known about the feasibility and acceptability of non-Fitbit wearables (Fitbit, Inc, San Francisco, California) combined with telephone counseling among adults aged more than 55 years. Objective The purpose of our study was to determine the feasibility, acceptability, and effect on physical activity of an intervention combining a wearable physical activity monitor, tablet device, and telephone counseling among adults aged 55-79 years. Methods Adults (N=40, aged 55-79 years, body mass index=25-35, <60 min of activity per week) were randomized to receive a 12-week intervention or to a wait list control. Intervention participants received a Jawbone Up24 monitor, a tablet with the Jawbone Up app installed, and brief weekly telephone counseling. Participants set daily and weekly step goals and used the monitor’s idle alert to notify them when they were sedentary for more than 1 h. Interventionists provided brief counseling once per week by telephone. Feasibility was measured using observation and study records, and acceptability was measured by self-report using validated items. Physical activity and sedentary time were measured using ActivPAL monitors following standard protocols. Body composition was measured using dual-energy x-ray absorptiometry scans, and fitness was measured using a 6-min walk test. Results Participants were 61.48 years old (SD 5.60), 85% (34/40) female, 65% (26/40) white. Average activity monitor wear time was 81.85 (SD 3.73) of 90 days. Of the 20 Up24 monitors, 5 were reported broken and 1 lost. No related adverse events were reported. Acceptability items were rated at least 4 on a scale of 1-5. Effect sizes for most outcomes were small, including stepping time per day (d

  6. Gestalt Therapy Interventions for Group Counseling

    ERIC Educational Resources Information Center

    Passons, William R.

    1972-01-01

    The author offers a brief introduction to some of the basic tenets of Gestalt therapy, noting goals that are similar to those in counseling theories. He also suggests several interventions from Gestalt therapy to be considered for group counseling and discusses their applications. (Author)

  7. Mindfulness-Based Interventions in Counseling

    ERIC Educational Resources Information Center

    Brown, Amanda P.; Marquis, Andre; Guiffrida, Douglas A.

    2013-01-01

    Mindfulness is a relatively new construct in counseling that is rapidly gaining interest as it is applied to people struggling with a myriad of problems. Research has consistently demonstrated that counseling interventions using mindfulness improve well-being and reduce psychopathology. This article provides a detailed definition of mindfulness,…

  8. Counseling Women and Couples on Family Planning: A Randomized Study in Jordan.

    PubMed

    El-Khoury, Marianne; Thornton, Rebecca; Chatterji, Minki; Kamhawi, Sarah; Sloane, Phoebe; Halassa, Mays

    2016-09-01

    This article evaluates the effects of involving men in family planning counseling in Jordan using a randomized experiment. We randomly assigned a sample of 1,247 married women to receive women-only counseling, couples counseling, or no counseling. We measured the effects of each type of counseling on family planning use, knowledge, attitudes, and spousal communication about family planning. Compared to no counseling, couples counseling led to a 54 percent increase in uptake of modern methods. This effect is not significantly different from the 46 percent increase in modern method uptake as a result of women-only counseling. This outcome may be due, in part, to lower rates of compliance with the intervention among those assigned to couples counseling compared to women-only counseling. To realize the possible added benefits of involving men, more tailored approaches may be needed to increase men's participation.

  9. Physical Exercise as a Counseling Intervention.

    ERIC Educational Resources Information Center

    Chung, Y. Barry; Baird, M. Kathleen

    1999-01-01

    Provides an integrative review of the literature on the relationship between physical exercise and three psychological variables (depression, anxiety, and self-esteem). Proposes guidelines for using exercise as a counseling intervention, and makes suggestions for evaluating exercise interventions. (Author/GCP)

  10. A Web-Based Self-Help Intervention With and Without Chat Counseling to Reduce Cannabis Use in Problematic Cannabis Users: Three-Arm Randomized Controlled Trial

    PubMed Central

    Wenger, Andreas; Berg, Oliver; Beck, Thilo; Stark, Lars; Buehler, Eveline; Haug, Severin

    2015-01-01

    Background After alcohol and tobacco, cannabis is the most widely used psychoactive substance in many countries worldwide. Although approximately one in ten users develops serious problems of dependency, only a minority attend outpatient addiction counseling centers. A Web-based intervention could potentially reach those users who hesitate to approach such treatment centers. Objective To test the efficacy of a Web-based self-help intervention with and without chat counseling—Can Reduce—in reducing the cannabis use of problematic cannabis users as an alternative to outpatient treatment services. Methods Altogether, 436 participants were recruited by various online and offline media for the Web-based trial. A total of 308 of these were eligible for study participation and were randomly allocated in an unblinded manner to either self-help with chat (n=114), self-help without chat (n=101), or a waiting list control group (n=93). The fully automated self-help intervention consisted of eight modules designed to reduce cannabis use, and was based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. Additional individual chat counseling sessions were based on the same therapeutic principles. The sessions were conducted by trained counselors and addressed participants' personal problems. The main outcomes were the frequency (number of days) and quantity of cannabis use (number of standardized joints) per week, as entered into the consumption diary at baseline and at the 3-month follow-up. Secondary outcomes included self-reported symptoms of cannabis use disorder, severity of cannabis dependence, risky alcohol use, and mental health symptoms. Intervention participation and retention were extracted from the user progress data and the consumption diary, respectively. Results Can Reduce participants were older (U=2.296, P=.02) and reported a greater number of cannabis use days at baseline than patients who

  11. Counseling Intervention in Cancer Therapy.

    ERIC Educational Resources Information Center

    Pusateri-Vlach, Nancy F.; Moracco, John C.

    1981-01-01

    Recounts the history of cancer treatment to illustrate the long-standing tradition of a holistic approach to the investigation and treatment of cancer, discusses the growing emphasis on holistic cancer treatment and the importance of counseling in such treatment. (Author)

  12. HIV Prevention Counseling Intervention Delivered During Routine Clinical Care Reduces HIV Risk Behavior in HIV-Infected South Africans Receiving Antiretroviral Therapy: The Izindlela Zokuphila/Options for Health Randomized Trial

    PubMed Central

    Fisher, Jeffrey D.; Cornman, Deborah H.; Shuper, Paul A.; Christie, Sarah; Pillay, Sandy; Macdonald, Susan; Ngcobo, Ntombenhle; Amico, K. Rivet; Lalloo, Umesh; Friedland, Gerald; Fisher, William A.

    2014-01-01

    Context Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. Objective To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. Design Cluster randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard-of-care. Setting Publicly funded HIV clinical care sites. Patients 1891 PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). Intervention Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information—Motivation—Behavioral Skills (IMB) model during routine clinical care. Main Outcome Measures Number of sexual events without a condom in the past four weeks with partners of any HIV status, and with partners perceived to be HIV-negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. Results Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared to standard-of-care participants. Differences in STI incidence between arms were not observed. Conclusion Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. PMID:25230288

  13. Maternal Dietary Counseling Reduces Consumption of Energy-Dense Foods among Infants: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Vitolo, Marcia Regina; Bortolini, Gisele Ane; Campagnolo, Paula Dal Bo; Hoffman, Daniel J.

    2012-01-01

    Objective: To evaluate the impact of a dietary counseling in reducing the intake of energy-dense foods by infants. Design: A randomized controlled trial. Setting and Participants: Sao Leopoldo, Brazil. Mothers and infants of a low-income-group population were randomized into intervention (n = 163) and received dietary counseling during 10 home…

  14. Behavioral Intervention Strategies for Employment Counseling

    ERIC Educational Resources Information Center

    Fuhriman, Addie; Pappas, James P.

    1971-01-01

    Unemployment is seen as unadaptive behavior, and its antecedent conditions are examined. Behavioral counseling tactics of goal setting, contingency management, counterconditioning procedures, and social systems intervention are considered in relation to the employment counselor's repertoire of potential helping responses. A hypothetical case is…

  15. Counseling Interventions for Adolescents and Young People in Penal Institutions

    ERIC Educational Resources Information Center

    Kiriakidis, Stavros

    2008-01-01

    The present study focuses on the counseling interventions for adolescents and young people held in custody. The study analyses the social effects of imprisonment, the incapacitation effects of custody, the need for delivering counseling in custody. In addition it reviews evidence regarding the effects of delivering counseling interventions in…

  16. Evaluating the Need for Counseling Intervention for Retained Elementary Students

    ERIC Educational Resources Information Center

    Landrum, Diedra

    2008-01-01

    Evaluating the Need for Counseling Intervention for Retained Elementary Students. Landrum, Diedra, 2007: Applied Dissertation, Nova Southeastern University, Fischler School of Education and Human Services. Elementary School Counseling/School Counseling/Grade Repetition/Counselor Teacher Cooperation/Parent School Relationship. This applied…

  17. Cognitive Counselling Intervention: Treatment Effectiveness in an Italian University Centre

    ERIC Educational Resources Information Center

    Strepparava, Maria Grazia; Bani, Marco; Zorzi, Federico; Corrias, Deborah; Dolce, Rossella; Rezzonico, Giorgio

    2016-01-01

    Offering counselling to students is increasingly considered as a key academic service. However, the reduction of resources allocated to Italian universities emphasises the need to assess the quality of interventions. This paper presents data reporting the effectiveness of a university counselling service. A sample of 45 undergraduate students…

  18. A Low-Intensity Mobile Health Intervention With and Without Health Counseling for Persons With Type 2 Diabetes, Part 1: Baseline and Short-Term Results From a Randomized Controlled Trial in the Norwegian Part of RENEWING HEALTH

    PubMed Central

    Jenum, Anne Karen; Småstuen, Milada Cvancarova; Årsand, Eirik; Holmen, Heidi; Wahl, Astrid Klopstad; Ribu, Lis

    2014-01-01

    Background Self-management support for people with type 2 diabetes is essential in diabetes care. Thus, mobile health technology with or without low-intensity theory-based health counseling could become an important tool for promoting self-management. Objectives The aim was to evaluate whether the introduction of technology-supported self-management using the Few Touch Application (FTA) diabetes diary with or without health counseling improved glycated hemoglobin (HbA1c) levels, self-management, behavioral change, and health-related quality of life, and to describe the sociodemographic, clinical, and lifestyle characteristics of the participants after 4 months. Methods A 3-armed randomized controlled trial was conducted in Norway during 2011-2013. In the 2 intervention groups, participants were given a mobile phone for 1 year, which provided access to the FTA diary, a self-help tool that recorded 5 elements: blood glucose, food habits, physical activity, personal goal setting, and a look-up system for diabetes information. One of the intervention groups was also offered theory-based health counseling with a specialist diabetes nurse by telephone for 4 months from baseline. Both intervention groups and the control group were provided usual care according to the national guidelines. Adults with type 2 diabetes and HbA1c ≥7.1% were included (N=151). There were 3 assessment points: baseline, 4 months, and 1 year. We report the short-term findings after 4 months. HbA1c was the primary outcome and the secondary outcomes were self-management (Health Education Impact Questionnaire, heiQ), behavioral change (diet and physical activity), and health-related quality of life (SF-36 questionnaire). The data were analyzed using univariate methods (ANOVA), multivariate linear, and logistic regression. Results Data were analyzed from 124 individuals (attrition rate was 18%). The groups were well balanced at baseline. There were no differences in HbA1c between groups after 4

  19. Evaluation of a primary care-oriented brief counselling intervention for obesity with and without orlistat

    Technology Transfer Automated Retrieval System (TEKTRAN)

    There is a significant need for an obesity treatment model suitable for the primary care environment. We examined the effectiveness of a brief counseling intervention alone, in combination with orlistat, and drug-alone in a 12-month randomized-clinical trial at a medical school obesity center. Parti...

  20. Interventions and Strategies in Counseling and Psychotherapy.

    ERIC Educational Resources Information Center

    Watts, Richard E., Ed.; Carlson, Jon, Ed.

    This book acknowledges the contributions of Alfred Adler and illustrates the many ways in which Adlerian ideas underpin and influence contemporary therapeutic approaches. It brings together today's leading thinkers to address the practice of counseling and psychotherapy from a social-cognitive perspective. Contributors apply the basic ideas of…

  1. A Systematic Review of Randomized Controlled Trials to Assess Outcomes of Genetic Counseling.

    PubMed

    Athens, Barbara A; Caldwell, Samantha L; Umstead, Kendall L; Connors, Philip D; Brenna, Ethan; Biesecker, Barbara B

    2017-03-02

    With the advancements in precision medicine and health care reform, it is critical that genetic counseling practice respond to emerging evidence to maximize client benefit. The objective of this review was to synthesize evidence on outcomes from randomized controlled trials (RCTs) of genetic counseling to inform clinical practice. Seven databases were searched in conducting this review. Studies were selected for inclusion if they were: (a) RCTs published from 1990 to 2015, and (b) assessed a direct outcome of genetic counseling. Extracted data included study population, aims, and outcomes. Risk of bias was evaluated using the Cochrane Handbook for Systematic Reviews of Interventions guidelines. A review of 1654 abstracts identified 58 publications of 54 unique RCTs that met inclusion criteria, the vast majority of which were conducted in cancer genetic counseling setting. Twenty-seven publications assessed 'enhancements' to genetic counseling, and 31 publications compared delivery modes. The methodological rigor varied considerably, highlighting the need for attention to quality criteria in RCT design. While most studies assessed several client outcomes hypothesized to be affected by genetic counseling (e.g., psychological wellbeing, knowledge, perceived risk, patient satisfaction), disparate validated and reliable scales and other assessments were often used to evaluate the same outcome(s). This limits opportunity to compare findings across studies. While RCTs of genetic counseling demonstrate enhanced client outcomes in a number of studies and pave the way to evidence-based practice, the heterogeneity of the research questions suggest an important need for more complementary studies with consistent outcome assessments.

  2. Assessment of pharmacist-led patient counseling in randomized controlled trials: a systematic review.

    PubMed

    Okumura, Lucas Miyake; Rotta, Inajara; Correr, Cassyano Januário

    2014-10-01

    Background Pharmacists' counseling has improved health-related outcomes in many acute and chronic conditions. Several studies have shown how pharmacists have been contributing to reduce morbidity and mortality related to drug-therapy (MMRDT). However, there still is a lack of reviews that assemble evidence-based clinical pharmacists' counseling. Equally, there is also a need to understand structure characteristics, processes and technical contents of these clinical services. Aim of the review To review the structure, processes and technical contents of pharmacist counseling or education reported in randomized controlled trials (RCT) that had positive health-related outcomes. Methods We performed a systematic search in specialized databases to identify RCT published between 1990 and 2013 that have evaluated pharmacists' counseling or educational interventions to patients. Methodological quality of the trials was assessed using the Jadad scale. Pharmacists' interventions with positive clinical outcomes (p < 0.05) were evaluated according to patients' characteristics, setting and timing of intervention, reported written and verbal counseling. Results 753 studies were found and 101 RCT matched inclusion criteria. Most of the included RCTs showed a Jadad score between two (37 studies) and three (32 studies). Pharmacists were more likely to provide counseling at ambulatories (60 %) and hospital discharge (25 %); on the other hand pharmacists intervention were less likely to happen when dispensing a medication. Teaching back and explanations about the drug therapy purposes and precautions related to its use were often reported in RCT, whereas few studies used reminder charts, diaries, group or electronic counseling. Most of studies reported the provision of a printed material (letter, leaflet or medication record card), regarding accessible contents and cultural-concerned informations about drug therapy and disease. Conclusion Pharmacist counseling is an intervention

  3. Sexual counselling for patients with cardiovascular disease: protocol for a pilot study of the CHARMS sexual counselling intervention

    PubMed Central

    Mc Sharry, Jenny; Casey, Dympna; Doherty, Sally; Gillespie, Paddy; Jaarsma, Tiny; Murphy, Andrew W; Newell, John; O'Donnell, Martin; Steinke, Elaine E; Toomey, Elaine; Byrne, Molly

    2016-01-01

    Introduction Sexual problems are common with cardiovascular disease, and can negatively impact quality of life. To address sexual problems, guidelines have identified the importance of sexual counselling during cardiac rehabilitation, yet this is rarely provided. The Cardiac Health and Relationship Management and Sexuality (CHARMS) intervention aims to improve the provision of sexual counselling in cardiac rehabilitation in Ireland. Methods and analysis This is a multicentre pilot study for the CHARMS intervention, a complex, multilevel intervention delivered within hospital-based cardiac rehabilitation programmes. The intervention includes (1) training in sexual counselling for staff, (2) a staff-led patient education and support intervention embedded within the cardiac rehabilitation programme, (3) a patient information booklet and (4) an awareness raising poster. The intervention will be delivered in two randomly selected cardiac rehabilitation centres. In each centre 30 patients will be recruited, and partners will also be invited to participate. Data will be collected from staff and patients/partners at T1 (study entry), T2 (3-month follow-up) and T3 (6-month follow-up). The primary outcome for patients/partners will be scores on the Sexual Self-Perception and Adjustment Questionnaire. Secondary outcomes for patients/partners will include relationship satisfaction; satisfaction with and barriers to sexual counselling in services; sexual activity, functioning and knowledge; physical and psychological well-being. Secondary outcomes for staff will include sexuality-related practice; barriers to sexual counselling; self-ratings of capability, opportunity and motivation; sexual attitudes and beliefs; knowledge of cardiovascular disease and sex. Fidelity of intervention delivery will be assessed using trainer self-reports, researcher-coded audio recordings and exit interviews. Longitudinal feasibility data will be gathered from patients/partners and staff via

  4. The Nature of Prejudice Revisited: Implications for Counseling Intervention.

    ERIC Educational Resources Information Center

    Ponterotto, Joseph G.

    1991-01-01

    Presents perspective on prejudice and counseling's role in prejudice prevention. Documents increasing race-based intergroup conflict; explaining conflict vis-a-vis racial identity theory, rapidly changing demographics, and Flight or Fight Response Theory of Racial Stress. Presents developmentally based interventions across elementary, high school,…

  5. Two Counseling Interventions to Reduce Teacher-Child Relationship Stress

    ERIC Educational Resources Information Center

    Ray, Dee C.

    2007-01-01

    This article discusses a study investigating the impact of two school counseling interventions, child-centered play therapy (CCPT) and teacher consultation, on teacher-child relationship stress. CCPT and teacher consultation were conducted with 93 (pre-kindergarten to fifth grade) elementary school students across three elementary schools deemed…

  6. A Developmentally Based Counseling Intervention Model for Managing Career Transitions.

    ERIC Educational Resources Information Center

    Daniels, Judy

    The counselor's role as an organizational change agent can be a catalytic force aimed at helping to create workplace wellness through psychological management of the change process. The Lewis and Lewis (1989) community counseling model provides helping professionals with guidelines to design comprehensive intervention strategies for assisting…

  7. Bring out the Brilliance: A Counseling Intervention for Underachieving Students

    ERIC Educational Resources Information Center

    Berger, Carolyn

    2014-01-01

    This study evaluated the impact of a small group counseling intervention designed for students who underachieve. The results of the study demonstrated significant improvement for ninth- and tenth-grade underachieving students in the areas of organizational skills, time management, and motivation. The author discusses implications and…

  8. Creative Counseling Interventions for Grieving Adolescents

    ERIC Educational Resources Information Center

    Slyter, Marty

    2012-01-01

    This article provides information on adolescent developmental issues and developmentally appropriate interventions that can help mental health practitioners work with adolescents grieving a death loss. Specific areas that are initially covered include core adolescent developmental issues that must be understood, including adolescent developmental…

  9. Patients' attitudes towards the role of dentists in tobacco cessation counselling after a brief and simple intervention.

    PubMed

    Ahmady, A Ebn; Homayoun, A; Lando, H A; Haghpanah, F; Khoshnevisan, M H

    2014-03-13

    Dental professionals are in a unique position to promote smoking cessation among their patients. We evaluated the effects of a brief counselling intervention by a dentist on patients' attitude towards the role of dentists in tobacco cessation programmes. In a semi-experimental study in Tehran, Islamic Republic of Iran, 70 eligible smokers were selected and randomly assigned to intervention and control groups. The initial attitudes of the patients regarding tobacco cessation counselling services provided by the dentist were determined using a validated questionnaire. The intervention group received a brief chair-side counselling by a dentist based on the 5 A's approach, while no intervention was provided for the control group. At 8-weeks follow-up, smokers receiving the intervention showed significantly more positive attitudes towards the role of the dentist in advising patients to quit smoking compared with those in the control group. More responsibility could be transferred to dentists for tobacco prevention.

  10. Facilitating Self-Management of Substance Use Disorders with Online Counseling: The Intervention and Study Design

    PubMed Central

    Haack, Mary R.; Alemi, Farrokh; Nemes, Susanna; Harge, Angela; Burda-Cohee, Charon; Benson, Laura

    2008-01-01

    This paper describes a pilot study using online counseling for court-involved parents who have been charged with child abuse and neglect related to substance use. All families resided in the medically underserved area of Newark, New Jersey and were recruited from halfway houses and the Family Court. The sample consisted of 30 participants randomly assigned to control (n=15) and experimental (n=15) groups. Of the participants, 83% were Black, 13% were White, and 3% were Hispanic. The control group had access to usual face-to-face treatment at a local treatment center where typical court-ordered offenders were referred. Usual face-to-face treatment often involved being wait-listed for periods of months even for a detox bed. The experimental group had immediate access to the online counseling intervention. The online counseling software and the live counseling components of the intervention were developed with a stages of change theoretical framework. Preliminary findings show promise for the feasibility of online interventions for underserved populations. PMID:22187519

  11. Randomized Trial of a Brief Dietary Intervention To Decrease Consumption of Fat and Increase Consumption of Fruits and Vegetables.

    ERIC Educational Resources Information Center

    Stevens, Victor J.; Glasgow, Russell E.; Toobert, Deborah J.; Karanja, Njeri; Smith, K. Sabina

    2002-01-01

    Tested the efficacy of a computer-assisted counseling intervention to reduce diet-related cancer risk. Healthy female HMO members were randomly assigned to nutrition counseling or attention-control interventions. Women completed dietary recalls and eating behavior questionnaires. Four-month follow-up results indicated that this moderate-intensity…

  12. Text Message Delivered Peer Network Counseling for Adolescent Smokers: A Randomized Controlled Trial.

    PubMed

    Mason, Michael; Mennis, Jeremy; Way, Thomas; Zaharakis, Nikola; Campbell, Leah Floyd; Benotsch, Eric G; Keyser-Marcus, Lori; King, Laura

    2016-10-01

    Although adolescent tobacco use has declined in the last 10 years, African American high school seniors' past 30-day use has increased by 12 %, and as they age they are more likely to report lifetime use of tobacco. Very few urban youth are enrolled in evidenced-based smoking prevention and cessation programming. Therefore, we tested a text messaging smoking cessation intervention designed to engage urban youth through an automated texting program utilizing motivational interviewing-based peer network counseling. We recruited 200 adolescents (90.5 % African American) into a randomized controlled trial that delivered either the experimental intervention of 30 personalized motivational interviewing-based peer network counseling messages, or the attention control intervention, consisting of text messages covering general (non-smoking related) health habits. All adolescents were provided smart phones for the study and were assessed at baseline, and at 1, 3, and 6 months post intervention. Utilizing repeated measures general linear models we examined the effects of the intervention while controlling for race, gender, age, presence of a smoker in the home, and mental health counseling. At 6 months, participants in the experimental condition significantly decreased the number of days they smoked cigarettes and the number of cigarettes they smoked per day; they significantly increased their intentions not to smoke in the future; and significantly increased peer social support among girls. For boys, participants in the experimental condition significantly reduced the number of close friends in their networks who smoke daily compared to those in the control condition. Effect sizes ranged from small to large. These results provide encouraging evidence of the efficacy of text messaging interventions to reduce smoking among adolescents and our intervention holds promise as a large-scale public health preventive intervention platform.

  13. Work-site cardiovascular risk reduction: a randomized trial of health risk assessment, education, counseling, and incentives.

    PubMed Central

    Gomel, M; Oldenburg, B; Simpson, J M; Owen, N

    1993-01-01

    OBJECTIVES. This study reports an efficacy trial of four work-site health promotion programs. It was predicted that strategies making use of behavioral counseling would produce a greater reduction in cardiovascular disease risk factors than screening and educational strategies. METHODS. Twenty-eight work sites were randomly allocated to a health risk assessment, risk factor education, behavioral counseling, or behavioral counseling plus incentives intervention. Participants were assessed before the intervention and at 3, 6, and 12 months. RESULTS. Compared with the average of the health risk assessment and risk factor education conditions, there were significantly higher validated continuous smoking cessation rates and smaller increases in body mass index and estimated percentage of body fat in the two behavioral counseling conditions. The behavioral counseling condition was associated with a greater reduction in mean blood pressure than was the behavioral counseling plus incentives condition. On average among all groups, there was a short-term increase in aerobic capacity followed by a return to baseline levels. CONCLUSIONS. Work-site interventions that use behavioral approaches can produce lasting changes in some cardiovascular risk factors and, if implemented routinely, can have a significant public health impact. PMID:8362997

  14. Peer Network Counseling with Urban Adolescents: A Randomized Controlled Trial with Moderate Substance Users.

    PubMed

    Mason, Michael; Light, John; Campbell, Leah; Keyser-Marcus, Lori; Crewe, Stephanie; Way, Thomas; Saunders, Heather; King, Laura; Zaharakis, Nikola M; McHenry, Chantal

    2015-11-01

    Close peer networks can affect adolescents' health behaviors by altering their social environments, and thus their risk for and protection against substance use involvement. We tested a 20 minute intervention named Peer Network Counseling that integrates motivational interviewing and peer network strategies with 119 urban adolescents who reported occasional or problem substance use. Adolescents presenting at primary care clinic were randomized to intervention or control conditions and followed for 6 months. Mixed-effect latent growth models were used to evaluate intervention effects on trajectories of alcohol and marijuana use, offers to use substances, and moderation models to test for interactions between intervention condition and peer network characteristics. A significant intervention effect was found for boys for offers to use alcohol from friends (p<.05), along with a trend significant effect for alcohol use (p<.08). Intervention was more effective in reducing marijuana use, vs. control, for participants with more peer social support (p<.001) and with more peer encouragement for prosocial behavior (school, clubs, sports, religious activities); however, intervention did not affect these network characteristics. Results provide support to continue this line of research to test brief interventions that activate protective peer network characteristics among at-risk adolescents, while also raising some interesting gender-based intervention questions for future research.

  15. The effect of adding group-based counselling to individual lifestyle counselling on changes in dietary intake. The Inter99 study – a randomized controlled trial

    PubMed Central

    Toft, Ulla; Kristoffersen, Lis; Ladelund, Steen; Ovesen, Lars; Lau, Cathrine; Pisinger, Charlotta; Smith, Lisa von Huth; Borch-Johnsen, Knut; Jørgensen, Torben

    2008-01-01

    Background Few studies have investigated the specific effect of single intervention components in randomized controlled trials. The purpose was to investigate the effect of adding group-based diet and exercise counselling to individual life-style counselling on long-term changes in dietary habits. Methods The study was a randomized controlled intervention study. From a general Danish population, aged 30 to 60 years (n = 61,301), two random sample were drawn (group A, n = 11,708; group B, n = 1,308). Subjects were invited for a health screening program. Participation rate was 52.5%. All participants received individual life-style counselling. Individuals at high risk of ischemic heart disease in group A were furthermore offered group-based life-style counselling. The intervention was repeated for high-risk individuals after one and three years. At five-year follow-up all participants were invited for a health examination. High risk individuals were included in this study (n = 2 356) and changes in dietary intake were analyzed using multilevel linear regression analyses. Results At one-year follow-up group A had significantly increased the unsaturated/saturated fat ratio compared to group B and in men a significantly greater decrease in saturated fat intake was found in group A compared to group B (net change: -1.13 E%; P = 0.003). No differences were found between group A and B at three-year follow-up. At five-year follow-up group A had significantly increased the unsaturated/saturated fat ratio (net change: 0.09; P = 0.01) and the fish intake compared to group B (net change: 5.4 g/day; P = 0.05). Further, in men a non-significant tendency of a greater decrease was found at five year follow-up in group A compared to group B (net change: -0.68 E%; P = 0.10). The intake of fibre and vegetables increased in both groups, however, no significant difference was found between the groups. No differences between groups were found for saturated fat intake in women. Conclusion

  16. Effects of a Controlled Family-Based Health Education/Counseling Intervention

    ERIC Educational Resources Information Center

    Salminen, Marika; Vahlberg, Tero; Ojanlatva, Ansa; Kivela, Sirkka-Liisa

    2005-01-01

    Objective: To describe the effects of a controlled family-based health education/counseling intervention on health behaviors of children with a familial history of cardiovascular diseases (FH-CVDs). Methods: The intervention group (IG, n=432) received 5 counseling sessions. The control groups 1 (CG1, n=200) and 2 (CG2, n=423) received no…

  17. A randomized controlled trial examining the efficacy of motivational counseling with observed therapy for antiretroviral therapy adherence.

    PubMed

    Goggin, Kathy; Gerkovich, Mary M; Williams, Karen B; Banderas, Julie W; Catley, Delwyn; Berkley-Patton, Jannette; Wagner, Glenn J; Stanford, James; Neville, Sally; Kumar, Vinutha K; Bamberger, David M; Clough, Lisa A

    2013-07-01

    This study determined whether motivational interviewing-based cognitive behavioral therapy (MI-CBT) adherence counseling combined with modified directly observed therapy (MI-CBT/mDOT) is more effective than MI-CBT counseling alone or standard care (SC) in increasing adherence over time. A three-armed randomized controlled 48-week trial with continuous electronic drug monitored adherence was conducted by randomly assigning 204 HIV-positive participants to either 10 sessions of MI-CBT counseling with mDOT for 24 weeks, 10 sessions of MI-CBT counseling alone, or SC. Poisson mixed effects regression models revealed significant interaction effects of intervention over time on non-adherence defined as percent of doses not-taken (IRR = 1.011, CI = 1.000-1.018) and percent of doses not-taken on time (IRR = 1.006, CI = 1.001-1.011) in the 30 days preceding each assessment. There were no significant differences between groups, but trends were observed for the MI-CBT/mDOT group to have greater 12 week on-time and worse 48 week adherence than the SC group. Findings of modest to null impact on adherence despite intensive interventions highlights the need for more effective interventions to maintain high adherence over time.

  18. [Multidimensional counseling and intervention in anxiety problems in school].

    PubMed

    Jeck, Stephan

    2003-01-01

    Multidimensional counselling and intervention in case of anxiety problems in school can be understood as a challenge for educational psychologists who has to solve individual anxiety disorders on the one hand and participate in processes of school development in order to prevent anxiety on the other hand. There are a lot of techniques and strategies to construct classroom settings which reduce anxiety. Improving self-efficacy and training stress management for teachers and students are possible programs presented in order to change the culture of educational organizations like schools. To realize such programs all members of the school community have to cooperate and teachers have to modify their instructional actions. Therefore they have to develop better diagnostic skills in order to detect anxious and inconspicuous students who need special fostering for better learning in school. For extreme anxiety disorders with school refusal there are many therapeutic treatments out of school, one of the best for children and adolescents are cognitive-behavioral settings.

  19. Hope-Focused Interventions in Substance Abuse Counselling

    ERIC Educational Resources Information Center

    Koehn, Corinne; O'Neill, Linda; Sherry, John

    2012-01-01

    Hope is a vital component of psychological healing and plays a critical role in counselling. With despair so prominent for individuals with serious substance abuse problems, the question arises as to how to foster hope in such clients. There are recent suggestions in the general counselling literature that some of the work in counselling involve…

  20. Advancing Career Counseling and Employment Support for Survivors: An Intervention Evaluation

    ERIC Educational Resources Information Center

    Davidson, M. Meghan; Nitzel, Camie; Duke, Alysondra; Baker, Cynthia M.; Bovaird, James A.

    2012-01-01

    The purpose of this research was to conduct a replication-based and extension study examining the effectiveness of a 5-week career group counseling intervention, Advancing Career Counseling and Employment Support for Survivors (ACCESS; Chronister, 2008). The present study was conducted in a markedly different geographic region within a larger…

  1. Improved Prevention Counseling by HIV Care Providers in a Multisite, Clinic-Based Intervention: Positive STEPs

    ERIC Educational Resources Information Center

    Thrun, Mark; Cook, Paul F.; Bradley-Springer, Lucy A.; Gardner, Lytt; Marks, Gary; Wright, Julie; Wilson, Tracey E.; Quinlivan, E. Byrd; O'Daniels, Christine; Raffanti, Stephen; Thompson, Melanie; Golin, Carol

    2009-01-01

    The Centers for Disease Control and Prevention have recommended that HIV care clinics incorporate prevention into clinical practice. This report summarizes HIV care providers' attitudes and counseling practices before and after they received training to deliver a counseling intervention to patients. Providers at seven HIV clinics received training…

  2. Using the Solving Problems Together Psychoeducational Group Counseling Model as an Intervention for Negative Peer Pressure

    ERIC Educational Resources Information Center

    Hall, Kimberly R.; Rushing, Jeri Lynn; Khurshid, Ayesha

    2011-01-01

    Problem-focused interventions are considered to be one of the most effective group counseling strategies with adolescents. This article describes a problem-focused group counseling model, Solving Problems Together (SPT), that focuses on working with students who struggle with negative peer pressure. Adapted from the teaching philosophy of…

  3. Telephone-based continuing care counseling in substance abuse treatment: economic analysis of a randomized trial

    PubMed Central

    Daley, Marilyn C.; Neuman, Matthew J.; Blaakman, Aaron P.; McKay, James R.

    2016-01-01

    Purpose To investigate whether telephone-based continuing care (TEL) is a promising alternative to traditional face-to-face counseling for clients in treatment for substance abuse. Methods Patients with alcohol and/or cocaine dependence who had completed a 4-week intensive outpatient program were randomly assigned through urn randomization into one of three 12-week interventions: standard continuing care (STD), in-person relapse prevention (RP), or telephone-based continuing care (TEL). This study performed cost, cost-effectiveness, and cost-benefit analyses of TEL and RP compared to STD, using results from the randomized clinical trial with two years of follow up (359 participants). In addition, the study examined the potential moderating effect of baseline patient costs on economic outcomes. Results The study found that TEL was less expensive per client from the societal perspective ($569) than STD ($870) or RP ($1,684). TEL also was also significantly more effective, with an abstinence rate of 57.1% compared to 46.7% for STD (p<0.05). Thus TEL dominated STD, with a highly favorable negative incremental cost-effectiveness ratio (−$1,400 per abstinent year). TEL also proved favorable under a benefit-cost perspective. Conclusions TEL proved to be a cost-effective and cost-beneficial contributor to long-term recovery over two years. Because TEL dominated STD care interventions, wider adoption should be considered. PMID:26718395

  4. A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

    PubMed Central

    2011-01-01

    Background Many newly screened people living with HIV (PLHIV) in Sub-Saharan Africa do not understand the importance of regular pre-antiretroviral (ARV) care because most of them have been counseled by staff who lack basic counseling skills. This results in low uptake of pre-ARV care and late treatment initiation in resource-poor settings. The effect of providing post-test counseling by staff equipped with basic counseling skills, combined with home visits by community support agents on uptake of pre-ARV care for newly diagnosed PLHIV was evaluated through a randomized intervention trial in Uganda. Methods An intervention trial was performed consisting of post-test counseling by trained counselors, combined with monthly home visits by community support agents for continued counseling to newly screened PLHIV in Iganga district, Uganda between July 2009 and June 2010, Participants (N = 400) from three public recruitment centres were randomized to receive either the intervention, or the standard care (the existing post-test counseling by ARV clinic staff who lack basic training in counseling skills), the control arm. The outcome measure was the proportion of newly screened and counseled PLHIV in either arm who had been to their nearest health center for clinical check-up in the subsequent three months +2 months. Treatment was randomly assigned using computer-generated random numbers. The statistical significance of differences between the two study arms was assessed using chi-square and t-tests for categorical and quantitative data respectively. Risk ratios and 95% confidence intervals were used to assess the effect of the intervention. Results Participants in the intervention arm were 80% more likely to accept (take up) pre-ARV care compared to those in the control arm (RR 1.8, 95% CI 1.4-2.1). No adverse events were reported. Conclusions Provision of post-test counseling by staff trained in basic counseling skills, combined with home visits by community support

  5. Coping and Communication-Enhancing Intervention versus Supportive Counseling for Women Diagnosed with Gynecological Cancers

    ERIC Educational Resources Information Center

    Manne, Sharon L.; Rubin, Stephen; Edelson, Mitchell; Rosenblum, Norman; Bergman, Cynthia; Hernandez, Enrique; Carlson, John; Rocereto, Thomas; Winkel, Gary

    2007-01-01

    This study compared the efficacy of 2 psychological interventions, a coping and communication-enhancing intervention (CCI) and supportive counseling (SC), in reducing depressive symptoms and cancer-specific distress of women diagnosed with gynecological cancer. Demographic, medical, and psychological moderators of intervention effects were…

  6. Emerging Approaches to Counseling Intervention: Theory, Research, Practice, and Training

    ERIC Educational Resources Information Center

    Murdock, Nancy L.; Duan, Changming; Nilsson, Johanna E.

    2012-01-01

    This article provides an overview of the major contribution that presents three emerging approaches to counseling: narrative therapy, dialectical behavior therapy, and acceptance and commitment therapy. The three theoretical systems were chosen because they are current, for the most part not addressed in the mainstream counseling psychology…

  7. Reducing cultural and psychological barriers to Latino enrollment in HIV-prevention counseling: initial data on an enrollment meta-intervention.

    PubMed

    Wilson, Kristina; Durantini, Marta R; Albarracín, Julia; Crause, Candi; Albarracín, Dolores

    2013-01-01

    Aspects of Latino culture (e.g., machismo, marianism) can act as barriers to enrollment in HIV-prevention programs. To lift these barriers, a culturally appropriate meta-intervention was designed to increase intentions to enroll in HIV-prevention counseling by Latinos. Latino participants (N=41) were recruited from the community and randomly assigned to either an experimental or control meta-intervention condition that varied the introduction to a HIV-prevention counseling program. Following the meta-intervention, participants were issued an invitation to take part in HIV-prevention counseling. The outcome measure was the intention to enroll in a HIV-prevention counseling session. Findings indicated that enrollment intentions were higher in the experimental meta-intervention condition (96%) than in the control meta-intervention condition (53%). In addition, the effects of the meta-intervention were comparable across genders and participant ages. Findings suggest that the use of a culturally appropriate meta-intervention may be an effective strategy for increasing Latino enrollment in HIV-prevention programs. These promising findings warrant further investigation into the efficacy and effectiveness of this meta-intervention.

  8. Reducing cultural and psychological barriers to Latino enrollment in HIV-prevention counseling: Initial data on an enrollment meta-intervention

    PubMed Central

    Wilson, Kristina; Durantini, Marta R.; Albarracín, Julia; Crause, Candi; Albarracín, Dolores

    2013-01-01

    Aspects of Latino culture (e.g., machismo, marianism) can act as barriers to enrollment in HIV-prevention programs. To lift these barriers, a culturally appropriate meta-intervention was designed to increase intentions to enroll in HIV-prevention counseling by Latinos. Latino participants (N = 41) were recruited from the community and randomly assigned to either an experimental or control meta-intervention condition that varied the introduction to a HIV-prevention counseling program. Following the meta-intervention, participants were issued an invitation to take part in HIV-prevention counseling. The outcome measure was the intention to enroll in a HIV-prevention counseling session. Findings indicated that enrollment intentions were higher in the experimental meta-intervention condition (96%) than in the control meta-intervention condition (53%). In addition, the effects of the meta-intervention were comparable across genders and participant ages. Findings suggest that the use of a culturally appropriate meta-intervention may be an effective strategy for increasing Latino enrollment in HIV-prevention programs. These promising findings warrant further investigation into the efficacy and effectiveness of this meta-intervention. PMID:23398305

  9. Interventions to improve patient access to and utilisation of genetic and genomic counselling services

    PubMed Central

    Benjamin, Caroline M; Thomas, Lois H; Skirton, Heather; Gustafson, Shanna; Coupe, Jacqueline; Patch, Christine; Belk, Rachel; Tishkovskaya, Svetlana; Calzone, Kathleen; Payne, Katherine

    2015-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows: Primary objective The primary objective is to assess the effectiveness of interventions to improve patient identification, access to and utilisation of genetic and genomic counselling services when compared to: No intervention; Usual or current practice; and Other active intervention. Secondary objective The secondary objective is to explore the resource use and costs associated with interventions aimed at improving patient identification, access to and utilisation of genetic and genomic counselling services from studies meeting the eligibility criteria. We will report on factors that may explain variation in the effectiveness of interventions aimed at improving patient identification, access to and utilisation of genetic and genomic counselling services from studies meeting the eligibility criteria. Another secondary objective is to explore how interventions which target improved patient identification, access to and utilisation of genetic and genomic counselling services affect the subsequent appropriate use of health services for the prevention or early detection of disease. It is also possible that the genetic counselling interaction itself will contribute to the possible use of preventative services. PMID:26989348

  10. Therapists' Use of Religious and Spiritual Interventions in Christian Counseling: A Preliminary Report

    ERIC Educational Resources Information Center

    Walker, Donald F.; Gorsuch, Richard L.; Tan, Siang-Yang

    2005-01-01

    The most frequently identified factor associated with the use of religious and spiritual interventions in counseling has been therapists' personal religious attitudes or behaviors. Church attendance and personal religious behaviors, in particular, have been found to correlate with therapists' use of religious and spiritual interventions in…

  11. Increasing the Screening and Counseling of Adolescents for Risky Health Behaviors: A Primary Care Intervention

    ERIC Educational Resources Information Center

    Ozer, Elizabeth M.; Adams, Sally H.; Lustig, Julie L.; Gee, Scott; Garber, Andrea K.; Gardner, Linda Rieder; Rehbein, Michael; Addison, Louise; Irwin, Charles E., Jr.

    2005-01-01

    Objective: To determine whether a systems intervention for primary care providers resulted in increased preventive screening and counseling of adolescent patients, compared with the usual standard of care. Methods: The intervention was conducted in 2 out-patient pediatric clinics; 2 other pediatric clinics in the same health maintenance…

  12. Effects of Ambulant Myofeedback Training and Ergonomic Counselling in Female Computer Workers with Work-Related Neck-Shoulder Complaints: A Randomized Controlled Trial

    PubMed Central

    Sandsjö, Leif; Vollenbroek-Hutten, Miriam M. R.; Larsman, Pernilla; Kadefors, Roland; Hermens, Hermie J.

    2007-01-01

    Objective: To investigate the effects of ambulant myofeedback training including ergonomic counselling (Mfb) and ergonomic counselling alone (EC), on work-related neck-shoulder pain and disability. Methods: Seventy-nine female computer workers reporting neck-shoulder complaints were randomly assigned to Mfb or EC and received four weeks of intervention. Pain intensity in neck, shoulders, and upper back, and pain disability, were measured at baseline, immediately after intervention, and at three and six months follow-up. Results: Pain intensity and disability had significantly decreased immediately after four weeks Mfb or EC, and the effects remained at follow up. No differences were observed between the Mfb and EC group for outcome and subjects in both intervention groups showed comparable chances for improvement in pain intensity and disability. Conclusions: Pain intensity and disability significantly reduced after both interventions and this effect remained at follow-up. No differences were observed between the two intervention groups. PMID:17260162

  13. Group Counseling with Traumatized East African Refugee Women in the United States: Using the "Kaffa" Ceremony Intervention

    ERIC Educational Resources Information Center

    Loewy, Michael I.; Williams, DiAnna Toliver; Keleta, Aster

    2002-01-01

    The Kaffa ceremony is a unique, culturally appropriate, group counseling intervention for female East African refugees. A counseling group is described in which the Kaffa ceremony was instrumental in helping to bridge the gap between Western counseling and East African culture, providing a context for the group members to resolve long-held trauma.…

  14. Couple-based HIV counseling and testing: a risk reduction intervention for U.S. drug-involved women and their primary male partners

    PubMed Central

    Pouget, Enrique R.; Tortu, Stephanie; Volpe, Ellen M.; Torres, Leilani; Rodriguez, William

    2014-01-01

    To help reduce the elevated risk of acquiring HIV for African American and Latina women drug users in primary heterosexual relationships, we developed a brief couple-based HIV counseling and testing prevention intervention. The intervention was based on an integrated HIV risk behavior theory that incorporated elements of social exchange theory, the theory of gender and power, the stages-of-change model, and the information-motivation-behavior skills model. In this article we describe the development, content and format of the couple-based HIV testing and counseling intervention, and its delivery to 110 couples (220 individuals) in a randomized effectiveness trial, the Harlem River Couples Project, conducted in New York City from 2005 to 2007. Components of the couple-based intervention included a personalized dyadic action plan based on the couple’s risk profile, and interactive exercises designed to help build interpersonal communication skills, and facilitated discussion of social norms regarding gender roles. The couple-based HIV testing and counseling intervention significantly reduced women’s overall HIV risk compared to a standard-of-care individual HIV testing and counseling intervention. Experiences and perceptions of the intervention were positive among both clients and interventionists. The study was the first to demonstrate the effectiveness and feasibility of delivering a brief couple-based HIV counseling and testing intervention to reduce risk among drug-using heterosexual couples in high HIV prevalent urban communities in the United States. The intervention can be expanded to include new HIV prevention strategies, such as pre-exposure prophylaxis. Further research is needed to evaluate cost-effectiveness and implementation of the intervention in clinical settings. PMID:25512179

  15. Family Counseling Interventions: Understanding Family Systems and the Referral Process.

    ERIC Educational Resources Information Center

    McWhirter, Ellen Hawley; And Others

    1993-01-01

    This article describes concepts underlying the idea of the "family as a system"; compares and contrasts four approaches to family therapy (those of Virginia Satir, Jay Haley, Murray Bowen, and Salvador Minuchin); and offers suggestions to teachers referring parents for family counseling. (DB)

  16. Counseling Supervision within a Feminist Framework: Guidelines for Intervention

    ERIC Educational Resources Information Center

    Degges-White, Suzanne E.; Colon, Bonnie R.; Borzumato-Gainey, Christine

    2013-01-01

    Feminist supervision is based on the principles of feminist theory. Goals include sharing responsibility for the supervision process, empowering the supervisee, attending to the contextual assumptions about clients, and analyzing gender roles. This article explores feminist supervision and guidelines for providing counseling supervision…

  17. Magic Arts Counseling: The Tricks of Illusion as Intervention

    ERIC Educational Resources Information Center

    Levin, David M.

    2006-01-01

    Magic arts counseling is defined as a nontraditional, experiential curriculum utilized for promoting student growth. Applicable research and the history of using magic with students provide the rationale for its employment in educational programming. In an effort to systematically explore its benefits several educational factors and key elements…

  18. Standards for the Reporting of Genetic Counseling Interventions in Research and Other Studies (GCIRS): an NSGC Task Force Report.

    PubMed

    Hooker, Gillian W; Babu, D; Myers, M F; Zierhut, H; McAllister, M

    2017-02-24

    As the demand for evidence to support the value of genetic counseling increases, it is critical that reporting of genetic counseling interventions in research and other types of studies (e.g. process improvement or service evaluation studies) adopt greater rigor. As in other areas of healthcare, the appraisal, synthesis, and translation of research findings into genetic counseling practice are likely to be improved if clear specifications of genetic counseling interventions are reported when studies involving genetic counseling are published. To help improve reporting practices, the National Society of Genetic Counselors (NSGC) convened a task force in 2015 to develop consensus standards for the reporting of genetic counseling interventions. Following review by the NSGC Board of Directors, the NSGC Practice Guidelines Committee and the editorial board of the Journal of Genetic Counseling, 23 items across 8 domains were proposed as standards for the reporting of genetic counseling interventions in the published literature (GCIRS: Genetic Counseling Intervention Reporting Standards). The authors recommend adoption of these standards by authors and journals when reporting studies involving genetic counseling interventions.

  19. Standard Compared With Mnemonic Counseling for Fecal Incontinence: A Randomized Controlled Trial

    PubMed Central

    Cichowski, Sara B; Dunivan, Gena C; Rogers, Rebecca G; Murrietta, Ambroshia M; Komesu, Yuko M

    2015-01-01

    Objective To estimate whether women who underwent mnemonic counseling had better recall of fecal incontinence therapies at 2 months and if mnemonic counseling resulted in greater satisfaction with physician counseling and improvement in quality of life when compared to a group who underwent standard counseling. Methods Counseling naive women with fecal incontinence were recruited from an academic Urogynecology clinic. Women underwent physical examinations, completed the Quality of the Physician-Patient Interaction, recorded fecal incontinence treatment options they recalled, and completed the Fecal Incontinence Severity Index and Manchester Health Questionnaire immediately after counseling and again at 2 months. Results Ninety women consented to participate, were randomized and completed baseline questionnaires. At baseline women did not differ in age, ethnicity, education, fecal incontinence severity index or Manchester Health Questionnaire scores. After counseling the mnemonic group reported higher satisfaction on Quality of the Physician-Patient Interaction (66.4± 6.5 vs 62.2 ± 10.7, p=0.03). Ninety percent (81/90) of women followed-up at 2 months. Our primary endpoint, two month recall of fecal incontinence treatments was not different between groups (2.3 ± 1.6 mnemonic counseling vs 1.8 ± 1.0 standard counseling; p=0.08). Secondary endpoints the mnemonic group reported greater improvement on total Manchester Health Questionnaire (p=0.02), emotional (p=0.03), sleep (0.045), role limitations (<0.01), and physical limitations (p=0.04) when compared to the standard group. Conclusions Fecal incontinence counseling with a mnemonic aid did not improve recall at 2 months but improved patient satisfaction and quality of life at 2 months. PMID:25932833

  20. Expanding Access to BRCA1/2 Genetic Counseling with Telephone Delivery: A Cluster Randomized Trial

    PubMed Central

    Butler, Karin M.; Schwartz, Marc D.; Mandelblatt, Jeanne S.; Boucher, Kenneth M.; Pappas, Lisa M.; Gammon, Amanda; Kohlmann, Wendy; Edwards, Sandra L.; Stroup, Antoinette M.; Buys, Saundra S.; Flores, Kristina G.; Campo, Rebecca A.

    2014-01-01

    Background The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling. Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic (rural areas) and structural (travel time, transportation, childcare) barriers to access. Methods This cluster-randomized clinical trial used population-based sampling of women at risk for BRCA1/2 mutations to compare telephone and in-person counseling for: 1) equivalency of testing uptake and 2) noninferiority of changes in psychosocial measures. Women 25 to 74 years of age with personal or family histories of breast or ovarian cancer and who were able to travel to one of 14 outreach clinics were invited to participate. Randomization was by family. Assessments were conducted at baseline one week after pretest and post-test counseling and at six months. Of the 988 women randomly assigned, 901 completed a follow-up assessment. Cluster bootstrap methods were used to estimate the 95% confidence interval (CI) for the difference between test uptake proportions, using a 10% equivalency margin. Differences in psychosocial outcomes for determining noninferiority were estimated using linear models together with one-sided 97.5% bootstrap CIs. Results Uptake of BRCA1/2 testing was lower following telephone (21.8%) than in-person counseling (31.8%, difference = 10.2%, 95% CI = 3.9% to 16.3%; after imputation of missing data: difference = 9.2%, 95% CI = -0.1% to 24.6%). Telephone counseling fulfilled the criteria for noninferiority to in-person counseling for all measures. Conclusions BRCA1/2 telephone counseling, although leading to lower testing uptake, appears to be safe and as effective as in-person counseling with regard to minimizing adverse psychological reactions, promoting informed decision making, and delivering patient-centered communication for both rural and urban women. PMID:25376862

  1. The effect of genetic counseling for adult offspring of patients with type 2 diabetes on attitudes toward diabetes and its heredity: a randomized controlled trial.

    PubMed

    Nishigaki, M; Tokunaga-Nakawatase, Y; Nishida, J; Kazuma, K

    2014-10-01

    The aim of this study is to investigate the effect of diabetes genetic counseling on attitudes toward diabetes and its heredity in relatives of type 2 diabetes patients. This study was an unmasked, randomized controlled trial at a medical check-up center in Japan. Subjects in this study are healthy adults between 30 and 60 years of age who have a family history of type 2 diabetes in their first degree relatives. Participants in the intervention group received a brief genetic counseling session for approximately 10 min. Genetic counseling was structured based on the Health Belief Model. Both intervention and control groups received a booklet for general diabetes prevention. Risk perception and recognition of diabetes, and attitude towards its prevention were measured at baseline, 1 week and 1 year after genetic counseling. Participants who received genetic counseling showed significantly higher recognition about their sense of control over diabetes onset than control group both at 1 week and 1 year after the session. On the other hand, anxiety about diabetes did not change significantly. The findings show that genetic counseling for diabetes at a medical check center helped adults with diabetes family history understand they are able to exert control over the onset of their disease through lifestyle modification.

  2. Mediators of a Coping and Communication-Enhancing Intervention and a Supportive Counseling Intervention among Women Diagnosed with Gynecological Cancers

    ERIC Educational Resources Information Center

    Manne, Sharon L.; Winkel, Gary; Rubin, Stephen; Edelson, Mitchell; Rosenblum, Norman; Bergman, Cynthia; Hernandez, Enrique; Carlson, John; Rocereto, Thomas

    2008-01-01

    The authors evaluated mechanisms of change for a coping and communication-enhancing intervention (CCI) and supportive counseling (SC). They proposed that the effects of CCI on depressive symptoms would be mediated by psychological processes targeted by CCI, namely increases in the following: positive reappraisal, acceptance, planful problem…

  3. “Computerized Counseling Reduces HIV-1 Viral Load and Sexual Transmission Risk: Findings from a Randomized Controlled Trial”

    PubMed Central

    KURTH, Ann E.; SPIELBERG, Freya; CLELAND, Charles M.; LAMBDIN, Barrot; BANGSBERG, David R.; FRICK, Pamela A.; SEVERYNEN, Anneleen O.; CLAUSEN, Marc; NORMAN, Robert G.; LOCKHART, David; SIMONI, Jane M.; HOLMES, King K.

    2014-01-01

    Objective Evaluate a computerized intervention supporting antiretroviral therapy (ART) adherence and HIV transmission prevention. Design Longitudinal RCT. Settings An academic HIV clinic and a community-based organization in Seattle. Subjects 240 HIV-positive adults on ART; 209 completed nine-month follow-up (87% retention). Intervention Randomization to computerized counseling or assessment-only, 4 sessions over 9 months. Main Outcome Measures HIV-1 viral suppression, and self-reported ART adherence, and transmission risks, compared using generalized estimating equations. Results Overall, intervention participants had reduced viral load (VL): mean 0.17 log10 decline, versus 0.13 increase in controls, p = 0.053, and significant difference in ART adherence baseline to 9 months (p = 0.046). Their sexual transmission risk behaviors decreased (OR = 0.55, p = 0.020), a reduction not seen among controls (OR = 1.1, p = 0.664), and a significant difference in change (p = 0.040). Intervention effect was driven by those most in need: among those with detectable virus at baseline (>30 copies/milliliter, n=89), intervention effect was mean 0.60 log10 VL decline versus 0.15 increase in controls, p=0.034. ART adherence at the final follow-up was 13 points higher among intervention participants versus controls, p = 0.038. Conclusions Computerized counseling is promising for integrated ART adherence and safer sex, especially for individuals with problems in these areas. This is the first intervention to report improved ART adherence, viral suppression, and reduced secondary sexual transmission risk behavior. PMID:24384803

  4. Teaching Job Required Behaviors Via the Systematic Use of Prescribed Group Counseling Interventions: The Program and Its Operational Feasibility.

    ERIC Educational Resources Information Center

    Tobias, Richard

    Directed at the manpower counselor, this report describes the project's experiences in teaching job-required behavioral skills to the hardcore through systematically prescribed group counseling interventions. While describing the overall system, it focuses on the detailed presentation of the prescribed group counseling interventions developed, the…

  5. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance

    PubMed Central

    Buchanan, Adam H.; Datta, Santanu K.; Skinner, Celette Sugg; Hollowell, Gail P.; Beresford, Henry F.; Freeland, Thomas; Rogers, Benjamin; Boling, John; Marcom, P. Kelly; Adams, Martha B.

    2015-01-01

    Telegenetics – genetic counseling via live videoconferencing – can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient satisfaction and CGC attendance from a randomized trial comparing telegenetics with in-person CGC among individuals referred to CGC in four rural oncology clinics. Participants (n=162) were randomized to receive CGC at their local oncology clinic in-person or via telegenetics. Cost analyses included telegenetics system; mileage; and personnel costs for genetic counselor, IT specialist, and clinic personnel. CGC attendance was tracked via study database. Patient satisfaction was assessed one week post-CGC via telephone survey using validated scales. Total costs were $106 per telegenetics patient and $244 per in-person patient. Patient satisfaction did not differ by group on either satisfaction scale. In-person patients were significantly more likely to attend CGC than telegenetics patients (89% vs. 79%, p=0.03), with bivariate analyses showing an association between lesser computer comfort and lower attendance rate (Chi-square=5.49, p=0.02). Our randomized trial of telegenetics vs. in-person counseling found that telegenetics cost less than in-person counseling, with high satisfaction among those who attended. This study provides support for future randomized trials comparing multiple service delivery models on longer-term psychosocial and behavioral outcomes. PMID:25833335

  6. Randomized Trial of Telegenetics vs. In-Person Cancer Genetic Counseling: Cost, Patient Satisfaction and Attendance.

    PubMed

    Buchanan, Adam H; Datta, Santanu K; Skinner, Celette Sugg; Hollowell, Gail P; Beresford, Henry F; Freeland, Thomas; Rogers, Benjamin; Boling, John; Marcom, P Kelly; Adams, Martha B

    2015-12-01

    Telegenetics-genetic counseling via live videoconferencing-can improve access to cancer genetic counseling (CGC) in underserved areas, but studies on cancer telegenetics have not applied randomized methodology or assessed cost. We report cost, patient satisfaction and CGC attendance from a randomized trial comparing telegenetics with in-person CGC among individuals referred to CGC in four rural oncology clinics. Participants (n = 162) were randomized to receive CGC at their local oncology clinic in-person or via telegenetics. Cost analyses included telegenetics system; mileage; and personnel costs for genetic counselor, IT specialist, and clinic personnel. CGC attendance was tracked via study database. Patient satisfaction was assessed 1 week post-CGC via telephone survey using validated scales. Total costs were $106 per telegenetics patient and $244 per in-person patient. Patient satisfaction did not differ by group on either satisfaction scale. In-person patients were significantly more likely to attend CGC than telegenetics patients (89 vs. 79 %, p = 0.03), with bivariate analyses showing an association between lesser computer comfort and lower attendance rate (Chi-square = 5.49, p = 0.02). Our randomized trial of telegenetics vs. in-person counseling found that telegenetics cost less than in-person counseling, with high satisfaction among those who attended. This study provides support for future randomized trials comparing multiple service delivery models on longer-term psychosocial and behavioral outcomes.

  7. Bereaved Adults with Intellectual Disabilities: A Combined Randomized Controlled Trial and Qualitative Study of Two Community-Based Interventions

    ERIC Educational Resources Information Center

    Dowling, S.; Hubert, J.; White, S.; Hollins, S.

    2006-01-01

    Background: Bereaved adults with intellectual disabilities are known to experience prolonged and atypical grief which is often unrecognized. The aim of this project was to find an effective way to improve mental health and behavioural outcomes. Methods: Subjects were randomized to two different therapeutic interventions: traditional counselling by…

  8. The Management Game: An Educational Intervention for Counseling Women with Nontraditional Career Goals.

    ERIC Educational Resources Information Center

    Hammer-Higgins, Paula; Atwood, Virginia A.

    1989-01-01

    Informs counselors of barriers to career achievement for women who choose nontraditional careers. Offers a simulation game, with management as the example, as a psychoeducational intervention strategy or preventive counseling model. Notes that The Management Game is based on empirical and descriptive research. Game directions; chance, situation,…

  9. Evidence-Based Counseling Interventions with Children of Divorce: Implications for Elementary School Counselors

    ERIC Educational Resources Information Center

    Connolly, Marianne E.; Green, Eric J.

    2009-01-01

    Parental divorce has become increasingly common for large numbers of families in schools (Lamden, King, & Goldman, 2002). This article addresses the effects of divorce on children and protective factors supporting their adjustment. Evidence-based interventions for children of divorce in elementary school counseling programs are discussed.…

  10. Community Consultation and Intervention: Supporting Students Who Do Not Access Counseling Services

    ERIC Educational Resources Information Center

    Mier, Sharon; Boone, Matthew; Shropshire, Sonya

    2009-01-01

    Although the severity of psychological problems among college students and the demand for campus counseling services has increased, many students who could benefit from mental health services still do not access them. This article describes Community Consultation and Intervention, a program designed to support students who are unlikely to access…

  11. Psycho-Demographic Correlates of Behaviour towards Seeking Counselling Intervention among Workers in Lagos, Nigeria

    ERIC Educational Resources Information Center

    Gesinde, Abiodun Matthew; Sanu, Oluwafunto Jolade

    2015-01-01

    This study sought to examine the impact which age, gender and psychological adjustment have on behaviour towards seeking professional counselling intervention. Multistage sampling technique was employed to select a total of three hundred workers across Lagos metropolis. The ex post facto research design was adopted for the study. Inventory of…

  12. Efficacy of a Brief Intervention to Improve Emergency Physicians' Smoking Cessation Counseling Skills, Knowledge, and Attitudes

    ERIC Educational Resources Information Center

    Bernstein, Steven L.; Boudreaux, Edwin D.; Cabral, Lisa; Cydulka, Rita K.; Schwegman, David; Larkin, Gregory L.; Adams, Annette L.; McCullough, Lynne B.; Rhodes, Karin V.

    2009-01-01

    The objective of this study was to test whether a brief educational/administrative intervention could increase tobacco counseling by emergency physicians (EPs). Pre-/post-study at eight emergency departments (EDs) with residency programs were carried out. EPs received a 1-hour lecture on the health effects of smoking and strategies to counsel…

  13. A Model for Teaching Experiential Counseling Interventions to Novice Counselors.

    ERIC Educational Resources Information Center

    Cummings, Anne L.

    1992-01-01

    Describes model for teaching experiential interventions to novice counselors. Includes two experiential interventions that are focus for new model: two-chair approach based on Gestalt therapy principles and resolution of problematic reaction points. Cognitive, affective, and behavioral concepts of model are related to transfer of learning with the…

  14. The Pap smear screening as an occasion for smoking cessation and physical activity counselling: baseline characteristics of women involved in the SPRINT randomized controlled trial

    PubMed Central

    2011-01-01

    Background Gender-specific smoking cessation strategies have rarely been developed. Evidence of effectiveness of physical activity (PA) promotion and intervention in adjunct to smoking cessation programs is not strong. SPRINT study is a randomized controlled trial (RCT) designed to evaluate a counselling intervention on smoking cessation and PA delivered to women attending the Italian National Health System Cervical Cancer Screening Program. This paper presents study design and baseline characteristics of the study population. Methods/Design Among women undergoing the Pap examination in three study centres (Florence, Turin, Mantua), participants were randomized to the smoking cessation counselling [S], the smoking cessation + PA counselling [S + PA], or the control [C] groups. The program under evaluation is a standard brief counselling on smoking cessation combined with a brief counselling on increasing PA, and was delivered in 2010. A questionnaire, administered before, after 6 months and 1 year from the intervention, was used to track behavioural changes in tobacco use and PA, and to record cessation rates in participants. Discussion Out of the 5,657 women undergoing the Pap examination, 1,100 participants (55% of smokers) were randomized in 1 of the 3 study groups (363 in the S, 366 in the S + PA and 371 in the C groups). The three arms did not differ on any demographic, PA, or tobacco-use characteristics. Recruited smokers were older, less educated than non-participant women, more motivated to quit (33% vs.9% in the Preparation stage, p < 0.001), smoked more cigarettes per day (12 vs.9, p < 0.001), and were more likely to have already done 1 or more quit attempts (64% vs.50%, p < 0.001). The approach of SPRINT study appeared suitable to enrol less educated women who usually smoke more and have more difficulties to quit. Trial registration number ISRCTN: ISRCTN52660565 PMID:22151834

  15. Development of an HIV risk reduction counselling intervention for use in South African sexually transmitted infection clinics.

    PubMed

    Mathiti, V; Simbayi, L C; Jooste, S; Kekana, Q; Nibe, X P; Shasha, L; Bidla, P; Magubane, P; Cain, D; Cherry, C; Kalichman, S C

    2005-07-01

    South Africa urgently needs HIV prevention interventions that can be disseminated for use in clinical and community settings. A brief theory-based HIV risk reduction counselling intervention originally developed in the USA has recently been adapted for use in a South African sexually transmitted infection clinic. The 60-minute risk reduction counselling intervention was grounded in the Information-Motivation-Behavioural Skills (IMB) model of HIV preventive behaviour change, adapted through a series of interdisciplinary collaborative workshops. This paper reports the process of developing and culturally adapting the brief risk reduction counselling intervention. The processes used for adapting the HIV risk reduction counselling for South Africa provides a potential model for conducting technology transfer activities with other HIV prevention interventions. Several lessons learned from this process may help guide future efforts to transfer HIV prevention technologies.

  16. Counseling and exercise intervention for smoking reduction in patients with schizophrenia: a feasibility study.

    PubMed

    Bernard, Paquito Philippe Noel; Esseul, Elodie Christine; Raymond, Laurent; Dandonneau, Loic; Xambo, Jean-Jacques; Carayol, Marion Sara; Ninot, Gregory Jean-Marie Guilyn

    2013-02-01

    Smoking cessation is possible for individuals with schizophrenia but the relapse rate is high. It is necessary to develop more flexible approaches to help these patients. The aim of this study was to examine the feasibility of an intervention approach that integrates counseling and exercise for participants with schizophrenia or schizoaffective disorder. A single group prospective design was used in this study. A sample of inpatients with schizophrenia or schizoaffective disorder participated in a program called "oxygen group", a program combining five sessions of smoking reduction counseling and three sessions of moderate intensity exercise over an 8-week period. Tobacco consumption, motivation, carbon monoxide level, anxiety and depression, smoking self-efficacy, nicotine dependence and waist circumference were measured pre- and post-intervention. Participants reported their satisfaction with the study characteristics after completion of the intervention. Smoking consumption and CO level were assessed at 6-week post-intervention follow-up. Twelve individuals (mean age 45.7±10.8years) were recruited. Participant attendance was 81.3%. There were no dropouts. Significant decreases were found for tobacco consumption (P=.04) and CO rate (P=.003) at the end of the intervention and were maintained at 6-week follow-up. Compared to baseline levels, there were no changes in depression and anxiety. Smoking cessation motivation increased significantly. This intervention appears feasible and acceptable to patients with schizophrenia and there were promising findings regarding smoking reduction. Larger trials to test the intervention are warranted.

  17. Who Benefits from a Psychosocial Counseling vs. Educational Intervention to Improve Psychological Quality of Life in Prostate Cancer Survivors?

    PubMed Central

    Segrin, Chris; Figueredo, Aurelio J; Harrington, Joanne; Sheppard, Kate; Passalacqua, Stacey; Pasvogel, Alice; Bishop, Maria

    2012-01-01

    Objective We examined selected survivor characteristics to determine what factors might moderate the response to two psychosocial interventions. Design Seventy-one prostate cancer survivors were randomly assigned to either a telephone-delivered health education (THE) intervention or a telephone-delivered interpersonal counseling (TIP-C) intervention. Measures Psychological QOL outcomes included depression, negative and positive affect, and perceived stress. Results For three of the psychological outcomes (depression, negative affect and stress), there were distinct advantages from participating in THE. For example, more favorable depression outcomes occurred when men were older, had lower prostate specific functioning, were in active chemotherapy, had lower social support from friends and lower cancer knowledge. Participating in the TIP-C provided a more favorable outcome for positive affect when men had higher education, prostate specific functioning, social support from friends and cancer knowledge. Conclusion Unique survivor characteristics must be considered when recommending interventions that might improve psychological QOL in prostate cancer survivors. Future research must examine who benefits most and from what components of psychosocial interventions to enable clinicians to recommend appropriate psychosocial care. PMID:23045995

  18. Development and Preliminary Testing of a Promotora- Delivered, Spanish Language, Counseling Intervention for Heavy Drinking among Male, Latino Day Laborers

    PubMed Central

    Karno, Mitchell P.; Ray, Lara; Ramirez, Karina; Barenstein, Veronica; Portillo, Marlom J.; Rizo, Patricia; Borok, Jenna; Liao, Diana H.; Barron, Juan; del Pino, Homero E.; Valenzuela, Abel; Barry, Kristin L.

    2016-01-01

    This study developed and then tested the feasibility, acceptability and initial efficacy of a 3-session, culturally adapted, intervention combining motivational enhancement therapy (MET) and strengths-based case management (SBCM) delivered by promotoras in Spanish to reduce heavy drinking among male, Latino day laborers. A pilot two-group randomized trial (N=29) was conducted to evaluate the initial efficacy of MET/SBCM compared to Brief Feedback (BF). Alcohol-related measures were assessed at 6, 12 and 18 weeks after baseline. Most intervention group participants (12/14) attended all counseling sessions and most participants (25/29) remained in the study at 18 weeks. Alcohol related measures improved in both groups over time with no statistically significant differences observed at any of the time points. However the comparative effect size of MET/SBCM on weekly drinking was in the large range at 6-weeks and in the moderate range at 12-weeks. Post hoc analyses identified a statistically significant reduction in number of drinks over time for participants in the intervention group but not for control group participants. Despite the extreme vulnerability of the population, most participants completed all sessions of MET/SBCM and reported high satisfaction with the intervention. We feel our community partnership facilitated these successes. Additional studies of community-partnered and culturally adapted interventions are needed to reduce heavy drinking among the growing population of Latinos in the U.S. PMID:26738641

  19. Mother's perceptions and experiences of infant feeding within a community-based peer counselling intervention in South Africa.

    PubMed

    Nor, Barni; Ahlberg, Beth Maina; Doherty, Tanya; Zembe, Yanga; Jackson, Debra; Ekström, Eva-Charlotte

    2012-10-01

    Exclusive breastfeeding (EBF) has the potential to significantly reduce infant mortality, but is frequently not practiced in low-income settings where infants are vulnerable to malnutrition and infections including human immunodeficiency virus (HIV). This study explores mothers' experiences of infant feeding after receiving peer counselling promoting exclusive breast or formula feeding. This qualitative study was embedded in a cluster randomized peer counselling intervention trial in South Africa that aimed to evaluate the effect of peer counselling on EBF. Participants were selected from the three districts that were part of the trial reflecting different socio-economic conditions, rural-urban locations and HIV prevalence rates. Seventeen HIV-positive and -negative mothers allocated to intervention clusters were recruited. Despite perceived health and economic benefits of breastfeeding, several barriers to EBF remained, which contributed to a preference for mixed feeding. The understanding of the promotional message of 'exclusive' feeding was limited to 'not mixing two milks': breast or formula and did not address early introduction of foods and other liquids. Further, a crying infant or an infant who did not sleep at night were given as strong reasons for introducing semi-solid foods as early as 1 month. In addition, the need to adhere to the cultural practice of 'cleansing' and the knowledge that this practice is not compatible with EBF appeared to promote the decision to formula feed in HIV-positive mothers. Efforts to reduce barriers to EBF need to be intensified and further take into account the strong cultural beliefs that promote mixed feeding.

  20. Effectiveness of personalized face-to-face and telephone nursing counseling interventions for cardiovascular risk factors: a controlled clinical trial 1

    PubMed Central

    Vílchez Barboza, Vivian; Klijn, Tatiana Paravic; Salazar Molina, Alide; Sáez Carrillo, Katia Lorena

    2016-01-01

    Abstract Objective: to evaluate the effect and gender differences of an innovative intervention involving in-person and telephone nursing counseling to control cardiovascular risk factors (arterial hypertension, dyslipidemia, and overweight), improve health-related quality of life and strengthen self-efficacy and social support in persons using the municipal health centers' cardiovascular health program. Method: a randomized controlled clinical trial involving participants randomized into the intervention group who received traditional consultation plus personalized and telephone nursing counseling for 7 months (n = 53) and the control group (n = 56). The study followed the Consolidated Standards of Reporting Trials Statement. Results: women in the intervention group presented a significant increase in the physical and mental health components compared to the control group, with decreases in weight, abdominal circumference, total cholesterol, low-density lipoprotein cholesterol, and the atherogenic index. The effects attributable to the intervention in the men in the intervention group were increased physical and emotional roles and decreased systolic and diastolic pressure, waist circumference, total cholesterol, low-density lipoprotein cholesterol, atherogenic index, cardiovascular risk factor, and 10-year coronary risk. Conclusion: this intervention is an effective strategy for the control of three cardiovascular risk factors and the improvement of health-related quality of life. PMID:27508917

  1. Behavioral Counseling Interventions Expert Forum: Overview and Primer on U.S. Preventive Services Task Force Methods.

    PubMed

    Curry, Susan J; Whitlock, Evelyn P

    2015-09-01

    The importance of behavioral counseling as a clinical preventive service derives from the social and economic burden of preventable disease in the U.S., the central role behavioral risk factors play as leading causes of premature morbidity and mortality, and the promise of the healthcare visit as a teachable moment for behavioral counseling support. In November 2013, the U.S. Preventive Services Task Force convened an expert forum on behavioral counseling interventions. The forum brought together NIH, CDC, and Agency for Healthcare Research and Quality leaders, leading behavioral counseling researchers, and members of the U.S. Preventive Services Task Force to discuss issues related to optimizing evidence-based behavioral counseling recommendations. This paper provides an overview of the methods used by the Task Force to develop counseling recommendations. Special focus is on the development and evaluation of evidence from systematic reviews. Assessment of the net benefit of a behavioral counseling intervention, based on the evidence review, determines the recommendation statement and accompanying letter grade. A recent Task Force recommendation on screening and behavioral counseling interventions in primary care to reduce alcohol misuse provides a brief example.

  2. A randomized controlled trial of a videoconferencing smoking cessation intervention for Korean American women: preliminary findings

    PubMed Central

    Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas

    2016-01-01

    Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged <50 years, whereas it was not for older women. Self-reported abstinence was high at 67% and 48% for the video and telephone arm at 1 month post-quit, respectively. The rates declined to 33% for the video arm and 28% for the telephone arm at 3 months post-quit when salivary cotinine test was performed. Conclusion Findings support that both videoconferencing and telephone counseling can be effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women. PMID:27660494

  3. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  4. Computer-Assisted Dieting: Effects of a Randomized Nutrition Intervention

    ERIC Educational Resources Information Center

    Schroder, Kerstin E. E.

    2011-01-01

    Objectives: To compare the effects of a computer-assisted dieting intervention (CAD) with and without self-management training on dieting among 55 overweight and obese adults. Methods: Random assignment to a single-session nutrition intervention (CAD-only) or a combined CAD plus self-management group intervention (CADG). Dependent variables were…

  5. A Block Randomized Controlled Trial of a Brief Smoking Cessation Counselling and Advice through Short Message Service on Participants Who Joined the Quit to Win Contest in Hong Kong

    ERIC Educational Resources Information Center

    Chan, Sophia S. C.; Wong, David C. N.; Cheung, Yee Tak Derek; Leung, Doris Y. P.; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing

    2015-01-01

    The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received…

  6. Effective Counseling Interventions with Youth and Families: A Review of Solution Focused Brief Therapy. School Counseling Research Brief 9.2

    ERIC Educational Resources Information Center

    Bond, C.; Woods, K.; Humphrey, N.; Symes, W.; Green, L.

    2015-01-01

    Responsive services--in the form of individual, group, and family interventions--are a core component of the work of many school counselors. Solution focused brief therapy (SFBT), also called solution focused counseling (SFC), is increasingly used in schools due to its flexibility, brevity, and efficacy. Having a theoretically sound, effective,…

  7. A randomized clinical trial of self-help intervention for smoking cessation: research design, interventions, and baseline data.

    PubMed

    Unrod, Marina; Simmons, Vani N; Sutton, Steven K; Meltzer, Lauren R; Harrell, Paul T; Meade, Cathy D; Craig, Benjamin M; Lee, Ji-Hyun; Brandon, Thomas H

    2014-07-01

    Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality.

  8. Evaluating psychosocial group counselling with afghan women: is this a useful intervention?

    PubMed

    Manneschmidt, Sybille; Griese, Karin

    2009-01-01

    Data from 109 Afghan women participating in psychosocial counselling groups was analyzed to measure the groups' effects on their lives. Most participants were survivors of war-related forms of violence. Others had experienced domestic violence and some were still living under abusive circumstances while attending counselling. The evaluation took place in the group setting and each participant was asked to answer a standardized set of four open-ended questions. All answers were tabulated, coded and eventually put into themes to be analyzed. Over 90% of the participants described an improvement in their social life or their general health. This research shows that this model of psychosocial care is a useful intervention to assist Afghan women suffering from a variety of physical or emotional problems.

  9. A randomized control trial of personalized cognitive counseling to reduce sexual risk among HIV-infected men who have sex with men.

    PubMed

    Schwarcz, Sandra K; Chen, Yea-Hung; Murphy, Jessie L; Paul, Jay P; Skinta, Matthew D; Scheer, Susan; Vittinghoff, Eric; Dilley, James W

    2013-01-01

    The increased life expectancy and well-being of HIV-infected persons presents the need for effective prevention methods in this population. Personalized cognitive counseling (PCC) has been shown to reduce unprotected anal intercourse (UAI) with a partner of unknown or different serostatus among HIV-uninfected men who have sex with men (MSM). We adapted PCC for use among HIV-infected MSM and tested its efficacy against standard risk-reduction counseling in a randomized clinical trial in San Francisco. Between November 2006 and April 2010, a total of 374 HIV-infected MSM who reported UAI with two or more men of negative or unknown HIV serostatus in the previous 6 months were randomized to two sessions of PCC or standard counseling 6 months apart. The primary outcome was the number of episodes of UAI with a non-primary male partner of different or unknown serostatus in the past 90 days, measured at baseline, 6, and 12 months. Surveys assessed participant satisfaction with the counseling. The mean number of episodes of UAI at baseline did not differ between PCC and control groups (2.97 and 3.14, respectively; p=0.82). The mean number of UAI episodes declined in both groups at 6 months, declined further in the PCC group at 12 months, while increasing to baseline levels among controls; these differences were not statistically significant. Episode mean ratios were 0.76 (95% confidence interval [CI] 0.25-2.19, p=0.71) at 6 months and 0.48 (95% CI 0.12-1.84, p=0.34) at 12 months. Participants in both groups reported a high degree of satisfaction with the counseling. The findings from this randomized trial do not support the efficacy of a two-session PCC intervention at reducing UAI among HIV-infected MSM and indicate the continued need to identify and implement effective prevention methods in this population.

  10. A Randomized Controlled Trial Comparing Integrated Cognitive Behavioral Therapy Versus Individual Addiction Counseling for Co-occurring Substance Use and Posttraumatic Stress Disorders

    PubMed Central

    McGovern, Mark P.; Lambert-Harris, Chantal; Alterman, Arthur I.; Xie, Haiyi; Meier, Andrea

    2012-01-01

    Objective Co-occurring posttraumatic stress (PTSD) and substance use disorders provide clinical challenges to addiction treatment providers. Interventions are needed that are effective, well-tolerated by patients, and capable of being delivered by typical clinicians in community settings. This is a randomized controlled trial of integrated cognitive behavioral therapy for co-occurring PTSD and substance use disorders. Methods Fifty-three participants sampled from seven community addiction treatment programs were randomized to integrated cognitive behavioral therapy plus standard care or individual addiction counseling plus standard care. Fourteen community therapists employed by these programs delivered both manual-guided therapies. Primary outcomes were PTSD symptoms, substance use symptoms and therapy retention. Participants were assessed at baseline, 3- and 6-month follow-up. Results Integrated cognitive behavioral therapy was more effective than individual addiction counseling in reducing PTSD re-experiencing symptoms and PTSD diagnosis. Individual addiction counseling was comparably effective to integrated cognitive behavioral therapy in substance use outcomes and on other measures of psychiatric symptom severity. Participants assigned to individual addiction counseling with severe PTSD were less likely to initiate and engage in the therapy than those assigned to integrated cognitive behavioral therapy. In general, participants with severe PTSD were more likely to benefit from integrated cognitive behavioral therapy. Conclusions The findings support the promise of efficacy of integrated cognitive behavioral therapy in improving outcomes for persons in addiction treatment with PTSD. Community counselors delivered both interventions with satisfactory adherence and competence. Despite several limitations to this research, a larger randomized controlled trial of integrated cognitive behavioral therapy appears warranted. PMID:22383864

  11. The Effect of the Student Success Skills Small Group Counseling Intervention on Factors Associated with Dropout Potential in High School

    ERIC Educational Resources Information Center

    Weinstein, Jodie

    2013-01-01

    The focus of this study is to add to the outcome research on effective school counseling interventions and to specifically evaluate the effectiveness of the Student Success Skills (SSS) small group intervention with students identified as having drop out potential in the 9th grade. This study analyzed two years of pre-existing, non-identifiable…

  12. Effect of Risk-Reduction Counseling With Rapid HIV Testing on Risk of Acquiring Sexually Transmitted Infections: The AWARE Randomized Clinical Trial

    PubMed Central

    Metsch, Lisa R.; Feaster, Daniel J.; Gooden, Lauren; Schackman, Bruce R.; Matheson, Tim; Das, Moupali; Golden, Matthew R.; Huffaker, Shannon; Haynes, Louise F.; Tross, Susan; Malotte, C. Kevin; Douaihy, Antoine; Korthuis, P. Todd; Duffus, Wayne A.; Henn, Sarah; Bolan, Robert; Philip, Susan S.; Castro, Jose G.; Castellon, Pedro C.; McLaughlin, Gayle; Mandler, Raul N.; Branson, Bernard; Colfax, Grant N.

    2014-01-01

    IMPORTANCE To increase HIV testing rates, many institutions and jurisdictions have revised policies to make the testing process rapid, simple, and routine. A major issue for testing scale-up efforts is the effectiveness of HIV risk-reduction counseling, which has historically been an integral part of the HIV testing process. OBJECTIVE To assess the effect of brief patient-centered risk-reduction counseling at the time of a rapid HIV test on the subsequent acquisition of sexually transmitted infections (STIs). DESIGN, SETTING, AND PARTICIPANTS From April to December 2010, Project AWARE randomized 5012 patients of 9 sexually transmitted disease (STD) clinics in the US to either receive brief patient-centered HIV risk-reduction counseling with a rapid HIV test or the rapid HIV test with information only. Participants were assessed for multiple sexually transmitted infections (STIs) at both baseline and at 6-month follow-up. INTERVENTION Participants randomized to counseling received individual patient-centered risk-reduction counseling based on an evidence-based model. The core elements included a focus on the patient’s specific HIV/STI risk behavior and negotiation of realistic and achievable risk-reduction steps. All participants received a rapid HIV test. MAIN OUTCOMES AND MEASURES The prespecified outcome was a composite endpoint of cumulative incidence of any of the measured STIs over 6 months. All participants were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Treponema pallidum (syphilis), Herpes Simplex Virus 2, and HIV. Women were also tested for Trichomonas vaginalis. RESULTS There was no significant difference in 6-month composite STI incidence by study group (aRR = 1.12, 95% CI (0.94–1.33). There were 250/2039 (12.3%) incident cases in the counseling group and 226/2032 (11.1%) in the information-only group. CONCLUSION AND RELEVANCE Risk-reduction counseling in conjunction with a rapid HIV test did not significantly affect STI acquisition

  13. [Effects of stepped counseling intervention on quality of life among newly diagnosed HIV-positive patients].

    PubMed

    Hsiao, Ching-Fang; Chao, Shu-Ling; Tsai, Tsui-Ching; Chuang, Peing

    2004-04-01

    The purpose of this research was to understand how stepped counseling intervention affects quality of life in newly diagnosed HIV-positive patients. The study made use of quasi-experimental methodology that included a three-step interview process over 45 days. The theoretical framework supporting interviews with 32 newly diagnosed HIV-positive patients in northern Taiwan included a combination of rational-emotive therapy, cognitive-behavior therapy, and health education. Participants were divided into an experimental and control group of equal size. Data collection also included responses to the WHOQOL-HIV instrument at the beginning and end of each interview session. Responses were analyzed with the SPSS software package. The results showed a 25-point difference between pre- and post-test scores in the experimental group (SD = 3.2) and a 6 point difference in the control group (SD = 4.3). The results indicate that stepped counseling techniques are effective in helping this patient population to adjust to the physical, emotional, social, and environmental stresses associated with their newly diagnosis. The researchers suggest that stepped counseling be used with all newly diagnosed HIV-positive Taiwanese patients in all hospitals and clinics to promote adaptive abilities and to control the further spread of HIV.

  14. Effectiveness of a Multi-Component Intervention for Overweight and Obese Children (Nereu Program): A Randomized Controlled Trial

    PubMed Central

    Serra-Paya, Noemi; Ensenyat, Assumpta; Castro-Viñuales, Iván; Real, Jordi; Sinfreu-Bergués, Xènia; Zapata, Amalia; Mur, Jose María; Galindo-Ortego, Gisela; Solé-Mir, Eduard; Teixido, Concepció

    2015-01-01

    Introduction Treatment of childhood obesity is a complex challenge for primary health care professionals. Objectives To evaluate the effectiveness of the Nereu Program in improving anthropometric parameters, physical activity and sedentary behaviours, and dietary intake. Methods Randomized, controlled, multicentre clinical trial comparing Nereu Program and usual counselling group interventions in primary care settings. The 8-month study recruited 113 children aged 6 to 12 years with overweight/obesity. Before recruitment, eligible participants were randomly allocated to an intensive, family-based multi-component behavioural intervention (Nereu Program group) or usual advice from their paediatrician on healthy eating and physical activity. Anthropometric parameters, objectively measured sedentary and physical activity behaviours, and dietary intake were evaluated pre- and post-intervention. Results At the end of the study period, both groups achieved a similar decrease in body mass index (BMIsd) compared to baseline. Nereu Program participants (n = 54) showed greater increases in moderate-intense physical activity (+6.27% vs. -0.61%, p<0.001) and daily fruit servings (+0.62 vs. +0.13, p<0.026), and decreased daily soft drinks consumption (-0.26 vs. -0.02, p<0.047), respectively, compared to the counselling group (n = 59). Conclusions At the end of the 8-month intervention, participants in the Nereu Program group showed improvement in physical activity and dietary behaviours, compared to the counselling group. Trial Registration ClinicalTrials.gov NCT01878994 PMID:26658988

  15. Effectiveness of Couple-Based HIV Counseling and Testing for Women Substance Users and Their Primary Male Partners: A Randomized Trial

    PubMed Central

    McMahon, James M.; Tortu, Stephanie; Pouget, Enrique R.; Torres, Leilani; Rodriguez, William; Hamid, Rahul

    2013-01-01

    A randomized trial was conducted to test the effectiveness of couple-based HIV counseling and testing (CB-HIV-CT) and women-only relationship-focused HIV counseling and testing (WRF-HIV-CT) in reducing HIV risk compared to the National Institute on Drug Abuse HIV-CT standard intervention. Substance using HIV-negative women and their primary heterosexual partner (N = 330 couples) were randomized to 1 of the 3 interventions. Follow-up assessments measuring HIV risk behaviors and other relevant variables were conducted at 3- and 9-months postintervention. Repeated measures generalized linear mixed model analysis was used to assess treatment effects. A significant reduction in HIV risk was observed over the 9-month assessment in the CB-HIV-CT group compared to that of the control group (b = −0.51, t[527] = −3.20, P = 0.002) and compared to that of the WRF-HIV-CT group (b = −0.34, t[527] = −2.07, P = 0.04), but no significant difference was observed between WRF-HIV-CT and controls (b = −0.17, t[527] = −1.09, P = 0.28). A brief couple-based HIV counseling and testing intervention designed to address both drug-related and sexual risk behaviors among substance using women and their primary male partners was shown to be more effective at reducing overall HIV risk compared to a standard HIV-CT intervention in an urban setting. PMID:23555059

  16. The Impact of a Rights-Based Counselling Intervention to Reduce Stigma in People Affected by Leprosy in Indonesia

    PubMed Central

    Lusli, Mimi; Peters, Ruth; van Brakel, Wim; Zweekhorst, Marjolein; Iancu, Sorana; Bunders, Joske; Irwanto; Regeer, Barbara

    2016-01-01

    Background This paper assesses the impact of a counselling intervention on reducing leprosy-related stigma in Cirebon District, Indonesia. The unique features of this intervention are its rights-based approach, the underlying Cognitive Behavioural Therapy (CBT) model, the three types of counselling and the lay and peer counsellors who were involved. Methodology/principal findings Mixed methods (e.g. three scales, interviews, focus group discussions and reflection notes) were used to assess the impact of the intervention, which ran over a two-year period. There was a control area with no interventions. The study participants were people affected by leprosy and other key persons (e.g. family members). The sample size differs per method, for example, data regarding 67 counselling clients and 57 controls from a cohort, and notes from 207 counselling clients were examined. The notes showed that most clients faced stigma on a daily basis, whether internalized, anticipated and/or enacted. A significant reduction was found between the before and after total scores of the SARI Stigma Scale (p-value < 0.001), Participation Scale Short (p-value < 0.001) and WHO Quality of Life score (p-value < 0.001) among the counselling clients. While there is also an effect in the control group, it is much larger in the intervention group. Qualitative data indicates that knowledge and rights trigger change. Clients took steps to improve their life such as re-connecting with neighbours, helping in household activities and applying for jobs. Challenges include the wish to conceal their condition. Conclusion/significance The findings show that the counselling intervention was effective in reducing stigma, promoting the rights of people with leprosy and facilitating their social participation. More research is needed on how to create a more sustainable intervention, preferably structurally embedded in the health or social services. PMID:27959932

  17. Specific strength training compared with interdisciplinary counseling for girls with tension-type headache: a randomized controlled trial

    PubMed Central

    Tornøe, Birte; Andersen, Lars L; Skotte, Jørgen H; Jensen, Rigmor; Jensen, Claus; Madsen, Bjarne K; Gard, Gunvor; Skov, Liselotte; Hallström, Inger

    2016-01-01

    Background Childhood tension-type headache (TTH) is a prevalent and debilitating condition for the child and family. Low-cost nonpharmacological treatments are usually the first choice of professionals and parents. This study examined the outcomes of specific strength training for girls with TTH. Methods Forty-nine girls aged 9–18 years with TTH were randomized to patient education programs with 10 weeks of strength training and compared with those who were counseled by a nurse and physical therapist. Primary outcomes were headache frequency, intensity, and duration; secondary outcomes were neck–shoulder muscle strength, aerobic power, and pericranial tenderness, measured at baseline, after 10 weeks intervention, and at 12 weeks follow-up. Health-related quality of life (HRQOL) questionnaires were assessed at baseline and after 24 months. Results For both groups, headache frequency decreased significantly, P=0.001, as did duration, P=0.022, with no significant between-group differences. The odds of having headache on a random day decreased over the 22 weeks by 0.65 (0.50–0.84) (odds ratio [95% confidence interval]). For both groups, neck extension strength decreased significantly with a decrease in cervicothoracic extension/flexion ratio to 1.7, indicating a positive change in muscle balance. In the training group, shoulder strength increased $10% in 5/20 girls and predicted VO2max increased $15% for 4/20 girls. In the training group, 50% of girls with a headache reduction of $30% had an increase in VO2max >5%. For the counseling group, this was the case for 29%. A 24-month follow-up on HRQOL for the pooled sample revealed statistically significant improvements. Fifty-five percent of the girls reported little to none disability. Conclusion The results indicate that both physical health and HRQOL can be influenced significantly by physical exercise and nurse counseling. More research is needed to examine the relationship between physical exercise, VO2max, and

  18. Customer-oriented counseling for physical activity in older people: study protocol and selected baseline results of a randomized-controlled trial (ISRCTN 07330512).

    PubMed

    Leinonen, R; Heikkinen, E; Hirvensalo, M; Lintunen, T; Rasinaho, M; Sakari-Rantala, R; Kallinen, M; Koski, J; Möttönen, S; Kannas, S; Huovinen, P; Rantanen, T

    2007-04-01

    The objective of this study is to describe the rationale, design and selected baseline results of a 2-year randomized-controlled trial (RCT) on the effects of physical activity counseling in community-living older people. After a four-phase screening and data-collection process targeting all independently living people in the city center of Jyväskylä, Finland, six hundred and thirty-two 75-81-year-old cognitively intact, sedentary persons who were able to move independently outdoors at least minimally and willing to take part in the RCT were randomized into intervention and control groups. At baseline, over half of the subjects exercised less than two to three times a month and two-thirds were willing to increase their physical activity level. The desire to increase physical activity was more common (86%) among subjects with mobility limitation compared with those without (60%, P=0.004). The intervention group received an individualized face-to-face counseling session, followed by phone contacts every 3 months throughout the intervention. The study outcomes include physical activity level, mobility limitation, functional impairments, disability, mood, quality of life, use of services, institutionalization and mortality. The screening and recruitment process was feasible and succeeded well, and showed that unmet physical activity needs are common in older people.

  19. Effectiveness of Facebook-Delivered Lifestyle Counselling and Physical Activity Self-Monitoring on Physical Activity and Body Mass Index in Overweight and Obese Adolescents: A Randomized Controlled Trial

    PubMed Central

    Ruotsalainen, Heidi; Kyngäs, Helvi; Tammelin, Tuija; Heikkinen, Hanna; Kääriäinen, Maria

    2015-01-01

    Background. The aim was to evaluate the effects of a 12-week, Facebook-delivered lifestyle counselling intervention, with or without physical activity self-monitoring, on physical activity and body mass index (BMI) in overweight and obese 13–16-year-old adolescents. Methods. Three-arm randomized controlled trial. Participants (n = 46) were randomly assigned to intervention and control groups: one group received Facebook-delivered lifestyle counselling and monitoring of their physical activity (Fb + Act, n = 15), whereas a second experimental group received the same Facebook-delivered lifestyle counselling without self-monitoring (Fb, n = 16) and a third group served as the control group (n = 15). Objective and self-reported physical activity assessment were used. Nonparametric statistical tests were used. Results. There were no significant intervention effects in terms of changes in physical activity levels or BMI from baseline to the 12-week postintervention measurements between the intervention and control groups. The Fb + Act group had lower sedentary time on weekdays compared to the control group during postintervention measurements (p = 0.021), but there was no interaction between time and group. Conclusions. Interventions were not effective at increasing physical activity in overweight and obese adolescents. Before implementing such interventions, more evaluations on their effectiveness are needed. This trial is registered with ClinicalTrials.gov identifier NCT02295761 (2014-11-17). PMID:26697218

  20. Differential response to an exclusive breastfeeding peer counseling intervention: the role of ethnicity.

    PubMed

    Anderson, Alex K; Damio, Grace; Chapman, Donna J; Pérez-Escamilla, Rafael

    2007-02-01

    The authors analyzed data from a trial assessing the efficacy of breastfeeding peer counseling (PC) for increasing exclusive breastfeeding (EBF) to (1) examine whether different ethnic groups responded differently to the intervention and (2) document the determinants of EBF. At 2 months postpartum, the prevalence of EBF in the intervention group was 11.4% among Puerto Ricans compared to 44.4% among non-Puerto Ricans (P = .008). Multivariate logistic regression analyses showed that women who had the intention prenatally to engage in EBF were more likely to do so and those whose mothers lived in the United States were less likely to engage in EBF at hospital discharge. At 2 months postpartum, mothers who were breastfed as children were more likely to engage in EBF, whereas non-Puerto Ricans had a significantly greater response to the intervention than Puerto Ricans (odds ratio, 6.40; 95% confidence interval, 1.45-28.33). There is a need for further studies to determine why different ethnic groups respond differently to EBF promotion interventions.

  1. HIV intervention for providers study: a randomized controlled trial of a clinician-delivered HIV risk-reduction intervention for HIV-positive people.

    PubMed

    Rose, Carol Dawson; Courtenay-Quirk, Cari; Knight, Kelly; Shade, Starley B; Vittinghoff, Eric; Gomez, Cynthia; Lum, Paula J; Bacon, Oliver; Colfax, Grant

    2010-12-15

    Clinician-delivered prevention interventions offer an opportunity to integrate risk-reduction counseling as a routine part of medical care. The HIV Intervention for Providers study, a randomized controlled trial, developed and tested a medical provider HIV prevention training intervention in 4 northern California HIV care clinics. Providers were assigned to either the intervention or control condition (usual care). The intervention arm received a 4-hour training on assessing sexual risk behavior with HIV-positive patients and delivering risk-reduction-oriented prevention messages to patients who reported risk behaviors with HIV-uninfected or unknown-status partners. To compare the efficacy of the intervention versus control on transmission risk behavior, 386 patients of the randomized providers were enrolled. Over six-months of follow-up, patients whose providers were assigned the intervention reported a relative increase in provider-patient discussions of safer sex (OR = 1.49; 95% CI = 1.06 to 2.09), assessment of sexual activity (OR = 1.60; 95% CI = 1.05 to 2.45), and a significant decrease in the number of sexual partners (OR = 0.49, 95% CI = 0.26 to 0.92). These findings show that a brief intervention to train HIV providers to identify risk and provide a prevention message results in increased prevention conversations and significantly reduced the mean number of sexual partners reported by HIV-positive patients.

  2. The Veterans LIFE Study: A Randomized Trial of Primary Care Based Physical Activity Counseling For Older Men

    PubMed Central

    Morey, Miriam C.; Peterson, Matthew J; Pieper, Carl F.; Sloane, Richard; Crowley, Gail M.; Cowper, Patricia A.; McConnell, Eleanor S.; Bosworth, Hayden B.; Ekelund, Carola C.; Pearson, Megan P.

    2009-01-01

    BACKGROUND Slow gait is predictive of adverse health outcomes and increased health service utilization. Physical activity counseling (PAC) may enhance mobility among elders. Primary care settings are appropriate for PAC because most older adults see their primary care physician annually. Innovative use of automated telephone messaging facilitates physician counseling. OBJECTIVE To determine the effects of multi-component PAC promoting physical activity (PA) guidelines on gait speed and related measures of PA and function in older veterans. DESIGN, SETTING, AND PARTICIPANTS Randomized controlled trial of 398 male veterans, ages 70 and over receiving primary care at the Veterans’ Affairs Medical Center of Durham, N.C. INTERVENTION Twelve months of usual care (UC) or multi-component PAC consisting of baseline in-person and biweekly then monthly telephone counseling by a lifestyle counselor, one-time clinical endorsement of PA and monthly automated telephone messaging by primary care provider, and quarterly tailored mailings of progress in PA. MEASUREMENTS Gait speed (usual and rapid), self-reported PA, function and disability at baseline, 3, 6 and 12 months. RESULTS Although no between-group differences were noted for usual gait speed, rapid gait speed improved significantly more for the PAC group (1.56 (0.41) m/s to 1.68 (0.44) m/s) compared to UC (1.57 (0.40) m/sec to 1.59 (0.42) m/sec, p = 0.04). Minutes of moderate/vigorous PA increased significantly in the PAC group (from a mean (SD) 57.1 (99.3) min/wk to 126.6 (142.9) min/week) compared to the UC group (from 60.2 (116.1) to 69.6 (116.1) min/wk, p < 0.001). Changes in other functional/disability outcomes were small. CONCLUSIONS In this group of older male veterans, multi-component PA significantly improved rapid gait and PA. Translation from increased PA to overall functioning was not observed. Integration with primary care was successful. PMID:19467149

  3. Couples Counseling in Alzheimer’s Disease: Additional Clinical Findings from a Novel Intervention Study

    PubMed Central

    AUCLAIR, URSULA; EPSTEIN, CYNTHIA; MITTELMAN, MARY

    2009-01-01

    This article describes the clinical findings of a study designed to assess the benefit of counseling for couples, one of whom is in the early stage of Alzheimer’s disease (AD). We previously reported our findings based on the first 12 couples that enrolled in the study. Based on the treatment of 30 additional couples, we have refined our treatment strategy to include concepts of Gestalt Therapy and Transactional Analysis and identified prevalent issues of concern to this cohort. The study design has remained as described in the earlier article (Epstein et al., 2006), and has proven to be appropriate to meet the goals of this intervention as indicated by our clinical experience and feedback from the participating couples. Case vignettes demonstrate how to conduct the sessions so that the experience of each member of the dyad is validated, while acknowledging the differential impact of the disease on them. PMID:19865591

  4. Understanding Research Gaps and Priorities for Improving Behavioral Counseling Interventions: Lessons Learned From the U.S. Preventive Services Task Force.

    PubMed

    Kurth, Ann E; Miller, Therese L; Woo, Meghan; Davidson, Karina W

    2015-09-01

    Behavioral counseling interventions can address significant causes of preventable morbidity and mortality. However, despite a growing evidence base for behavioral counseling interventions, there remain significant research gaps that limit translating the evidence into clinical practice. Using U.S. Preventive Services Task Force (USPSTF) examples, we address how researchers and funders can move the research portfolio forward to achieve better application of behavioral counseling interventions to address substantial health burdens in the U.S. This paper describes the types of gaps that the USPSTF encounters across its behavioral counseling intervention topics and provides suggestions for opportunities to address these gaps to enhance the evidence base for primary care-based behavioral counseling recommendations. To accomplish this, we draw from both the USPSTF experience and issues identified by researchers and clinicians during the USPSTF-sponsored Behavioral Counseling Intervention Forum. We also discuss the dilemma posed by having "insufficient" evidence with which to make a behavioral counseling intervention-related recommendation, and describe two case examples (screening for alcohol misuse in adolescence and screening for child maltreatment), detailing the research gaps that remain. Recommendations are outlined for researchers, funders, and practice implementers to improve behavioral counseling intervention research and application.

  5. Stage-specific education/counseling intervention in women with elevated blood pressure.

    PubMed

    Daley, Linda K; Fish, Anne F; Frid, David J; Mitchell, G Lynn

    2009-06-01

    Many women with elevated blood pressure who seek exercise opportunities require a flexible program with systematic follow-up. The study framework included motivational readiness (exercise stage of change) from the Transtheoretical Model and self-efficacy theory. This pilot study, which used a one-group repeated measures design, tested the feasibility of a stage-specific education/counseling intervention aimed at improving exercise outcomes in women with elevated blood pressure. Forty women completed a 2.5-hour session including prescription for moderate-vigorous exercise on their own, practice on equipment, maintenance of an exercise diary, and contracting; three follow-up calls (Weeks 1, 2, 3); a visit (Week 4); and a final call (Week 5). After the intervention, 85% of women moved to or remained in the action or maintenance stages of change, the highest levels of readiness; none relapsed. Exercise self-efficacy and benefits increased and barriers decreased (P<.05); 70% of participants increased exercise performance. The intervention was feasible. Further testing is warranted using larger samples and including a control group.

  6. Validation of a Multivariate Career and Educational Counseling Intervention Model Using Long-Term Follow-Up

    ERIC Educational Resources Information Center

    Greenwood, Janet I.

    2008-01-01

    In this study, the author sought to validate the effectiveness of a multivariate career and educational counseling intervention model through long-term follow-up of clients seen in private practice. Effectiveness was measured by clients' commitment to and enjoyment of their chosen career paths and the relationship of these factors to adherence to…

  7. A Randomized Trial of Parental Behavioral Counseling and Cotinine Feedback for Lowering Environmental Tobacco Smoke Exposure in Children With Asthma

    PubMed Central

    Farber, Harold J.; Knowles, Sarah B.; Lavori, Philip W.

    2011-01-01

    Background: Secondhand tobacco smoke exposure impairs the control of pediatric asthma. Evidence of the efficacy of interventions to reduce children’s exposure and improve disease outcomes has been inconclusive. Methods: Caregivers of 519 children aged 3 to 12 years with asthma and reported smoke exposure attended two baseline assessment visits, which involved a parent interview, sampling of the children’s urine (for cotinine assay), and spirometry (children ≥ 5 years). The caregivers and children (n = 352) with significant documented exposure (cotinine ≥ 10 ng/mL) attended a basic asthma education session, provided a third urine sample, and were randomized to the Lowering Environmental Tobacco Smoke: LET’S Manage Asthma (LET’S) intervention (n = 178) or usual care (n = 174). LET’S included three in-person, stage-of-change-based counseling sessions plus three follow-up phone calls. Cotinine feedback was given at each in-person session. Follow-up visits at 6 and 12 months postrandomization repeated the baseline data collection. Multivariate regression analyses estimated the intervention effect on the natural logarithm of the cotinine to creatinine ratio (lnCCR), use of health-care services, and other outcomes. Results: In the sample overall, the children in the LET’S intervention had lower follow-up lnCCR values compared with the children in usual care, but the group difference was not significant (β coefficient = −0.307, P = .064), and there was no group difference in the odds of having > one asthma-related medical visit (β coefficient = 0.035, P = .78). However, children with high-risk asthma had statistically lower follow-up lnCCR values compared with children in usual care (β coefficient = −1.068, P = .006). Conclusions: The LET’S intervention was not associated with a statistically significant reduction in tobacco smoke exposure or use of health-care services in the sample as a whole. However, it appeared effective in reducing exposure

  8. Randomized Noninferiority Trial of Telephone Versus In-Person Genetic Counseling for Hereditary Breast and Ovarian Cancer

    PubMed Central

    Schwartz, Marc D.; Valdimarsdottir, Heiddis B.; Peshkin, Beth N.; Mandelblatt, Jeanne; Nusbaum, Rachel; Huang, An-Tsun; Chang, Yaojen; Graves, Kristi; Isaacs, Claudine; Wood, Marie; McKinnon, Wendy; Garber, Judy; McCormick, Shelley; Kinney, Anita Y.; Luta, George; Kelleher, Sarah; Leventhal, Kara-Grace; Vegella, Patti; Tong, Angie; King, Lesley

    2014-01-01

    Purpose Although guidelines recommend in-person counseling before BRCA1/BRCA2 gene testing, genetic counseling is increasingly offered by telephone. As genomic testing becomes more common, evaluating alternative delivery approaches becomes increasingly salient. We tested whether telephone delivery of BRCA1/2 genetic counseling was noninferior to in-person delivery. Patients and Methods Participants (women age 21 to 85 years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area) were randomly assigned to usual care (UC; n = 334) or telephone counseling (TC; n = 335). UC participants received in-person pre- and post-test counseling; TC participants completed all counseling by telephone. Primary outcomes were knowledge, satisfaction, decision conflict, distress, and quality of life; secondary outcomes were equivalence of BRCA1/2 test uptake and costs of delivering TC versus UC. Results TC was noninferior to UC on all primary outcomes. At 2 weeks after pretest counseling, knowledge (d = 0.03; lower bound of 97.5% CI, −0.61), perceived stress (d = −0.12; upper bound of 97.5% CI, 0.21), and satisfaction (d = −0.16; lower bound of 97.5% CI, −0.70) had group differences and confidence intervals that did not cross their 1-point noninferiority limits. Decision conflict (d = 1.1; upper bound of 97.5% CI, 3.3) and cancer distress (d = −1.6; upper bound of 97.5% CI, 0.27) did not cross their 4-point noninferiority limit. Results were comparable at 3 months. TC was not equivalent to UC on BRCA1/2 test uptake (UC, 90.1%; TC, 84.2%). TC yielded cost savings of $114 per patient. Conclusion Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs. PMID:24449235

  9. Effect of Sexual Counseling on Marital Satisfaction of Pregnant Women Referring to Health Centers in Malayer (Iran): An educational randomized experimental study

    PubMed Central

    Masoumi, Seyedeh Zahra; Kazemi, Farideh; Nejati, Behnaz; Parsa, Parisa; Karami, Manoochehr

    2017-01-01

    Introduction One of the most important factors in marital satisfaction is the satisfaction of a healthy sexual relationship between spouses. During pregnancy marital satisfaction may decrease due to sexual problems. Sexual counseling to pregnant women may reduce the complications of these problems at this time. This study aimed to investigate the effects of sexual counseling on marital satisfaction of pregnant women. This article is sponsored by the Hamadan University of Medical Sciences. Methods This educational randomized experimental study was conducted on 80 pregnant women referring to health centers of Malayer. Samples were two groups of experimental and control, with forty participants in each group, four consultation sessions were held, and each session lasted 40 to 90 minutes Data gathering tools were demographic questionnaire and Enriching Relationship Issues Communication and Happiness (ENRICH), a short form of marital satisfaction questionnaire with 47 items. Data were analyzed by Software SPSS 22 and the results were compared by independent t-test, chi-square test, and repeated measure ANOVA. Results Comparing the marital satisfaction mean scores in the experimental group showed a significant difference between pre-consultation, and the consultation after two and four weeks. Marital satisfaction score of 8.05 ± 51.20 before the consultation was increased to 7.76 ± 54.52 after two weeks and 6.48 ± 59.20 after four weeks (respectively p < 0.001, p < 0.001). In addition, mean and standard deviation of marital satisfaction in the control group before the intervention, two weeks and four weeks after the intervention were respectively 10.10 ± 45.67, 11.75 ± 47.75, and 10.02 ± 46.30 and Bonferroni post hoc test showed a significant difference between before and two weeks after intervention (p = 0.03). However, marital satisfaction before and four weeks after the intervention was not significant (p = 0.59). The results showed that sexual counseling was

  10. Effect of Workplace Counseling Interventions Launched by Workplace Health Promotion and Tobacco Control Centers in Taiwan: An Evaluation Based on the Ottawa Charter

    PubMed Central

    Chen, Tzu-Hua; Huang, Joh-Jong; Chang, Fong-Ching; Chang, Yu-Tsz; Chuang, Hung-Yi

    2016-01-01

    Workplace health promotion (WHP) is important to prevent work-related diseases, reduce workplace hazards, and improve personal health of the workers. Health promotion projects were launched through the centers of WHP funded by the Taiwan Bureau of Health Promotion since 2003. Hence, the aim of this study is to evaluate the impact of WHP programs intervention from 2003 to 2007. The intervention group consisted of 838 business entities which had ever undergone counseling of the three centers in northern, central, and southern Taiwan from 2003 to 2007. The control group was composed of 1000 business entities randomly selected from the business directories of the Ministry of Economic Affairs, Taiwan. The questionnaire survey included general company profiles and the assessment of workplace health according to the five action areas of the Ottawa Charter for Health Promotion. We have received 447 (53.3%) questionnaires from the intervention group and 97 questionnaires from the control group. The intervention group was more effective in using the external resources and medical consultation, and they had better follow-up rates of the abnormal results of annual health examinations. Compared to the control group, the intervention group had a significantly decreased smoking rate in 246 companies (61.2%) and a reduced second-hand smoke exposure in 323 companies (78.6%) (p<0.001). By means of the intervention of WHP programs, we can enhance the awareness of the enterprises and the employees to improve worksite health and to create a healthy work environment. PMID:26954498

  11. Effect of Workplace Counseling Interventions Launched by Workplace Health Promotion and Tobacco Control Centers in Taiwan: An Evaluation Based on the Ottawa Charter.

    PubMed

    Chen, Tzu-Hua; Huang, Joh-Jong; Chang, Fong-Ching; Chang, Yu-Tsz; Chuang, Hung-Yi

    2016-01-01

    Workplace health promotion (WHP) is important to prevent work-related diseases, reduce workplace hazards, and improve personal health of the workers. Health promotion projects were launched through the centers of WHP funded by the Taiwan Bureau of Health Promotion since 2003. Hence, the aim of this study is to evaluate the impact of WHP programs intervention from 2003 to 2007. The intervention group consisted of 838 business entities which had ever undergone counseling of the three centers in northern, central, and southern Taiwan from 2003 to 2007. The control group was composed of 1000 business entities randomly selected from the business directories of the Ministry of Economic Affairs, Taiwan. The questionnaire survey included general company profiles and the assessment of workplace health according to the five action areas of the Ottawa Charter for Health Promotion. We have received 447 (53.3%) questionnaires from the intervention group and 97 questionnaires from the control group. The intervention group was more effective in using the external resources and medical consultation, and they had better follow-up rates of the abnormal results of annual health examinations. Compared to the control group, the intervention group had a significantly decreased smoking rate in 246 companies (61.2%) and a reduced second-hand smoke exposure in 323 companies (78.6%) (p<0.001). By means of the intervention of WHP programs, we can enhance the awareness of the enterprises and the employees to improve worksite health and to create a healthy work environment.

  12. Nutrition Assessment, Counseling, and Support (NACS) interventions to improve health-related outcomes in people living with HIV/AIDS: a systematic review of the literature

    PubMed Central

    Tang, AM; Quick, T; Chung, M; Wanke, CA

    2015-01-01

    Background While numerous studies have shown that severe to moderate wasting at the time of antiretroviral therapy (ART) initiation is strongly predictive of mortality, it remains unclear whether nutritional interventions at or prior to ART initiation will improve outcomes. This review examines data on nutrition assessment, counseling, and support (NACS) interventions in resource-limited settings. Methods We identified articles published between 2005 and 2014 on the effectiveness of NACS interventions, particularly its impact on five outcomes: mortality, morbidity, retention in care, quality of life, and/or prevention of ongoing HIV transmission. We rated the overall quality of individual articles and summarized the body of evidence and expected impact for each outcome. Results Twenty-one articles met all inclusion criteria. The overall quality of evidence was weak, predominantly due to few studies being designed to directly address the question of interest. Only two studies were randomized trials with proper control groups. The remainder were randomized studies of one type of food support versus another, cohort (non-randomized) studies, or single-arm studies. Ratings of individual study quality ranged from “medium” to “weak,” and the quality of the overall body of evidence ranged from “fair” to “poor.” We rated the expected impact on all outcomes as “uncertain.” Conclusion Rigorous, better designed studies in resource-limited settings are urgently needed to understand the effectiveness of nutrition assessment and counseling alone, as well as studies to understand better modalities of food support (targeting, timing, composition, form, and duration) to improve both short- and long-term patient retention in care and treatment, and clinical outcomes. PMID:25768873

  13. Physical activity counseling in overweight and obese primary care patients: Outcomes of the VA-STRIDE randomized controlled trial

    PubMed Central

    Gao, Shasha; Stone, Roslyn A.; Hough, Linda J.; Haibach, Jeffrey P.; Marcus, Bess H.; Ciccolo, Joseph T.; Kriska, Andrea M.; Burkitt, Kelly H.; Steenkiste, Ann R.; Berger, Marie A.; Sevick, Mary A.

    2015-01-01

    The purpose of this 2-arm randomized clinical trial was to evaluate the effectiveness of a 12-month, expert system-based, print-delivered physical activity intervention in a primary care Veteran population in Pittsburgh, Pennsylvania. Participants were not excluded for many health conditions that typically are exclusionary criteria in physical activity trials. The primary outcome measures were physical activity reported using the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire and an accelerometer-based activity assessment at baseline, 6, and 12 months. Of the 232 Veterans enrolled in the study, 208 (89.7%) were retained at the 6-month follow-up and 203 (87.5%) were retained at 12 months. Compared to the attention control, intervention participants had significantly increased odds of meeting the U.S. recommended guideline of ≥ 150 min/week of at least moderate-intensity physical activity at 12 months for the modified CHAMPS (odds ratio [OR] = 2.86; 95% CI: 1.03–7.96; p = 0.04) but not at 6 months (OR = 1.54; 95% CI: 0.56–4.23; p = 0.40). Based on accelerometer data, intervention participants had significantly increased odds of meeting ≥ 150 min/week of moderate-equivalent physical activity at 6 months (OR = 6.26; 95% CI: 1.26–31.22; p = 0.03) and borderline significantly increased odds at 12 months (OR = 4.73; 95% CI: 0.98–22.76; p = 0.053). An expert system physical activity counseling intervention can increase or sustain the proportion of Veterans in primary care meeting current recommendations for moderate-intensity physical activity. Trial Registration Clinical trials.gov identifier: NCT00731094 URL: http://www.clinicaltrials.gov/ct2/show/NCT00731094. PMID:26844197

  14. Development and Preliminary Testing of a Promotora-Delivered, Spanish Language, Counseling Intervention for Heavy Drinking among Male, Latino Day Laborers.

    PubMed

    Moore, Alison A; Karno, Mitchell P; Ray, Lara; Ramirez, Karina; Barenstein, Veronica; Portillo, Marlom J; Rizo, Patricia; Borok, Jenna; Liao, Diana H; Barron, Juan; del Pino, Homero E; Valenzuela, Abel; Barry, Kristin L

    2016-03-01

    This study developed and then tested the feasibility, acceptability and initial efficacy of a 3-session, culturally adapted, intervention combining motivational enhancement therapy (MET) and strengths-based case management (SBCM) delivered by promotoras in Spanish to reduce heavy drinking among male, Latino day laborers. A pilot two-group randomized trial (N=29) was conducted to evaluate the initial efficacy of MET/SBCM compared to brief feedback (BF). Alcohol-related measures were assessed at 6, 12 and 18weeks after baseline. Most intervention group participants (12/14) attended all counseling sessions and most participants (25/29) remained in the study at 18weeks. Alcohol related measures improved in both groups over time with no statistically significant differences observed at any of the time points. However the comparative effect size of MET/SBCM on weekly drinking was in the large range at 6-weeks and in the moderate range at 12-weeks. Post hoc analyses identified a statistically significant reduction in number of drinks over time for participants in the intervention group but not for control group participants. Despite the extreme vulnerability of the population, most participants completed all sessions of MET/SBCM and reported high satisfaction with the intervention. We feel our community partnership facilitated these successes. Additional studies of community-partnered and culturally adapted interventions are needed to reduce heavy drinking among the growing population of Latinos in the U.S.

  15. Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    Lahham, Aroub; McDonald, Christine F; Holland, Anne E

    2016-01-01

    Background Physical inactivity is associated with poor outcomes in COPD, and as a result, interventions to improve physical activity (PA) are a current research focus. However, many trials have been small and inconclusive. Objective The aim of this systematic review and meta-analysis was to study the effects of randomized controlled trials (RCTs) targeting PA in COPD. Methods Databases (Physiotherapy Evidence Database [PEDro], Embase, MEDLINE, CINAHL and the Cochrane Central Register for Controlled Trials) were searched using the following keywords: “COPD”, “intervention” and “physical activity” from inception to May 20, 2016; published RCTs that aimed to increase PA in individuals with COPD were included. The PEDro scale was used to rate study quality. Standardized mean differences (effect sizes, ESs) with 95% confidence intervals (CIs) were determined. Effects of included interventions were also measured according to the minimal important difference (MID) in daily steps for COPD (599 daily steps). Results A total of 37 RCTs with 4,314 participants (mean forced expiratory volume in one second (FEV1) % predicted 50.5 [SD=10.4]) were identified. Interventions including exercise training (ET; n=3 studies, 103 participants) significantly increased PA levels in COPD compared to standard care (ES [95% CI]; 0.84 [0.44–1.25]). The addition of activity counseling to pulmonary rehabilitation (PR; n=4 studies, 140 participants) showed important effects on PA levels compared to PR alone (0.47 [0.02–0.92]), achieving significant increases that exceeded the MID for daily steps in COPD (mean difference [95% CI], 1,452 daily steps [549–2,356]). Reporting of methodological quality was poor in most included RCTs. Conclusion Interventions that included ET and PA counseling during PR were effective strategies to improve PA in COPD. PMID:27994451

  16. Feasibility and acceptability of a multiple risk factor intervention: The Step Up randomized pilot trial

    PubMed Central

    2011-01-01

    Background Interventions are needed which can successfully modify more than one disease risk factor at a time, but much remains to be learned about the acceptability, feasibility, and effectiveness of multiple risk factor (MRF) interventions. To address these issues and inform future intervention development, we conducted a randomized pilot trial (n = 52). This study was designed to assess the feasibility and acceptability of the Step Up program, a MRF cognitive-behavioral program designed to improve participants' mental and physical well-being by reducing depressive symptoms, promoting smoking cessation, and increasing physical activity. Methods Participants were recruited from a large health care organization and randomized to receive usual care treatment for depression, smoking, and physical activity promotion or the phone-based Step Up counseling program plus usual care. Participants were assessed at baseline, three and six months. Results The intervention was acceptable to participants and feasible to offer within a healthcare system. The pilot also offered important insights into the optimal design of a MRF program. While not powered to detect clinically significant outcomes, changes in target behaviors indicated positive trends at six month follow-up and statistically significant improvement was also observed for depression. Significantly more experimental participants reported a clinically significant improvement (50% reduction) in their baseline depression score at four months (54% vs. 26%, OR = 3.35, 95% CI [1.01- 12.10], p = 0.05) and 6 months (52% vs. 13%, OR = 7.27, 95% CI [1.85 - 37.30], p = 0.004) Conclusions Overall, results suggest the Step Up program warrants additional research, although some program enhancements may be beneficial. Key lessons learned from this research are shared to promote the understanding of others working in this field. Trial registration The trial is registered with ClinicalTrials.gov (NCT00644995). PMID:21414216

  17. Using participatory mapping to inform a community-randomized trial of HIV counseling and testing

    PubMed Central

    Maman, Suzanne; Lane, Tim; Ntogwisangu, Jacob; Modiba, Precious; vanRooyen, Heidi; Timbe, Andrew; Visrutaratna, Surasing; Fritz, Katherine

    2014-01-01

    Participatory mapping and transect walks were used to inform the research and intervention design and to begin building community relations in preparation for Project Accept, a community-randomized trial sponsored by the U.S. National Institute of Mental Health (NIMH). NIMH Project Accept is being conducted in five sites within four countries including Thailand, Zimbabwe, South Africa and Tanzania. Results from the mapping exercises informed decisions about the research design such as defining community boundaries, and identifying appropriate criteria for matching community pairs for the trial. The mapping also informed intervention related decisions such as where to situate the services. The participatory methods enabled each site to develop an understanding of the communities that could not have been derived from existing data or data collected through standard data collection techniques. Furthermore, the methods lay the foundation for collaborative community research partnerships. PMID:25328451

  18. A theoretically based Behavioral Nutrition Intervention for Community Elders at high risk: the B-NICE randomized controlled clinical trial.

    PubMed

    Locher, Julie L; Bales, Connie W; Ellis, Amy C; Lawrence, Jeannine C; Newton, Laura; Ritchie, Christine S; Roth, David L; Buys, David L; Vickers, Kristin S

    2011-01-01

    We conducted a study designed to evaluate the efficacy and feasibility of a multilevel self-management intervention to improve nutritional intake in a group of older adults receiving Medicare home health services who were at especially high risk for experiencing undernutrition. The Behavioral Nutrition Intervention for Community Elders (B-NICE) trial used a prospective randomized controlled design to determine whether individually tailored counseling focused on social and behavioral aspects of eating resulted in increased caloric intake and improved nutrition-related health outcomes in a high-risk population of older adults. The study was guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory. The development and implementation of the B-NICE protocol, including the theoretical framework, methodology, specific elements of the behavioral intervention, and assurances of the treatment fidelity, as well as the health policy implications of the trial results, are presented in this article.

  19. Randomized Controlled Trial of Personalized Motivational Interventions in Substance Using Patients With Facial Injuries

    PubMed Central

    Shetty, Vivek; Murphy, Debra A.; Zigler, Corwin; Yamashita, Dennis-Duke R.; Belin, Thomas R.

    2011-01-01

    Purpose The proximate use of illicit drugs or alcohol (substance use) is the most common precipitator of facial injuries among socioeconomically disadvantaged populations. Reducing these risky behaviors could minimize adverse health sequelae and potential reinjury. The objective of our study was to test whether a culturally competent, personalized motivational intervention incorporated into surgical care could significantly reduce existing substance use behaviors in facial injury patients. Patients and Methods Substance-using subjects (n = 218) presenting with facial injuries to a level 1 trauma center were randomly assigned to either a personalized motivational intervention (PMI) condition or a health-information (HI) control condition. After a brief assessment of the individual’s substance use severity and willingness to change these behaviors, both groups attended 2 counseling sessions with a trained interventionist. The PMI subjects (n = 118) received individualized, motivational interventions, whereas the HI subjects (n = 100) received only general health information. Both groups were reassessed at 6 and 12 months postinjury, and changes in substance-use patterns were measured to assess the effects of intervention. Results The PMI and HI groups were closely matched on their sociodemographic and substance use characteristics. Subjects in the PMI group showed statistically significant declines in drug use at both the 6- and 12-month assessments. The intervention’s effect on lowering illicit drug use was greatest at the 6-month assessment but had weakened by the 1-year follow-up. The efficacy of the PMI was moderated by an individual’s initial drug use severity; individuals with greater drug use dependency at baseline were seen to have larger intervention effects, as did individuals who were most aware of their drug problem and willing to change their substance use behaviors. Unlike illicit drug use, changes in alcohol use did not differ significantly

  20. A Randomized Depression Prevention Trial Comparing Interpersonal Psychotherapy--Adolescent Skills Training to Group Counseling in Schools.

    PubMed

    Young, Jami F; Benas, Jessica S; Schueler, Christie M; Gallop, Robert; Gillham, Jane E; Mufson, Laura

    2016-04-01

    Given the rise in depression disorders in adolescence, it is important to develop and study depression prevention programs for this age group. The current study examined the efficacy of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), a group prevention program for adolescent depression, in comparison to group programs that are typically delivered in school settings. In this indicated prevention trial, 186 adolescents with elevated depression symptoms were randomized to receive IPT-AST delivered by research staff or group counseling (GC) delivered by school counselors. Hierarchical linear modeling examined differences in rates of change in depressive symptoms and overall functioning from baseline to the 6-month follow-up assessment. Cox regression compared rates of depression diagnoses. Adolescents in IPT-AST showed significantly greater improvements in self-reported depressive symptoms and evaluator-rated overall functioning than GC adolescents from baseline to the 6-month follow-up. However, there were no significant differences between the two conditions in onset of depression diagnoses. Although both intervention conditions demonstrated significant improvements in depressive symptoms and overall functioning, results indicate that IPT-AST has modest benefits over groups run by school counselors which were matched on frequency and duration of sessions. In particular, IPT-AST outperformed GC in reduction of depressive symptoms and improvements in overall functioning. These findings point to the clinical utility of this depression prevention program, at least in the short-term. Additional follow-up is needed to determine the long-term effects of IPT-AST, relative to GC, particularly in preventing depression onset.

  1. The Counseling Older Adults to Control Hypertension (COACH) trial: design and methodology of a group-based lifestyle intervention for hypertensive minority older adults.

    PubMed

    Ogedegbe, Gbenga; Fernandez, Senaida; Fournier, Leanne; Silver, Stephanie A; Kong, Jian; Gallagher, Sara; de la Calle, Franze; Plumhoff, Jordan; Sethi, Sheba; Choudhury, Evelyn; Teresi, Jeanne A

    2013-05-01

    The disproportionately high prevalence of hypertension and its associated mortality and morbidity in minority older adults is a major public health concern in the United States. Despite compelling evidence supporting the beneficial effects of therapeutic lifestyle changes on blood pressure reduction, these approaches remain largely untested among minority elders in community-based settings. The Counseling Older Adults to Control Hypertension trial is a two-arm randomized controlled trial of 250 African-American and Latino seniors, 60 years and older with uncontrolled hypertension, who attend senior centers. The goal of the trial is to evaluate the effect of a therapeutic lifestyle intervention delivered via group classes and individual motivational interviewing sessions versus health education, on blood pressure reduction. The primary outcome is change in systolic and diastolic blood pressure from baseline to 12 months. The secondary outcomes are blood pressure control at 12 months; changes in levels of physical activity; body mass index; and number of daily servings of fruits and vegetables from baseline to 12 months. The intervention group will receive 12 weekly group classes followed by individual motivational interviewing sessions. The health education group will receive an individual counseling session on healthy lifestyle changes and standard hypertension education materials. Findings from this study will provide needed information on the effectiveness of lifestyle interventions delivered in senior centers. Such information is crucial in order to develop implementation strategies for translation of evidence-based lifestyle interventions to senior centers, where many minority elders spend their time, making the centers a salient point of dissemination.

  2. Effects of dietary counselling on food habits and dietary intake of Finnish pregnant women at increased risk for gestational diabetes - a secondary analysis of a cluster-randomized controlled trial.

    PubMed

    Kinnunen, Tarja I; Puhkala, Jatta; Raitanen, Jani; Ahonen, Suvi; Aittasalo, Minna; Virtanen, Suvi M; Luoto, Riitta

    2014-04-01

    The incidence of gestational diabetes mellitus (GDM) is increasing and GDM might be prevented by improving diet. Few interventions have assessed the effects of dietary counselling on dietary intake of pregnant women. This study examined the effects of dietary counselling on food habits and dietary intake of Finnish pregnant women as secondary outcomes of a trial primarily aiming at preventing GDM. A cluster-randomized controlled trial was conducted in 14 municipalities in Finland, including 399 pregnant women at increased risk for developing GDM. The intervention consisted of dietary counselling focusing on dietary fat, fibre and saccharose intake at four routine maternity clinic visits. Usual counselling practices were continued in the usual care municipalities. A validated 181-item food frequency questionnaire was used to assess changes in diet from baseline to 26-28 and 36-37 weeks gestation. The data were analysed using multilevel mixed-effects linear regression models. By 36-37 weeks gestation, the intervention had beneficial effects on total intake of vegetables, fruits and berries (coefficient for between-group difference in change 61.6 g day(-1), 95% confidence interval 25.7-97.6), the proportions of high-fibre bread of all bread (7.2% units, 2.5-11.9), low-fat cheeses of all cheeses (10.7% units, 2.6-18.9) and vegetable fats of all dietary fats (6.1% -units, 2.0-10.3), and the intake of saturated fatty acids (-0.67 energy-%-units, -1.16 to -0.19), polyunsaturated fatty acids (0.38 energy-%-units, 0.18-0.58), linoleic acid (764 mg day(-1), 173-1354) and fibre (2.07 g day(-1) , 0.39-3.75). The intervention improved diet towards the recommendations in pregnant women at increased risk for GDM suggesting the counselling methods could be implemented in maternity care.

  3. Psychological and Educational Intervention to Improve Tuberculosis Treatment Adherence in Ethiopia Based on Health Belief Model: A Cluster Randomized Control Trial

    PubMed Central

    Shojaeizadeh, Davoud; Tol, Azar; Garmaroudi, Gholamreza; Yekaninejad, Mir Saeed; Kebede, Abebaw; Ejeta, Luche Tadesse; Kassa, Desta; Klinkenberg, Eveline

    2016-01-01

    Background Treatment non-adherence results in treatment failure, prolonged transmission of disease and emergence of drug resistance. Although the problem widely investigated, there remains an information gap on the effectiveness of different methods to improve treatment adherence and the predictors of non-adherence in resource limited countries based on theoretical models. This study aimed to evaluate the impact of psychological counseling and educational intervention on tuberculosis (TB) treatment adherence based on Health Belief Model (HBM). Methodology A cluster randomized control trial was conducted in Addis Ababa from May to December, 2014. Patients were enrolled into study consecutively from 30 randomly selected Health Centers (HCs) (14 HCs intervention and 16 HCs control groups). A total of 698 TB patients, who were on treatment for one month to two months were enrolled. A structured questionnaire was administered to both groups of patients at baseline and endpoint of study. Control participants received routine directly-observed anti-TB therapy and the intervention group additionally received combined psychological counseling and adherence education. Treatment non-adherence level was the main outcome of the study, and multilevel logistic regression was employed to assess the impact of intervention on treatment adherence. Results At enrollment, the level of non-adherence among intervention (19.4%) and control (19.6%) groups was almost the same. However, after intervention, non-adherence level decreased among intervention group from 19.4 (at baseline) to 9.5% (at endpoint), while it increased among control group from 19.4% (baseline) to 25.4% (endpoint). Psychological counseling and educational interventions resulted in significant difference with regard to non-adherence level between intervention and control groups (Adjusted OR = 0.31, 95% Confidence Interval (CI) (0.18–0.53), p < 0.001)). Conclusion Psychological counseling and educational interventions

  4. Intervention to Improve Follow-up for Abnormal Papanicolaou Tests: A Randomized Clinical Trial

    PubMed Central

    Breitkopf, Carmen Radecki; Dawson, Lauren; Grady, James J.; Breitkopf, Daniel M.; Nelson-Becker, Carolyn; Snyder, Russell R.

    2014-01-01

    Objective To evaluate the effect of a theory-based, culturally-targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test. Methods 5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to 1 of 3 groups to receive their results: Intervention (I): culturally-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7–14 days later with the CDDQ and CES-D. Results 299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p=0.73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p=0.77. Delay in care (in days) was (M ±SD): 58 ±75 (I), 69 ±72 (AC), and 54 ±75 (SCO), p=0.75. Adherence was associated with higher anxiety at notification, p<0.01 while delay <90 days (vs. 90+) was associated with greater perceived personal responsibility, p<0.05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p<0.05. Conclusions A theory-based, culturally-targeted message was not more effective than a non-targeted message or standard care in improving behavior. PMID:23730719

  5. Is Office-Based Counseling About Media Use, Timeouts, and Firearm Storage Effective? Results From a Cluster-Randomized, Controlled Trial

    PubMed Central

    Barkin, Shari L.; Finch, Stacia A.; Ip, Edward H.; Scheindlin, Benjamin; Craig, Joseph A.; Steffes, Jennifer; Weiley, Victoria; Slora, Eric; Altman, David; Wasserman, Richard C.

    2015-01-01

    Objective The objective of this study was to determine whether patients' families' violence-prevention behaviors would be affected by their primary care practitioner's use of a violence-prevention clinical intervention during the routine well-child examination. Methods In this cluster-randomized, controlled trial (2002–2006), 137 Pediatric Research in Office Settings practices were randomly assigned and initiated patient recruitment for either an office-based violence-prevention intervention or a control group (educational handout on literacy promotion provided). Primary caregivers of children who were aged 2 to 11 years and presented for a well-child visit were surveyed at baseline and 1 and 6 months. Practitioners were trained to (1) review a parent previsit summary regarding patient-family behavior and parental concern about media use, discipline strategies, and children's exposure to firearms, (2) counsel using brief principles of motivational interviewing, (3) identify and provide local agency resources for anger and behavior management when indicated, and (4) instruct patient-families on use of tangible tools (minute timers to monitor media time/timeouts and firearm cable locks to store firearms more safely where children live or play). Main outcomes were change over time in self-reported media use < 120 minutes per day, use of timeouts, and use of firearm cable locks. Results Generalized estimating equation analysis revealed a significant effect at 6 months for decreased media use and safer firearm storage. The intervention group compared with the control group showed an increase in limiting media use to < 120 minutes per day. There was no significant effect for timeout use. There was a substantial increase in storing firearms with cable locks for the intervention group versus a decrease for the control group. Conclusions This randomized, controlled trial demonstrated decreased media exposure and increased safe firearm storage as a result of a brief office

  6. Teaching tobacco dependence treatment and counseling skills during medical school: rationale and design of the Medical Students helping patients Quit tobacco (MSQuit) group randomized controlled trial

    PubMed Central

    Hayes, Rashelle B.; Geller, Alan; Churchill, Linda; Jolicoeur, Denise; Murray, David M.; Shoben, Abigail; David, Sean P.; Adams, Michael; Okuyemi, Kola; Fauver, Randy; Gross, Robin; Leone, Frank; Xiao, Rui; Waugh, Jonathan; Crawford, Sybil; Ockene, Judith K.

    2014-01-01

    INTRODUCTION Physician-delivered tobacco treatment using the 5As is clinically recommended, yet its use has been limited. Lack of adequate training and confidence to provide tobacco treatment are cited as leading reasons for limited 5A use. Tobacco dependence treatment training while in medical school is recommended, but is minimally provided. The MSQuit trial (Medical Students helping patients Quit tobacco) aims to determine if a multi-modal and theoretically-guided tobacco educational intervention will improve tobacco dependence treatment skills (i.e. 5As) among medical students. METHODS/DESIGN 10 U.S. medical schools were pair-matched and randomized in a group-randomized controlled trial to evaluate whether a multi-modal educational (MME) intervention compared to traditional education (TE) will improve observed tobacco treatment skills. MME is primarily composed of TE approaches (i.e. didactics) plus a 1st year web-based course and preceptor-facilitated training during a 3rd year clerkship rotation. The primary outcome measure is an objective score on an Objective Structured Clinical Examination (OSCE) tobacco-counseling smoking case among 3rd year medical students from schools who implemented the MME or TE. DISCUSSION MSQuit is the first randomized to evaluate whether a tobacco treatment educational intervention implemented during medical school will improve medical students’ tobacco treatment skills. We hypothesize that the MME intervention will better prepare students in tobacco dependence treatment as measured by the OSCE. If a comprehensive tobacco treatment educational learning approach is effective, while also feasible and acceptable to implement, then medical schools may substantially influence skill development and use of the 5As among future physicians. PMID:24486635

  7. A Randomized Clinical Trial of a Tailored Lifestyle Intervention for Obese, Sedentary, Primary Care Patients

    PubMed Central

    Eaton, Charles B.; Hartman, Sheri J.; Perzanowski, Elizabeth; Pan, Guohui; Roberts, Mary B.; Risica, Patricia M.; Gans, Kim M.; Jakicic, John M.; Marcus, Bess H.

    2016-01-01

    PURPOSE The aim of the study was to test a tailored lifestyle intervention for helping obese primary care patients achieve weight loss and increase physical activity. METHODS We conducted a 24-month randomized clinical trial in Rhode Island. Primary care physicians identified obese, sedentary patients motivated to lose weight and increase their moderate to vigorous physical activity. These patients were randomized to 1 of 2 experimental groups: enhanced intervention (EI) or standard intervention (SI). Both groups received 3 face-to-face weight loss meetings. The enhanced intervention group also received telephone counseling calls, individually tailored print materials, and DVDs focused on diet and physical activity. Active intervention occurred in year 1 with a tapered maintenance phase in year 2. RESULTS Two hundred eleven obese, sedentary patients were recruited from 24 primary care practices. Participants were 79% women and 16% minorities. They averaged 48.6 years of age, with a mean body mass index (BMI) of 37.8 kg/m2, and 21.2 minutes/week of moderate to vigorous physical activity. Significantly more EI participants lost 5% of their baseline weight than SI participants (group by visit, P <.001). The difference was significant during active treatment at 6 months (37.2% EI vs 12.9% SI) and 12 months (47.8% vs 11.6%), but was no longer significant during the maintenance phase at 18 months (31.4% vs 26.7%,) or 24 months (33.3% vs 24.6%). The EI group reported significantly more minutes of moderate to vigorous physical activity over time than the SI group (group by visit, P = 0.04). The differences in minutes per week at 6 months was 95.7 for the EI group vs 68.3 minutes for the SI group; at 12 months, it was 126.1 vs 73.7; at 18 months, 103.7 vs 63.7, and at 24 months, 101.3 vs 75.4. Similar trends were found for absolute weight loss and the percentage reaching national guidelines for physical activity. CONCLUSION A home-based tailored lifestyle intervention in

  8. Focused breastfeeding counselling improves short- and long-term success in an early-discharge setting: A cluster-randomized study.

    PubMed

    Nilsson, Ingrid M S; Strandberg-Larsen, Katrine; Knight, Christopher H; Hansen, Anne Vinkel; Kronborg, Hanne

    2017-02-14

    Length of postnatal hospitalization has decreased and has been shown to be associated with infant nutritional problems and increase in readmissions. We aimed to evaluate if guidelines for breastfeeding counselling in an early discharge hospital setting had an effect on maternal breastfeeding self-efficacy, infant readmission and breastfeeding duration. A cluster randomized trial was conducted and assigned nine maternity settings in Denmark to intervention or usual care. Women were eligible if they expected a single infant, intended to breastfeed, were able to read Danish, and expected to be discharged within 50 hr postnatally. Between April 2013 and August 2014, 2,065 mothers were recruited at intervention and 1,476 at reference settings. Results show that the intervention did not affect maternal breastfeeding self-efficacy (primary outcome). However, less infants were readmitted 1 week postnatally in the intervention compared to the reference group (adjusted OR 0.55, 95% CI 0.37, -0.81), and 6 months following birth, more infants were exclusively breastfed in the intervention group (adjusted OR 1.36, 95% CI 1.02, -1.81). Moreover, mothers in the intervention compared to the reference group were breastfeeding more frequently (p < .001), and spend more hours skin to skin with their infants (p < .001). The infants were less often treated for jaundice (p = 0.003) and there was more paternal involvement (p = .037). In an early discharge hospital setting, a focused breastfeeding programme concentrating on increased skin to skin contact, frequent breastfeeding, good positioning of the mother infant dyad, and enhanced involvement of the father improved short-term and long-term breastfeeding success.

  9. A randomized clinical trial of tailored interventions for health promotion and recidivism reduction among homeless parolees: outcomes and cost analysis

    PubMed Central

    Zhang, Sheldon; Salem, Benissa E.; Farabee, David; Hall, Betsy; Marlow, Elizabeth; Faucette, Mark; Bond, Doug; Yadav, Kartik

    2015-01-01

    Objectives This study conducted a randomized controlled trial with 600 recently released homeless men exiting California jails and prisons. Methods The purpose of this study was to primarily ascertain how different levels of intensity in peer coaching and nurse-partnered intervention programs may impact reentry outcomes; specifically: (a) an intensive peer coach and nurse case managed (PC-NCM) program; (b) an intermediate peer coaching (PC) program with brief nurse counseling; and (c) the usual care (UC) program involving limited peer coaching and brief nurse counseling. Secondary outcomes evaluated the operational cost of each program. Results When compared to baseline, all three groups made progress on key health-related outcomes during the 12-month intervention period; further, 84.5 % of all participants eligible for hepatitis A/B vaccination completed their vaccine series. The results of the detailed operational cost analysis suggest the least costly approach (i.e., UC), which accounted for only 2.11 % of the total project expenditure, was as effective in achieving comparable outcomes for this parolee population as the PC-NCM and PC approaches, which accounted for 53.98 % and 43.91 %, respectively, of the project budget. Conclusions In this study, all three intervention strategies were found to be comparable in achieving a high rate of vaccine completion, which over time will likely produce tremendous savings to the public health system. PMID:27217822

  10. Effectiveness of the Engagement and Counseling for Latinos (ECLA) Intervention in Low-Income Latinos

    PubMed Central

    Ludman, Evette; Kafali, Nilay; Lapatin, Sheri; Vila, Doriliz; Shrout, Patrick E.; Keefe, Kristen; Cook, Benjamin; Ault, Andrea; Li, Xinliang; Bauer, Amy; Epelbaum, Claudia; Alcantara, Carmela; Pineda, Tulia Inés Guerra; Tejera, Gloria Gonzalez; Suarez, Gloria; Leon, Karla; Lessios, Anna S.; Ramirez, Rafael R; Canino, Glorisa

    2014-01-01

    Background Persistent disparities in access and quality of mental health care for Latinos indicate a need for evidence-based, culturally adapted and outside-the-clinic-walls treatments. Objective Evaluate treatment effectiveness of telephone (ECLA –T) or face-to-face (ECLA-F) delivery of a 6–8 session cognitive behavioral therapy and care-management intervention for low-income Latinos, as compared to usual care for depression. Design Multi-site randomized controlled trial. Setting Eight community health clinics in Boston, Massachusetts and San Juan, Puerto Rico. Participants 257 Latino patients recruited from primary care between May 2011 and September 2012. Main Outcome Measures The primary outcome was severity of depression, assessed with the Patient Health Questionnaire-9 (PHQ-9) and the Hopkins Symptom Checklist-20 (HSCL-20). The secondary outcome was functioning over the previous 30 days, measured using the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). Results Both telephone and face-to-face versions of the ECLA were more effective than usual care. The effect sizes of both intervention conditions on PHQ-9 were moderate when combined data from both sites are analyzed (.56 and .64 for face-to-face and telephone, respectively). Similarly, effect sizes of ECLA-F and ECLA-T on the HSCL were quite large in the Boston site (.64 and .73. respectively) but not in Puerto Rico (.10 and .03). Conclusions and Relevance The intervention appears to help Latino patients reduce depressive symptoms and improve functioning. Of particular importance is the higher treatment initiation for the telephone vs. face-to-face intervention (89.7% vs. 78.8%), which suggests that telephone-based care may improve access and quality of care. PMID:25310525

  11. From Observation to Intervention: Development of a Psychoeducational Intervention to Increase Uptake of BRCA Genetic Counseling Among High-Risk Breast Cancer Survivors

    PubMed Central

    Malo, Teri L.; Nam, Kelli M.; Nelson, Alison; de la Cruz, Cara Z.; Quinn, Gwendolyn P.

    2015-01-01

    We describe the development of a psychoeducational intervention (PEI) to increase uptake of genetic counseling targeted to high-risk breast cancer survivors. Based on previous research, scientific literature, and a review of cancer education websites, we identified potential PEI content. We then assessed the initial acceptability and preference of two booklets of identical content but different layouts, by presenting the booklets to individuals with a personal or family history of breast cancer (n=57). The preferred booklet was evaluated by two focus groups of ten breast cancer patients who had not attended genetic counseling. The booklet was refined based on participants' feedback at each stage. Focus group participants generally found the booklet visually appealing, informative, and helpful, but some thought that it was too long. Final changes were made based on learner verification principles of attraction, comprehension, cultural acceptability, and persuasion. This project produced an interventional tool to present key constructs that may facilitate decision making about risk-appropriate genetic counseling uptake among high-risk breast cancer survivors. The process described for creating, testing, and adapting materials from a patient perspective can be used for developing other PEIs. This newly developed, unique PEI can be used in many clinical settings. PMID:24706196

  12. From observation to intervention: development of a psychoeducational intervention to increase uptake of BRCA genetic counseling among high-risk breast cancer survivors.

    PubMed

    Vadaparampil, Susan T; Malo, Teri L; Nam, Kelli M; Nelson, Alison; de la Cruz, Cara Z; Quinn, Gwendolyn P

    2014-12-01

    We describe the development of a psychoeducational intervention (PEI) to increase uptake of genetic counseling targeted to high-risk breast cancer survivors. Based on previous research, scientific literature, and a review of cancer education websites, we identified potential PEI content. We then assessed the initial acceptability and preference of two booklets of identical content but different layouts, by presenting the booklets to individuals with a personal or family history of breast cancer (n = 57). The preferred booklet was evaluated by two focus groups of ten breast cancer patients who had not attended genetic counseling. The booklet was refined based on participants' feedback at each stage. Focus group participants generally found the booklet visually appealing, informative, and helpful, but some thought that it was too long. Final changes were made based on learner verification principles of attraction, comprehension, cultural acceptability, and persuasion. This project produced an interventional tool to present key constructs that may facilitate decision making about risk-appropriate genetic counseling uptake among high-risk breast cancer survivors. The process described for creating, testing, and adapting materials from a patient perspective can be used for developing other PEIs. This newly developed, unique PEI can be used in many clinical settings.

  13. The effectiveness of physical activity monitoring and distance counseling in an occupational setting – Results from a randomized controlled trial (CoAct)

    PubMed Central

    2012-01-01

    Background Lack of physical activity (PA) is a known risk factor for many health conditions. The workplace is a setting often used to promote activity and health. We investigated the effectiveness of an intervention on PA and productivity-related outcomes in an occupational setting. Methods We conducted a randomized controlled trial of 12 months duration with two 1:1 allocated parallel groups of insurance company employees. Eligibility criteria included permanent employment and absence of any condition that risked the participant’s health during PA. Subjects in the intervention group monitored their daily PA with an accelerometer, set goals, had access to an online service to help them track their activity levels, and received counseling via telephone or web messages for 12 months. The control group received the results of a fitness test and an information leaflet on PA at the beginning of the study. The intervention’s aim was to increase PA, improve work productivity, and decrease sickness absence. Primary outcomes were PA (measured as MET minutes per week), work productivity (quantity and quality of work; QQ index), and sickness absence (SA) days at 12 months. Participants were assigned to groups using block randomization with a computer-generated scheme. The study was not blinded. Results There were 544 randomized participants, of which 521 were included in the analysis (64% female, mean age 43 years). At 12 months, there was no significant difference in physical activity levels between the intervention group (n = 264) and the control group (n = 257). The adjusted mean difference was −206 MET min/week [95% Bayesian credible interval −540 to 128; negative values favor control group]. There was also no significant difference in the QQ index (−0.5 [−4.4 to 3.3]) or SA days (0.0 [−1.2 to 0.9]). Of secondary outcomes, body weight (0.5 kg [0.0 to 1.0]) and percentage of body fat (0.6% [0.2% to 1.1%]) were slightly higher in the

  14. Project QUIT (Quit Using Drugs Intervention Trial): A randomized controlled trial of a primary care-based multi-component brief intervention to reduce risky drug use

    PubMed Central

    Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.

    2015-01-01

    Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p<0.005). No compensatory increases in use of other measured substances were found (p>0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159

  15. Effectiveness and Cost-Effectiveness of a Cluster-Randomized Prenatal Lifestyle Counseling Trial: A Seven-Year Follow-Up

    PubMed Central

    Kolu, Päivi; Raitanen, Jani; Puhkala, Jatta; Tuominen, Pipsa; Husu, Pauliina; Luoto, Riitta

    2016-01-01

    There is a link between the pregnancy and its long-term influence on health and susceptibility to future chronic disease both in mother and offspring. The objective was to determine whether individual counseling on physical activity and diet and weight gain at five antenatal visits can prevent type 2 diabetes mellitus (T2DM) and overweight or improve glycemic parameters, among all at-risk-mothers and their children. Another objective was to evaluate whether gestational lifestyle intervention was cost-effective as measured with mother’s sickness absence and quality-adjusted life years (QALY). This study was a seven-year follow-up study for women, who were enrolled to the antenatal cluster-randomized controlled trial (RCT). Analysis of the outcome included all women whose outcome was available, in addition with subgroup analysis including women adherent to all lifestyle aims. A total of 173 women with their children participated to the study, representing 43% (173/399) of the women who finished the original RCT. Main outcome measures were: T2DM based on medication use or fasting blood glucose or oral glucose tolerance test (OGTT), body mass index (BMI), glycosylated hemoglobin (HbA1c). None of the women were diagnosed to have T2DM. HbA1c or fasting blood glucose differences were not found among mothers or children. Differences in BMI were non-significant among mothers (Intervention 27.3, Usual care 28.1 kg/m2, p = 0.33) and children (I 21.3 vs U 22.5 kg/m2, p = 0.07). Children’s BMI was significantly lower among adherent group (I 20.5 vs U 22.5, p = 0.04). The mean total cost per person was 30.6% lower in the intervention group than in the usual care group (I €2,944 vs. U €4,243; p = 0.74). Intervention was cost-effective in terms of sickness absence but not in QALY gained i.e. if society is willing to pay additional €100 per one avoided sickness absence day; there is a 90% probability of the intervention arm to be cost-effective. Long-term effectiveness of

  16. Functional hypothalamic amenorrhoea: leptin treatment, dietary intervention and counselling as alternatives to traditional practice - systematic review.

    PubMed

    Kyriakidis, M; Caetano, L; Anastasiadou, N; Karasu, T; Lashen, H

    2016-03-01

    Functional hypothalamic amenorrhoea (FHA) is a neuroendocrine disorder caused by an energy deficit and characterized by low leptin levels. Based on this, previous studies have suggested that leptin administration may play a crucial role in FHA treatment. However, FHA is also associated with abnormal psychosocial and dietary behaviour that needs to be addressed. In this context, this systematic review examined the efficacy of leptin treatment, non-pharmacological therapy and nutritional interventions in FHA. PubMed, Medline and Cochrane Library databases were searched in order to find relevant papers, including randomized controlled trials, clinical trials, prospective studies and case reports. The effects of different treatments on reproductive function, hormonal status and bone markers were recorded. Studies regarding other forms of treatment were excluded. In total, 111 papers were retrieved. After the removal of 29 duplicate papers, the abstracts and titles of 82 papers were examined. Subsequently, 53 papers were excluded based on title, and seven papers were omitted based on abstract. The remaining 11 papers were used: three based on leptin treatment, three regarding non-pharmacological treatment and five regarding dietary intervention. This literature review indicates that all of these treatment strategies improved reproductive function and hormonal status significantly, although conclusive results could not be drawn on bone markers. While leptin may be a promising new treatment, social aspects of FHA should also be addressed. As a result, a multifaceted therapeutic approach should be applied to treat affected women.

  17. A teachable moment communication process for smoking cessation talk: description of a group randomized clinician-focused intervention

    PubMed Central

    2012-01-01

    Background Effective clinician-patient communication about health behavior change is one of the most important and most overlooked strategies to promote health and prevent disease. Existing guidelines for specific health behavior counseling have been created and promulgated, but not successfully adopted in primary care practice. Building on work focused on creating effective clinician strategies for prompting health behavior change in the primary care setting, we developed an intervention intended to enhance clinician communication skills to create and act on teachable moments for smoking cessation. In this manuscript, we describe the development and implementation of the Teachable Moment Communication Process (TMCP) intervention and the baseline characteristics of a group randomized trial designed to evaluate its effectiveness. Methods/Design This group randomized trial includes thirty-one community-based primary care clinicians practicing in Northeast Ohio and 840 of their adult patients. Clinicians were randomly assigned to receive either the Teachable Moments Communication Process (TMCP) intervention for smoking cessation, or the delayed intervention. The TMCP intervention consisted of two, 3-hour educational training sessions including didactic presentation, skill demonstration through video examples, skills practices with standardized patients, and feedback from peers and the trainers. For each clinician enrolled, 12 patients were recruited for two time points. Pre- and post-intervention data from the clinicians, patients and audio-recorded clinician‒patient interactions were collected. At baseline, the two groups of clinicians and their patients were similar with regard to all demographic and practice characteristics examined. Both physician and patient recruitment goals were met, and retention was 96% and 94% respectively. Discussion Findings support the feasibility of training clinicians to use the Teachable Moments Communication Process. The next steps

  18. A multicomponent behavioral intervention to reduce stroke risk factor behaviors: The SHARE Cluster-Randomized Controlled Trial

    PubMed Central

    Brown, Devin L.; Conley, Kathleen M.; Sánchez, Brisa N.; Resnicow, Kenneth; Cowdery, Joan E.; Sais, Emma; Murphy, Jillian; Skolarus, Lesli E.; Lisabeth, Lynda D.; Morgenstern, Lewis B.

    2015-01-01

    Background and Purpose The Stroke Health and Risk Education (SHARE) Project was a cluster-randomized, faith-based, culturally-sensitive, theory-based multicomponent behavioral intervention trial to reduce key stroke risk factor behaviors in Hispanics/Latinos and European Americans. Methods Ten Catholic churches were randomized to intervention or control group. The intervention group received a 1-year multicomponent intervention (with poor adherence) that included self-help materials, tailored newsletters, and motivational interviewing counseling calls. Multilevel modeling, accounting for clustering within subject pairs and parishes, was used to test treatment differences in the average change since baseline (ascertained at 6 and 12 months) in dietary sodium, fruit and vegetable intake, and physical activity, measured using standardized questionnaires. A priori, the trial was considered successful if any one of the three outcomes was significant at the 0.05/3 level. Results Of 801 subjects who consented, 760 completed baseline data assessments, and of these, 86% completed at least one outcome assessment. The median age was 53; 84% were Hispanic/Latino; 64% were women. The intervention group had a greater increase in fruit and vegetable intake than the control group (0.25 cups per day (95% CI: 0.08, 0.42), p = 0.002), a greater decrease in sodium intake (−123.17 mg/day (−194.76, −51.59), p=0.04), but no difference in change in moderate or greater intensity physical activity (−27 MET-minutes per week (−526, 471), p=0.56). Conclusions This multicomponent behavioral intervention targeting stroke risk factors in predominantly Hispanics/Latinos was effective in increasing fruit and vegetable intake, reaching its primary endpoint. The intervention also seemed to lower sodium intake. Church-based health promotions can be successful in primary stroke prevention efforts. PMID:26374480

  19. Breastfeeding peer counseling: from efficacy through scale-up.

    PubMed

    Chapman, Donna J; Morel, Katherine; Anderson, Alex Kojo; Damio, Grace; Pérez-Escamilla, Rafael

    2010-08-01

    An increasing number of publications have evaluated various breastfeeding peer counseling models. This article describes a systematic review of (a) the randomized trials assessing the effectiveness of breastfeeding peer counseling in improving rates of breastfeeding initiation, duration, exclusivity, and maternal and child health outcomes and (b) scientific literature describing the scale-up of breastfeeding peer counseling programs. Twenty-six peer-reviewed publications were included in this review. The overwhelming majority of evidence from randomized controlled trials evaluating breastfeeding peer counseling indicates that peer counselors effectively improve rates of breastfeeding initiation, duration, and exclusivity. Peer counseling interventions were also shown to significantly decrease the incidence of infant diarrhea and significantly increase the duration of lactational amenorrhea. Breastfeeding peer counseling initiatives are effective and can be scaled up in both developed and developing countries as part of well-coordinated national breastfeeding promotion or maternal-child health programs.

  20. A Description and Qualitative Assessment of a 4-Year Intervention to Improve Patient Counseling by Improving Medical Student Health

    PubMed Central

    Frank, Erica; Smith, Donna; Fitzmaurice, Dorothy

    2005-01-01

    Background To test whether promoting medical student health could efficiently improve patient counseling, we developed and implemented a 4-year-long curricular and extracurricular intervention to promote healthy behaviors among students in the Class of 2003 at Emory University School of Medicine, Atlanta, Georgia. Methods We asked students: (1) “What did you think about these [listed intervention components]”; (2) “did any of these interventions influence your personal health habits/attitudes toward your personal health”; and (3) “did any of these interventions influence your behavior or attitudes regarding current or future clinical practices, including history taking or counseling? If so, how? If not, why not?” Students evaluated the effectiveness of these formats and proposed changes in our intervention. The focus groups were transcribed and analyzed with QSR N5. Results Several major themes emerged from the focus groups: Listen to the students early, often, substantively, and noticeably;Incorporate many faculty and student leaders;Quietly integrate the curricular activities into the regular curriculum;Provide a strong, science-based, pragmatic prevention curriculum to complement the personal health promotion;Don't just use lectures to teach;Offer plentiful, nonrequired, fun extracurriculars;Don't nag;Have achievable interventions and recommendations;Provide collective data, but don't overexpose the students to it, and don't assume that collective data apply to every student, especially if it's unpleasant news;Provide personalized data where possible; andUncouple evaluations from the intervention, and keep evaluations brief. Conclusions Some students seemed pleased to have their medical school be attentive to their health, and believed that the project positively influenced their personal health practices and clinical practices (which was our goal). The students enjoyed many components of the intervention, especially the extracurricular activities

  1. The effect of minimal dietary changes with raisins in NAFLD patients with non-significant fibrosis: a randomized controlled intervention.

    PubMed

    Kaliora, Andriana C; Kokkinos, Alexander; Diolintzi, Anastacia; Stoupaki, Maria; Gioxari, Aristea; Kanellos, Panagiotis T; Dedoussis, George V Z; Vlachogiannakos, Jiannis; Revenas, Constantinos; Ladas, Spiros D; Karathanos, Vaios T

    2016-11-09

    Aiming at investigating the potential effect of minimal dietary changes in NAFLD patients with non-significant fibrosis, 55 patients with NAFLD were enrolled in a randomized controlled clinical trial. Patients were assigned into two isocaloric dietary treatment groups for 24 weeks: (a) nutritional counseling (Control arm, N = 27), (b) nutritional counseling with currants included (two fruit servings, 36 g per day), substituting snacks of similar caloric content (Currant arm, N = 28). Clinical tests, anthropometrics, inflammatory and oxidative stress markers were conducted pre- and post-intervention. A total of 50 patients completed the trial. Significant differences between the two arms post-intervention were observed in fasting glucose and in IL-6 levels, these being significantly decreased only in Currant patients. Body weight, BMI, HbA1c, CRP and EUS values decreased in both arms, differences being insignificant between the two arms post-intervention. Participants in the Currant arm had significantly reduced total body fat, WC and trunk fat. Ultrasound scanning improved significantly in patients snacking currants daily. Also, volunteers enrolled in the Currant arm showed a reduced intake of saturated fatty acids. Because BW regulation has been officially recognised as a treatment approach in NAFLD an additional analysis was repeated in patients adhering to this. Post-intervention, the decrease in IL-6 and in fasting glucose was significantly higher in Currant patients who lost BW compared to their counterparts in the Control arm. Conclusively, minimal modifications in snacking choices, such as the inclusion of dried grapes in diet, are beneficial in NAFLD patients with non-significant fibrosis.

  2. Possible site-specific effect of an intervention combining nutrition and lifestyle counselling with consumption of fortified dairy products on bone mass: the Postmenopausal Health Study II.

    PubMed

    Moschonis, George; Kanellakis, Spyridon; Papaioannou, Nikolaos; Schaafsma, Anne; Manios, Yannis

    2011-07-01

    The aim of the present study was to examine whether a holistic approach combining nutrition and lifestyle counselling with the consumption of milk and yoghurt enriched with calcium, vitamin D(3) and phylloquinone (vitamin K(1)) or menaquinone (vitamin K(2)) would have any additional benefit on bone mineral density (BMD) indices measured at various skeletal sites using two different techniques, dual energy X-ray absorptiometry and quantitative ultrasonography (QUS). A sample of 115 postmenopausal women were randomized to three intervention groups, receiving daily via fortified milk and yoghurt and for 12 months, 800 mg calcium and 10 μg vitamin D(3) (CaD group, n = 26); 800 mg calcium, 10 μg vitamin D(3) and 100 μg vitamin K(1) (CaDK1 group, n = 26); 800 mg calcium, 10 μg vitamin D(3) and 100 μg vitamin K(2) (CaDK2 group, n = 24); and a control group (CO group, n = 39) following their usual diet. All three intervention groups attended biweekly nutrition and lifestyle counselling sessions. Total BMD significantly increased in all three intervention groups and these changes were significantly higher compared to the CO (P < 0.001). Furthermore, the significant increases observed for L2-L4 BMD in the CaDK1 and CaDK2 groups were found to be significantly higher compared to the decrease observed in the CO (P = 0.001). No significant differences were observed for QUS parameters. The combined approach used in the current study led to favourable changes for all three intervention groups in total body BMD, while an additional benefit was observed for L2-L4 BMD in CaDK1 and CaDK2 groups. No significant differences were observed among groups in any of the QUS parameters.

  3. Randomized trial outcomes of a TTM-tailored condom use and smoking intervention in urban adolescent females

    PubMed Central

    Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.

    2015-01-01

    Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females were recruited and randomized within four urban family planning clinics. Participants received TTM or standard care (SC) computerized feedback and stage-targeted or SC counseling at baseline, 3, 6 and 9 months. Blinded follow-up telephone surveys were conducted at 12 and 18 months. Analyses revealed significantly more consistent condom use in the TTM compared with the SC group at 6 and 12, but not at 18 months. In baseline consistent condom users (40%), significantly less relapse was found in the TTM compared with the SC group at 6 and 12, but not at 18 months. No significant effects for smoking prevention or cessation were found, although cessation rates matched those found previously. This TTM-tailored intervention demonstrated effectiveness for increasing consistent condom use at 6 and 12 months, but not at 18 months, in urban adolescent females. This intervention, if replicated, could be disseminated to promote consistent condom use and additional health behaviors in youth at risk. PMID:24794584

  4. Brief intervention to promote smoking cessation and improve glycemic control in smokers with type 2 diabetes: a randomized controlled trial

    PubMed Central

    Li, William H. C.; Wang, M. P.; LAM, T. H.; Cheung, Yannes T. Y.; Cheung, Derek Y. T.; Suen, Y. N.; Ho, K. Y.; Tan, Kathryn C. B.; CHAN, Sophia S. C.

    2017-01-01

    The aim of the study was to examine the effects of a brief stage-matched smoking cessation intervention group compared with a control group (with usual care) in type 2 diabetes mellitus patients who smoked by randomized controlled trial. There were 557 patients, randomized either into the intervention group (n = 283) who received brief (20- minute) individualized face-to-face counseling by trained nurses and a diabetes mellitus-specific leaflet, or a control group (n = 274) who received standard care. Patient follow-ups were at 1 week, 1 month, 3 months, 6 months, and 12 months via telephone, and assessment of smoking status from 2012 to 2014. Patients smoked an average of 14 cigarettes per day for more than 37 years, and more than 70% were in the precontemplation stage of quitting. The primary outcome showed that both the intervention and control groups had similar 7-day point-prevalence smoking abstinence (9.2% vs. 13.9%; p = 0.08). The secondary outcome showed that HbA1c levels with 7.95% [63 mmol/mol] vs. 8.05% [64 mmol/mol], p = 0.49 at 12 months, respectively. There was no evidence for effectiveness in promoting the brief stage-matched smoking cessation or improving glycemic control in smokers with type 2 diabetes mellitus, particularly those in the pre-contemplation stage. PMID:28378764

  5. A Randomized Clinical Trial of a Telephone Depression Intervention to Reduce Employee Presenteeism and Absenteeism

    PubMed Central

    Lerner, Debra; Adler, David A.; Rogers, William H.; Chang, Hong; Greenhill, Annabel; Cymerman, Elina; Azocar, Francisca

    2015-01-01

    Objectives The study tested an intervention aimed at improving work functioning among middle-aged and older adults with depression and work limitations. Methods A randomized clinical trial allocated an initial sample of 431 eligible employed adults (age ≥45) to a work-focused intervention (WFI) or usual care. Inclusion criteria were depression as measured by the Patient Health Questionnaire–9 (PHQ-9) and at-work limitations indicated by a productivity loss score ≥5% on the Work Limitations Questionnaire (WLQ). Study sites included 19 employers and five related organizations. Telephone-based counseling provided three integrated modalities: care coordination, cognitive-behavioral therapy strategy development, and work coaching and modification. Effectiveness (change in productivity loss scores from preintervention to four months postintervention) was tested with mixed models adjusted for confounders. Secondary outcomes included change in WLQ work performance scales, self-reported absences, and depression. Results Of 1,227 eligible employees (7% of screened), 431 (35%) enrolled and 380 completed the study (12% attrition). At-work productivity loss improved 44% in the WFI group versus 13% in usual care (difference in change, p<.001). WFI group scores on the four WLQ scales improved 44% to 47%, significantly better than in usual care (p<.001 for each scale). Absence days declined by 53% in the WFI group versus 13% in usual care (difference in change, p<.001). Mean PHQ-9 depression symptom severity scores declined 51% for WFI versus 26% for usual care (difference in change, p<.001). Conclusions The WFI was more effective than usual care at four-month follow-up. Given increasing efforts to provide more patient-centered, value-based care, the WFI could be an important resource. PMID:25726984

  6. Long-term lifestyle interventions in middle-aged and elderly men with nonalcoholic fatty liver disease: a randomized controlled trial

    PubMed Central

    Dong, Fangyuan; Zhang, Yan; Huang, Yiqin; Wang, Yiqian; Zhang, Gansheng; Hu, Xiaona; Wang, Jiaofeng; Chen, Jie; Bao, Zhijun

    2016-01-01

    Nonalcoholic fatty liver disease (NAFLD), a metabolic disorder related to insulin resistance and metabolic syndrome, has become a public health concern. Currently, the principal therapeutic modalities targeting NAFLD are lifestyle interventions. However, the efficacy of long-term lifestyle interventions in managing NAFLD remains largely unexplored. This study aimed to evaluate the efficacy of long-term lifestyle interventions in middle-aged and elderly men with NAFLD. All 280 eligible patients were randomized to the control or test group. Patients in the test group received counseling on diet and exercise from 2 physicians every 3 months via a phone call. Patients in the control group received only counseling in annual checkups without regular intervention. After the 2-year periodic intervention, body weight, abdominal circumference, ALT, TCH, LDL-C and HDL-C decreased in the test group. Specifically, the fatty liver index (FLI) and NAFLD-fibrosis score (NAFLD-FS) reduced markedly in the test group. However, in the control group, there was only a significant decrease in LDL-C, HDL-C and NAFLD-FS (P < 0.001). The liver steatosis grade of the test group decreased significantly, while it increased in the control group. In NAFLD, long-term lifestyle interventions exert an anti-obesity effect and attenuate liver dysfunction and steatosis. PMID:27830836

  7. Nutrition intervention for migraine: a randomized crossover trial

    PubMed Central

    2014-01-01

    Background Limited evidence suggests that dietary interventions may offer a promising approach for migraine. The purpose of this study was to determine the effects of a low-fat plant-based diet intervention on migraine severity and frequency. Methods Forty-two adult migraine sufferers were recruited from the general community in Washington, DC, and divided randomly into two groups. This 36-week crossover study included two treatments: dietary instruction and placebo supplement. Each treatment period was 16 weeks, with a 4-week washout between. During the diet period, a low-fat vegan diet was prescribed for 4 weeks, after which an elimination diet was used. Participants were assessed at the beginning, midpoint, and end of each period. Significance was determined using student’s t-tests. Results Worst headache pain in last 2 weeks, as measured by visual analog scale, was initially 6.4/10 cm (SD 2.1 cm), and declined 2.1 cm during the diet period and 0.7 cm during the supplement period (p=0.03). Average headache intensity (0–10 scale) was initially 4.2 (SD 1.4) per week, and this declined by 1.0 during the diet period and by 0.5 during the supplement period (p=0.20). Average headache frequency was initially 2.3 (SD 1.8) per week, and this declined by 0.3 during the diet period and by 0.4 during the supplement period (p=0.61). The Patient’s Global Impression of Change showed greater improvement in pain during the diet period (p<0.001). Conclusions These results suggest that a nutritional approach may be a useful part of migraine treatment, but that methodologic issues necessitate further research. Trial registration Clinicaltrials.gov, NCT01699009 and NCT01547494. PMID:25339342

  8. Evaluating Non-Randomized Educational Interventions: A Graphical Discussion

    ERIC Educational Resources Information Center

    Theobald, Roddy; Richardson, Thomas

    2014-01-01

    A central goal of the education literature is to demonstrate that specific educational interventions--instructional interventions at the student or classroom level, structural interventions at the school level, or funding interventions at the school district level, for example--have a "treatment effect" on student achievement. This paper…

  9. Helping Her Heal: a pilot study of an educational counseling intervention for spouses of women with breast cancer.

    PubMed

    Lewis, Frances Marcus; Cochrane, Barbara B; Fletcher, Kristin A; Zahlis, Ellen H; Shands, Mary Ellen; Gralow, Julie R; Wu, Salene M; Schmitz, KrisAnn

    2008-02-01

    Breast cancer is known to cause substantial anxiety, depressed mood, and diminished marital functioning in the diagnosed woman's spouse. Despite the scope and magnitude of these issues, few intervention studies have included spouses or addressed the causes of their lower functioning. The purpose of this pilot study was to evaluate the short-term impact of a 5-session, clinic-based, educational counseling intervention for spouses whose wife was recently diagnosed with early stage breast cancer. The goals of the intervention were to enhance spouses' skills and confidence to communicate and interpersonally support his wife about the breast cancer as well as improve spouses' self-care, depressed mood, anxiety, and marital adjustment. Pre-post-test results obtained from 20 spouses from valid and reliable standardized questionnaires showed significant improvements in spouses' depressed mood, anxiety, skills, self-confidence, and self-care. Confidential post-intervention interviews with spouses and wives included detailed examples of positive changes in the spouse's communication and support to his wife about the breast cancer, diminished tension in the spouse, and improved quality in the couple's relationship. Further evaluation of the Helping Her Heal Program is warranted within a clinical trial.

  10. Patient-centered care interventions for the management of alcohol use disorders: a systematic review of randomized controlled trials

    PubMed Central

    Barrio, Pablo; Gual, Antoni

    2016-01-01

    Issues Patient-centered care (PCC) is increasingly accepted as an integral component of good health care, including addiction medicine. However, its implementation has been controversial in people with alcohol use disorders. Approach A systematic search strategy was devised to find completed randomized controlled trials enrolling adults (>18 years) with alcohol use disorders. Studies had to use a PCC approach such that they should have been individualized, respectful to the patients’ own goals, and empowering. Studies until September 2015 were searched using PubMed, Scopus, the Cochrane Library, PsychINFO, and Web of Knowledge. Key findings In total, 40 studies enrolling 16,020 patients met the inclusion criteria. Assessment revealed two main categories of study: psychosocial (n=35 based on motivational interviewing) and pharmacological (n=5 based on an as needed dosing regimen). Psychosocial interventions were further classified according to the presence or absence of an active comparator. When no active comparator was present, studies were classified according to the number of sessions (≥1). Results from single sessions of motivational interviewing showed no clear benefit on alcohol consumption outcomes, with few studies indicating benefit of PCC versus control. Although the results for studies of multiple sessions of counseling were also mixed, many did show a significant benefit of the PCC intervention. By contrast, studies consistently demonstrated a benefit of pharmacologically supported PCC interventions, with most of the differences reaching statistical significance. Implications PCC-based interventions may be beneficial for reducing alcohol consumption in people with alcohol use disorders. PMID:27695301

  11. Citalopram Intervention for Hostility: Results of a Randomized Clinical Trial

    PubMed Central

    Kamarck, Thomas W.; Haskett, Roger F.; Muldoon, Matthew; Flory, Janine D.; Anderson, Barbara; Bies, Rob; Pollock, Bruce; Manuck, Stephen B.

    2009-01-01

    Hostility is associated with an increased risk for cardiovascular disease (CVD). Because central serotonin may modulate aggression, we might expect selective serotonin reuptake inhibitors (SSRIs) to be effective in reducing hostility. Such effects have never been examined in individuals scoring high on hostility who are otherwise free from major DSM-IV Axis I psychopathology. 159 participants (ages 30–50, 50 % female) scoring high on 2 measures of hostility and with no current major Axis I diagnosis were randomly assigned to 2 months of citalopram (40 mg, fixed flexible dose) or placebo. Adherence was assessed by electronic measurement and by drug exposure assessment. Treated subjects showed larger reductions in state anger (condition-by-time p = .01), hostile affect (p = 02), and, among women only, physical and verbal aggression (p = .005) relative to placebo controls. Treatment was also associated with relative increases in perceived social support (p = .04). Findings have implications for understanding the CNS correlates of hostility, its associations with other psychosocial risk factors for CVD, and, potentially, for the design of effective interventions. PMID:19170463

  12. Randomized Impact Evaluation of Education Interventions: Experiences and Lessons from a Reading to Learn Intervention in East Africa

    ERIC Educational Resources Information Center

    Ngware, Moses Waithanji; Abuya, Benta; Oketch, Moses; Admassu, Kassahun; Mutisya, Maurice; Musyoka, Peter

    2015-01-01

    This paper presents the experiences and lessons learnt during the design and implementation of the randomized impact evaluation (IE) of a reading to learn (RtL) intervention in early primary grades. The study was to assess the impact of RtL on literacy and numeracy among pupils in low-performing districts in East Africa. The intervention was…

  13. Evaluating the Impact of an Anti-stigma Intervention on Pharmacy Students' Willingness to Counsel People Living with Mental Illness.

    PubMed

    Bamgbade, Benita A; Barner, Jamie C; Ford, Kentya H

    2016-12-15

    Third-year pharmacy students (n = 88) participated in an anti-stigma intervention program consisting of presentations, videos, discussion and active-learning exercises. Willingness to counsel (WTC) people with mental illness (MI) was evaluated using immediate pre and post-tests comparing diabetes, depression and schizophrenia. At pre-test, WTC diabetes was highest (higher = increased WTC) while schizophrenia was the lowest. There were no statistically significant differences between pre/post-test WTC for diabetes and depression, while schizophrenia WTC increased significantly (p < 0.05). At post-test, diabetes WTC was significantly higher than depression and schizophrenia (p < 0.0001). Regression results for WTC depression showed that comfortability and gender were significant (p < 0.05) predictors. Regression results for WTC schizophrenia showed that comfortability was a significant (p < 0.05) predictor. As highly accessible healthcare providers, pharmacists have the potential to positively impact healthcare, but this depends on WTC. Colleges of pharmacy may consider instituting policies that support experiential education involving counseling people living with MI, as this may increase comfortability.

  14. How Do Perceptions About Cessation Outcomes Moderate the Effectiveness of a Gain-Framed Smoking Cessation Telephone Counseling Intervention?

    PubMed Central

    Latimer-Cheung, Amy E.; Fucito, Lisa M.; Carlin-Menter, Shannon; Rodriguez, Jocelyn; Raymond, Lindsey; Salovey, Peter; Makuch, Robert; Cummings, K. Michael; Toll, Benjamin A.

    2013-01-01

    The distinction between prevention and detection behaviors provides a useful guideline for appropriately framing health messages in terms of gains or losses. However, this guideline assumes that everyone perceives the outcomes associated with a behavior in a consistent manner, as prevention or detection. Individuals’ perceptions of a behavior vary, and so the effects of framed messages may be optimized by considering individuals’ perceptions rather than the prevention or detection function of the behavior. The authors tested this message-framing paradigm in a secondary analysis of data from a trial evaluating gain-framed smoking cessation counseling delivered through a state quitline (Toll et al., 2010). Smokers (N = 2,032) who called a state quitline received either gain-framed or standard care messages. Smokers’ beliefs about the positive consequences of stopping smoking (outcome expectancies) were evaluated at baseline. Smoking status and self-efficacy were assessed at 3 months. Outcome expectancies moderated the framing effects among men but not among women. Men in the gain-framed counseling condition who had positive outcome expectancies were more likely to quit and had more confidence in their ability to quit or to remain abstinent than men who were uncertain of the positive outcome of smoking cessation. Among men, self-efficacy mediated the moderated framing effects of the intervention on quit status. These findings suggest that it may be useful to consider sex and individual differences in outcome expectancies when delivering gain-framed smoking cessation messages in the context of a state quitline. PMID:22765277

  15. How do perceptions about cessation outcomes moderate the effectiveness of a gain-framed smoking cessation telephone counseling intervention?

    PubMed

    Latimer-Cheung, Amy E; Fucito, Lisa M; Carlin-Menter, Shannon; Rodriguez, Jocelyn; Raymond, Lindsey; Salovey, Peter; Makuch, Robert; Cummings, K Michael; Toll, Benjamin A

    2012-01-01

    The distinction between prevention and detection behaviors provides a useful guideline for appropriately framing health messages in terms of gains or losses. However, this guideline assumes that everyone perceives the outcomes associated with a behavior in a consistent manner, as prevention or detection. Individuals' perceptions of a behavior vary, and so the effects of framed messages may be optimized by considering individuals' perceptions rather than the prevention or detection function of the behavior. The authors tested this message-framing paradigm in a secondary analysis of data from a trial evaluating gain-framed smoking cessation counseling delivered through a state quitline (Toll et al., 2010 ). Smokers (N = 2,032) who called a state quitline received either gain-framed or standard care messages. Smokers' beliefs about the positive consequences of stopping smoking (outcome expectancies) were evaluated at baseline. Smoking status and self-efficacy were assessed at 3 months. Outcome expectancies moderated the framing effects among men but not among women. Men in the gain-framed counseling condition who had positive outcome expectancies were more likely to quit and had more confidence in their ability to quit or to remain abstinent than men who were uncertain of the positive outcome of smoking cessation. Among men, self-efficacy mediated the moderated framing effects of the intervention on quit status. These findings suggest that it may be useful to consider sex and individual differences in outcome expectancies when delivering gain-framed smoking cessation messages in the context of a state quitline.

  16. Comparative Effectiveness of a Practice-Based Comprehensive Lifestyle Intervention vs. Single Session Counseling in Hypertensive Blacks

    PubMed Central

    Schoenthaler, Antoinette; Luerassi, Leanne; Silver, Stephanie; Odedosu, Taiye; Kong, Jian; Ravenell, Joseph; Teresi, Jeanne A.

    2016-01-01

    BACKGROUND Although the efficacy of therapeutic lifestyle change (TLC) interventions are well proven, their relative effectiveness vs. single-session lifestyle counseling (SSC) on blood pressure (BP) reduction in primary care practices remains largely untested in hypertensive Blacks. The aim of this trial was to evaluate the comparative effectiveness of a comprehensive practice-based TLC intervention (motivational interviewing (MINT)-TLC) vs. SSC on BP reduction among 194 Blacks with uncontrolled hypertension. METHODS The MINT-TLC arm included 10 weekly group classes on TLC, followed by 3 individual MINT sessions. The SSC group received 1 individual counseling session on lifestyle modification plus print versions of the intervention material. The primary outcome was within-patient change in systolic BP (SBP) and diastolic BP (DBP) from baseline to 6 months. The secondary outcome was BP control at 6 months. RESULTS Mean age of the total sample was 57 (10.2) years; 50% were women, and the mean baseline BP was 147.4/89.3mm Hg. Eighty-four percent of SSC and 77% of MINT-TLC patients completed the final 6-month assessments. BP declined significantly (P < 0.001) in both groups at 6 months with a net-adjusted systolic BP reduction of 12.9mm Hg for the SSC group vs. 9.5mm Hg for the MINT-TLC group (P = 0.18); and diastolic BP reduction of 7.6 and 7.2mm Hg for the SSC and MINT-TLC group, respectively (P = 0.79). The between-group difference in proportion of patients with adequate BP control at 6 months was nonsignificant (P = 0.82). CONCLUSION A significant group difference in BP between the intervention groups was not observed among a sample of hypertensive Blacks. Implementation of the pragmatic single-session intervention and its effects on utilization of healthcare services should be further evaluated. CLINICAL TRIAL REGISTRATION Trial Number NCT01070056 at http://clinicaltrials.gov/ct2/show/NCT01070056?term=TLC+clinic&rank=1 PMID:26135553

  17. Lay Counsellor-Based Risk Reduction Intervention with HIV Positive Diagnosed Patients at Public HIV Counselling and Testing Sites in Mpumalanga, South Africa

    ERIC Educational Resources Information Center

    Peltzer, Karl; Tabane, Cily; Matseke, Gladys; Simbayi, Leickness

    2010-01-01

    Objective: To evaluate the feasibility, fidelity, and effect of a human immunodeficiency virus (HIV) risk reduction intervention delivered to HIV-infected patients by lay counsellors during routine HIV counselling and testing (HCT) public service in Mpumalanga, South Africa. Methods: A total of 488 HIV-infected patients, aged 18 years and older,…

  18. Impact Evaluation of a School-Based Counselling Intervention in Northern Ireland: Is It Effective for Pupils Who Have Been Bullied?

    ERIC Educational Resources Information Center

    McElearney, Aisling; Adamson, Gary; Shevlin, Mark; Bunting, Brendan

    2013-01-01

    Bullying remains a significant issue in the lives of many children and young people at school and can have serious negative implications for emotional health and well-being in the short and longer term. This paper reports on an impact evaluation of the effectiveness of a school counselling intervention in promoting positive change in the peer…

  19. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong.

    PubMed

    Chan, Sophia S C; Wong, David C N; Cheung, Yee Tak Derek; Leung, Doris Y P; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing

    2015-08-01

    The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received eight text messages through mobile phone and (iii) The CONTROL group (n = 330) did not receive the above interventions. Participants with biochemically verified abstinence at 6-month follow-up could receive cash incentive. The primary outcome was the self-reported 7-day point prevalence (PP) of tobacco abstinence at 6-month follow-up. The abstinence rate in the TEL, SMS and CONTROL group was 22.2, 20.6 and 20.3%, respectively (P for TEL versus CONTROL = 0.32; P for SMS versus CONTROL = 0.40). When abstinence at 2-, 6- and 12-month follow-up was modelled simultaneously, the TEL group had a higher abstinence than the CONTROL group (Adjusted OR = 1.38, 95% CI = 1.01-1.88, P = 0 .04). In the Quit to Win Contest, the brief telephone counselling might have increased abstinence, but the text messages had no significant effect. Further studies on intensive intervention and interactive messaging services are warranted.

  20. A block randomized controlled trial of a brief smoking cessation counselling and advice through short message service on participants who joined the Quit to Win Contest in Hong Kong

    PubMed Central

    Chan, Sophia S. C.; Wong, David C. N.; Cheung, Yee Tak Derek; Leung, Doris Y. P.; Lau, Lisa; Lai, Vienna; Lam, Tai-Hing

    2015-01-01

    The present trial examined the effectiveness of brief interventions for smokers who joined the Hong Kong Quit to Win Contest to quit smoking. A block randomized controlled trial allocated 1003 adult daily smokers to three groups: (i) The TEL group (n = 338) received a 5-min nurse-led telephone counselling; (ii) The SMS group (n = 335) received eight text messages through mobile phone and (iii) The CONTROL group (n = 330) did not receive the above interventions. Participants with biochemically verified abstinence at 6-month follow-up could receive cash incentive. The primary outcome was the self-reported 7-day point prevalence (PP) of tobacco abstinence at 6-month follow-up. The abstinence rate in the TEL, SMS and CONTROL group was 22.2, 20.6 and 20.3%, respectively (P for TEL versus CONTROL = 0.32; P for SMS versus CONTROL = 0.40). When abstinence at 2-, 6- and 12-month follow-up was modelled simultaneously, the TEL group had a higher abstinence than the CONTROL group (Adjusted OR = 1.38, 95% CI = 1.01–1.88, P = 0 .04). In the Quit to Win Contest, the brief telephone counselling might have increased abstinence, but the text messages had no significant effect. Further studies on intensive intervention and interactive messaging services are warranted. PMID:26116584

  1. Effect of a Stepped-Care Intervention Approach on Weight Loss in Adults: The Step-Up Study Randomized Trial

    PubMed Central

    Jakicic, John M.; Tate, Deborah F.; Lang, Wei; Davis, Kelli K.; Polzien, Kristen; Rickman, Amy D.; Erickson, Karen; Neiberg, Rebecca H.; Finkelstein, Eric A.

    2014-01-01

    Context Given the obesity epidemic, effective but resource efficient weight loss treatments are needed. Stepped treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment paradigms. Objective We hypothesized that compared to a standard behavioral weight loss intervention (SBWI), a stepped-care weight loss intervention (STEP) would result in greater weight loss. Design Randomized trial with participants enrolled between May 2008 and February 2010. Data collection was completed by September 2011. Setting 2 universities affiliated with academic medical centers. Participants Participants were 363 overweight and obese adults (BMI: 25 to <40 kg/m2; age: 18–55 years; 33% non-white, 83% female) who were randomized to SBWI or STEP interventions. Interventions All participants were placed on a low calorie diet, prescribed increases in physical activity and had group counseling sessions ranging from weekly to monthly during an 18-month time period. SBWI participants were assigned to a fixed program. Among STEP participants, counseling frequency, type, and weight loss strategies could be modified every 3 months in response to observed weight loss as it related to weight loss goals. Main Outcome Measure Mean change in weight over 18 months. Additional outcomes include resting heart rate and blood pressure, waist girth, body composition, fitness, physical activity, dietary intake, and costs. Results Of the 363 participants randomized, 260 participants (71.6%) provided a measure of mean change in weight over 18 months. The 18 month intervention resulted in weight decreasing from 93.1 kg (95% CI: 91.0, 95.2) to 85.6 kg (95% CI: 83.4, 88.0) (p<0.01) in SBWI and from 92.7 kg (95% CI: 90.8, 94.6) to 86.4 kg (95% CI: 84.5, 88.4) in STEP (p<0.01). Percent weight change from baseline to 18 months was −8.1% (95% CI: −9.4, −6.9) in SBWI (p<0.01) and −6.9% (95% CI: −8.0, −5

  2. Promoting Early Intervention Referral through a Randomized Controlled Home-Visiting Program

    ERIC Educational Resources Information Center

    Schwarz, Donald F.; O'Sullivan, Ann L.; Guinn, Judith; Mautone, Jennifer A.; Carlson, Elyse C.; Zhao, Huaqing; Zhang, Xuemei; Esposito, Tara L.; Askew, Megan; Radcliffe, Jerilynn

    2012-01-01

    The MOM Program is a randomized, controlled trial of an intervention to promote mothers' care for the health and development of their children, including accessing early intervention (EI) services. Study aims were to determine whether, relative to controls, this intervention increased receipt of and referral to EI services. Mothers (N = 302)…

  3. Randomized Trial of a Broad Preventive Intervention for Mexican American Adolescents

    ERIC Educational Resources Information Center

    Gonzales, Nancy A.; Dumka, Larry E.; Millsap, Roger E.; Gottschall, Amanda; McClain, Darya B.; Wong, Jessie J.; German, Miguelina; Mauricio, Anne M.; Wheeler, Lorey; Carpentier, Francesca D.; Kim, Su Yeong

    2012-01-01

    Objective: This randomized trial of a family-focused preventive intervention for Mexican American (MA) adolescents evaluated intervention effects on adolescent substance use, internalizing and externalizing symptoms, and school discipline and grade records in 8th grade, 1 year after completion of the intervention. The study also examined…

  4. A Body Image and Disordered Eating Intervention for Women in Midlife: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    McLean, Sian A.; Paxton, Susan J.; Wertheim, Eleanor H.

    2011-01-01

    Objective: This study examined the outcome of a body image and disordered eating intervention for midlife women. The intervention was specifically designed to address risk factors that are pertinent in midlife. Method: Participants were 61 women aged 30 to 60 years (M = 43.92, SD = 8.22) randomly assigned to intervention (n = 32) or (delayed…

  5. A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq

    PubMed Central

    Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

    2016-01-01

    ABSTRACT Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein’s government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen’s d, 0.57; P = .02) and dysfunction (Cohen’s d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes

  6. A Randomized Controlled Trial of a Trauma-Informed Support, Skills, and Psychoeducation Intervention for Survivors of Torture and Related Trauma in Kurdistan, Northern Iraq.

    PubMed

    Bass, Judith; Murray, Sarah McIvor; Mohammed, Thikra Ahmed; Bunn, Mary; Gorman, William; Ahmed, Ahmed Mohammed Amin; Murray, Laura; Bolton, Paul

    2016-09-28

    Supportive counseling type interventions are frequently provided to meet the mental health needs of populations in emergency and post-conflicts contexts, but it has seldom been rigorously evaluated. Existing evaluations from low- and middle-income countries provide mixed evidence of effectiveness. While Iraqi Kurdistan experienced relative stability following the fall of Saddam Hussein's government, the population in the northern Dohuk region has continued to experience periodic violence due to conflicts with neighboring Turkey as well as more recent ISIS-associated violence. We evaluated the impact of a trauma-informed support, skills, and psychoeducation intervention provided by community mental health workers (CMHWs) on depressive symptoms and dysfunction (primary outcomes) as well as post-traumatic stress, traumatic grief, and anxiety symptoms (secondary outcomes). Between June 2009 and June 2010, 295 adults were screened; 209 (71%) met eligibility criteria (trauma exposure and a symptom severity score indicating significant distress and functional impairment, among others) and consented to participate. Of these, 159 were randomized to supportive counseling while 50 were randomized to a waitlist control condition. Comparing average symptom severity scores post-treatment among those in the intervention group with those in the waitlist control group, the supportive counseling program had statistically and clinically significant impacts on the primary outcomes of depression (Cohen's d, 0.57; P = .02) and dysfunction (Cohen's d, 0.53; P = .03) and significant but smaller impacts on anxiety. Although studies by the same research team of psychotherapeutic interventions in other parts of Kurdistan and in southern Iraq found larger effects, this study adds to the global research literature on mental health and psychosocial support and shows that a well-trained and supervised program of trauma-informed support, skills, and psychoeducation that emphasizes the therapeutic

  7. MyHEART: A Non Randomized Feasibility Study of a Young Adult Hypertension Intervention

    PubMed Central

    Johnson, Heather M; LaMantia, Jamie N; Warner, Ryan C; Pandhi, Nancy; Bartels, Christie M; Smith, Maureen A; Lauver, Diane R

    2016-01-01

    Background In the United States, young adults (18–39 year-olds) have the lowest hypertension control rates (35%) compared to middle-aged (58%) and older (54%) adults. Ambulatory care for hypertension management often focuses on medication with little time for self-management and behavioral counseling. This study was designed to evaluate the feasibility of MyHEART, a telephone-based health coach self-management intervention for young adults. The goals were to determine the intervention’s ability to: 1) recruit young adults with uncontrolled hypertension, 2) maintain ongoing communication between the coach and participants, 3) increase participants’ engagement in self-management, 4) document coach-patient communication in the electronic health record, and 5) assess patient acceptability. Methods Eligible participants were identified through the electronic health record. Inclusion criteria included 18–39 year-olds, with ICD-9 hypertension diagnoses and uncontrolled hypertension (≥ 140/90 mmHg), receiving regular primary care at a large multispecialty group practice. The intervention consisted of 6 telephone self-management sessions by a health coach targeting lifestyle modifications. Patients completed an open-ended acceptability survey. Results Study uptake was 47% (9 enrolled/19 eligible). Mean (SD) age was 35.8 (2.6) years, 78% male, and 33% Black. Over 85% of enrolled young adults maintained communication with their health coach. At baseline, 11% reported checking their blood pressure outside of clinic; 44% reported blood pressure monitoring after the study. All coach-patient encounters were successfully documented in the electronic health record for primary care provider review. Open-ended responses from all surveys indicated that participants had a positive experience with the MyHEART intervention. Conclusions This study demonstrated that MyHEART was feasible and acceptable to young adults with uncontrolled hypertension. Health coaches can effectively

  8. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

    PubMed Central

    2013-01-01

    Background Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing. The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity. Methods/Design The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the

  9. Healthy Homes/Healthy Kids: A Randomized Trial of a Pediatric Primary Care Based Obesity Prevention Intervention for At-Risk 5-10 Year Olds

    PubMed Central

    Sherwood, Nancy E.; Levy, Rona L.; Langer, Shelby L.; Senso, Meghan M.; Crain, A. Lauren; Hayes, Marcia G.; Anderson, Julie D.; Seburg, Elisabeth M.; Jeffery, Robert W.

    2014-01-01

    Pediatric primary care is an important setting in which to address obesity prevention, yet relatively few interventions have been evaluated and even fewer have been shown to be effective. The development and evaluation of cost-effective approaches to obesity prevention that leverage opportunities of direct access to families in the pediatric primary care setting, overcome barriers to implementation in busy practice settings, and facilitate sustained involvement of parents is an important public health priority. The goal of the Healthy Homes/Healthy Kids (HHHK 5-10) randomized controlled trial is to evaluate the efficacy of a relatively low-cost primary care-based obesity prevention intervention aimed at 5 to 10 year old children who are at risk for obesity. Four hundred twenty one parent/child dyads were recruited and randomized to either the obesity prevention arm or a contact control condition that focuses on safety and injury prevention. The HHHK 5-10 obesity prevention intervention combines brief counseling with a pediatric primary care provider during routine well-child visits and follow-up telephone coaching that supports parents in making home environmental changes to support healthful eating, activity patterns, and body weight. The contact control condition combines the same provider counseling with telephone coaching focused on safety and injury prevention messages. This manuscript describes the study design and baseline characteristics of participants enrolled in the HHHK 5-10 trial. PMID:23816490

  10. Narrative Intervention: A School-Based Counseling Strategy for Students with Attention-Deficit/Hyperactivity Disorder

    ERIC Educational Resources Information Center

    Kamali, Khosrow; Yoosefi Looyeh, Majid

    2013-01-01

    This article describes a group narrative intervention for improving the behavior of 8- to 11-year-old children with attention-deficit/hyperactivity disorder at home and school. (Contains 2 tables and 1 note.)

  11. Can a minimal intervention reduce secondhand smoke exposure among children with asthma from low income minority families? Results of a randomized trial.

    PubMed

    Streja, Leanne; Crespi, Catherine M; Bastani, Roshan; Wong, Glenn C; Jones, Craig A; Bernert, John T; Tashkin, Donald; Hammond, S Katharine; Berman, Barbara A

    2014-04-01

    We report on the results of a low-intensity behavioral intervention to reduce second hand smoke (SHS) exposure of children with asthma from low income minority households in Los Angeles, California. In this study, 242 child/adult dyads were randomized to a behavioral intervention (video, workbook, minimal counseling) or control condition (brochure). Main outcome measures included child's urine cotinine and parental reports of child's hours of SHS exposure and number of household cigarettes smoked. Implementation of household bans was also considered. No differences in outcomes were detected between intervention and control groups at follow-up. Limitations included high attrition and low rates of collection of objective measures (few children with urine cotinine samples). There continues to be a need for effective culturally and linguistically appropriate strategies that support reduction of household SHS exposure among children with asthma in low income, minority households.

  12. Efficacy of an HIV/STI Sexual Risk-Reduction Intervention for African American Adolescent Girls in Juvenile Detention Centers: A Randomized Controlled Trial

    PubMed Central

    DiClemente, Ralph J.; Davis, Teaniese L.; Swartzendruber, Andrea; Fasula, Amy M.; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C.; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M.; Brown, Jennifer L.; Staples-Horne, Michelle

    2014-01-01

    Background Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. Objective The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. Methods We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N=188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. Intervention The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment and counseling. Results At the 6-month assessment (3-months post-intervention) Imara participants reported higher condom use self-efficacy (p<0.001), HIV/STI knowledge (p<0.001), and condom use skills (p<0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Conclusions Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains. PMID:25190056

  13. Measuring the impacts of seclusion on psychiatry inpatients and the effectiveness of a pilot single-session post-seclusion counselling intervention.

    PubMed

    Whitecross, Fiona; Seeary, Amy; Lee, Stuart

    2013-12-01

    Despite the accumulation of evidence demonstrating patients' accounts of trauma associated with seclusion, the use of evidence-based post-seclusion debriefing is not apparent in the published work. This study aimed to identify the impacts seclusion has on an individual using the Impact of Events - Revised (IES-R), a standardized and widely used measure of trauma symptoms, and measure the effectiveness of a post-seclusion counselling intervention in mitigating the experience of seclusion-related trauma and reducing time spent in seclusion. The study design involved a comparison of the seclusion-related trauma and time in seclusion that was experienced by consenting patients managed on the two inpatient wards of Alfred Psychiatry. To investigate the efficacy of post-seclusion counselling to reduce event-related trauma as well as the use of seclusion, a brief single-session intervention was piloted comparing outcomes for patients treated on a ward implementing semistructured post-seclusion counselling and patients treated on a ward continuing with post-seclusion support as usual. A total of 31 patients consented to participate, with approximately 47% reporting trauma symptoms consistent with 'probable post-traumatic stress disorder' (IES-R total score, >33), although there was no difference in trauma experience between groups. Significantly fewer hours were spent in seclusion for patients treated on the ward piloting the post-seclusion counselling intervention. Findings, therefore, highlight not only the potential for significant trauma stemming from a seclusion event, but also the capacity for the implementation of such interventions as post-seclusion counselling to raise awareness of the need to minimize time spent in seclusion for patients.

  14. Counseling Older Adults at Risk of Suicide: Recognizing Barriers, Reviewing Strategies, and Exploring Opportunities for Intervention

    ERIC Educational Resources Information Center

    Sawyer, Patricia; Williams, Beverly Rosa

    2012-01-01

    Age-related challenges to health and well-being among older adults give rise to a distinctive array of risk factors for suicide, calling for a unique approach to suicide interventions. Americans over the age of 65 are disproportionally overrepresented in the number of completed suicides. This paper examines the epidemiology of geriatric suicide,…

  15. Putting Research into Practice in School Violence Prevention and Intervention: How Is School Counseling Doing?

    ERIC Educational Resources Information Center

    McAdams, Charles; Shillingford, M. Ann; Trice-Black, Shannon

    2011-01-01

    This article reports the findings of a national survey of practicing school counselors regarding their knowledge of current research in school violence prevention and intervention. The authors describe four active areas of youth violence research over the past two decades and present findings that suggest that a potentially dangerous gap may exist…

  16. Counselling Intervention and Support Programmes for Families of Children with Special Educational Needs

    ERIC Educational Resources Information Center

    Fareo, Dorcas Oluremi

    2015-01-01

    All couples look forward to having normal healthy babies. The issues of disabilities in their children shake the families and serve as sources of severe psychological disruption to family adjustment. The parents of such children live with many difficult issues and frequently experience trauma, grief and stress. Intervention programmes are…

  17. Micro-Randomized Trials: An Experimental Design for Developing Just-in-Time Adaptive Interventions

    PubMed Central

    Klasnja, Predrag; Hekler, Eric B.; Shiffman, Saul; Boruvka, Audrey; Almirall, Daniel; Tewari, Ambuj; Murphy, Susan A.

    2015-01-01

    Objective This paper presents an experimental design, the micro-randomized trial, developed to support optimization of just-in-time adaptive interventions (JITAIs). JITAIs are mHealth technologies that aim to deliver the right intervention components at the right times and locations to optimally support individuals’ health behaviors. Micro-randomized trials offer a way to optimize such interventions by enabling modeling of causal effects and time-varying effect moderation for individual intervention components within a JITAI. Methods The paper describes the micro-randomized trial design, enumerates research questions that this experimental design can help answer, and provides an overview of the data analyses that can be used to assess the causal effects of studied intervention components and investigate time-varying moderation of those effects. Results Micro-randomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Conclusions Micro-randomized trials can help researchers understand whether their interventions are having intended effects, when and for whom they are effective, and what factors moderate the interventions’ effects, enabling creation of more effective JITAIs. PMID:26651463

  18. Lifestyle Intervention Using an Internet-Based Curriculum with Cell Phone Reminders for Obese Chinese Teens: A Randomized Controlled Study

    PubMed Central

    Abraham, Anisha A.; Chow, Wing-Chi; So, Hung-Kwan; Yip, Benjamin Hon-Kei; Li, Albert M.; Kumta, Shekhar M.; Woo, Jean; Chan, Suk-Mei; Lau, Esther Yuet-Ying; Nelson, E. Anthony S.

    2015-01-01

    Objectives Obesity is an increasing public health problem affecting young people. The causes of obesity are multi-factorial among Chinese youth including lack of physical activity and poor eating habits. The use of an internet curriculum and cell phone reminders and texting may be an innovative means of increasing follow up and compliance with obese teens. The objectives of this study were to determine the feasibility of using an adapted internet curriculum and existing nutritional program along with cell phone follow up for obese Chinese teens. Design and Methods This was a randomized controlled study involving obese teens receiving care at a paediatric obesity clinic of a tertiary care hospital in Hong Kong. Forty-eight subjects aged 12 to 18 years were randomized into three groups. The control group received usual care visits with a physician in the obesity clinic every three months. The first intervention (IT) group received usual care visits every three months plus a 12-week internet-based curriculum with cell phone calls/texts reminders. The second intervention group received usual care visits every three months plus four nutritional counselling sessions. Results The use of the internet-based curriculum was shown to be feasible as evidenced by the high recruitment rate, internet log-in rate, compliance with completing the curriculum and responses to phone reminders. No significant differences in weight were found between IT, sLMP and control groups. Conclusion An internet-based curriculum with cell phone reminders as a supplement to usual care of obesity is feasible. Further study is required to determine whether an internet plus text intervention can be both an effective and a cost-effective adjunct to changing weight in obese youth. Trial Registration Chinese Clinical Trial Registry ChiCTR-TRC-12002624 PMID:25946465

  19. A Pilot Trial of a Sexual Health Counseling Intervention for HIV-Positive Gay and Bisexual Men Who Report Anal Sex without Condoms

    PubMed Central

    Hart, Trevor A.; Stratton, Natalie; Coleman, Todd A.; Wilson, Holly A.; Simpson, Scott H.; Julien, Rick E.; Adam, Barry D.

    2016-01-01

    Background Even in the presence of promising biomedical treatment as prevention, HIV incidence among men who have sex with men has not always decreased. Counseling interventions, therefore, continue to play an important role in reducing HIV sexual transmission behaviors among gay and bisexual men and other men who have sex with men. The present study evaluated effects of a small-group counseling intervention on psychosocial outcomes and HIV sexual risk behavior. Method HIV-positive (HIV+) peer counselors administered seven 2-hour counseling sessions to groups of 5 to 8 HIV+ gay and bisexual men. The intervention employed information provision, motivational interviewing, and behavioral skills building to reduce sexual transmission risk behaviors. Results There was a significant reduction in condomless anal sex (CAS) with HIV-negative and unknown HIV-status partners, from 50.0% at baseline to 28.9% of the sample at 3-month follow-up. Findings were robust even when controlling for whether the participant had an undetectable viral load at baseline. Significant reductions were also found in the two secondary psychosocial outcomes, loneliness and sexual compulsivity. Conclusions The findings provide preliminary evidence that this intervention may offer an efficient way of concurrently reducing CAS and mental health problems, such as sexual compulsivity and loneliness, for HIV+ gay and bisexual men. Trial Registration ClinicalTrials.gov NCT02546271 PMID:27054341

  20. Randomized Controlled Trial of a Web-based Indoor Tanning Intervention: Acceptability and Preliminary Outcomes

    PubMed Central

    Stapleton, Jerod L.; Manne, Sharon L.; Darabos, Katie; Greene, Kathryn; Ray, Anne E.; Turner, Amber L.; Coups, Elliot J.

    2015-01-01

    Objective This manuscript describes the acceptability and preliminary behavioral outcomes from a pilot randomized control trial of a web-based indoor tanning intervention for young adult women. The intervention targets indoor tanning user’s perceptions of then benefits and value of tanning and addresses the role of body image-related constructs in indoor tanning. Methods Participants were 186 young adult women who reported indoor tanning at least once in the past 12 months. The study design was a 2-arm randomized controlled trial with pre and post assessments and random assignment to an intervention or control condition. Intervention acceptability was assessed by obtaining participants’ evaluation of the intervention. Regression analyses were used to test for intervention condition differences in preliminary behavioral outcomes measured at 6-weeks post-intervention. Results Participants provided favorable evaluations of the intervention on several dimensions and a highly positive overall rating. Intervention participants were more likely to report abstaining from indoor tanning and indicated a lower likelihood of using indoor tanning in the future compared to control participants on the post-intervention assessment. No differences were found for sunburns. Conclusions The results of this pilot randomized controlled trial provide evidence that the indoor tanning intervention is acceptable to participants and may encourage cessation of indoor tanning behavior. The findings provide preliminary support for an indoor tanning intervention that engages tanners to challenge their beliefs about the benefits of indoor tanning. The use of a web-based indoor tanning intervention is unique and provides strong potential for dissemination. PMID:26651469

  1. Efficacy of an HIV/STI sexual risk-reduction intervention for African American adolescent girls in juvenile detention centers: a randomized controlled trial.

    PubMed

    DiClemente, Ralph J; Davis, Teaniese L; Swartzendruber, Andrea; Fasula, Amy M; Boyce, Lorin; Gelaude, Deborah; Gray, Simone C; Hardin, James; Rose, Eve; Carry, Monique; Sales, Jessica M; Brown, Jennifer L; Staples-Horne, Michelle

    2014-01-01

    Few HIV/STI interventions exist for African American adolescent girls in juvenile detention. The objective was to evaluate the efficacy of an intervention to reduce incident STIs, improve HIV-preventive behaviors, and enhance psychosocial outcomes. We conducted a randomized controlled trial among African American adolescent girls (13-17 years, N = 188) in juvenile detention from March 2011 to May 2012. Assessments occurred at baseline and 3- and 6-months post-randomization and included: audio computer-assisted self-interview, condom skills assessment, and self-collected vaginal swab to detect Chlamydia and gonorrhea. The Imara intervention included three individual-level sessions and four phone sessions; expedited partner therapy was offered to STI-positive adolescents. The comparison group received the usual care provided by the detention center: STI testing, treatment, and counseling. At the 6-month assessment (3-months post-intervention), Imara participants reported higher condom use self-efficacy (p < 0.001), HIV/STI knowledge (p < 0.001), and condom use skills (p < 0.001) compared to control participants. No significant differences were observed between trial conditions in incident Chlamydia or gonorrhea infections, condom use, or number of vaginal sex partners. Imara for detained African American adolescent girls can improve condom use skills and psychosocial outcomes; however, a critical need for interventions to reduce sexual risk remains.

  2. A Pilot Randomized Controlled Trial of a Clinic and Home-Based Behavioral Intervention to Decrease Obesity in Preschoolers

    PubMed Central

    Stark, Lori J.; Spear, Stephanie; Boles, Richard; Kuhl, Elizabeth; Ratcliff, Megan; Scharf, Cindy; Bolling, Christopher; Rausch, Joseph

    2015-01-01

    We evaluated the efficacy of a 6-month clinic and home-based behavioral intervention (Learning about Activity and Understanding Nutrition for Child Health; LAUNCH) to reduce obesity in preschool children ≥95th BMI percentile compared to enhanced standard of care (Pediatrician Counseling; PC). LAUNCH was a family-based behavioral intervention that taught parents to use child behavior management strategies to increase healthy eating and activity for their children and themselves. PC presented the same diet and activity recommendations, but was delivered in a one-time PC session. Eighteen children aged 2–5 years (mean 4.71 ± 1.01) with an average BMI percentile of 98 (±1.60) and an overweight parent were randomized to LAUNCH or PC. Assessments were conducted at baseline, 6 months (end of LAUNCH treatment) and 12 months (6 months following LAUNCH treatment). LAUNCH showed a significantly greater decrease on the primary outcomes of child at month 6 (post-treatment) BMI z (−0.59 ± 0.17), BMI percentile (−2.4 ± 1.0), and weight gain (−2.7 kg ± 1.2) than PC and this difference was maintained at follow-up (month 12). LAUNCH parents also had a significantly greater weight loss (−5.5 kg ± 0.9) at month 6 and 12 (−8.0 kg ± 3.5) than PC parents. Based on the data from this small sample, an intensive intervention that includes child behavior management strategies to improve healthy eating and activity appears more promising in reducing preschool obesity than a low intensity intervention that is typical of treatment that could be delivered in primary care. PMID:20395948

  3. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Three Depression Prevention Programs

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2010-01-01

    Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…

  4. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    ERIC Educational Resources Information Center

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2009-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at post-intervention (2 months), after completion of 4 monthly booster sessions (6…

  5. A Randomized Test of a Small-Group Interactive Social Norms Intervention

    ERIC Educational Resources Information Center

    Reilly, Daniel William; Wood, Mark David

    2008-01-01

    Social norms interventions are a common approach to addressing the problem of college student drinking. An increasingly popular but not yet well-validated social-norms-based intervention consists of providing normative feedback to students in small groups. Objective, Participants, and Methods: In this study, the authors used a randomized design to…

  6. An Intervention for Sensory Difficulties in Children with Autism: A Randomized Trial

    ERIC Educational Resources Information Center

    Schaaf, Roseann C.; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna

    2014-01-01

    This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored…

  7. Randomized Controlled Trial of the Resilience and Coping Intervention (RCI) with Undergraduate University Students

    ERIC Educational Resources Information Center

    Houston, J. Brian; First, Jennifer; Spialek, Matthew L.; Sorenson, Mary E.; Mills-Sandoval, Toby; Lockett, McKenzie; First, Nathan L.; Nitiéma, Pascal; Allen, Sandra F.; Pfefferbaum, Betty

    2017-01-01

    Objective: The purpose of this pilot study was to evaluate the Resilience and Coping Intervention (RCI) with college students. Participants: College students (aged 18-23) from a large Midwest US university who volunteered for a randomized controlled trial during the 2015 spring semester. Methods: College students were randomly assigned to an…

  8. Ethical Practice and Evaluation of Interventions in Crime and Justice: The Moral Imperative for Randomized Trials.

    ERIC Educational Resources Information Center

    Weisburd, David

    2003-01-01

    Although some argue that randomization of treatments or interventions violates accepted norms of conduct of social science research, this article makes the case that there is a moral imperative for the conduct of randomized experiments in crime and justice studies. (SLD)

  9. Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

    ERIC Educational Resources Information Center

    Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

    2009-01-01

    When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

  10. Randomized Controlled Trial of a Preventive Intervention for Perinatal Depression in High-Risk Latinas

    ERIC Educational Resources Information Center

    Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.

    2011-01-01

    Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…

  11. Impulsive lifestyle counseling to prevent dropout from treatment for substance use disorders in people with antisocial personality disorder: A randomized study.

    PubMed

    Thylstrup, Birgitte; Hesse, Morten

    2016-06-01

    Patients with antisocial personality disorder in outpatient treatment for substance use disorders are at high risk of drop-out. Using a randomized design, this study tested the impact of adding a brief psycho-educational program, the Impulsive Lifestyle Counseling program, to outpatient substance abuse treatment in order to prevent treatment dropout. Patients (N=175) were recruited from 13 municipal treatment centers in Denmark, and assigned to treatment as usual or to the experimental condition. In all, 172 patients could be included in the analyses. In the intent-to-treat analysis, the risk of treatment dropout was reduced among patients randomized to the experimental program (hazard ratio=0.63, p=.031), after controlling for age, gender, and substitution treatment status. The study supported the efficacy of the Impulsive Lifestyle Counseling program as a method for preventing treatment dropout for patients with comorbid antisocial personality disorder in substance abuse treatment. Trial registration #ISRCTN67266318.

  12. Genetic Counseling

    MedlinePlus

    ... Home > Pregnancy > Before or between pregnancies > Genetic counseling Genetic counseling E-mail to a friend Please fill ... a genetic counselor in your area. What is genetic counseling? Genetic counseling helps you understand how genes , ...

  13. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial

    PubMed Central

    Peterson, Arthur V.; Marek, Patrick M.; Kealey, Kathleen A.; Bricker, Jonathan B.; Ludman, Evette J.; Heffner, Jaimee L.

    2016-01-01

    Background The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention. Methods High school smokers (n = 2,151) were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention) or control (no intervention) condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided. Results No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI) = -3.4 to 5.8, p = .61), nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year. Conclusions There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention

  14. Intervention effects on negative affect of CPS-referred children: results of a randomized clinical trial.

    PubMed

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-09-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children's self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n=56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n=61).

  15. Intervention Effects on Negative Affect of CPS-Referred Children: Results of a Randomized Clinical Trial

    PubMed Central

    Lind, Teresa; Bernard, Kristin; Ross, Emily; Dozier, Mary

    2014-01-01

    Exposure to early adversity places young children at risk for behavioral, physiological, and emotional dysregulation, predisposing them to a range of long-term problematic outcomes. Attachment and Biobehavioral Catch-up (ABC) is a 10-session intervention designed to enhance children’s self-regulatory capabilities by helping parents to behave in nurturing, synchronous, and non-frightening ways. The effectiveness of the intervention was assessed in a randomized clinical trial, with parents who had been referred to Child Protective Services (CPS) for allegations of maltreatment. Parent-child dyads received either the ABC intervention or a control intervention. Following the intervention, children from the ABC intervention (n = 56) expressed lower levels of negative affect during a challenging task compared to children from the control intervention (n = 61). PMID:24814751

  16. One-Year Effect of a Nurse-Led Psychosocial Intervention on Depressive Symptoms in Patients With Head and Neck Cancer: A Randomized Controlled Trial

    PubMed Central

    May, Anne M.; Ros, Wynand J.G.; Oosterom, Miriam; Hordijk, Gert-Jan; Koole, Ron; de Leeuw, J. Rob J.

    2013-01-01

    Background. Many patients with head and neck cancer (HNC) experience depressive symptoms after treatment. This randomized controlled trial investigated the effects of a psychosocial nurse counseling and after intervention (NUCAI) versus usual care on the depressive and HNC-related physical symptoms of patients with HNC at 1 year after diagnosis. Methods. A total of 205 patients with HNC were randomly assigned to either intervention (n = 103) or usual care (n = 102), with stratification for gender and tumor stage. The NUCAI, which consisted of six bimonthly 45-minute counseling sessions, was a problem-focused intervention aimed at helping patients to manage the physical, psychological, and social consequences of HNC and its treatment. It was nurse-led and offered in combination with regular medical follow-up visits at the University Medical Center Utrecht, the Netherlands. Depressive symptoms at 1 year after diagnosis were the primary outcome. Analyses were performed on an intention-to-treat basis for the total sample and for a predefined subgroup of patients with raised levels of depressive symptoms (Center for Epidemiologic Studies–Depression score ≥12; n = 91) at baseline using mixed-effect models. Results. One year after HNC treatment, levels of depressive symptoms were significantly lower in the intervention group than in the control group in the total sample and in the subgroup of patients with raised levels of depressive symptoms. Conclusion. The NUCAI was feasible and effective in reducing depressive symptoms in patients with HNC 1 year after HNC treatment, and especially in patients with raised levels of depressive symptoms. The results of this study need to be confirmed in future studies before the NUCAI can be used in daily clinical practice. PMID:23429740

  17. Intervention randomized controlled trials involving wrist and shoulder arthroscopy: a systematic review

    PubMed Central

    2014-01-01

    Background Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arthroscopy. PubMed and Cochrane Library databases were searched up to December 2012. Two researchers reviewed each article and recorded the condition treated, randomization method, number of randomized participants, time of randomization, outcomes measures, blinding, and description of dropouts and withdrawals. We used the modified Jadad scale that considers the randomization method, blinding, and dropouts/withdrawals; score 0 (lowest quality) to 5 (highest quality). The scores for the wrist and shoulder RCTs were compared with the Mann–Whitney test. Results The first references to both wrist and shoulder arthroscopy appeared in the late 1970s. The search found 4 wrist arthroscopy intervention RCTs (Kienböck’s disease, dorsal wrist ganglia, volar wrist ganglia, and distal radius fracture; first 3 compared arthroscopic with open surgery). The median number of participants was 45. The search found 50 shoulder arthroscopy intervention RCTs (rotator cuff tears 22, instability 14, impingement 9, and other conditions 5). Of these, 31 compared different arthroscopic treatments, 12 compared arthroscopic with open treatment, and 7 compared arthroscopic with nonoperative treatment. The median number of participants was 60. The median modified Jadad score for the wrist RCTs was 0.5 (range 0–1) and for the shoulder RCTs 3.0 (range 0–5) (p = 0.012). Conclusion Despite the increasing use of wrist arthroscopy in the treatment of various wrist disorders the efficacy of arthroscopically

  18. Humour-related interventions for people with mental illness: a randomized controlled pilot study.

    PubMed

    Rudnick, Abraham; Kohn, Paul M; Edwards, Kim R; Podnar, David; Caird, Sara; Martin, Rod

    2014-08-01

    This study explored the feasibility and effects of humour-related interventions for mentally ill adults. Twelve, randomly assigned, participated in each of 3 arms--stand up comedy training (the experimental arm), discussing comedy videos (the active control arm), and no humour-related intervention (the passive control arm). Quantitative and qualitative data were collected at baseline, end of interventions (3 months) and follow up (after another 3 months). Scale comparisons were largely negative, although self-esteem marginally increased in the experimental arm. Interview responses indicated benefits for the interventions, including improved self-esteem in the experimental arm. These results, though mixed, justify further study.

  19. A randomized trial of enhanced HIV risk reduction and vaccine trial education interventions among HIV-negative, high-risk women who use non-injection drugs: The UNITY Study

    PubMed Central

    Koblin, Beryl A.; Bonner, Sebastian; Hoover, Donald R.; Xu, Guozhen; Lucy, Debbie; Fortin, Princess; Putnam, Sara; Latka, Mary H.

    2014-01-01

    Background Limited data are available on interventions to reduce sexual risk behaviors and increase knowledge of HIV vaccine trial concepts in high risk populations eligible to participate in HIV vaccine efficacy trials. Methods The UNITY Study was a two-arm randomized trial to determine the efficacy of enhanced HIV risk reduction and vaccine trial education interventions to reduce the occurrence of unprotected vaginal sex acts and increase HIV vaccine trial knowledge among 311 HIV-negative non-injection drug using women. The enhanced vaccine education intervention using pictures along with application vignettes and enhanced risk reduction counseling consisting of three one-on-one counseling sessions were compared to standard conditions. Follow-up visits at one week and one, six and twelve months after randomization included HIV testing and assessment of outcomes. Results During follow up, the percent of women reporting sexual risk behaviors declined significantly, but did not differ significantly by study arm. Knowledge of HIV vaccine trial concepts significantly increased but did not significantly differ by study arm. Concepts about HIV vaccine trials not adequately addressed by either condition included those related to testing a vaccine for both efficacy and safety, guarantees about participation in future vaccine trials, assurances of safety, medical care, and assumptions about any protective effect of a test vaccine. Conclusions Further research is needed to boost educational efforts and strengthen risk reduction counseling among high-risk non-injection drug using women. PMID:20190585

  20. Lifestyle Intervention on Metabolic Syndrome and its Impact on Quality of Life: A Randomized Controlled Trial

    PubMed Central

    Saboya, Patrícia Pozas; Bodanese, Luiz Carlos; Zimmermann, Paulo Roberto; Gustavo, Andreia da Silva; Macagnan, Fabricio Edler; Feoli, Ana Pandolfo; Oliveira, Margareth da Silva

    2017-01-01

    Background Lifestyle intervention programs can reduce the prevalence of metabolic syndrome (MetS) and, therefore, reduce the risk for cardiac disease, one of the main public health problems nowadays. Objective The aim of this study was to compare the effects of three types of approach for lifestyle change programs in the reduction of metabolic parameters, and to identify its impact on the quality of life (QOL) of individuals with MetS. Methods A randomized controlled trial included 72 individuals with MetS aged 30-59 years. Individuals were randomized into three groups of multidisciplinary intervention [Standard Intervention (SI) - control group; Group Intervention (GI); and Individual Intervention (II)] during 12 weeks. The primary outcome was change in the metabolic parameters, and secondarily, the improvement in QOL measures at three moments: baseline, 3 and 9 months. Results Group and individual interventions resulted in a significant reduction in body mass index, waist circumference, systolic blood pressure at 3 months and the improvement of QOL, although it was significantly associated with the physical functioning domain. However, these changes did not remain 6 months after the end of intervention. Depression and anxiety were significantly associated with worse QOL, although they showed no effect on the response to intervention. Conclusion Multidisciplinary intervention, especially in a group, might be an effective and economically feasible strategy in the control of metabolic parameters of MetS and improvement of QOL compared to SI, even in a dose-effect relationship. PMID:27982160

  1. Worksite intervention effects on sleep quality: a randomized controlled trial.

    PubMed

    Atlantis, Evan; Chow, Chin-Moi; Kirby, Adrienne; Singh, Maria A Fiatarone

    2006-10-01

    Employees with sleep disturbance are at increased risk of disease. Exercise is believed to be effective for improving sleep quality, but few studies have been conducted. This study investigated the effects of a 24-week worksite exercise/behavioral intervention on self-rated sleep quality, via the Pittsburgh Sleep Quality Index (PSQI), in 73 employees. Greater post-test improvements in the PSQI (-2.0 +/- 2.6 vs. -1.3 +/- 2.7 points, p = .006, and -16 +/- 61 vs. -1 +/- 76%, p = .02) were found in treatment versus controls, and in women versus men (by -2.7 points [-5.0 to -0.3 points, p = .03], and by -72% [-142 to -2%, p = .04]). Similar results were found in the shift worker subgroup. Changes in sleep scores were not significantly related to baseline characteristics, changes in psychological health or quality-of-life scores, or level of exercise compliance.

  2. The efficacy of a behavioral activation intervention among depressed US Latinos with limited English language proficiency: study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Major depressive disorder is highly prevalent among Latinos with limited English language proficiency in the United States. Although major depressive disorder is highly treatable, barriers to depression treatment have historically prevented Latinos with limited English language proficiency from accessing effective interventions. The project seeks to evaluate the efficacy of behavioral activation treatment for depression, an empirically supported treatment for depression, as an intervention that may address some of the disparities surrounding the receipt of efficacious mental health care for this population. Methods/design Following a pilot study of behavioral activation treatment for depression with 10 participants which yielded very promising results, the current study is a randomized control trial testing behavioral activation treatment for depression versus a supportive counseling treatment for depression. We are in the process of recruiting 60 Latinos with limited English language proficiency meeting criteria for major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders 4th and 5th Edition for participation in a single-center efficacy trial. Participants are randomized to receive 10 sessions of behavioral activation treatment for depression (n = 30) or 10 sessions of supportive counseling (n = 30). Assessments occur prior to each session and at 1 month after completing treatment. Intervention targets include depressive symptomatology and the proposed mechanisms of behavioral activation treatment for depression: activity level and environmental reward. We will also examine other factors related to treatment outcome such as treatment adherence, treatment satisfaction, and therapeutic alliance. Discussion This randomized controlled trial will allow us to determine the efficacy of behavioral activation treatment for depression in a fast-growing, yet highly underserved population in US mental health services

  3. Limited efficacy of a nonrestricted intervention on antimicrobial prescription of commonly used antibiotics in the hospital setting: results of a randomized controlled trial.

    PubMed

    Masiá, M; Matoses, C; Padilla, S; Murcia, A; Sánchez, V; Romero, I; Navarro, A; Hernández, I; Gutiérrez, F

    2008-07-01

    Most interventions aimed at diminishing the use of antimicrobials in hospitals have focussed on newly introduced antibiotics and very few have been randomly controlled. We evaluated the impact on antibiotic consumption of an intervention without restrictions in antibiotic use, focussed on commonly used antibiotics with a controlled randomized trial. All new prescriptions of levofloxacin, carbapenems, or vancomycin in hospitalized patients were randomized to an intervention or a control group. Intervention consisted of an antibiotic regimen counselling targeted to match local antibiotic guidelines, performed using only patients' charts. Clinical charts of patients assigned to the control group were reviewed daily by a pharmacist. The primary endpoint was a reduction in consumption of the targeted antibiotics. Two hundred seventy-eight prescriptions corresponding to 253 patients were included: 146 were assigned to the intervention and 132 to the control group. Total consumption of the targeted antibiotics (median [IQR]) was slightly lower in the intervention (8 [4-12] defined daily doses [DDDs] per patient) than in the control group (10 [6-16] DDDs per patient; p = 0.04). No differences in number of DDDs were observed when antibiotics of substitution were included (11.05 [6-18.2] vs 10 [6-16.5] in the intervention and control groups, respectively, p = 0.13). The total number of days on treatment with the targeted antibiotics was lower in the intervention (4 [3-7] days per patient) than in the control group (6 [4-10] days per patient; p = 0.002). Differences in number of days on treatment only reached statistical significance in the prescriptions of carbapenems. There were no differences between intervention and control groups in terms of number of deaths, hospital readmissions, length of hospital stay, or antibiotic costs. In this trial, an intervention without restrictions focussed on antimicrobial prescriptions of commonly used antibiotics in the hospital setting

  4. Is intensive counseling in maternity care feasible and effective in promoting physical activity among women at risk for gestational diabetes? Secondary analysis of a cluster randomized NELLI study in Finland

    PubMed Central

    2012-01-01

    Background Women who are physically active during early pregnancy have notably lower odds of developing gestational diabetes than do inactive women. The purpose of the intervention was to examine whether intensified physical activity (PA) counseling in Finnish maternity care is feasible and effective in promoting leisure-time PA (LTPA) among pregnant women at risk of gestational diabetes. Methods Fourteen municipalities were randomized to intervention (INT) and usual care group (UC). Nurses in INT integrated five PA counseling sessions into routine maternity visits and offered monthly group meetings on PA instructed by physiotherapists. In UC conventional practices were continued. Feasibility evaluation included safety (incidence of PA-related adverse events; questionnaire), realization (timing and duration of sessions, number of sessions missed, attendance at group meetings; systematic record-keeping of the nurses and physiotherapists) and applicability (nurses’ views; telephone interview). Effectiveness outcomes were weekly frequency and duration of total and intensity-specific LTPA and meeting PA recommendation for health self-reported at 8-12 (baseline), 26-28 and 36-37 weeks’ gestation. Multilevel analysis with adjustments was used in testing for between-group differences in PA changes. Results The decrease in the weekly days of total and moderate-to-vigorous-intensity LTPA was smaller in INT (N = 219) than in UC (N = 180) from baseline to the first follow-up (0.1 vs. -1.2, p = 0.040 and −0.2 vs. -1.3, p = 0.016). A similar trend was seen in meeting the PA recommendation (−11%-points vs. -28%-points, p = 0.06). INT did not experience more adverse events classified as warning signs to terminate exercise than UC, counseling was implemented as planned and viewed positively by the nurses. Conclusions Intensified counseling had no effects on the duration of total or intensity-specific weekly LTPA. However, it was able to reduce the

  5. Project Enhance: A Randomized Controlled Trial of an Individualized HIV Prevention Intervention for HIV-Infected Men Who Have Sex With Men Conducted in a Primary Care Setting

    PubMed Central

    Safren, Steven A.; O’Cleirigh, Conall M.; Skeer, Margie; Elsesser, Steven A.; Mayer, Kenneth H.

    2013-01-01

    Objective Men who have sex with men (MSM) are the largest group of individuals in the U.S. living with HIV and have the greatest number of new infections. This study was designed to test a brief, culturally relevant prevention intervention for HIV-infected MSM, which could be integrated into HIV care. Method HIV-infected MSM who received HIV care in a community health center (N = 201), and who reported HIV sexual transmission-risk behavior (TRB) in the prior 6 months, were randomized to receive the intervention or treatment as usual. The intervention, provided by a medical social worker, included proactive case management for psychosocial problems, counseling about living with HIV, and HIV TRB risk reduction. Participants were followed every 3 months for one year. Results Participants, regardless of study condition, reported reductions in HIV TRB, with no significant differential effect by condition in primary intent-to-treat analyses. When examining moderators, the intervention was differentially effective in reducing HIV TRB for those who screened in for baseline depression, but this was not the case for those who did not screen in for depression. Conclusions The similar level of reduction in HIV TRB in the intervention and control groups, consistent with other recent secondary prevention interventions, speaks to the need for new, creative designs, or more potent interventions in secondary HIV prevention trials, as the control group seemed to benefit from risk assessment, study contact, and referrals provided by study staff. The differential finding for those with depression may suggest that those without depression could reap benefits from limited interventions, but those with a comorbid psychiatric diagnosis may require additional interventions to modify their sexual risk behaviors. PMID:22746262

  6. Tailored telephone counseling increases colorectal cancer screening

    PubMed Central

    Rawl, Susan M.; Christy, Shannon M.; Monahan, Patrick O.; Ding, Yan; Krier, Connie; Champion, Victoria L.; Rex, Douglas

    2015-01-01

    To compare the efficacy of two interventions to promote colorectal cancer screening participation and forward stage movement of colorectal cancer screening adoption among first-degree relatives of individuals diagnosed with adenomatous polyps. One hundred fifty-eight first-degree relatives of individuals diagnosed with adenomatous polyps were randomly assigned to receive one of two interventions to promote colorectal cancer screening. Participants received either a tailored telephone counseling plus brochures intervention or a non-tailored print brochures intervention. Data were collected at baseline and 3 months post-baseline. Group differences and the effect of the interventions on adherence and stage movement for colorectal cancer screening were examined using t-tests, chi-square tests, and logistic regression. Individuals in the tailored telephone counseling plus brochures group were significantly more likely to complete colorectal cancer screening and to move forward on stage of change for fecal occult blood test, any colorectal cancer test stage and stage of the risk-appropriate test compared with individuals in the non-tailored brochure group at 3 months post-baseline. A tailored telephone counseling plus brochures intervention successfully promoted forward stage movement and colorectal cancer screening adherence among first-degree relatives of individuals diagnosed with adenomatous polyps. PMID:26025212

  7. Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

    PubMed Central

    King, Summer; Green, Heather Joy

    2015-01-01

    Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

  8. Comparing the Effectiveness of Automated Online Counseling to Standard Web-Based Education on Improving Acne Knowledge: A Randomized Controlled Trial

    PubMed Central

    Tuong, William; Wang, Audrey S.

    2015-01-01

    Background Evidence regarding what comprises effective education for acne vulgaris patients is lacking. Internet-based education may improve patient knowledge of this condition. Objectives Our objective was to compare the effectiveness of standard web-based education and an automated counseling website in improving acne knowledge. Design In a randomized trial, participants visited either a standard website or an automated counseling website to learn about acne. Multiple-choice questions were administered at baseline and after 12 weeks to assess change in acne knowledge. Results A total of 97 high school students were enrolled, and 95 completed the study. The standard website group had a significant increase in knowledge from baseline (3.61 ± 1.22) to 12-week follow-up (5.46 ± 1.31, p < 0.001). Similarly, the automated counseling website group had a significant increase in knowledge between both time points (3.53 ± 1.50 vs. 6.49 ± 1.06, p < 0.001). After 12 weeks, mean improvement in knowledge was higher in the automated counseling group (2.96 ± 1.85) than in the standard website group (1.85 ± 1.46, d = 0.67, p = 0.002). The number of website visits was positively correlated with improvement in knowledge in both groups. Finally, the automated counseling website group rated their educational material more useful (p = 0.004) and more enjoyable to view (p = 0.003) than did the standard website group. Limitations This study is limited to adolescents with mild-to-moderate acne vulgaris. Conclusion Internet-based patient education appears to be an effective method of improving acne knowledge among adolescents. PMID:25502610

  9. Improving parental stress levels among mothers living with HIV: a randomized control group intervention study.

    PubMed

    Johnson, Erica R; Davies, Susan L; Aban, Inmaculada; Mugavero, Michael J; Shrestha, Sadeep; Kempf, Mirjam-Colette

    2015-04-01

    Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85(th) and 90(th) percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH.

  10. Improving Parental Stress Levels Among Mothers Living with HIV: A Randomized Control Group Intervention Study

    PubMed Central

    Johnson, Erica R.; Davies, Susan L.; Aban, Inmaculada; Mugavero, Michael J.; Shrestha, Sadeep

    2015-01-01

    Abstract Limited knowledge exists regarding parenting efficacy interventions for mothers living with HIV (MLH). This study evaluated the impact of a supportive group intervention on lowering parenting stress among MLH. Eighty MLH were randomized to a parenting (N=34) or health focused (control) (N=46) group intervention. Pre- and post-intervention stress levels were assessed using the Parental Stress Index-Short Form (PSI/SF). Differences in PSI/SF scores were examined using ANOVA, and predictors of PSI/SF scores were evaluated using multivariable linear regression. Findings indicate that both groups experienced significant decreases in parenting stress from baseline to post-intervention (p=0.0001), with no significant differences between interventions. At baseline, 41% of participants were identified as highly stressed and 30% as clinically stressed, with PSI/SF scores above the 85th and 90th percentile, respectively. Amongst the highly stressed subpopulation, significant improvements in PSI/SF scores for Parental Distress PSI/SF (p=0.039), Difficult Child PSI/SF (p=0.048), and total PSI/SF (p=0.036) were seen, with greater improvements in the parenting intervention. Among the clinically stressed subpopulation, significant improvements in total post-intervention PSI/SF scores were seen (p=0.049), with greater improvements in the parenting intervention. Results indicate that screening for high levels of stress should be considered in clinical practice to effectively implement stress-reducing interventions among MLH. PMID:25734870

  11. Use of a low-cost incentive intervention to improve counseling attendance among methadone-maintained patients.

    PubMed

    Sigmon, Stacey C; Stitzer, Maxine L

    2005-12-01

    Despite the importance of counseling in methadone maintenance treatment, many patients do not take advantage of these services. Incentives for attending group counseling were offered to methadone-maintained patients during an orientation phase of treatment or during required attendance at a relapse group later in treatment. Upon attending each counseling session, patients could draw for prizes under an escalating draw system with a 50% probability that draws would result in a prize. Incentives included small (1dollar), moderate (5 dollars), and large (20 dollars) prizes, with chances of winning inversely related to prize costs, and a maximum possible total of 160 dollars per patient. It was anticipated that this policy would provide a relatively low-cost approach to improving counseling attendance in our methadone clinic. The incentive policy significantly increased the percent of counseling sessions attended (52% vs. 76%) and promoted periods of continuous attendance. These data further support the effectiveness of low-cost incentive programs in enhancing counseling attendance among methadone patients.

  12. Screening and Brief Interventions for Hazardous and Harmful Alcohol Use among University Students in South Africa: Results from a Randomized Controlled Trial

    PubMed Central

    Pengpid, Supa; Peltzer, Karl; van der Heever, Hendry; Skaal, Linda

    2013-01-01

    The aim of this study was to assess the effectiveness of Screening and Brief Intervention (SBI) for alcohol problems among university students in South Africa. The study design for this efficacy study is a randomized controlled trial with 6- and 12-month follow-ups to examine the effects of a brief alcohol intervention to reduce alcohol use by hazardous and harmful drinkers in a university setting. The unit of randomization is the individual university student identified as a hazardous or harmful drinker attending public recruitment venues in a university campus. University students were screened for alcohol problems, and those identified as hazardous or harmful drinkers were randomized into an experimental or control group. The experimental group received one brief counseling session on alcohol risk reduction, while the control group received a health education leaflet. Results indicate that of the 722 screened for alcohol and who agreed to participate in the trial 152 (21.1%) tested positive for the Alcohol Use Disorder Identification Test (AUDIT) (score 8 or more). Among the 147 (96.7%) university students who also attended the 12-month follow-up session, the intervention effect on the AUDIT score was −1.5, which was statistically significant (P = 0.009). Further, the depression scores marginally significantly decreased over time across treatment groups, while other substance use (tobacco and cannabis use), self-rated health status and Posttraumatic Stress Disorder (PTSD) scores did not change over time across treatment groups. The study provides evidence of effective brief intervention by assistant nurses with hazardous and harmful drinkers in a university setting in South Africa. The short duration of the brief intervention makes it a realistic candidate for use in a university setting. PMID:23698697

  13. Counseling and Guidance for Gifted Underachievers.

    ERIC Educational Resources Information Center

    Kyung-Won, Jeon

    This review examines literature on counseling techniques for use with gifted underachievers (GUA). The review begins with a discussion of definitions of underachievement and the various types of underachievement. The paper then evaluates types of counseling, counselor variables, length of counseling intervention, and grade level of counseling.…

  14. Enhancing Risk Detection Among Homeless Youth: A Randomized Clinical Trial of a Promising Pilot Intervention.

    PubMed

    Bender, Kimberly A; DePrince, Anne; Begun, Stephanie; Hathaway, Jessica; Haffejee, Badiah; Schau, Nicholas

    2016-03-02

    Homeless youth frequently experience victimization, and youth with histories of trauma often fail to detect danger risks, making them vulnerable to subsequent victimization. The current study describes a pilot test of a skills-based intervention designed to improve risk detection among homeless youth through focusing attention to internal, interpersonal, and environmental cues. Youth aged 18 to 21 years (N = 74) were recruited from a shelter and randomly assigned to receive usual case management services or usual services plus a 3-day manualized risk detection intervention. Pretest and posttest interviews assessed youths' risk detection abilities through vignettes describing risky situations and asking youth to identify risk cues present. Separate 2 (intervention vs. control) × 2 (pretest vs. posttest) mixed ANOVAs found significant interaction effects, as intervention youth significantly improved in overall risk detection compared with control youth. Post hoc subgroup analyses found the intervention had a greater effect for youth without previous experiences of indirect victimization than those with previous indirect victimization experiences.

  15. Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial.

    PubMed

    Jahn, Patrick; Kuss, Oliver; Schmidt, Heike; Bauer, Alexander; Kitzmantel, Maria; Jordan, Karin; Krasemann, Susann; Landenberger, Margarete

    2014-04-01

    Patients' self-management skills are affected by their knowledge, activities, and attitudes toward pain management. This trial aimed to test the Self Care Improvement through Oncology Nursing (SCION)-PAIN program, a multimodular structured intervention to reduce patients' barriers to self-management of cancer pain. Two hundred sixty-three patients with diagnosed malignancy, pain>3 days, and average pain > or = 3/10 participated in a cluster-randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, in addition to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic, nonpharmacologic pain management, and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training, and counseling. Starting with admission, patients received booster sessions every third day and one follow-up telephone counseling session within 2 to 3 days after discharge. Patients in the control group received standard care. Primary end point was the group difference in patient-related barriers to self-management of cancer pain (Barriers Questionnaire-BQ II) 7 days after discharge. The SCION-PAIN program resulted in a significant reduction of patient-related barriers to pain management 1 week after discharge from the hospital: mean difference on BQ II was -0.49 points (95% confidence interval -0.87 points to -0.12 points; P=0.02). Furthermore, patients showed improved adherence to pain medication; odds ratio 8.58 (95% confidence interval 1.66-44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain.

  16. A survey of eMedia-delivered interventions for schizophrenia used in randomized controlled trials

    PubMed Central

    Naeem, Farooq; Munshi, Tariq; Xiang, Shuo; Yang, Megan; Shokraneh, Farhad; Syed, Yumeen; Ayub, Muhammad; Adams, Clive E; Farooq, Saeed

    2017-01-01

    Background Randomized trials evaluating electronic Media (eMedia) delivery of interventions are increasingly frequent in mental health. Although a number of reviews have reported efficacy of these interventions, none has reviewed the type of eMedia interventions and quality of their description. We therefore decided to conduct a survey of eMedia-delivered interventions for schizophrenia. Methods We surveyed all relevant trials reliably identified in the Cochrane Schizophrenia Group’s comprehensive register of trials by authors working independently. Data were extracted regarding the size of the trial, interventions, outcomes and how well the intervention was described. Results eMedia delivery of interventions is increasingly frequent in trials relevant to the care of people with schizophrenia. The trials varied considerably in sample sizes (mean =123, median =87, range =20–507), and interventions were diverse, rarely evaluating the same approaches and were poorly reported. This makes replication impossible. Outcomes in these studies are limited, have not been noted to be chosen by end users and seem unlikely to be easy to apply in routine care. No study reported on potential adverse effects or cost, end users satisfaction or ease of use. None of the papers mentioned the use of CONSORT eHealth guidelines. Conclusion There is a need to improve reporting and testing of psychosocial interventions delivered by eMedia. New trials should comply with CONSORT eHealth guidance on design, conduct and reporting, and existing CONSORT should be updated regularly, as the field is constantly evolving. PMID:28203078

  17. Moderators of Theory-Based Interventions to Promote Physical Activity in 77 Randomized Controlled Trials.

    PubMed

    Bernard, Paquito; Carayol, Marion; Gourlan, Mathieu; Boiché, Julie; Romain, Ahmed Jérôme; Bortolon, Catherine; Lareyre, Olivier; Ninot, Gregory

    2017-04-01

    A meta-analysis of randomized controlled trials (RCTs) has recently showed that theory-based interventions designed to promote physical activity (PA) significantly increased PA behavior. The objective of the present study was to investigate the moderators of the efficacy of these theory-based interventions. Seventy-seven RCTs evaluating theory-based interventions were systematically identified. Sample, intervention, methodology, and theory implementation characteristics were extracted, coded by three duos of independent investigators, and tested as moderators of interventions effect in a multiple-meta-regression model. Three moderators were negatively associated with the efficacy of theory-based interventions on PA behavior: intervention length (≥14 weeks; β = -.22, p = .004), number of experimental patients (β = -.10, p = .002), and global methodological quality score (β = -.08, p = .04). Our findings suggest that the efficacy of theory-based interventions to promote PA could be overestimated consequently due to methodological weaknesses of RCTs and that interventions shorter than 14 weeks could maximize the increase of PA behavior.

  18. Single-Session Personalized Cognitive Counseling to Change HIV Risk Behavior among HIV-Negative Men Who Have Sex with Men: A Two-Part Case Study

    ERIC Educational Resources Information Center

    McPhee, Brian; Skinta, Matthew D.; Paul, Jay; Dilley, James W.

    2012-01-01

    Two previous randomized controlled clinical trials have shown the effectiveness of a single-session cognitive intervention, personalized cognitive counseling (PCC), in decreasing HIV risk among men who have sex with men (MSM; Dilley et al., 2002; Dilley et al., 2007). PCC is a counseling technique based on social cognitive theory and the stages of…

  19. Can Senior Volunteers Deliver Reminiscence and Creative Activity Interventions? Results of the Legacy Intervention Family Enactment (LIFE) Randomized Controlled Trial

    PubMed Central

    Allen, Rebecca S.; Harris, Grant M.; Burgio, Louis D.; Azuero, Casey B.; Miller, Leslie A.; Shin, Hae Jung; Eichorst, Morgan K.; Csikai, Ellen L.; DeCoster, Jamie; Dunn, Linda L.; Kvale, Elizabeth; Parmelee, Patricia

    2014-01-01

    Context Palliative care patients and their family caregivers may have a foreshortened perspective of time left to live, or the expectation of the patient’s death in the near future. Patients and caregivers may report distress in physical, psychological, or existential/spiritual realms. Objectives To conduct a randomized controlled trial examining the effectiveness of retired senior volunteers (RSVs) in delivering a reminiscence and creative activity intervention aimed at alleviating palliative care patient and caregiver distress. Methods Of the 45 dyads that completed baseline, 28 completed post-intervention and 24 completed follow-up. The intervention group received three home visits by RSVs; control group families received three supportive telephone calls by research staff. Measures included symptom assessment and associated burden, depression, religiousness/spirituality, and meaning in life. Results Patients in the intervention group reported a significantly greater reduction in frequency of emotional symptoms (P = 0.02) and emotional symptom bother (P = 0.04) than the control group, as well as improved spiritual functioning. Family caregivers in the intervention group were more likely than control caregivers to endorse items on the Meaning in Life Scale (P = 0.02). Only improvement in intervention patients’ emotional symptom bother maintained at follow-up after discontinuing RSV contact (P = 0.024). Conclusion Delivery of the intervention by RSVs had a positive impact on palliative care patients’ emotional symptoms and burden and caregivers’ meaning in life. Meaningful prolonged engagement with palliative care patients and caregivers, possibly through alternative modes of treatment delivery such as continued RSV contact, may be necessary for maintenance of therapeutic effects. PMID:24667180

  20. Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project

    ERIC Educational Resources Information Center

    Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny

    2012-01-01

    Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…

  1. Effects of nutritional intervention in head and neck cancer patients undergoing radiotherapy: A prospective randomized clinical trial.

    PubMed

    Kang, Wen-Xing; Li, Wentao; Huang, Shi-Gao; Dang, Yazhang; Gao, Hongxiang

    2016-09-01

    Head and neck malignant tumors have numerous locations of the disease. After patients receive radiotherapy, their nutritional status is very poor, thus the curative effect is unsatisfactory. The aims of the present study were to investigate and analyze the nutritional status of patients with head and neck cancer undergoing radiotherapy (RT) in order to provide positive nutrition intervention for assisting the radiotherapy effect. A total of 40 patients with head and neck cancer were selected using a method of subjective global assessment (SGA) to assess nutritional status, including calorie intake and energy expenditure. In a randomized, controlled study, 20 patients received intensive dietary counseling and nutritional therapy (G1) and 20 received regular dietary as controls (G0) preradiotherapy and postradiotherapy. The primary endpoint was calorie intake and energy expenditure. The secondary endpoint was SGA rating with nutritional therapy. At the end of RT, energy intake showed a net increase in G1 (1,691±301 kcal) compared with that in G0 (1,066±312 kcal) (P<0.05); energy expenditure increased in G1 (1,673±279 kcal) compared with G0 (1,490±298 kcal) (P<0.05). The prevalence of severe malnutrition following radiotherapy was significantly different between the two study groups (10 patients in G0 and 4 patients in G1; P<0.05). The number of the normal malnutrition patients postRT in G0 decreased from 4 to 2 and conversely, in G1 it increased from 3 to 6 (P<0.05). In conclusion, patients with head and neck cancer were most malnutritioned, which impacted on clinical outcome. Timely nutritional intervention can effectively prevent weight loss and muscle wasting. Additionally, it may improve quality of life by decreasing the frequency of severe malnutrition.

  2. Efficacy of immediate patient feedback in emergency psychiatry: a randomized controlled trial in a crisis intervention & brief therapy team

    PubMed Central

    2013-01-01

    Background This study looks at the effect of immediate session-by-session feedback using short questionnaires for evaluating outcome of and alliance in the therapy. Research data strongly suggests that using this feedback informed treatment improves the outcome of therapy. However, until now, this method of Miller and Duncan has only been examined in clients (generally students) with mild problems and in partner counselling. The question addressed by this study is whether immediate feedback is also effective when applied during crisis intervention and subsequent brief therapy in a psychiatric patient population in emergency situations. It also looks at whether 'feedback-informed treatment' affects the quality of the alliance. Method/Design To test the hypotheses, all patients seeking help from the Crisis Intervention & Brief Therapy Team over a two-year period will be followed throughout their treatment up to a maximum of six months and a follow-up period of three months after ending the treatment. Patients are randomly assigned to two conditions: treatment without feedback and treatment with immediate feedback for each session. The therapists all operate in both conditions and so they deliver both treatments. An estimated total of 180 patients, aged 18 years and over, will be included in the study. Discussion The aim of this study is to make clear whether, and to what extent, systematic feedback from the patient in this target group during therapy determines the course and outcomes of therapy. We also look at whether, and to what extent, the quality of the alliance and the motivation of the person delivering treatment with respect to the instruments play a role. Trial registration NTR3168 PMID:24305085

  3. Effects of nutritional intervention in head and neck cancer patients undergoing radiotherapy: A prospective randomized clinical trial

    PubMed Central

    Kang, Wen-Xing; Li, Wentao; Huang, Shi-Gao; Dang, Yazhang; Gao, Hongxiang

    2016-01-01

    Head and neck malignant tumors have numerous locations of the disease. After patients receive radiotherapy, their nutritional status is very poor, thus the curative effect is unsatisfactory. The aims of the present study were to investigate and analyze the nutritional status of patients with head and neck cancer undergoing radiotherapy (RT) in order to provide positive nutrition intervention for assisting the radiotherapy effect. A total of 40 patients with head and neck cancer were selected using a method of subjective global assessment (SGA) to assess nutritional status, including calorie intake and energy expenditure. In a randomized, controlled study, 20 patients received intensive dietary counseling and nutritional therapy (G1) and 20 received regular dietary as controls (G0) preradiotherapy and postradiotherapy. The primary endpoint was calorie intake and energy expenditure. The secondary endpoint was SGA rating with nutritional therapy. At the end of RT, energy intake showed a net increase in G1 (1,691±301 kcal) compared with that in G0 (1,066±312 kcal) (P<0.05); energy expenditure increased in G1 (1,673±279 kcal) compared with G0 (1,490±298 kcal) (P<0.05). The prevalence of severe malnutrition following radiotherapy was significantly different between the two study groups (10 patients in G0 and 4 patients in G1; P<0.05). The number of the normal malnutrition patients postRT in G0 decreased from 4 to 2 and conversely, in G1 it increased from 3 to 6 (P<0.05). In conclusion, patients with head and neck cancer were most malnutritioned, which impacted on clinical outcome. Timely nutritional intervention can effectively prevent weight loss and muscle wasting. Additionally, it may improve quality of life by decreasing the frequency of severe malnutrition. PMID:27588193

  4. The Wild Wild West: A Framework to Integrate mHealth Software Applications and Wearables to Support Physical Activity Assessment, Counseling and Interventions for Cardiovascular Disease Risk Reduction.

    PubMed

    Lobelo, Felipe; Kelli, Heval M; Tejedor, Sheri Chernetsky; Pratt, Michael; McConnell, Michael V; Martin, Seth S; Welk, Gregory J

    2016-01-01

    Physical activity (PA) interventions constitute a critical component of cardiovascular disease (CVD) risk reduction programs. Objective mobile health (mHealth) software applications (apps) and wearable activity monitors (WAMs) can advance both assessment and integration of PA counseling in clinical settings and support community-based PA interventions. The use of mHealth technology for CVD risk reduction is promising, but integration into routine clinical care and population health management has proven challenging. The increasing diversity of available technologies and the lack of a comprehensive guiding framework are key barriers for standardizing data collection and integration. This paper reviews the validity, utility and feasibility of implementing mHealth technology in clinical settings and proposes an organizational framework to support PA assessment, counseling and referrals to community resources for CVD risk reduction interventions. This integration framework can be adapted to different clinical population needs. It should also be refined as technologies and regulations advance under an evolving health care system landscape in the United States and globally.

  5. The Wild Wild West: A Framework to Integrate mHealth Software Applications and Wearables to Support Physical Activity Assessment, Counseling and Interventions for Cardiovascular Disease Risk Reduction

    PubMed Central

    Lobelo, Felipe; Kelli, Heval M.; Tejedor, Sheri Chernetsky; Pratt, Michael; McConnell, Michael V.; Martin, Seth S.; Welk, Gregory J.

    2017-01-01

    Physical activity (PA) interventions constitute a critical component of cardiovascular disease (CVD) risk reduction programs. Objective mobile health (mHealth) software applications (apps) and wearable activity monitors (WAMs) can advance both assessment and integration of PA counseling in clinical settings and support community-based PA interventions. The use of mHealth technology for CVD risk reduction is promising, but integration into routine clinical care and population health management has proven challenging. The increasing diversity of available technologies and the lack of a comprehensive guiding framework are key barriers for standardizing data collection and integration. This paper reviews the validity, utility and feasibility of implementing mHealth technology in clinical settings and proposes an organizational framework to support PA assessment, counseling and referrals to community resources for CVD risk reduction interventions. This integration framework can be adapted to different clinical population needs. It should also be refined as technologies and regulations advance under an evolving health care system landscape in the United States and globally. PMID:26923067

  6. Positive Family Intervention for Severe Challenging Behavior I: A Multisite Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.

    2013-01-01

    The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…

  7. A Randomized Controlled Trial Study of the ABRACADABRA Reading Intervention Program in Grade 1

    ERIC Educational Resources Information Center

    Savage, Robert S.; Abrami, Philip; Hipps, Geoffrey; Deault, Louise

    2009-01-01

    This study reports a randomized controlled trial evaluation of a computer-based balanced literacy intervention, ABRACADABRA (http://grover.concordia.ca/abra/version1/abracadabra.html). Children (N = 144) in Grade 1 were exposed either to computer activities for word analysis, text comprehension, and fluency, alongside shared stories (experimental…

  8. Fraction Intervention for Students with Mathematics Difficulties: Lessons Learned from Five Randomized Control Trials

    ERIC Educational Resources Information Center

    Fuchs, Lynn S.; Malone, Amelia S.; Schumacher, Robin F.; Namkung, Jessica; Wang, Amber

    2016-01-01

    The purpose of this article was to summarize results from 5 randomized control trials assessing the effects of intervention to improve the fraction performance of 4th-grade students at-risk for difficulty in learning about fractions. We begin by explaining the importance of competence with fractions and why an instructional focus on fractions…

  9. Early Development of Delinquency within Divorced Families: Evaluating a Randomized Preventive Intervention Trial

    ERIC Educational Resources Information Center

    DeGarmo, David S.; Forgatch, Marion S.

    2005-01-01

    This paper reports on an experimental test of coercion theory early onset model of delinquency. Results are from the Oregon Divorce Study-II, a randomized preventive intervention trial with a sample of 238 recently separated mothers and their sons in early elementary school. The objective was to experimentally manipulate parenting variables…

  10. Randomized Comparison of Augmented and Nonaugmented Language Interventions for Toddlers with Developmental Delays and Their Parents

    ERIC Educational Resources Information Center

    Romski, MaryAnn; Sevcik, Rose A.; Adamson, Lauren B.; Cheslock, Melissa; Smith, Ashlyn; Barker, R. Michael; Bakeman, Roger

    2010-01-01

    Purpose: This study compared the language performance of young children with developmental delays who were randomly assigned to 1 of 3 parent-coached language interventions. Differences in performance on augmented and spoken word size and use, vocabulary size, and communication interaction skills were examined. Method: Sixty-eight toddlers with…

  11. Extensions of a Versatile Randomization Test for Assessing Single-Case Intervention Effects

    ERIC Educational Resources Information Center

    Levin, Joel R.; Lall, Venessa F.; Kratochwill, Thomas R.

    2011-01-01

    The purpose of the present study was to investigate the statistical properties of two extensions of the Levin-Wampold (1999) single-case simultaneous start-point model's comparative effectiveness randomization test. The two extensions were (a) adapting the test to situations where there are more than two different intervention conditions and (b)…

  12. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons with HIV Infection

    ERIC Educational Resources Information Center

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2008-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…

  13. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States

    PubMed Central

    Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.

    2016-01-01

    Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P < .001; intervention = −0.73; control = +0.27). Behavioral changes included statistically significant improvements in fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067

  14. An effective group psychoeducational intervention for improving compliance with vaginal dilation: A randomized controlled trial

    SciTech Connect

    Jeffries, Sherryl A.; Robinson, John W. . E-mail: johnrobi@cancerboard.ab.ca; Craighead, Peter S.; Keats, Melanie R.

    2006-06-01

    Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators.

  15. Running injuries in novice runners enrolled in different training interventions: a pilot randomized controlled trial.

    PubMed

    Baltich, J; Emery, C A; Whittaker, J L; Nigg, B M

    2016-08-03

    The purpose of this trial was to evaluate injury risk in novice runners participating in different strength training interventions. This was a pilot randomized controlled trial. Novice runners (n = 129, 18-60 years old, <2 years recent running experience) were block randomized to one of three groups: a "resistance" strength training group, a "functional" strength training group, or a stretching "control" group. The primary outcome was running related injury. The number of participants with complaints and the injury rate (IR = no. injuries/1000 running hours) were quantified for each intervention group. For the first 8 weeks, participants were instructed to complete their training intervention three to five times a week. The remaining 4 months was a maintenance period.

  16. Moderators of intervention effects on parenting practices in a randomized controlled trial in early childhood.

    PubMed

    Theise, Rachelle; Huang, Keng-Yen; Kamboukos, Dimitra; Doctoroff, Greta L; Dawson-McClure, Spring; Palamar, Joseph J; Brotman, Laurie Miller

    2014-01-01

    The current study examined whether parent psychological resources (parenting stress, depression, and social support from friends and family) moderated the effects of early family preventive intervention on parenting among high-risk families. Ninety-two preschool-age children (M age = 3.94 years) at familial risk for conduct problems participated in a randomized controlled trial of a family intervention to prevent conduct problems. The majority of families were African American or Latino and experienced multiple stressors associated with poverty and familial antisocial behavior. Families were randomized to a 22-session group-based intervention or to a no-intervention, assessment-only control condition. Parents reported on their psychological resources (parenting stress, depression and social support from friends and family) at baseline. Parenting (responsive, harsh, stimulation for learning) was assessed through self-report and observational measures four times over 24 months. Previously-reported intervention effects on responsive parenting and stimulation for learning were moderated by depression and social support from friends, respectively, such that benefits were concentrated among those at greatest risk (i.e., depressed, limited support from friends). The intervention effect on harsh parenting was not moderated by any of the parent psychological resources examined, such that parents with high and low resources benefited comparably. Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact among families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-focused, group-based intervention is promising for strengthening parenting among the highest risk families.

  17. An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

    PubMed Central

    Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B.

    2015-01-01

    Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24. PMID:26257780

  18. Effect of Six-Month Diet Intervention on Sleep among Overweight and Obese Men with Chronic Insomnia Symptoms: A Randomized Controlled Trial.

    PubMed

    Tan, Xiao; Alén, Markku; Wang, Kun; Tenhunen, Jarkko; Wiklund, Petri; Partinen, Markku; Cheng, Sulin

    2016-11-23

    Growing evidence suggests that diet alteration affects sleep, but this has not yet been studied in adults with insomnia symptoms. We aimed to determine the effect of a six-month diet intervention on sleep among overweight and obese (Body mass index, BMI ≥ 25 kg/m²) men with chronic insomnia symptoms. Forty-nine men aged 30-65 years with chronic insomnia symptoms were randomized into diet (n = 28) or control (n = 21) groups. The diet group underwent a six-month individualized diet intervention with three face-to-face counseling sessions and online supervision 1-3 times per week; 300-500 kcal/day less energy intake and optimized nutrient composition were recommended. Controls were instructed to maintain their habitual lifestyle. Sleep parameters were determined by piezoelectric bed sensors, a sleep diary, and a Basic Nordic sleep questionnaire. Compared to the controls, the diet group had shorter objective sleep onset latency after intervention. Within the diet group, prolonged objective total sleep time, improved objective sleep efficiency, lower depression score, less subjective nocturnal awakenings, and nocturia were found after intervention. In conclusion, modest energy restriction and optimized nutrient composition shorten sleep onset latency in overweight and obese men with insomnia symptoms.

  19. Effect of Six-Month Diet Intervention on Sleep among Overweight and Obese Men with Chronic Insomnia Symptoms: A Randomized Controlled Trial

    PubMed Central

    Tan, Xiao; Alén, Markku; Wang, Kun; Tenhunen, Jarkko; Wiklund, Petri; Partinen, Markku; Cheng, Sulin

    2016-01-01

    Growing evidence suggests that diet alteration affects sleep, but this has not yet been studied in adults with insomnia symptoms. We aimed to determine the effect of a six-month diet intervention on sleep among overweight and obese (Body mass index, BMI ≥ 25 kg/m2) men with chronic insomnia symptoms. Forty-nine men aged 30–65 years with chronic insomnia symptoms were randomized into diet (n = 28) or control (n = 21) groups. The diet group underwent a six-month individualized diet intervention with three face-to-face counseling sessions and online supervision 1–3 times per week; 300–500 kcal/day less energy intake and optimized nutrient composition were recommended. Controls were instructed to maintain their habitual lifestyle. Sleep parameters were determined by piezoelectric bed sensors, a sleep diary, and a Basic Nordic sleep questionnaire. Compared to the controls, the diet group had shorter objective sleep onset latency after intervention. Within the diet group, prolonged objective total sleep time, improved objective sleep efficiency, lower depression score, less subjective nocturnal awakenings, and nocturia were found after intervention. In conclusion, modest energy restriction and optimized nutrient composition shorten sleep onset latency in overweight and obese men with insomnia symptoms. PMID:27886073

  20. Language outcome in autism: randomized comparison of joint attention and play interventions.

    PubMed

    Kasari, Connie; Paparella, Tanya; Freeman, Stephanny; Jahromi, Laudan B

    2008-02-01

    This study reports results of a randomized controlled trial aimed at joint attention (JA) and symbolic play (SP) in preschool children with autism, with prediction to language outcome 12 months later. Participants were 58 children (46 boys) with autism between 3 and 4 years of age. Children were randomized to a JA intervention, an SP intervention, or control group. Interventions were conducted 30 min daily for 5-6 weeks. Assessments of JA skills, SP skills, mother-child interactions, and language development were collected at 4 time points: pre- and postintervention and 6 and 12 months postintervention by independent testers. Results indicate that expressive language gains were greater for both treatment groups compared with the control group, and results could not be explained by differences in other interventions in which children participated. For children beginning treatment with the lowest language levels, the JA intervention improved language outcome significantly more than did the SP or control interventions. These findings suggest clinically significant benefits of actively treating JA and SP skills in young children with autism.

  1. Randomized Controlled Theory-Based, E-Mail-Mediated Walking Intervention.

    PubMed

    Richards, Elizabeth A; Ogata, Niwako; Cheng, Ching-Wei

    2017-02-01

    The purpose of this study was to evaluate the ability of two concurrent randomized controlled interventions based on social cognitive theory to increase walking. A second purpose was to compare the efficacy of the intervention between two distinct groups: dog owners and non-dog owners. Adult dog owners ( n = 40) and non-dog owners ( n = 65) were randomized into control or intervention groups. Intervention groups received bi-weekly emails for first 4 weeks and then weekly email for the next 8 weeks targeting self-efficacy, social support, goal setting, and benefits/barriers to walking. Dog owner messages focused on dog walking while non-dog owners received general walking messages. Control groups received a 1-time email reviewing current physical activity guidelines. At 6 months, both intervention groups reported greater increases in walking and maintained these increases at 12 months. The greatest increases were seen in the dog owner intervention group. In conclusion, dog owners accumulated more walking, which may be attributed to the dog-owner relationship.

  2. Randomized controlled trial of a collaborative care intervention to manage cancer-related symptoms: lessons learned

    PubMed Central

    Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark

    2012-01-01

    Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters

  3. Motivational Interviewing with computer assistance as an intervention to empower women to make contraceptive choices while incarcerated: study protocol for randomized controlled trial

    PubMed Central

    2012-01-01

    Background Unplanned pregnancies and sexually transmitted infections (STIs) are important and costly public health problems in the United States resulting from unprotected sexual intercourse. Risk factors for unplanned pregnancies and STIs (poverty, low educational attainment, homelessness, substance abuse, lack of health insurance, history of an abusive environment, and practice of commercial sex work) are especially high among women with a history of incarceration. Project CARE (Contraceptive Awareness and Reproductive Education) is designed to evaluate an innovative intervention, Motivational Interviewing with Computer Assistance (MICA), aimed at enhancing contraceptive initiation and maintenance among incarcerated women who do not want a pregnancy within the next year and who are anticipated to be released back to the community. This study aims to: (1) increase the initiation of highly effective contraceptives while incarcerated; (2) increase the continuation of highly effective contraceptive use at 3, 6, 9, and 12 months after release; and (3) decrease unsafe sexual activity. Methods/Design This randomized controlled trial will recruit 400 women from the Rhode Island Department of Corrections (RI DOC) women’s jail at risk for an unplanned pregnancy (that is, sexually active with men and not planning/wanting to become pregnant in the next year). They will be randomized to two interventions: a control group who receive two educational videos (on contraception, STIs, and pre-conception counseling) or a treatment group who receive two sessions of personalized MICA. MICA is based on the principles of the Transtheoretical Model (TTM) and on Motivational Interviewing (MI), an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. Women will be followed at 3, 6, 9, and 12 months post release and assessed for STIs, pregnancy, and reported condom use. Discussion Results from this study are expected to enhance our

  4. Development of early mathematical skills with a tablet intervention: a randomized control trial in Malawi

    PubMed Central

    Pitchford, Nicola J.

    2015-01-01

    Evaluation of educational interventions is necessary prior to wide-scale rollout. Yet very few rigorous studies have been conducted on the effectiveness of tablet-based interventions, especially in the early years and in developing countries. This study reports a randomized control trial to evaluate the effectiveness of a tablet intervention for supporting the development of early mathematical skills in primary school children in Malawi. A total sample of 318 children, spanning Standards 1–3, attending a medium-sized urban primary school, were randomized to one of three groups: maths tablet intervention, non-maths tablet control, and standard face-to-face practice. Children were pre-tested using tablets at the start of the school year on two tests of mathematical knowledge and a range of basic skills related to scholastic progression. Class teachers then delivered the intervention over an 8-weeks period, for the equivalent of 30-min per day. Technical support was provided from the local Voluntary Service Overseas (VSO). Children were then post-tested on the same assessments as given at pre-test. A final sample of 283 children, from Standards 1–3, present at both pre- and post-test, was analyzed to investigate the effectiveness of the maths tablet intervention. Significant effects of the maths tablet intervention over and above standard face-to-face practice or using tablets without the maths software were found in Standards 2 and 3. In Standard 3 the greater learning gains shown by the maths tablet intervention group compared to both of the control groups on the tablet-based assessments transferred to paper and pencil format, illustrating generalization of knowledge gained. Thus, tablet technology can effectively support early years mathematical skills in developing countries if the software is carefully designed to engage the child in the learning process and the content is grounded in a solid well-constructed curriculum appropriate for the child

  5. Improving Colorectal Cancer Screening in Asian Americans: Results of a Randomized Intervention Study

    PubMed Central

    Carney, Patricia A.; Lin, Frances Lee; Mongoue-Tchokote, Solange; Mori, Motomi; Leung, Holden; Lau, Christine; Le, TD; Lieberman, David A.

    2014-01-01

    Objective To test, using a randomized controlled trial design, the impact of an educational intervention delivered by specially trained community health workers among Chinese, Korean and Vietnamese participants aged 50–75 on knowledge, attitudes, beliefs and intention regarding colorectal cancer screening. Methods We collected baseline data on participants’ baseline demographic characteristics, knowledge, attitudes, beliefs about cancer, its risk factors and intention to keep up-to-date on cancer screening in the future. Fifteen intervention sessions were held between April and June of 2011. Follow-up surveys were administered in the post-test period to both intervention and control participants. Those randomized to the control group received educational pamphlets in their native language. Results The intervention had the greatest influence on the Chinese subgroup, which had improved scores relative to the control group for Perceived Behavior Control and Intentions (pre- vs. post- change in control group −0.16; change in intervention group 0.11, p=0.004), Behavioral Beliefs on Cancer Screening (pre- vs. post- change in control group −0.06; change in intervention group 0.24, p=0.0001), and for Attitudes Toward Behavior (pre- vs. post- change in control group −0.24; change in intervention group 0.35, p=<0.0001). The intervention had no effect on Behavioral Beliefs on Cancer, Control Beliefs, and Perceived Behavioral Control (Reliance on Family). Though intention to stay up-to-date for cancer screening increased in two study groups (Chinese and Vietnamese), these were not significant. Conclusions An educational program delivered by culturally specific community health educators using culturally appropriate language influences some knowledge, attitude and behavioral beliefs but not others. PMID:24595714

  6. Do Hospitalized Premature Infants Benefit from Music Interventions? A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique

    2016-01-01

    Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID

  7. Effectiveness of a Multidimensional Randomized Control Intervention to Reduce Quartz Exposure Among Construction Workers.

    PubMed

    van Deurssen, Erik; Meijster, Tim; Oude Hengel, Karen M; Boessen, Ruud; Spaan, Suzanne; Tielemans, Erik; Heederik, Dick; Pronk, Anjoeka

    2015-10-01

    There is little evidence with respect to the effectiveness of intervention programs that focus on the reduction of occupational quartz exposure in the construction industry. This article evaluates the effectiveness of a multidimensional intervention which was aimed at reducing occupational quartz exposure among construction workers by increasing the use of technical control measures. Eight companies participating in the cluster randomized controlled trial were randomly allocated to the intervention (four companies) or control condition (four companies). The multidimensional intervention included engineering, organizational, and behavioural elements at both organizational and individual level. Full-shift personal quartz exposure measurements and detailed observations were conducted before and after the intervention among bricklayers, carpenters, concrete drillers, demolishers, and tuck pointers (n = 282). About 59% of these workers measured at baseline were reassessed during follow-up. Bayesian hierarchical models were used to evaluate the intervention effect on exposure levels. Concrete drillers in the intervention group used technical control measures, particularly water suppression, for a significantly greater proportion of the time spent on abrasive tasks during follow-up compared to baseline (93 versus 62%; P < 0.05). A similar effect, although not statistically significant, was observed among demolishers. A substantial overall reduction in quartz exposure (73 versus 40% in the intervention and control group respectively; P < 0.001) was observed for concrete drillers, demolishers, and tuck pointers. The decrease in exposure in the intervention group compared to controls was significantly larger for demolishers and tuck pointers, but not for concrete drillers. The observed effect could at least partly be explained by the introduced interventions; the statistically significant increased use of control measures among concrete drillers explains the observed effect

  8. Randomized Controlled Trial Lifestyle Interventions for Asian Americans: A Systematic Review

    PubMed Central

    Bender, Melinda S.; Choi, JiWon; Won, Gloria Y.; Fukuoka, Yoshimi

    2014-01-01

    Objective Asian Americans are the fastest-growing race in the United States. However, they are largely underrepresented in health research, particularly lifestyle interventions. A systematic review was conducted to analyze the characteristics and quality of lifestyle intervention literature promoting changes in physical activity (PA), diet, and/or weight management targeting Asian Americans. Method A systematic electronic database search identified randomized controlled clinical trials (RCT), involving lifestyle interventions for Asian Americans, published from 1995 to 2013 conducted in the U.S. Data extraction was conducted from August through December 2013. Results Seven RCTs met the review criteria. Cross-study comparisons were difficult due to diversity in: RCT intervention designs, cultural appropriateness, outcome measures, sample size, and race/ethnic groups. Overall, risk of bias and cultural appropriateness scores were moderate to low. Five out of seven RCTs showed significant between group differences for PA, diet, and weight. In general, sample sizes were small or lacked sufficient power to fully analyze intervention efficacy. Conclusion Evidence of the efficacy for lifestyle interventions among Asian Americans was mixed. Recommendations include: more rigorous RCT designs, more objective measures, larger Asian American sample sizes, culturally appropriate interventions, individual tailoring, maintenance phase with support, and providing education and modeling of lifestyle behaviors. PMID:25086326

  9. Efficacy of musical interventions in dementia: evidence from a randomized controlled trial.

    PubMed

    Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine

    2014-01-01

    Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress.

  10. Intervention for infants with brain injury: Results of a randomized controlled study

    PubMed Central

    Badr, Lina Kurdahi; Garg, Meena; Kamath, Meghna

    2009-01-01

    A randomized clinical trail (RCT) employed a 12-month individualized cognitive/sensorimotor stimulation program to look at the efficacy of the intervention on 62 infants with suspected brain injury. The control group infants received the State-funded follow-up program provided by the Los Angeles (LA) Regional Centers while the intervention group received intensive stimulation using the Curriculum and Monitoring System (CAMS) taught by public health nurses (PHNs). The developmental assessments and outcome measures were performed at 6, 12 and 18 months corrected age and included the Bayley motor and mental development, the Home, mother–infant interaction (Nursing Child Assessment Feeding Scale (NCAFS) and Nursing Child Assessment Teaching Scale (NCATS)), parental stress and social support. At 18 months, 43 infants remained in the study. The results indicate that the intervention had minimal positive effects on the Bayley mental and motor development scores of infants in the intervention group. Likewise, the intervention did not contribute to less stress or better mother–infant interaction at 12 or 18 months although there were significant differences in the NCAFS scores favoring the intervention group at 6 months. There was a significant trend, however, for the control group to have a significant decrease over time on the Bayley mental scores. Although the sample was not large and attrition was at 31%, this study provides further support to the minimal effects of stimulation and home intervention for infants with brain injury and who may have more significant factors contributing to their developmental outcome. PMID:17138264

  11. Using a technology-based intervention to promote weight loss in sedentary overweight or obese adults: a randomized controlled trial study design

    PubMed Central

    Barry, Vaughn W; McClain, Amanda C; Shuger, Sara; Sui, Xuemei; Hardin, James W; Hand, Gregory A; Wilcox, Sara; Blair, Steven N

    2011-01-01

    Purpose: The SenseWear™ Armband is an activity monitor developed to improve lifestyle self-monitoring. Currently, few studies assess electronic self-monitoring and weight loss with a lifestyle intervention program. To our knowledge, only one study has used the SenseWear Armband in combination with a lifestyle intervention to improve weight loss, and no studies have evaluated whether a self-monitoring intervention based solely on the armband can promote weight loss. Consequently, the aims of the study were to assess weight loss from electronic self-monitoring, to compare these values to the lifestyle intervention and standard care groups, and to compare weight loss with lifestyle intervention with and without the armband. Patients and methods: We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 years; BMI, 33.3 ± 5.2 kg/m2) to participate in the 9-month study. Participants were randomized into one of four weight loss groups: 1) the standard care group received a self-directed weight loss program, complete with an evidence-based weight loss manual (standard care, n = 50); 2) a 14-week group-based behavioral weight loss program followed by weekly, biweekly, and monthly telephone counseling calls (GWL, n = 49); 3) the use of the armband to help improve lifestyle self-monitoring (SWA alone, n = 49); or (4) the group-based behavioral weight loss program and follow-up telephone counseling calls plus the armband (GWL + SWA, n = 49). All participants received the evidence-based weight loss manual at baseline. All measures were performed at baseline and months 4 and 9. The primary outcomes were weight loss and waist circumference reduction. Results: This study is a well-designed randomized controlled study powered to detect a 0.5-kg weight loss and 0.6-cm waist circumference reduction in overweight and obese sedentary adults. Conclusion: Innovative technologies are providing lifestyle self-monitoring and weight loss tools. Utilizing these technologies

  12. Effectiveness and moderators of the preventive intervention kids in divorce situations: A randomized controlled trial.

    PubMed

    Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja

    2015-10-01

    Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.

  13. Promoting First Relationships: Randomized Trial of a Relationship-Based Intervention for Toddlers in Child Welfare

    PubMed Central

    Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.

    2013-01-01

    We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational ratings of caregiver sensitivity improved more in the PFR condition than in the comparison condition, with an effect size for the difference in adjusted means post-intervention of d = .41. Caregiver understanding of toddlers’ social emotional needs and caregiver reports of child competence also differed by intervention condition post-intervention (d = .36 and d = .42) with caregivers in the PFR condition reporting more understanding of toddlers and child competence. Models of PFR effects on within-individual change were significant for caregiver sensitivity and understanding of toddlers. At the 6-month follow-up 61% of original sample dyads were still intact and there were no significant differences on caregiver or child outcomes, although caregivers in the PFR group did report marginally (p<.10) fewer child sleep problems (d = −.34). PMID:22949743

  14. A Framework for Sex Role Counseling.

    ERIC Educational Resources Information Center

    Cook, Ellen Piel

    1985-01-01

    The androgyny model of masculinity and femininity serves as the basis for a framework for sex role counseling applicable to both sexes. Examples of sex role problems, counseling goals, and interventions are described. (Author/BL)

  15. COUNSELING PRACTICES.

    ERIC Educational Resources Information Center

    WATERLOO, GLENN E.

    THE NEED FOR COUNSELING IS EMPHASIZED BY THE FACT THAT 875,000 CHILDREN IN THE UNITED STATES HAVE MENTAL AND PHYSICAL IMPEDIMENTS TO LEARNING. TYPICAL COUNSELING PRACTICES ARE PROBLEM-CENTERED COUNSELING, EXCLUSIVELY "VOCATIONAL" OR "EDUCATIONAL" COUNSELING WITH LITTLE CONCERN FOR THE WHOLE INDIVIDUAL, EXTREME DIRECTIVE OR…

  16. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial.

    PubMed

    Formby, Craig; Hawley, Monica L; Sherlock, LaGuinn P; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M; Juneau, Roger; Desporte, Edward J; Siegle, Gregory R

    2015-05-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy-based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1-full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2-partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3-partial treatment achieved with binaural sound generators alone; and (4) group 4-a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were significantly

  17. A Sound Therapy-Based Intervention to Expand the Auditory Dynamic Range for Loudness among Persons with Sensorineural Hearing Losses: A Randomized Placebo-Controlled Clinical Trial

    PubMed Central

    Formby, Craig; Hawley, Monica L.; Sherlock, LaGuinn P.; Gold, Susan; Payne, JoAnne; Brooks, Rebecca; Parton, Jason M.; Juneau, Roger; Desporte, Edward J.; Siegle, Gregory R.

    2015-01-01

    The primary aim of this research was to evaluate the validity, efficacy, and generalization of principles underlying a sound therapy–based treatment for promoting expansion of the auditory dynamic range (DR) for loudness. The basic sound therapy principles, originally devised for treatment of hyperacusis among patients with tinnitus, were evaluated in this study in a target sample of unsuccessfully fit and/or problematic prospective hearing aid users with diminished DRs (owing to their elevated audiometric thresholds and reduced sound tolerance). Secondary aims included: (1) delineation of the treatment contributions from the counseling and sound therapy components to the full-treatment protocol and, in turn, the isolated treatment effects from each of these individual components to intervention success; and (2) characterization of the respective dynamics for full, partial, and control treatments. Thirty-six participants with bilateral sensorineural hearing losses and reduced DRs, which affected their actual or perceived ability to use hearing aids, were enrolled in and completed a placebo-controlled (for sound therapy) randomized clinical trial. The 2 × 2 factorial trial design was implemented with or without various assignments of counseling and sound therapy. Specifically, participants were assigned randomly to one of four treatment groups (nine participants per group), including: (1) group 1—full treatment achieved with scripted counseling plus sound therapy implemented with binaural sound generators; (2) group 2—partial treatment achieved with counseling and placebo sound generators (PSGs); (3) group 3—partial treatment achieved with binaural sound generators alone; and (4) group 4—a neutral control treatment implemented with the PSGs alone. Repeated measurements of categorical loudness judgments served as the primary outcome measure. The full-treatment categorical-loudness judgments for group 1, measured at treatment termination, were

  18. Clown intervention to reduce preoperative anxiety in children and parents: a randomized controlled trial.

    PubMed

    Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto

    2014-03-01

    This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety.

  19. A Randomized Controlled Trial of a Cognitive Behavioural Intervention for Anger Management in Children Diagnosed with Asperger Syndrome

    ERIC Educational Resources Information Center

    Sofronoff, Kate; Attwood, Tony; Hinton, Sharon; Levin, Irina

    2007-01-01

    The purpose of the study described was to evaluate the effectiveness of a cognitive behavioural intervention for anger management with children diagnosed with Asperger syndrome. Forty-five children and their parents were randomly assigned to either intervention or wait-list control conditions. Children in the intervention participated in six 2-h…

  20. Video-Feedback Intervention to Promote Positive Parenting Adapted to Autism (VIPP-AUTI): A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Poslawsky, Irina E; Naber, Fabiënne BA; Bakermans-Kranenburg, Marian J; van Daalen, Emma; van Engeland, Herman; van IJzendoorn, Marinus H

    2015-01-01

    In a randomized controlled trial, we evaluated the early intervention program Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI) with 78 primary caregivers and their child (16-61 months) with Autism Spectrum Disorder. VIPP-AUTI is a brief attachment-based intervention program, focusing on improving parent-child…

  1. Computerized v. In-person Brief Intervention for Drug Misuse: A Randomized Clinical Trial

    PubMed Central

    Schwartz, Robert P.; Gryczynski, Jan; Mitchell, Shannon Gwin; Gonzales, Arturo; Moseley, Ana; Peterson, Thomas R.; Ondersma, Steven J.; O’Grady, Kevin E.

    2014-01-01

    Background and aims Several studies have found that brief interventions (BIs) for drug misuse have superior effectiveness to no-treatment controls. However, many health centers do not provide BIs for drug use consistently due to insufficient behavioral health staff capacity. Computerized BIs for drug use are a promising approach, but their effectiveness compared with in-person BIs has not been established. This study compared the effectiveness of a computerized brief intervention (CBI) to an in-person brief intervention (IBI) delivered by a behavioral health counselor. Methods Two-arm randomized clinical trial, conducted in two health centers in New Mexico, USA. Participants were 360 adult primary care patients with moderate-risk drug scores on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) who were randomly assigned on a 1:1 basis to a computerized brief intervention (CBI) or to an in-person brief intervention (IBI) delivered by a behavioral health counselor. Assessments were conducted at baseline and 3-month follow-up, and included the ASSIST and drug testing on hair samples. Results The IBI and CBI conditions did not differ at 3 months on global ASSIST drug scores (b=−1.79; 95% CI=−4.37,0.80) or drug-positive hair tests (OR=.97; 95% CI= 0.47,2.02). There was a statistically significant advantage of CBI over IBI in substance-specific ASSIST scores for marijuana (b=−1.73; 95% CI= −2.91,−0.55; Cohen’s d=.26; p=.004) and cocaine (b= −4.48; 95% CI= −8.26,−0.71; Cohen’s d=.50; p=.021) at 3 months. Conclusions Computerized brief intervention can be an effective alternative to in-person brief intervention for addressing moderate drug use in primary care. PMID:24520906

  2. Early Intervention for Toddlers With Language Delays: A Randomized Controlled Trial

    PubMed Central

    Kaiser, Ann P.

    2015-01-01

    OBJECTIVE: Early interventions for toddlers with expressive and receptive language delays have not resulted in positive expressive language outcomes. This randomized controlled trial tested the effects on language outcomes of a caregiver-implemented communication intervention targeting toddlers at risk for persistent language delays. METHODS: Participants included 97 toddlers, who were between 24 and 42 months with language scores at least 1.33 SDs below the normative mean and no other developmental delays, and their caregivers. Toddlers were randomly assigned to the caregiver-implemented intervention or a usual-care control group. Caregivers and children participated in 28 sessions in which caregivers were taught to implement the intervention. The primary outcome was the Preschool Language Scale, Fourth Edition, a broad-based measure of language. Outcome measurement was not blinded. RESULTS: Caregivers in the intervention improved their use of all language facilitation strategies, such as matched turns (adjusted mean difference, intervention-control, 40; 95% confidence interval 34 to 46; P < .01). Children in the intervention group had significantly better receptive language skills (5.3; 95% confidence interval 0.15 to 10.4), but not broad-based expressive language skills (0.37, 95% confidence interval −4.5 to 5.3; P = .88). CONCLUSIONS: This trial provides preliminary evidence of the short-term effects of systematic caregiver instruction on caregiver use of language facilitation strategies and subsequent changes in children’s language skills. Future research should investigate the ideal dosage levels for optimizing child outcomes and determine which language facilitation strategies are associated with specific child outcomes. Research on adaptations for families from culturally and linguistically diverse backgrounds is needed. PMID:25733749

  3. Effects of home-based voluntary counselling and testing on HIV-related stigma: findings from a cluster-randomized trial in Zambia.

    PubMed

    Jürgensen, Marte; Sandøy, Ingvild Fossgard; Michelo, Charles; Fylkesnes, Knut

    2013-03-01

    HIV-related stigma continues to be a prominent barrier to testing, treatment and care. However, few studies have investigated changes in stigma over time and the factors contributing to these changes, and there is no evidence of the impact of HIV testing and counselling on stigma. This study was nested within a pair-matched cluster-randomized trial on the acceptance of home-based voluntary HIV counselling and testing conducted in a rural district in Zambia between 2009 and 2011, and investigated changes in stigma over time and the impact of HIV testing and counselling on stigma. Data from a baseline survey (n = 1500) and a follow-up survey (n = 1107) were used to evaluate changes in stigma. There was an overall reduction of seven per cent in stigma from baseline to follow-up. This was mainly due to a reduction in individual stigmatizing attitudes but not in perceived stigma. The reduction did not differ between the trial arms (β = -0.22, p = 0.423). Being tested for HIV was associated with a reduction in stigma (β = -0.57, p = 0.030), and there was a trend towards home-based Voluntary Counselling and Testing having a larger impact on stigma than other testing approaches (β = -0.78, p = 0.080 vs. β = -0.37, p = 0.551), possibly explained by a strong focus on counselling and the safe environment of the home. The reduction observed in both arms may give reason to be optimistic as it may have consequences for disclosure, treatment access and adherence. Yet, the change in stigma may have been affected by social desirability bias, as extensive community mobilization was carried out in both arms. The study underscores the challenges in measuring and monitoring HIV-related stigma. Adjustment for social desirability bias and inclusion of qualitative methods are recommended for further studies on the impact of HIV testing on stigma.

  4. Randomized Clinical Trial: Moderators and Mediators of a Psycho-education Group Intervention on IBS Symptoms

    PubMed Central

    Labus, Jennifer; Gupta, Arpana; Gill, Harkiran K.; Posserud, Iris; Mayer, Minou; Raeen, Heidi; Bolus, Roger; Simren, Magnus; Naliboff, Bruce D.; Mayer, Emeran A.

    2013-01-01

    Summary Background & aims Evidence supports the effectiveness of cognitive behavioral approaches in improving IBS symptoms. Duration, cost, and resistance of many patients towards a psychological therapy have limited their acceptance. We evaluated the effectiveness of a psycho-educational intervention on IBS symptoms. Methods 69 IBS patients (72% female) were randomized to an intervention or a wait-list control group. The IBS class consisted of education on a biological mind body disease model emphasizing self-efficacy and practical relaxation techniques. Results Patients in the intervention showed significant improvement on GI symptom severity, visceral sensitivity, depression, and QoL post intervention and most of these gains were maintained at 3 month follow up (Hedge’s g =−.46 to .77). Moderated mediation analyses indicated change in anxiety, visceral sensitivity, QoL and catastrophizing due to the intervention had moderate mediation effects (Hedge’s g= −.38 to −.60) on improvements in GI symptom severity for patients entering the trial with low to average QoL. Also, change in GI symptom severity due to the intervention had moderate mediation effects on improvements in QoL especially patients with low to average levels of QoL at baseline. Moderated mediation analyses indicated mediation was less effective for patients entering the intervention with high QoL. Conclusions A brief psycho-educational group intervention is efficacious in changing cognitions and fears about IBS symptoms, and these changes are associated with clinically meaningful improvement in IBS symptoms and QoL. The intervention seems particularly tailored to patients with low to moderate QoL baseline levels. PMID:23205588

  5. Impacts on Breastfeeding Practices of At-Scale Strategies That Combine Intensive Interpersonal Counseling, Mass Media, and Community Mobilization: Results of Cluster-Randomized Program Evaluations in Bangladesh and Viet Nam

    PubMed Central

    Menon, Purnima; Nguyen, Phuong Hong; Saha, Kuntal Kumar; Tran, Lan Mai; Sanghvi, Tina; Hajeebhoy, Nemat; Afsana, Kaosar; Haque, Raisul; Frongillo, Edward A.; Ruel, Marie T.; Rawat, Rahul

    2016-01-01

    Background Despite recommendations supporting optimal breastfeeding, the number of women practicing exclusive breastfeeding (EBF) remains low, and few interventions have demonstrated implementation and impact at scale. Alive & Thrive was implemented over a period of 6 y (2009–2014) and aimed to improve breastfeeding practices through intensified interpersonal counseling (IPC), mass media (MM), and community mobilization (CM) intervention components delivered at scale in the context of policy advocacy (PA) in Bangladesh and Viet Nam. In Bangladesh, IPC was delivered through a large non-governmental health program; in Viet Nam, it was integrated into government health facilities. This study evaluated the population-level impact of intensified IPC, MM, CM, and PA (intensive) compared to standard nutrition counseling and less intensive MM, CM, and PA (non-intensive) on breastfeeding practices in these two countries. Methods and Findings A cluster-randomized evaluation design was employed in each country. For the evaluation sample, 20 sub-districts in Bangladesh and 40 communes in Viet Nam were randomized to either the intensive or the non-intensive group. Cross-sectional surveys (n ~ 500 children 0–5.9 mo old per group per country) were implemented at baseline (June 7–August 29, 2010, in Viet Nam; April 28–June 26, 2010, in Bangladesh) and endline (June 16–August 30, 2014, in Viet Nam; April 20–June 23, 2014, in Bangladesh). Difference-in-differences estimates (DDEs) of impact were calculated, adjusting for clustering. In Bangladesh, improvements were significantly greater in the intensive compared to the non-intensive group for the proportion of women who reported practicing EBF in the previous 24 h (DDE 36.2 percentage points [pp], 95% CI 21.0–51.5, p < 0.001; prevalence in intensive group rose from 48.5% to 87.6%) and engaging in early initiation of breastfeeding (EIBF) (16.7 pp, 95% CI 2.8–30.6, p = 0.021; 63.7% to 94.2%). In Viet Nam, EBF increases

  6. Linguistic and Cultural Adaptation of a Computer-Based Counseling Program (CARE+ Spanish) to Support HIV Treatment Adherence and Risk Reduction for People Living With HIV/AIDS: A Randomized Controlled Trial

    PubMed Central

    Chhun, Nok; Cleland, Charles M; Crespo-Fierro, Michele; Parés-Avila, José A; Lizcano, John A; Shedlin, Michele G; Johnston, Barbara E; Sharp, Victoria L

    2016-01-01

    Background Human immunodeficiency virus (HIV) disease in the United States disproportionately affects minorities, including Latinos. Barriers including language are associated with lower antiretroviral therapy (ART) adherence seen among Latinos, yet ART and interventions for clinic visit adherence are rarely developed or delivered in Spanish. Objective The aim was to adapt a computer-based counseling tool, demonstrated to reduce HIV-1 viral load and sexual risk transmission in a population of English-speaking adults, for use during routine clinical visits for an HIV-positive Spanish-speaking population (CARE+ Spanish); the Technology Acceptance Model (TAM) was the theoretical framework guiding program development. Methods A longitudinal randomized controlled trial was conducted from June 4, 2010 to March 29, 2012. Participants were recruited from a comprehensive HIV treatment center comprising three clinics in New York City. Eligibility criteria were (1) adults (age ≥18 years), (2) Latino birth or ancestry, (3) speaks Spanish (mono- or multilingual), and (4) on antiretrovirals. Linear and generalized mixed linear effects models were used to analyze primary outcomes, which included ART adherence, sexual transmission risk behaviors, and HIV-1 viral loads. Exit interviews were offered to purposively selected intervention participants to explore cultural acceptability of the tool among participants, and focus groups explored the acceptability and system efficiency issues among clinic providers, using the TAM framework. Results A total of 494 Spanish-speaking HIV clinic attendees were enrolled and randomly assigned to the intervention (arm A: n=253) or risk assessment-only control (arm B, n=241) group and followed up at 3-month intervals for one year. Gender distribution was 296 (68.4%) male, 110 (25.4%) female, and 10 (2.3%) transgender. By study end, 433 of 494 (87.7%) participants were retained. Although intervention participants had reduced viral loads, increased

  7. Economic analysis of a randomized trial of academic detailing interventions to improve use of antihypertensive medications.

    PubMed

    Simon, Steven R; Rodriguez, Hector P; Majumdar, Sumit R; Kleinman, Ken; Warner, Cheryl; Salem-Schatz, Susanne; Miroshnik, Irina; Soumerai, Stephen B; Prosser, Lisa A

    2007-01-01

    The authors estimated the costs and cost savings of implementing a program of mailed practice guidelines and single-visit individual and group academic detailing interventions in a randomized controlled trial to improve the use of antihypertensive medications. Analyses took the perspective of the payer. The total costs of the mailed guideline, group detailing, and individual detailing interventions were estimated at 1000 dollars, 5500 dollars, and 7200 dollars, respectively, corresponding to changes in the average daily per person drug costs of -0.0558 dollars (95% confidence interval, -0.1365 dollars to 0.0250 dollars) in the individual detailing intervention and -0.0001 dollars (95% confidence interval, -0.0803 dollars to 0.0801 dollars) in the group detailing intervention, compared with the mailed intervention. For all patients with incident hypertension in the individual detailing arm, the annual total drug cost savings were estimated at 21,711 dollars (95% confidence interval, 53,131 dollars savings to 9709 dollars cost increase). Information on costs of academic detailing could assist with health plan decision making in developing interventions to improve prescribing.

  8. Attachment-Focused Integrative Reminiscence with Older African-Americans: A Randomized Controlled Intervention Study

    PubMed Central

    Henderson, Charles R.; Kang, Suk-Young; Pillemer, Karl

    2015-01-01

    Objectives Prior integrative reminiscence interventions have had a limited focus on attachment themes. The Attachment-Focused Integrative Reminiscence (AFIR) intervention differs from these in its central emphasis on attachment themes. The wide range of health benefits resulting from integrative reminiscence may be due in part to reminiscing about, mourning, and integrating unresolved attachment experiences. Method Participants were randomized into treatment and wait-list control conditions; completed a pre-test; met for 8 consecutive weekly 2-hour sessions of largely attachment-focused reminiscence; then completed post-tests immediately following the intervention and again 6 months later. Results Results show treatment effects for depression (p = .01 and .05 at 8 weeks and 6 months), perceived stress (p = .01 and .04), and emergency room (ER) visits at 6 months (p = .04), with the intervention group showing lower depression and stress and fewer ER visits. Conclusion Integrative reminiscence interventions are cost-effective, have rapid impact, and carry a certain appeal to older adults. Augmenting such interventions with a focus on attachment experiences may reduce perceived stress, an important health risk factor. Wider application of AFIRs may further reduce health disparities among U.S. older adults. PMID:25812080

  9. Family-based models for childhood-obesity intervention: a systematic review of randomized controlled trials.

    PubMed

    Sung-Chan, P; Sung, Y W; Zhao, X; Brownson, R C

    2013-04-01

    Effective interventions are needed to address the growing epidemic of childhood obesity. In the past 35 years, family-based approach has gradually developed as a preferred intervention. This review aimed to examine the methodological rigour and treatment effectiveness of family-based interventions according to intervention types and theoretical orientations. A total of 15 randomized controlled trials (RCTs) of family-based lifestyle interventions for children and adolescents aged 2-19 years were included. The adapted Methodological Quality Rating Scales (MQRS) and a four-grade qualitative scoring scheme were adopted to evaluate the methodological rigour and the effectiveness of treatment, respectively. The average MQRS score was 7.93 out of 14 points. Ten of the 15 RCTs had well aligned their research questions with appropriate research methods. The overall short-term outcome of the15 RCTs were satisfactory with an average score of 3.1. Family-based interventions rooted in behaviour theory achieved better results than those theoretically connected to family systems theory in terms of treatment effectiveness. Results suggest future studies to improve the methodological design and continue to explore the potential of the family systems approach.

  10. Quality and Reporting of Cluster Randomized Controlled Trials Evaluating Occupational Therapy Interventions

    PubMed Central

    Tokolahi, Ema; Hocking, Clare; Kersten, Paula; Vandal, Alain C.

    2015-01-01

    Growing use of cluster randomized control trials (RCTs) in health care research requires careful attention to study designs, with implications for the development of an evidence base for practice. The objective of this study is to investigate the characteristics, quality, and reporting of cluster RCTs evaluating occupational therapy interventions to inform future research design. An extensive search of cluster RCTs evaluating occupational therapy was conducted in several databases. Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomized, and five reported intercluster correlation coefficients (50%): Protocols had higher compliance. Risk of bias was most evident in unblinding of participants. Statistician involvement was associated with improved trial quality and reporting. Quality of cluster RCTs of occupational therapy interventions is comparable with those from other areas of health research and needs improvement. PMID:27504689

  11. Review of Randomized Controlled Trials on Psychological Interventions in Child Sexual Abuse: Current Status and Emerging Needs in the Indian Context

    PubMed Central

    Choudhary, Vandana; Satapathy, Sujata; Sagar, Rajesh

    2016-01-01

    Child sexual abuse (CSA) is a critical, psychologically traumatic and sometimes life-threatening incident often associated with sequel of adverse physical, behavioral, and mental health consequences. Factors such as developmental age of the child, severity of abuse, closeness to the perpetrator, availability of medico-legal-social support network and family care, gender stereotypes in the community complicate the psychological trauma. Although the research on the effects of CSA as well as psychological intervention to reduce the victimization and promote the mental health of the child is in its infancy stage in India, the global research in the past three decades has progressed much ahead. A search was performed using MEDLINE, PubMed, PsycINFO, and Google Scholar from 1984 to 2015 and only 17 randomized controlled trials (RCTs) out of 96 potentially relevant studies were included. While nonspecific therapies covering a wide variety of outcome variables were prominent till 1999s, the trend changed to specific and focused forms of trauma-focused therapies in next one-and-half decades. Novel approaches to psychological interventions have also been witnessed. One intervention (non-RCT) study on effects on general counseling has been reported from India. PMID:27570336

  12. An Adaptive Physical Activity Intervention for Overweight Adults: A Randomized Controlled Trial

    PubMed Central

    Adams, Marc A.; Sallis, James F.; Norman, Gregory J.; Hovell, Melbourne F.; Hekler, Eric B.; Perata, Elyse

    2013-01-01

    Background Physical activity (PA) interventions typically include components or doses that are static across participants. Adaptive interventions are dynamic; components or doses change in response to short-term variations in participant's performance. Emerging theory and technologies make adaptive goal setting and feedback interventions feasible. Objective To test an adaptive intervention for PA based on Operant and Behavior Economic principles and a percentile-based algorithm. The adaptive intervention was hypothesized to result in greater increases in steps per day than the static intervention. Methods Participants (N = 20) were randomized to one of two 6-month treatments: 1) static intervention (SI) or 2) adaptive intervention (AI). Inactive overweight adults (85% women, M = 36.9±9.2 years, 35% non-white) in both groups received a pedometer, email and text message communication, brief health information, and biweekly motivational prompts. The AI group received daily step goals that adjusted up and down based on the percentile-rank algorithm and micro-incentives for goal attainment. This algorithm adjusted goals based on a moving window; an approach that responded to each individual's performance and ensured goals were always challenging but within participants' abilities. The SI group received a static 10,000 steps/day goal with incentives linked to uploading the pedometer's data. Results A random-effects repeated-measures model accounted for 180 repeated measures and autocorrelation. After adjusting for covariates, the treatment phase showed greater steps/day relative to the baseline phase (p<.001) and a group by study phase interaction was observed (p = .017). The SI group increased by 1,598 steps/day on average between baseline and treatment while the AI group increased by 2,728 steps/day on average between baseline and treatment; a significant between-group difference of 1,130 steps/day (Cohen's d = .74). Conclusions The adaptive

  13. Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

    PubMed Central

    2011-01-01

    Background Targeted analgesic dietary interventions are a promising strategy for alleviating pain and improving quality of life in patients with persistent pain syndromes, such as chronic daily headache (CDH). High intakes of the omega-6 (n-6) polyunsaturated fatty acids (PUFAs), linoleic acid (LA) and arachidonic acid (AA) may promote physical pain by increasing the abundance, and subsequent metabolism, of LA and AA in immune and nervous system tissues. Here we describe methodology for an ongoing randomized clinical trial comparing the metabolic and clinical effects of a low n-6, average n-3 PUFA diet, to the effects of a low n-6 plus high n-3 PUFA diet, in patients with CDH. Our primary aim is to determine if: A) both diets reduce n-6 PUFAs in plasma and erythrocyte lipid pools, compared to baseline; and B) the low n-6 plus high n-3 diet produces a greater decline in n-6 PUFAs, compared to the low n-6 diet alone. Secondary clinical outcomes include headache-specific quality-of-life, and headache frequency and intensity. Methods Adults meeting the International Classification of Headache Disorders criteria for CDH are included. After a 6-week baseline phase, participants are randomized to a low n-6 diet, or a low n-6 plus high n-3 diet, for 12 weeks. Foods meeting nutrient intake targets are provided for 2 meals and 2 snacks per day. A research dietitian provides intensive dietary counseling at 2-week intervals. Web-based intervention materials complement dietitian advice. Blood and clinical outcome data are collected every 4 weeks. Results Subject recruitment and retention has been excellent; 35 of 40 randomized participants completed the 12-week intervention. Preliminary blinded analysis of composite data from the first 20 participants found significant reductions in erythrocyte n-6 LA, AA and %n-6 in HUFA, and increases in n-3 EPA, DHA and the omega-3 index, indicating adherence. Trial Registration ClinicalTrials.gov (NCT01157208) PMID:21496264

  14. Cluster Randomized Controlled Trial Evaluation of a Gender Equity and Family Planning Intervention for Married Men and Couples in Rural India

    PubMed Central

    Raj, Anita; Ghule, Mohan; Ritter, Julie; Battala, Madhusudana; Gajanan, Velhal; Nair, Saritha; Dasgupta, Anindita; Silverman, Jay G.; Balaiah, Donta; Saggurti, Niranjan

    2016-01-01

    Background Despite ongoing recommendations to increase male engagement and gender-equity (GE) counseling in family planning (FP) services, few such programs have been implemented and rigorously evaluated. This study evaluates the impact of CHARM, a three-session GE+FP counseling intervention delivered by male health care providers to married men, alone (sessions 1&2) and with their wives (session 3) in India. Methods and Findings A two-armed cluster randomized controlled trial was conducted with young married couples (N = 1081 couples) recruited from 50 geographic clusters (25 clusters randomized to CHARM and a control condition, respectively) in rural Maharashtra, India. Couples were surveyed on demographics, contraceptive behaviors, and intimate partner violence (IPV) attitudes and behaviors at baseline and 9 &18-month follow-ups, with pregnancy testing at baseline and 18-month follow-up. Outcome effects on contraceptive use and incident pregnancy, and secondarily, on contraceptive communication and men’s IPV attitudes and behaviors, were assessed using logistic generalized linear mixed models. Most men recruited from CHARM communities (91.3%) received at least one CHARM intervention session; 52.5% received the couple’s session with their wife. Findings document that women from the CHARM condition, relative to controls, were more likely to report contraceptive communication at 9-month follow-up (AOR = 1.77, p = 0.04) and modern contraceptive use at 9 and 18-month follow-ups (AORs = 1.57–1.58, p = 0.05), and they were less likely to report sexual IPV at 18-month follow-up (AOR = 0.48, p = 0.01). Men in the CHARM condition were less likely than those in the control clusters to report attitudes accepting of sexual IPV at 9-month (AOR = 0.64, p = 0.03) and 18-month (AOR = 0.51, p = 0.004) follow-up, and attitudes accepting of physical IPV at 18-month follow-up (AOR = 0.64, p = 0.02). No significant effect on pregnancy was seen. Conclusions Findings demonstrate

  15. An intervention for sensory difficulties in children with autism: a randomized trial.

    PubMed

    Schaaf, Roseann C; Benevides, Teal; Mailloux, Zoe; Faller, Patricia; Hunt, Joanne; van Hooydonk, Elke; Freeman, Regina; Leiby, Benjamin; Sendecki, Jocelyn; Kelly, Donna

    2014-07-01

    This study evaluated a manualized intervention for sensory difficulties for children with autism, ages 4-8 years, using a randomized trial design. Diagnosis of autism was confirmed using gold standard measures. Results show that the children in the treatment group (n = 17) who received 30 sessions of the occupational therapy intervention scored significantly higher (p = 0.003, d = 1.2) on Goal Attainment Scales (primary outcome), and also scored significantly better on measures of caregiver assistance in self-care (p = 0.008 d = 0.9) and socialization (p = 0.04, d = 0.7) than the Usual Care control group (n = 15). The study shows high rigor in its measurement of treatment fidelity and use of a manualized protocol, and provides support for the use of this intervention for children with autism. Findings are discussed in terms of their implications for practice and future research.

  16. A Multidisciplinary Intervention Utilizing Virtual Communication Tools to Reduce Health Disparities: A Pilot Randomized Controlled Trial

    PubMed Central

    Emerson, John F.; Welch, Madelyn; Rossman, Whitney E.; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G.; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew

    2015-01-01

    Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a

  17. Can Targeted Intervention Mitigate Early Emotional and Behavioral Problems?: Generating Robust Evidence within Randomized Controlled Trials

    PubMed Central

    Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.

    2016-01-01

    This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184

  18. Interactive video behavioral intervention to reduce adolescent females' STD risk: a randomized controlled trial.

    PubMed

    Downs, Julie S; Murray, Pamela J; Bruine de Bruin, Wändi; Penrose, Joyce; Palmgren, Claire; Fischhoff, Baruch

    2004-10-01

    A longitudinal randomized design was used to evaluate the impact of a theoretically based, stand-alone interactive video intervention on 300 urban adolescent girls' (a) knowledge about sexually transmitted diseases (STDs), (b) self-reported sexual risk behavior, and (c) STD acquisition. It was compared to two controls, representing high-quality informational interventions. One used the same content in book form; the other used commercially available brochures. Following randomization, the interventions were administered at baseline, with booster sessions at 1, 3, and 6 months. Self-reports revealed that those assigned to the interactive video were significantly more likely to be abstinent in the first 3 months following initial exposure to the intervention, and experienced fewer condom failures in the following 3 months, compared to controls. Six months after enrollment, participants in the video condition were significantly less likely to report having been diagnosed with an STD. A non-significant trend in data from a clinical PCR assay of Chlamydia trachomatis was consistent with that finding.

  19. Randomized Controlled Trial of a Spring Break Intervention to Reduce High-Risk Drinking

    PubMed Central

    Lee, Christine M.; Neighbors, Clayton; Lewis, Melissa A.; Kaysen, Debra; Mittmann, Angela; Geisner, Irene M.; Atkins, David C.; Zheng, Cheng; Garberson, Lisa A.; Kilmer, Jason R.; Larimer, Mary E.

    2014-01-01

    Objective While recent studies have documented high-risk drinking occurring during Spring Break (SB), particularly on SB trips with friends, published intervention studies are few. The present study evaluated the efficacy of Event Specific Prevention (ESP) strategies for reducing SB drinking among college students, compared to general prevention strategies and an assessment-only control group, as well as evaluated inclusion of peers in interventions and mode of intervention delivery (in-person vs. web). Method Participants included 783 undergraduates (56.1% women, average age 20.5) intending to go on a SB trip with friends as well as to drink heavily on at least one day of SB. Participants completed assessments prior to SB and were randomized to one of five intervention conditions: SB in-person BASICS, SB web BASICS, SB in-person BASICS with friend, SB web BASICS with friend, general BASICS, or an attention control condition. Follow-up assessment was completed one week after SB. Results While the SB web BASICS (with and without friends) and general BASICS interventions were not effective at reducing SB drinking, results indicated significant intervention effects for SB in-person BASICS in reducing SB drinking, particularly on trip days. Follow-up analyses indicated change in descriptive norms mediated treatment effect and reductions in drinking, while SB drinking intentions and positive expectancies did not. Conclusions Overall, results suggest an in-person SB-specific intervention is effective at reducing SB drinking, especially during trips. In contrast, interventions that contain non-SB related content, are web-based, or seek to involve friends may be less effective at reducing SB drinking. PMID:24491072

  20. A Combined Patient and Provider Intervention for Managing Osteoarthritis in Veterans: Randomized Clinical Trial

    PubMed Central

    Allen, Kelli D.; Yancy, William S.; Bosworth, Hayden B.; Coffman, Cynthia J.; Jeffreys, Amy S.; Datta, Santanu K.; McDuffie, Jennifer; Strauss, Jennifer L.; Oddone, Eugene Z.

    2015-01-01

    Background Management of osteoarthritis (OA) requires both medical and behavioral strategies, but there is low use of some recommended therapies. Objectives This study examined the effectiveness of a combined patient and provider intervention for improving OA outcomes. Design Cluster randomized clinical trial with assignment to OA Intervention and Usual Care arms. Setting Department of Veterans Affairs Medical Center (VA) in Durham, NC, USA. Participants 30 providers (clusters) and 300 outpatients with symptomatic hip and / or knee OA Interventions The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved delivery of patient-specific OA treatment recommendations to primary care providers through the electronic medical record. Measurements Primary outcome: Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) total score (range: 0-96) at 12 months. Secondary outcomes: WOMAC function subscale (range: 0-68), WOMAC pain subscale (0-20), physical performance (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models adjusted for clustering of providers assessed the difference in improvement in outcomes between arms. Results At 12-month follow-up, WOMAC scores were 4.1 points lower (indicating improvement) in the OA Intervention arm vs. Usual Care [95% confidence interval (CI) = −7.2, −1.1; p=0.009]. The WOMAC function subscale was 3.3 points lower in the intervention arm [95% CI = −5.7, −1.0; p=0.005]. There was no difference in WOMAC pain subscale scores between arms (p=0.126). Physical performance and depressive symptoms did not differ between the two arms. Limitations The study was conducted in one VA medical center. Conclusions The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee OA

  1. Efficacy of a Multi-level Intervention to Reduce Injecting and Sexual Risk Behaviors among HIV-Infected People Who Inject Drugs in Vietnam: A Four-Arm Randomized Controlled Trial

    PubMed Central

    Go, Vivian F.; Frangakis, Constantine; Minh, Nguyen Le; Latkin, Carl; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy W.; Zelaya, Carla; Vu, Pham The; Celentano, David D.; Quan, Vu Minh

    2015-01-01

    Introduction Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID) and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed. Methods 455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1) standard of care; 2) community level intervention; 3) individual level intervention; and 4) community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members. Results Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively). There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df); p = 0.33; Wald = 6.73 (3 df); p = 0.08). There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms. Discussion Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming. Trial Registration ClinicalTrials.gov NCT

  2. A Randomized, Controlled Community-Wide Intervention to Reduce Environmental Tobacco Smoke Exposure

    PubMed Central

    2013-01-01

    Introduction: Tobacco use in low- to middle-income countries is a major public health concern for both smokers and those exposed to environmental tobacco smoke (ETS). Egypt has made important strides in controlling tobacco use, but smoking and ETS remain highly prevalent. This randomized intervention sought to improve the target population’s knowledge regarding the hazards of smoking and ETS and to change attitudes and smoking behaviors within the community and the household. Methods: In this 2005–2006 study in Egypt’s Qalyubia governorate, trained professionals visited schools, households, mosques, and health care centers in rural villages randomly selected for the intervention to discuss the adverse effects of smoking and ETS exposure and ways to reduce one’s ETS exposure. Data collected in interviewer-facilitated surveys before and after the intervention period were analyzed in pairwise comparisons with data from control villages to assess the effectiveness of the intervention in achieving its aims. Results: The intervention group showed a greater increase in understanding the dangers associated with smoking cigarettes and waterpipes and became more proactive in limiting ETS exposure by asking smokers to stop, avoiding areas with ETS, and enacting smoking bans in the home. However, the intervention had little to no impact on the number of smokers and the amount of tobacco smoked. Conclusions: Results are consistent with previous studies showing that changing smokers’ behavior can be difficult, but community-wide efforts to reduce ETS exposure through smoking bans, education, and empowering people to ask smokers to stop are effective. The method can be generalized to other settings. PMID:23328881

  3. Implementing a provider-initiated testing and counselling (PITC) intervention in Cape town, South Africa: a process evaluation using the normalisation process model

    PubMed Central

    2013-01-01

    Background Provider-initiated HIV testing and counselling (PITC) increases HIV testing rates in most settings, but its effect on testing rates varies considerably. This paper reports the findings of a process evaluation of a controlled trial of PITC for people with sexually transmitted infections (STI) attending publicly funded clinics in a low-resource setting in South Africa, where the trial results were lower than anticipated compared to the standard Voluntary Counselling and Testing (VCT) approach. Method This longitudinal study used a variety of qualitative methods, including participant observation of project implementation processes, staff focus groups, patient interviews, and observation of clinical practice. Data were content analysed by identifying the main influences shaping the implementation process. The Normalisation Process Model (NPM) was used as a theoretical framework to analyse implementation processes and explain the trial outcomes. Results The new PITC intervention became embedded in practice (normalised) during a two-year period (2006 to 2007). Factors that promoted the normalising include strong senior leadership, implementation support, appropriate accountability mechanisms, an intervention design that was responsive to service needs and congruent with professional practice, positive staff and patient perceptions, and a responsive organisational context. Nevertheless, nurses struggled to deploy the intervention efficiently, mainly because of poor sequencing and integration of HIV and STI tasks, a focus on HIV education, tension with a patient-centred communication style, and inadequate training on dealing with the operational challenges. This resulted in longer consultation times, which may account for the low test coverage outcome. Conclusion Leadership and implementation support, congruent intervention design, and a responsive organisational context strengthened implementation. Poor compatibility with nurse skills on the level of the

  4. Religion and Spirituality in Group Counseling: Beliefs and Practices of University Counseling Center Counselors

    ERIC Educational Resources Information Center

    Post, Brian C.; Cornish, Marilyn A.; Wade, Nathaniel G.; Tucker, Jeritt R.

    2013-01-01

    Fifty-four counselors at 9 university counseling centers participated in a study regarding religion and spirituality (R/S) in group counseling. The majority indicated that R/S is an appropriate topic for group counseling and that some religious and spiritual interventions are appropriate to use. However, counselors rarely use these interventions.…

  5. Implementation and Operational Research: Computer-Assisted Intervention for Safer Sex in HIV-Positive Men Having Sex With Men: Findings of a European Randomized Multi-Center Trial

    PubMed Central

    Platteau, Tom; Bogner, Johannes; Buyze, Jozefien; Dec-Pietrowska, Joanna; Dias, Sonia; Newbury-Helps, John; Kocsis, Agnes; Mueller, Matthias; Rojas, Daniela; Stanekova, Danica; van Lankveld, Jacques; Colebunders, Robert

    2016-01-01

    Objective: Men who have sex with men (MSM) are the key population most affected by HIV in Europe. We performed the first European multicenter, simple-randomized parallel-group study to test the effectiveness of a theory-guided computer-assisted intervention to improve safer sex among HIV-positive men who have sex with men. Methods: Between February, 2011 and February, 2013, 112 participants were enrolled in 8 different European HIV-care settings. Intervention participants received 3 individual counseling sessions facilitated by trained service providers using computer-assisted tools. The control-group received sexual health advice delivered as part of regular HIV care. Outcome behavior (self-reported condom use at last intercourse; combined HIV transmission risk score), its influencing factors, and mediating variables were assessed at baseline, and at 3 and 6 months follow-up. Mixed effects models were used to compare primary outcomes (condom use at last intercourse, HIV transmission risk score), and mediation analysis to explore intervention effects. Results: Condom use at last intercourse increased more among intervention than control participants at 3 months follow-up (odds ratio of 3.83; P = 0.03), but not significantly at 6 months follow-up. Intervention participants reported a lower transmission risk at 3 months follow-up than controls (odds ratio compared with baseline of 11.53 and 1.28, respectively; P = 0.008), but this effect became nonsignificant at 6 months. Intervention effects were mediated by the proximal variables, self-efficacy to negotiate condom use and condom attitudes. Conclusions: This intervention showed short-term effectiveness. The intervention should be replicated in other settings, eventually investigating if booster-counseling sessions would yield a longer lasting effect. PMID:26866955

  6. Family, Community and Clinic Collaboration to Treat Overweight and Obese Children: Stanford GOALS -- a Randomized Controlled Trial of a Three-Year, Multi-Component, Multi-Level, Multi-Setting Intervention

    PubMed Central

    Robinson, Thomas N.; Matheson, Donna; Desai, Manisha; Wilson, Darrell M.; Weintraub, Dana L.; Haskell, William L.; McClain, Arianna; McClure, Samuel; Banda, Jorge; Sanders, Lee M.; Haydel, K. Farish; Killen, Joel D.

    2013-01-01

    Objective To test the effects of a three-year, community-based, multi-component, multi-level, multi-setting (MMM) approach for treating overweight and obese children. Design Two-arm, parallel group, randomized controlled trial with measures at baseline, 12, 24, and 36 months after randomization. Participants Seven through eleven year old, overweight and obese children (BMI ≥ 85th percentile) and their parents/caregivers recruited from community locations in low-income, primarily Latino neighborhoods in Northern California. Interventions Families are randomized to the MMM intervention versus a community health education active-placebo comparison intervention. Interventions last for three years for each participant. The MMM intervention includes a community-based after school team sports program designed specifically for overweight and obese children, a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and a primary care behavioral counseling intervention linked to the community and home interventions. The active-placebo comparison intervention includes semi-annual health education home visits, monthly health education newsletters for children and for parents/guardians, and a series of community-based health education events for families. Main Outcome Measure Body mass index trajectory over the three-year study. Secondary outcome measures include waist circumference, triceps skinfold thickness, accelerometer-measured physical activity, 24-hour dietary recalls, screen time and other sedentary behaviors, blood pressure, fasting lipids, glucose, insulin, hemoglobin A1c, C-reactive protein, alanine aminotransferase, and psychosocial measures. Conclusions The Stanford GOALS trial is testing the efficacy of a novel community-based multi-component, multi-level, multi-setting treatment for childhood overweight and obesity in low-income, Latino families

  7. Lay Health Worker Intervention Improved Compliance with Hepatitis B Vaccination in Asian Americans: Randomized Controlled Trial

    PubMed Central

    Park, Eunmi; Lee, Sunmin

    2016-01-01

    Background This study aimed to evaluate the effect of a lay health worker (LHW) telephone intervention on completing a series of hepatitis B virus (HBV) vaccinations among foreign-born Asian Americans in the Baltimore-Washington Metropolitan area. Methods During the period of April 2013 and March 2014, we recruited Asian Americans who were 18 years of age and older in the community-based organizations. Of the 645 eligible participants, 600 (201 Chinese, 198 Korean, 201 Vietnamese) completed a pretest survey and received hepatitis B screening. Based on the screening results, we conducted a randomized controlled trial among those unprotected (HBsAg-/HBsAB-) by assigning them either to an intervention group (n = 124) or control group (n = 108). The intervention group received a list of resources by mails for where to get free vaccinations as well as reminder calls for vaccinations from trained LHWs, while the control group received only list of resources by mail. Seven months after mailing the HBV screening results, trained LHWs followed up with all participants by phone to ask how many of the recommended series of 3 vaccinations they had received: none, 1 or 2, or all 3 (complete). Their self-reported vaccinations were verified with the medical records. Multinomial logistic regressions were used to examine the effect of the LHW intervention. Process evaluation was conducted by asking study participants in the intervention group to evaluate the performance of the LHWs. Results After seven months, those in the intervention group were more likely to have 1 or more vaccines than the control group, compared to the no vaccination group (OR = 3.04, 95% CI, 1.16, 8.00). Also, those in the intervention group were more likely to complete a series of vaccinations than the control group, compared to the no vaccination group (OR = 7.29, 95% CI 3.39, 15.67). The most important barrier preventing them from seeking hepatitis B vaccinations was lack of time to get the vaccination

  8. Results from an Online Computer-Tailored Weight Management Intervention for Overweight Adults: Randomized Controlled Trial

    PubMed Central

    van Empelen, Pepijn; Boon, Brigitte; Borsboom, Gerard; Visscher, Tommy; Oenema, Anke

    2012-01-01

    Background Prevention of weight gain has been suggested as an important strategy in the prevention of obesity and people who are overweight are a specifically important group to target. Currently there is a lack of weight gain prevention interventions that can reach large numbers of people. Therefore, we developed an Internet-delivered, computer-tailored weight management intervention for overweight adults. The focus of the intervention was on making small (100 kcal per day), but sustained changes in dietary intake (DI) or physical activity (PA) behaviors in order to maintain current weight or achieve modest weight loss. Self-regulation theory was used as the basis of the intervention. Objective This study aims to evaluate the efficacy of the computer-tailored intervention in weight-related anthropometric measures (Body Mass Index, skin folds and waist circumference) and energy balance-related behaviors (physical activity; intake of fat, snacks and sweetened drinks) in a randomized controlled trial. Methods The tailored intervention (TI) was compared to a generic information website (GI). Participants were 539 overweight adults (mean age 47.8 years, mean Body Mass Index (BMI) 28.04, 30.9% male, 10.7% low educated) who where recruited among the general population and among employees from large companies by means of advertisements and flyers. Anthropometric measurements were measured by trained research assistants at baseline and 6-months post-intervention. DI and PA behaviors were assessed at baseline, 1-month and 6-month post-intervention, using self-reported questionnaires. Results Repeated measurement analyses showed that BMI remained stable over time and that there were no statistically significant differences between the study groups (BMI: TI=28.09, GI=27.61, P=.09). Similar results were found for waist circumference and skin fold thickness. Amount of physical activity increased and intake of fat, snacks and sweetened drinks decreased during the course of the

  9. Randomized controlled trial of a brief dyadic cognitive-behavioral intervention designed to prevent PTSD

    PubMed Central

    Brunet, Alain; Des Groseilliers, Isabeau Bousquet; Cordova, Matthew J.; Ruzek, Josef I.

    2013-01-01

    Background There is a dearth of effective interventions to prevent the development of post-traumatic stress disorder (PTSD). Method We evaluated the efficacy of a brief dyadic two-session cognitive-behavioral intervention through a controlled trial involving trauma-exposed individuals recruited at the hospital's emergency room. Participants were randomly assigned to either the dyadic intervention group (n=37) or to a waiting list (assessment only) group (n=37). Results In an intent-to-treat analysis, a time-by-group interaction was found, whereby the treated participants had less PTSD symptoms at the post-treatment but not at the pre-treatment compared to controls. Controlling for the improvement observed in the control participants, the intervention yielded a net effect size of d=0.39. Conclusions A brief, early, and effective intervention can be provided by nurses or social workers in hospital settings, at a fairly low cost to individuals presenting to the emergency room as the result of trauma exposure. PMID:23986816

  10. A randomized, controlled study of computer-based intervention in middle school struggling readers.

    PubMed

    Given, Barbara K; Wasserman, John D; Chari, Sharmila A; Beattie, Karen; Eden, Guinevere F

    2008-08-01

    The current study was conducted to test the premise that computer-based intervention that targets auditory temporal processing combined with language exercises (Fast ForWord) is effective in remediating children with disorders of language and reading. Sixty-five middle school struggling readers were randomly assigned to one of five groups and over a 12-week-period received one of the following interventions: (1) two phases of intervention with Fast ForWord (FFW, experimental group), (2) two phases of intervention with SuccessMaker (SM, active control group), (3) FFW followed by SM, (4) SM followed by FFW, or (5) no intervention beyond the regular class curriculum (developmental control group). Changes in reading, phonemic awareness, spelling and language skills were assessed via a repeated measures MANOVA. Results indicated significant within-subjects effects (i.e., change for all participants over time), but no between-subject group differences, failing to show that Fast ForWord resulted in any gains over and above those seen in the other groups.

  11. A Web-Based Intervention to Reduce Indoor Tanning Motivations in Adolescents: a Randomized Controlled Trial.

    PubMed

    Hillhouse, Joel; Turrisi, Rob; Scaglione, Nichole M; Cleveland, Michael J; Baker, Katie; Florence, L Carter

    2017-02-01

    Youthful indoor tanning as few as ten sessions can increase the risk of melanoma by two to four times with each additional session adding another 2 % to the risk. Recent research estimates that indoor tanning can be linked to approximately 450,000 cases of skin cancer annually in the USA, Europe, and Australia. Despite these risks, indoor tanning remains popular with adolescents. This study tested the efficacy of a web-based skin cancer prevention intervention designed to reduce indoor tanning motivations in adolescent females. A nationally representative sample of 443 female teens was enrolled from an online panel into a two-arm, parallel group design, randomized controlled trial. Treatment participants received an appearance-focused intervention grounded in established health behavior change models. Controls viewed a teen alcohol prevention website. Outcome variables included willingness and intentions to indoor tan, willingness to sunless tan, and measures of indoor tanning attitudes and beliefs. The intervention decreased willingness and intentions to indoor tan and increased sunless tanning willingness relative to controls. We also examined indirect mechanisms of change through intervening variables (e.g., indoor tanning attitudes, norms, positive and negative expectancies) using the product of coefficient approach. The web-based intervention demonstrated efficacy in changing adolescent indoor tanning motivations and improving their orientation toward healthier alternatives. Results from the intervening variable analyses give guidance to future adolescent skin cancer prevention interventions.

  12. A randomized intervention trial to reduce mechanical exposures in the Colombian flower industry.

    PubMed

    Barrero, L H; Ceballos, C; Ellegast, R; Pulido, J A; Monroy, M; Berrio, S; Quintana, L A

    2012-01-01

    Evidence on the effectiveness of ergonomic interventions to reduce mechanical demands and upper-extremity MSDs is scarce in agriculture. We conducted an intervention to reduce mechanical exposures during manual flower cutting through job rotation, education and reduction of force requirements. One-hundred and twenty workers (20 to 60 years old; 89% women) from six companies that cultivate roses participated in this study. Three companies were randomly assigned to control and intervention groups. We studied changes between baseline and follow-up in self-reported effort and upper-extremity postures, kinematics and muscular activity. Most of the observed changes were moderate for both groups. The intervention group showed differential improvements compared to the control group for the maximum wrist radial deviation and forearm pronation, and acceleration of the forearm supination-pronation and elbow flexion-extension; and the muscular activity of the flexor and extensor carpi radialis and the flexor carpi ulnaris. However, we also observed that the maximum ulnar deviation, velocity of the wrist flexion-extension and muscular activity of the extensor carpi ulnaris improved more in the control group. These mixed results may be related to limited time for intervention adjustment, and uncontrolled task changes in the control group. Future research should address these issues and test other solutions.

  13. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

    PubMed

    Cheng, Chung-Wah; Bian, Zhao-Xiang; Li, You-Ping; Moher, David; Wu, Tai-Xiang; Dagenais, Simon; Li, Jing; Li, Ting-Qian

    2008-09-01

    Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

  14. What qualitative research can contribute to a randomized controlled trial of a complex community intervention.

    PubMed

    Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula

    2015-11-01

    Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.

  15. Effects of a Social Network HIV/STD Prevention Intervention for Men Who Have Sex with Men in Russia and Hungary: A Randomized Controlled Trial

    PubMed Central

    Amirkhanian, Yuri A.; Kelly, Jeffrey A.; Takacs, Judit; McAuliffe, Timothy L.; Kuznetsova, Anna V.; Toth, Tamas P.; Mocsonaki, Laszlo; DiFranceisco, Wayne J.; Meylakhs, Anastasia

    2015-01-01

    Objective To test a novel social network HIV risk reduction intervention for MSM in Russia and Hungary, where same-sex behavior is stigmatized and men may best be reached through their social network connections. Design A 2-arm trial with 18 sociocentric networks of MSM randomized to the social network intervention or standard HIV/STD testing/counseling. Setting St. Petersburg, Russia and Budapest, Hungary. Participants 18 “seeds” from community venues invited the participation of their MSM friends who, in turn, invited their own MSM friends into the study, a process that continued outward until eighteen 3-ring sociocentric networks (mean size=35 members, n=626) were recruited. Intervention Empirically-identified network leaders were trained and guided to convey HIV prevention advice to other network members. Main Outcome and Measures Changes in sexual behavior from baseline to 3- and 12-month followup, with composite HIV/STD incidence measured at 12-months to corroborate behavior changes. Results There were significant reductions between baseline, first followup, and second followup in the intervention versus comparison arm for proportion of men engaging in any unprotected anal intercourse (P=.04); UAI with a nonmain partner (P=.04); and UAI with multiple partners (P=.002). The mean percentage of unprotected AI acts significantly declined (P=.001), as well as the mean number of UAI acts among men who initially had multiple partners (P=.05). Biological HIV/STD incidence was 15% in comparison condition networks and 9% in intervention condition networks. Conclusions Even where same-sex behavior is stigmatized, it is possible to reach MSM and deliver HIV prevention through their social networks. PMID:25565495

  16. A Behavioral Intervention for War-Affected Youth in Sierra Leone: A Randomized Controlled Trial

    PubMed Central

    Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.

    2016-01-01

    Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI

  17. Assessment of effectiveness of smoking cessation intervention among male prisoners in India: A randomized controlled trial

    PubMed Central

    Naik, Sachin; Khanagar, Sanjeev; Kumar, Amit; Ramachandra, Sujith; Vadavadagi, Sunil V.; Dhananjaya, Kiran Murthy

    2014-01-01

    Background: Tobacco smoking is an integral part of prison life and an established part of the culture. Little attention has been paid to prevention of smoking in prison. Approximately 70–80% of prisoners have been identified as current smokers. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Aim: To assess the effectiveness of smoking cessation intervention among male prisoners at Central Jail, Bangalore city. Materials and Methods: A randomized controlled trial was planned among male prisoners in Central Jail, Bangalore city. There were 1600 convicted prisoners. A self-administered questionnaire was given to the prisoners to assess their smoking behavior by which prevalence of tobacco smoking was found. Exactly 1352 tobacco users were studied. Among them, there were 1252 smokers. Based on inclusion criteria and informed consent given by the prisoners, a sample of 600 was chosen for the study by systematic random sampling. Among the 600 prisoners, 300 were randomly selected for the study group and 300 for the control group. Results: Prevalence of tobacco smoking among the prisoners was 92.60%. In the present study, after smoking cessation intervention, 17% showed no change in smoking, 21.66% reduced smoking, 16% stopped smoking, and 45.33% relapsed (P < 0.0001) at the end of 6-month follow-up in the study group. Conclusion: Tobacco use was high among the prisoners. Tobacco reduction is possible in the prison even if the living conditions are not favorable. Relatively high rate of relapse in our study indicates that some policies should be adopted to improve smokers’ information on consequences of tobacco on health and motivational intervention should be added to prisoners. PMID:25558450

  18. Do Minority or White Patients Respond to Brief Alcohol Intervention in Trauma Centers? A Randomized Trial

    PubMed Central

    Roudsari, Bahman; Caetano, Raul; Frankowski, Ralph; Field, Craig

    2009-01-01

    Objectives The current study evaluated if the effectiveness of brief alcohol intervention in reducing 6- and 12-month risk of injuries in a large level 1 urban trauma center varies based on trauma patients’ ethnicity. Methods Eligible White, Hispanic and Black trauma patients ≥ 18 years old were randomized to brief alcohol intervention, or treatment as usual. The intervention, implemented by trained health educators, was a “non-confrontational, patient centered conversation” focused on patients’ drinking pattern with the purpose of encouraging them to change risky drinking. Study outcomes were patient-reported 6 and 12 month incidence of all-type injuries, alcohol-related injuries and serious injuries (i.e. injuries requiring emergency department visit or hospital admission). Results A total of 1,493 trauma patients (668 Whites, 537 Hispanics, 288 Blacks) participated in this study. After one year of follow-up, we were not able to detect any important association between brief intervention and the risk of all-type injuries, alcohol-related injuries or, serious injuries among study participants. In addition, the association between brief intervention and the outcomes of interest was not modified by patients’ ethnicity. Conclusions Our study, congruent with some recent publications, implies that there are some patient- and provider-related impediments that could restrict the effectiveness of brief intervention programs in trauma centers, regardless of patient ethnicity. Unless those impediments are identified and eliminated, assuming that brief intervention will be an effective strategy for controlling future alcohol-related injuries among trauma patients and should be provided under any circumstances, might not be reasonable. PMID:19250705

  19. Brief Cognitive-Behavioral and Relaxation Training Interventions for Breast Cancer: A Randomized Controlled Trial

    PubMed Central

    Gudenkauf, Lisa M.; Antoni, Michael H.; Stagl, Jamie M.; Lechner, Suzanne C.; Jutagir, Devika R.; Bouchard, Laura C.; Blomberg, Bonnie B.; Glück, Stefan; Derhagopian, Robert P.; Giron, Gladys L.; Avisar, Eli; Torres-Salichs, Manuel A.; Carver, Charles S.

    2015-01-01

    Objective Women with breast cancer (BCa) report elevated distress post-surgery. Group-based cognitive-behavioral stress management (CBSM) following surgery improves psychological adaptation, though its key mechanisms remain speculative. This randomized controlled dismantling trial compared two interventions featuring elements thought to drive CBSM effects: a 5-week Cognitive-Behavioral Training (CBT) and 5-week Relaxation Training (RT) vs. a 5-week Health Education (HE) control group. Method Women with stage 0-III BCa (N = 183) were randomized to CBT, RT, or HE condition 2–10 weeks post-surgery. Psychosocial measures were collected at baseline (T1) and post-intervention (T2). Repeated-measures ANOVAs tested whether CBT and RT treatments improved primary measures of psychological adaptation and secondary measures of stress management resource perceptions from pre- to post-intervention relative to HE. Results Both CBT and RT groups reported reduced depressive affect. The CBT group reported improved emotional well-being/quality of life and less cancer-specific thought intrusions. The RT group reported improvements on illness-related social disruption. Regarding stress management resources, the CBT group reported increased reliability of social support networks, while the RT group reported increased confidence in relaxation skills. Psychological adaptation and stress management resource constructs were unchanged in the HE control group. Conclusions Non-metastatic breast cancer patients participating in two forms of brief, 5-week group-based stress management intervention after surgery showed improvements in psychological adaptation and stress management resources compared to an attention-matched control group. Findings provide preliminary support suggesting that using brief group-based stress management interventions may promote adaptation among non-metastatic breast cancer patients. PMID:25939017

  20. Very preterm birth is reduced in women receiving an integrated behavioral intervention: a randomized controlled trial.

    PubMed

    El-Mohandes, Ayman A E; Kiely, Michele; Gantz, Marie G; El-Khorazaty, M Nabil

    2011-01-01

    This study examines whether an integrated behavioral intervention with proven efficacy in reducing psycho-behavioral risks (smoking, environmental tobacco smoke exposure (ETSE), depression, and intimate partner violence (IPV)) in African-Americans is associated with improved pregnancy outcomes. A randomized controlled trial targeting risks during pregnancy was conducted in the District of Columbia. African-American women were recruited if reporting at least one of the risks mentioned above. Randomization to intervention or usual care was site and risk specific. Sociodemographic, health risk and pregnancy outcome data were collected. Data on 819 women, and their singleton live born infants were analyzed using an intent-to-treat approach. Bivariate analyses preceded a reduced logistical model approach to elucidate the effect of the intervention on the reduction of prematurity and low birth weight. The incidence of low birthweight (LBW) was 12% and very low birthweight (VLBW) was 1.6%. Multivariate logistic regression results showed that depression was associated with LBW (OR = 1.71, 95% CI = 1.12-2.62). IPV was associated with preterm birth (PTB) and very preterm birth (VPTB) (OR 1.64, 95% CI = 1.07-2.51, OR = 2.94, 95% CI = 1.40-6.16, respectively). The occurrence of VPTB was significantly reduced in the intervention compared to the usual care group (OR = 0.42, 95% CI = 0.19-0.93). Our study confirms the significant associations between multiple psycho-behavioral risks and poor pregnancy outcomes, including LBW and PTB. Our behavioral intervention with demonstrated efficacy in addressing multiple risk factors simultaneously reduced VPTB within an urban minority population.

  1. Genetic counseling

    MedlinePlus

    ... this page: //medlineplus.gov/ency/patientinstructions/000510.htm Genetic counseling To use the sharing features on this ... cystic fibrosis or Down syndrome. Who May Want Genetic Counseling? It is up to you whether or ...

  2. Brief intervention for daily marijuana users identified by screening in primary care: a subgroup analysis of the ASPIRE randomized clinical trial

    PubMed Central

    Fuster, Daniel; Cheng, Debbie M.; Wang, Na; Bernstein, Judith A.; Palfai, Tibor P.; Alford, Daniel P.; Samet, Jeffrey H.; Saitz, Richard

    2015-01-01

    Background The use of brief intervention for decreasing frequent marijuana use holds potential, but its efficacy in primary care is not known. Methods Objective To assess the impact of two brief interventions on marijuana use among daily/ or almost daily marijuana users. Design Subgroup analysis of a 3-arm randomized clinical trial of two brief counseling interventions compared to no brief intervention on daily marijuana use in a primary care setting (ASPIRE). Participants ASPIRE study participants who both reported 21–30 days of marijuana use during the past month and identified marijuana as their drug of most concern. Interventions 1) Brief Negotiated Interview (BNI), a 10–15 minute structured interview, and 2) an Adaptation of Motivational Interviewing (MOTIV), a 30–45 minute intervention. Control group participants received only a list of substance use treatment resources. Main measures The primary outcome was number of days of marijuana use in the past 30 days at the 6-month follow-up. Secondary outcomes were 1) number of days of marijuana use at 6-week follow-up and 2) drug problems (Short Inventory of Problems, SIP-D) at 6-week and 6-month. Differences between intervention groups were analyzed using negative binomial regression models. Results Among the 167 eligible participants, we did not find any significant impact of either of the two interventions on past 30 days of marijuana use at 6-months [adjusted incidence rate ratio (aIRR): 0.95 (95% confidence interval (CI)):0.75–1.15, p=0.82 for BNI vs. control; aIRR:1.02, 95%CI:0.85–1.23, p=0.82 for MOTIV vs. control]. There was no significant impact on drug-related problems at 6-month follow-up [aIRR:1.12 (95%CI:0.69–1.82) p=0.66 and aIRR:1.46 (95%CI:0.89–2.38) p=0.27 for BNI vs. control and MOTIV vs. control, respectively]. Results were similar at 6 weeks. Conclusions Brief intervention has no apparent impact on marijuana use or drug-related problems among primary care patients with frequent

  3. Assessing the efficacy of a voluntary HIV counseling and testing intervention for pregnant women and male partners in Urumqi City, China.

    PubMed

    Khoshnood, Kaveh; Wilson, Katherine S; Filardo, Giovanni; Liu, Zhendong; Keung, Ng Hon; Wu, Zunyou

    2006-11-01

    This study investigated the efficacy of voluntary counseling and testing (VCT) in an educated cohort of pregnant women attending antenatal clinics in Urumqi, China. VCT was given to women and their partners (experimental group) or women alone (control group). Both groups were given pre- and post-intervention questionnaires to assess HIV knowledge and willingness to get HIV testing. Multivariate analysis showed that all women improved significantly in HIV knowledge between baseline and follow-up. Moreover, HIV knowledge was significantly associated with HIV testing willingness. At follow-up, women in the control and experimental groups were 6.8 and 7.9 times more willing to receive HIV testing than at baseline, respectively. VCT seems effective in this cohort of educated pregnant women.

  4. Long-term efficacy of a rural community-based integrated intervention for prevention and management of chronic obstructive pulmonary disease: a cluster randomized controlled trial in China's rural areas.

    PubMed

    Yuan, X; Tao, Y; Zhao, J P; Liu, X S; Xiong, W N; Xie, J G; Ni, W; Xu, Y J; Liu, H G

    2015-11-01

    This study aimed to assess the efficacy of a rural community-based integrated intervention for early prevention and management of chronic obstructive pulmonary disease (COPD) in China. This 18-year cluster-randomized controlled trial encompassing 15 villages included 1008 patients (454 men and 40 women in the intervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the control group [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villages were randomly assigned to the intervention or the control group, and study participants residing within the villages received treatment accordingly. Intervention group patients took part in a program that included systematic health education, smoking cessation counseling, and education on management of COPD. Control group patients received usual care. The groups were compared after 18 years regarding the incidence of COPD, decline in lung function, and mortality of COPD. COPD incidence was lower in the intervention group than in the control group (10% vs 16%, <0.05). A decline in lung function was also significantly delayed in the intervention group compared to the control group of COPD and high-risk patients. The intervention group showed significant improvement in smoking cessation compared with the control group, and smokers in the intervention group had lower smoking indices than in the control group (350 vs 450, <0.05). The intervention group also had a significantly lower cumulative COPD-related death rate than the control group (37% vs 47%, <0.05). A rural community-based integrated intervention is effective in reducing the incidence of COPD among those at risk, delaying a decline in lung function in COPD patients and those at risk, and reducing mortality of COPD.

  5. A Randomized Controlled Trial of a Comprehensive Migraine Intervention Prior to Discharge From an Emergency Department

    PubMed Central

    Friedman, Benjamin W.; Solorzano, Clemencia; Norton, Jennifer; Adewumni, Victoria; Campbell, Caron M.; Esses, David; Bijur, Polly E.; Solomon, Seymour; Lipton, Richard B.; Gallagher, E. John

    2012-01-01

    Objectives Patients who use an emergency department (ED) for acute migraine headaches have higher migraine disability scores and lower socioeconomic status and are unlikely to have used a migraine-specific medication prior to presentation to the ED. The objective was to determine if a comprehensive migraine intervention, delivered just prior to ED discharge, could improve migraine impact scores 1 month after the ED visit. Methods This was a randomized controlled trial of a comprehensive migraine intervention versus typical care among patients who presented to an ED for management of acute migraine. At the time of discharge, for patients randomized to comprehensive care, the authors’ protocol reinforced their diagnosis, shared a migraine education presentation from the National Library of Medicine, provided them with six tablets of sumatriptan 100 mg and 14 tablets of naproxen 500 mg, and if they wished, provided them with an expedited free appointment to our institution's headache clinic. Patients randomized to typical care received the care their attending emergency physicians (EPs) felt was appropriate. The primary outcome was a between-group comparison of the Headache Impact Test (HIT-6) score, a validated headache assessment instrument, 1 month after ED discharge. Secondary outcomes included an assessment of satisfaction with headache care and frequency of use of migraine-specific medication within that 1-month period. Results Over a 19-month period, 50 migraine patients were enrolled. One-month follow-up was successfully obtained in 92% of patients. Baseline characteristics were comparable. One-month HIT-6 scores in the two groups were nearly identical (59 vs. 56, 95% confidence interval [CI] for difference of 3 = –5 to 11), as was dissatisfaction with overall headache care (17% vs. 18%, 95% CI for difference of 1% = –22% to 24%). Patients randomized to the comprehensive intervention were more likely to be using triptans or migraine-specific therapy (43

  6. Preventing College Women's Sexual Victimization Through Parent Based Intervention: A Randomized Controlled Trial

    PubMed Central

    Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob

    2010-01-01

    A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alcohol + Sex PBI (n= 218), Control (n=288) or Unmeasured Control (n=167). Mothers in the intervention conditions were provided an informational handbook and encouraged to discuss its contents with their daughters prior to college matriculation. Consistent with hypotheses, PBI, either standard or enhanced, was associated with lower incidence of incapacitated rape in the first year of college relative to controls. Path analysis revealed support for a hypothesized indirect effects model, by which intervention increased mother-daughter communication, which predicted lower frequency of first semester heavy episodic drinking, resulting in lower rates of alcohol-involved sexual victimization in the first year of college. PMID:20169410

  7. Early intervention for autism with a parent-delivered Qigong massage program: a randomized controlled trial.

    PubMed

    Silva, Louisa M T; Schalock, Mark; Gabrielsen, Kristen

    2011-01-01

    A recent randomized controlled trial (RCT) of a dual parent and trainer-delivered qigong massage intervention for young children with autism resulted in improvement of measures of autism as well as improvement of abnormal sensory responses and self-regulation. The RCT evaluated the effects of the parent-delivered component of the intervention. Forty-seven children were randomly assigned to treatment and wait-list control groups. Treatment group children received the parent-delivered program for 4 mo. Trained therapists provided parent training and support. Improvement was evaluated in two settings--preschool and home--by teachers (blind to group) and parents. Results showed that the parent-delivered program was effective in improving measures of autism (medium effect size) and sensory and self-regulatory responses (large effect size). Teacher data on measures of autism were confirmed by parent data. Results indicate that the parent-delivered component of the program provided effective early intervention for autism that was suitable for delivery at home.

  8. Effects of Interventions on Use of Hearing Protectors among Farm Operators: A Randomized Controlled Trial

    PubMed Central

    McCullagh, Marjorie C.; Banerjee, Tanima; Cohen, Michael A.; Yang, James J.

    2016-01-01

    Objective The purpose of this study was to compare the effectiveness of three interventions designed to promote hearing protector device (HPD) use. Design Randomized controlled trial. Study Sample Farm operators (n=491) were randomly assigned to one of 5 intervention groups: 1) interactive Web-based information with mailed assortment of HPDs; 2) Interactive Web-based information only; 3) static Web-based information with mailed assortment of HPDs; 4) Static Web-based information only; or 5) mailed assortment of HPDs only. Data were analyzed using a mixed model approach. Results HPD use increased among all participants, and increased more among participants receiving the mailed HPDs (with or without information) compared to participants receiving other interventions. Participants receiving the interactive Web-based information had comparable increased use of HPDs to those receiving the static Web-based information. Participants receiving the mailed HPDs had more positive situational influences scale scores than other participants. Program satisfaction was highest among mailed and Web-based information groups. Conclusions A mailed assortment of hearing protectors was more effective than information. Interactive and static information delivered via Web were similarly effective. Programs interested in increasing HPD use among farmers should consider making hearing protectors more available to farmers. PMID:26766172

  9. Counseling Males.

    ERIC Educational Resources Information Center

    Scher, Murray, Ed.

    1981-01-01

    Contains 16 articles about counseling males including: (1) gender role conflict; (2) sex-role development; (3) counseling adolescent, adult, and gay males; (4) teenage fathers; (5) female therapists and male clients; (6) career development; (7) hypermasculinity; (8) counseling physically abusive men, uncoupling men; (9) group therapy, men's…

  10. Counseling Endorphins.

    ERIC Educational Resources Information Center

    Kottman, Terry

    1994-01-01

    The author introduces, through personal narrative, the idea that the experience of counseling another person can create "counseling endorphins" and invites other mental health professionals to enter into a dialogue about the possibility of a counseling "high" and about how to design research to explore this phenomenon. (Author/JPS)

  11. Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence A Randomized Trial

    PubMed Central

    Robbins, JoAnne; Gensler, Gary; Hind, Jacqueline; Logemann, Jeri A.; Lindblad, Anne S.; Brand, Diane; Baum, Herbert; Lilienfeld, David; Kosek, Steven; Lundy, Donna; Dikeman, Karen; Kazandjian, Marta; Gramigna, Gary D.; McGarvey-Toler, Susan; Gardner, Patricia J. Miller

    2008-01-01

    Background Aspiration pneumonia is common among frail elderly persons with dysphagia. Although interventions to prevent aspiration in these patients are routinely used in these patients, little is known about the effectiveness of those interventions. Objective To compare the effectiveness of chin-down posture and 2 consistencies (nectar or honey) of thickened liquids on the 3-month cumulative incidence of pneumonia in participants with dementia or Parkinson disease. Design Randomized, controlled, parallel-design trial in which patients were enrolled from 9 June 1998 to 19 September 2005. Setting 47 hospitals and 79 subacute facilities. Patients 515 patients age 50 years or older with dementia or Parkinson disease who aspirated thin liquids (demonstrated videofluoroscopically). Of these, 504 were followed until death or 3 months. Interventions Participants were randomly assigned to drink all liquids in a chin-down posture (n = 259) or to drink nectar-thick (n = 133) or honey-thick (n = 123) liquids in a head-neutral position. Measurements The primary outcome was pneumonia diagnosed by chest radiography or by the presence of 3 respiratory indicators. Results 52 participants had pneumonia, yielding an overall estimated 3-month cumulative incidence of 11%. The 3-month cumulative incidence of pneumonia was 0.098 and 0.116 in the chin-down posture and thickened-liquid groups, respectively (hazard ratio [HR], 0.84 [95% CI, 0.49 to 1.45]; P = 0.53). The 3-month cumulative incidence of pneumonia was 0.084 in the nectar-thick liquid group compared with 0.150 in the honey-thick liquid group (HR, 0.50 [CI, 0.23 to 1.09]; P = 0.083). More patients assigned to thickened liquids than those assigned to the chin-down posture intervention had dehydration (6% vs. 2%), urinary tract infection (6% vs. 3%), and fever (4% vs. 2%). Limitations A no-treatment control group was not included. Follow-up was limited to 3 months. Care providers were not blinded, and differences in cumulative

  12. Computer-Delivered Screening and Brief Intervention for Alcohol Use in Pregnancy: A Pilot Randomized Trial

    PubMed Central

    Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.

    2015-01-01

    Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235

  13. Effects of a multifactorial injury prevention intervention in physical education teachers: A randomized controlled trial.

    PubMed

    Vercruysse, Sien; Haerens, Leen; Verhagen, Evert; Goossens, Lennert; De Clercq, Dirk

    2016-10-01

    Physical education (PE) teachers are at a high risk of musculoskeletal sports or work-related injuries because of the physical activity as inherent part of their profession. Such injuries have a negative impact on work and leisure time activities, and effective injury prevention interventions are needed. The present study aimed at testing the effectiveness of an injury prevention intervention that was developed and optimized according to PE teachers' wishes and values. Fifty-five PE teachers were randomly assigned to intervention or control group. Intervention group teachers engaged in two days of training during which they familiarized with eight injury prevention strategies (seven intrinsic and one extrinsic). A special feature of the intervention was that the way of delivery was based on the self-determination theory in order to stimulate participants' motivation to adhere to the proposed strategies. Prospective registrations during one school year were conducted concerning injuries and preventive behaviours. Results showed that the intervention group teachers had a lower number of injuries per 1000 h time of exposure (TOE) than the controls (INT: 0.49, CON: 1.14 injuries/1000 h TOE, OR: 2.32, 95% CI: 1.06-5.07), and applied a broader variety of strategies including dynamic and static stretching, core stability, balance and strength training, when compared to the controls who mainly engaged in warming-up. In conclusion, with the same amount of time, an injury reduction was found in PE teachers through a more balanced use of provided preventive strategies.

  14. Weight change among people randomized to minimal intervention control groups in weight loss trials

    PubMed Central

    Johns, David J.; Hartmann‐Boyce, Jamie; Jebb, Susan A.; Aveyard, Paul

    2016-01-01

    Objective Evidence on the effectiveness of behavioral weight management programs often comes from uncontrolled program evaluations. These frequently make the assumption that, without intervention, people will gain weight. The aim of this study was to use data from minimal intervention control groups in randomized controlled trials to examine the evidence for this assumption and the effect of frequency of weighing on weight change. Methods Data were extracted from minimal intervention control arms in a systematic review of multicomponent behavioral weight management programs. Two reviewers classified control arms into three categories based on intensity of minimal intervention and calculated 12‐month mean weight change using baseline observation carried forward. Meta‐regression was conducted in STATA v12. Results Thirty studies met the inclusion criteria, twenty‐nine of which had usable data, representing 5,963 participants allocated to control arms. Control arms were categorized according to intensity, as offering leaflets only, a single session of advice, or more than one session of advice from someone without specialist skills in supporting weight loss. Mean weight change at 12 months across all categories was −0.8 kg (95% CI −1.1 to −0.4). In an unadjusted model, increasing intensity by moving up a category was associated with an additional weight loss of −0.53 kg (95% CI −0.96 to −0.09). Also in an unadjusted model, each additional weigh‐in was associated with a weight change of −0.42 kg (95% CI −0.81 to −0.03). However, when both variables were placed in the same model, neither intervention category nor number of weigh‐ins was associated with weight change. Conclusions Uncontrolled evaluations of weight loss programs should assume that, in the absence of intervention, their population would weigh up to a kilogram on average less than baseline at the end of the first year of follow‐up. PMID:27028279

  15. Intervention to promote physician well-being, job satisfaction, and professionalism: a randomized clinical trial.

    PubMed

    West, Colin P; Dyrbye, Liselotte N; Rabatin, Jeff T; Call, Tim G; Davidson, John H; Multari, Adamarie; Romanski, Susan A; Hellyer, Joan M Henriksen; Sloan, Jeff A; Shanafelt, Tait D

    2014-04-01

    IMPORTANCE Despite the documented prevalence and clinical ramifications of physician distress, few rigorous studies have tested interventions to address the problem. OBJECTIVE To test the hypothesis that an intervention involving a facilitated physician small-group curriculum would result in improvement in well-being. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial of 74 practicing physicians in the Department of Medicine at the Mayo Clinic in Rochester, Minnesota, conducted between September 2010 and June 2012. Additional data were collected on 350 nontrial participants responding to annual surveys timed to coincide with the trial surveys. INTERVENTIONS The intervention involved 19 biweekly facilitated physician discussion groups incorporating elements of mindfulness, reflection, shared experience, and small-group learning for 9 months. Protected time (1 hour of paid time every other week) for participants was provided by the institution. MAIN OUTCOMES AND MEASURES Meaning in work, empowerment and engagement in work, burnout, symptoms of depression, quality of life, and job satisfaction assessed using validated metrics. RESULTS Empowerment and engagement at work increased by 5.3 points in the intervention arm vs a 0.5-point decline in the control arm by 3 months after the study (P = .04), an improvement sustained at 12 months (+5.5 vs +1.3 points; P = .03). Rates of high depersonalization at 3 months had decreased by 15.5% in the intervention arm vs a 0.8% increase in the control arm (P = .004). This difference was also sustained at 12 months (9.6% vs 1.5% decrease; P = .02). No statistically significant differences in stress, symptoms of depression, overall quality of life, or job satisfaction were seen. In additional comparisons including the nontrial physician cohort, the proportion of participants strongly agreeing that their work was meaningful increased 6.3% in the study intervention arm but decreased 6.3% in the study control arm

  16. Psychological Outcomes After a Sexual Assault Video Intervention: A Randomized Trial.

    PubMed

    Miller, Katherine E; Cranston, Christopher C; Davis, Joanne L; Newman, Elana; Resnick, Heidi

    2015-01-01

    Sexual assault survivors are at risk for a number of mental and physical health problems, including posttraumatic stress disorder and anxiety. Unfortunately, few seek physical or mental health services after a sexual assault (Price, Davidson, Ruggiero, Acierno, & Resnick, 2014). Mitigating the impact of sexual assault via early interventions is a growing and important area of research. This study adds to this literature by replicating and expanding previous studies (e.g., Resnick, Acierno, Amstadter, Self-Brown, & Kilpatrick, 2007) examining the efficacy of a brief video-based intervention that provides psychoeducation and modeling of coping strategies to survivors at the time of a sexual assault nurse examination. Female sexual assault survivors receiving forensic examinations were randomized to standard care or to the video intervention condition (N = 164). The participants completed mental health assessments 2 weeks (n = 69) and 2 months (n = 74) after the examination. Analyses of covariance revealed that women in the video condition had significantly fewer anxiety symptoms at the follow-up assessments. In addition, of those participants in the video condition, survivors reporting no previous sexual assault history reported significantly fewer posttraumatic stress symptoms 2 weeks after the examination than those with a prior assault history. Forensic nurses have the unique opportunity to intervene immediately after a sexual assault. This brief video intervention is a cost-effective tool to aid with that process.

  17. Mechanical Low Back Pain: Secular Trend and Intervention Topics of Randomized Controlled Trials

    PubMed Central

    Gianola, Silvia; Banfi, Giuseppe; Bonovas, Stefanos; Moja, Lorenzo

    2016-01-01

    Purpose: To evaluate the number of published randomized controlled trials (RCTs) focusing on mechanical low back pain (MLBP) rehabilitation, the secular (i.e., long-term) trend, and the distribution of interventions studied. Methods: All included RCTs were extracted from all Cochrane systematic reviews focusing on rehabilitation therapies for MLBP, and two independent reviewers screened and analyzed the information on interventions. Results: After removal of duplicates, the data set consisted of 196 RCTs published between 1961 and 2010. The number of RCTs published increased consistently over time: 2 trials (1% of the total) were published in 1961–1970, 10 (5%) in 1971–1980, 41 (21%) in 1981–1990, 68 (35%) in 1991–2000, and 75 (38%) in 2001–2010. The intervention of interest in the majority of RCTs was exercise therapy (115/399; 29%), followed by spinal manipulation therapies (60/399; 15%). Conclusion: The number of RCTs focusing on MLBP has risen over time; of all interventions studied, exercise therapy has attracted the most research interest. PMID:27504049

  18. A Systematic Review of Randomized Controlled Interventions for Parents' Distress in Pediatric Leukemia

    PubMed Central

    Bougea, A.; Darviri, C.; Alexopoulos, E. C.

    2011-01-01

    Objective. This review aims to summarize the existing evidence concerning interventions towards reducing stress in parents with a child with leukemia and their effect in child and family wellbeing. Methods. A systematic review strategy was conducted using MEDLINE covering the period January 1980 to June 2010. Results. Seven randomized controlled trials met the inclusion criteria including in total 1045 parents participants. A variety of cognitive-behavioral interventions problem-solving skills training programs have been used for managing distress in parents and children. Outcome measures are assessed by self-report, observer report, behavioral/psychological, and physiological measures. The most prominent methodological problems were the marked heterogeneity in stress measurement and the relative absence of proper measurement and adjustment of moderating and mediating factors. The largest effect has been obtained by combined cognitive-behavioral interventions with promising but limited evidence for several other psychological interventions. Conclusions. Recommendations for future RCTs are provided, and particular attention to the quality of trial design and reporting is highlighted. PMID:22091439

  19. A randomized controlled trial of a multi-dose bystander intervention program using peer education theater.

    PubMed

    McMahon, Sarah; Winter, Samantha C; Palmer, Jane E; Postmus, Judy L; Peterson, N Andrew; Zucker, Sharon; Koenick, RuthAnne

    2015-08-01

    This article reports findings from a longitudinal, experimental evaluation of a peer education theater program, Students Challenging Realities and Educating Against Myths (SCREAM) Theater. This study examines the impact of SCREAM Theater on a range of bystander-related outcomes (i.e. bystander intentions, bystander efficacy, perception of friend norms and bystander behaviors) in situations involving sexual violence and whether there was a differential impact of the program by participant sex. First-year college students completed three waves of surveys (pretest, first post-test and second post-test). All participants received one dose of the intervention during summer orientation after the pretest. After the first post-test, participants were randomly assigned to receive two additional doses, or to a control condition, in which they received no additional doses. Students in both one- and three-dose groups reported a number of positive increases. Overall, an intent-to-treat analysis (n = 1390) indicated three doses of the intervention during the first semester of college resulted in better outcomes than the one-time intervention during summer orientation alone. Although both male and female students' scores increased during the study period, female students consistently scored higher than male students on each outcome. The findings suggest that peer education theater holds promise for bystander intervention education on college campuses.

  20. A Randomized Clinical Trial of Alternative Stress Management Interventions in Persons With HIV Infection

    PubMed Central

    McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney

    2015-01-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of three 10-week stress management approaches—cognitive–behavioral relaxation training (RLXN), focused tai chi training (TCHI), and spiritual growth groups (SPRT)—in comparison to a wait-listed control group (CTRL) among 252 individuals with HIV infection. Using repeated measures mixed modeling, the authors found that in comparison to the CTRL group, (a) both the RLXN and TCHI groups used less emotion-focused coping, and (b) all treatment groups had augmented lymphocyte proliferative function. Despite modest effects of the interventions on psychosocial functioning, robust findings of improved immune function have important clinical implications, particularly for persons with immune-mediated illnesses. PMID:18540736

  1. Randomized Controlled Trial of a Family Cognitive-Behavioral Preventive Intervention for Children of Depressed Parents

    PubMed Central

    Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.

    2010-01-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted. PMID:19968378

  2. Randomized controlled trial of a family cognitive-behavioral preventive intervention for children of depressed parents.

    PubMed

    Compas, Bruce E; Forehand, Rex; Keller, Gary; Champion, Jennifer E; Rakow, Aaron; Reeslund, Kristen L; McKee, Laura; Fear, Jessica M; Colletti, Christina J M; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K; Cole, David A

    2009-12-01

    A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; by parent reports on internalizing and externalizing problems; and by child and parent reports on a standardized diagnostic interview. Parent depressive symptoms and parent episodes of major depression also were assessed. Evidence emerged for significant differences favoring the family group intervention on both child and parent outcomes; strongest effects for child outcomes were found at the 12-month assessment with medium effect sizes on most measures. Implications for the prevention of adverse outcomes in children of depressed parents are highlighted.

  3. A randomized clinical trial of alternative stress management interventions in persons with HIV infection.

    PubMed

    McCain, Nancy L; Gray, D Patricia; Elswick, R K; Robins, Jolynne W; Tuck, Inez; Walter, Jeanne M; Rausch, Sarah M; Ketchum, Jessica McKinney

    2008-06-01

    Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of three 10-week stress management approaches--cognitive-behavioral relaxation training (RLXN), focused tai chi training (TCHI), and spiritual growth groups (SPRT)--in comparison to a wait-listed control group (CTRL) among 252 individuals with HIV infection. Using repeated measures mixed modeling, the authors found that in comparison to the CTRL group, (a) both the RLXN and TCHI groups used less emotion-focused coping, and (b) all treatment groups had augmented lymphocyte proliferative function. Despite modest effects of the interventions on psychosocial functioning, robust findings of improved immune function have important clinical implications, particularly for persons with immune-mediated illnesses.

  4. Patterns of Enrollment and Engagement of Custodial Grandmothers in a Randomized Clinical Trial of Psychoeducational Interventions

    PubMed Central

    Smith, Gregory C.; Strieder, Frederick; Greenberg, Patty; Hayslip, Bert; Montoro-Rodriguez, Julian

    2016-01-01

    The authors used Andersen’s (2008) behavior model to investigate patterns of enrollment and treatment engagement among 343 custodial grandmothers who participated in a randomized clinical trial of three psychosocial interventions:(a) a behavioral parenting program, (b) a cognitive behavioral coping program, or (c) an information-only condition. Treatment completion was superior to that typically found with birth parents, even though the grandmothers and their target grandchildren both had high levels of mental and physical health challenges. Compliance did not differ significantly by condition but was higher among grandmothers who self-reported less positive affect, were older, and were using mental health professionals. Treatment satisfaction was highest in grandmothers who attended more treatment sessions, reported lower annual family income, had a health problem, and were using mental health professionals. The practice and policy implications of these findings are discussed, especially in terms of strategies for enhancing the engagement of custodial grandfamilies in future psychoeducational interventions. PMID:27667888

  5. Dosage Effects on School Readiness: Evidence from a Randomized Classroom-Based Intervention

    PubMed Central

    Zhai, Fuhua; Raver, C. Cybele; Jones, Stephanie M.; Li-Grining, Christine P.; Pressler, Emily; Gao, Qin

    2016-01-01

    Variations in the dosage of social interventions and the effects of dosage on program outcomes remain understudied. This study examines the dosage effects of the Chicago School Readiness Project, a randomized, multifaceted classroom-based intervention conducted in Head Start settings. Using a principal score matching method to address the issue of selection bias, the study finds that high-dosage levels of teacher training and mental health consultant class visits have larger effects on children’s school readiness than the effects estimated through intention-to-treat (ITT) analyses. Low-dosage levels of treatment are found to have effects that are smaller than those estimated in ITT analyses or to have no statistically significant program effects. Moreover, individual mental health consultation services provided to high-risk children are found to have statistically significant effects on their school readiness. The study discusses the implications of these findings for research and policy. PMID:21488322

  6. Influence of a Suggestive Placebo Intervention on Psychobiological Responses to Social Stress: A Randomized Controlled Trial.

    PubMed

    Zimmermann-Viehoff, Frank; Steckhan, Nico; Meissner, Karin; Deter, Hans-Christian; Kirschbaum, Clemens

    2016-01-01

    We tested the hypothesis that a suggestive placebo intervention can reduce the subjective and neurobiological stress response to psychosocial stress. Fifty-four healthy male subjects with elevated levels of trait anxiety were randomly assigned in a 4:4:1 fashion to receive either no treatment (n = 24), a placebo pill (n = 24), or a herbal drug (n = 6) before undergoing a stress test. We repeatedly measured psychological variables as well as salivary cortisol, alpha-amylase, and heart rate variability prior to and following the stress test. The stressor increased subjective stress and anxiety, salivary cortisol, and alpha-amylase, and decreased heart rate variability (all P < .001). However, no significant differences between subjects receiving placebo or no treatment were found. Subjects receiving placebo showed increased wakefulness during the stress test compared with no-treatment controls (P < .001). Thus, the suggestive placebo intervention increased alertness, but modulated neither subjective stress and anxiety nor the physiological response to psychosocial stress.

  7. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial

    PubMed Central

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S.

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179

  8. A Yoga Intervention for Posttraumatic Stress: A Preliminary Randomized Control Trial.

    PubMed

    Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S

    2015-01-01

    Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.

  9. Combining Intensive Counseling by Frontline Workers with a Nationwide Mass Media Campaign Has Large Differential Impacts on Complementary Feeding Practices but Not on Child Growth: Results of a Cluster-Randomized Program Evaluation in Bangladesh123

    PubMed Central

    Nguyen, Phuong Hong; Saha, Kuntal Kumar; Khaled, Adiba; Sanghvi, Tina; Baker, Jean; Afsana, Kaosar; Haque, Raisul; Frongillo, Edward A; Ruel, Marie T; Rawat, Rahul

    2016-01-01

    Background: Complementary feeding (CF) contributes to child growth and development, but few CF programs are delivered at scale. Alive & Thrive addressed this in Bangladesh through intensified interpersonal counseling (IPC), mass media (MM), and community mobilization (CM). Objective: The objective was to evaluate the impact of providing IPC + MM + CM (intensive) compared with standard nutrition counseling + less intensive MM + CM (nonintensive) on CF practices and anthropometric measurements. Methods: We used a cluster-randomized, nonblinded evaluation with cross-sectional surveys [n = ∼600 and 1090 children 6–23.9 mo and 24–47.9 mo/group, respectively, at baseline (2010) and n = ∼500 and 1100 children of the same age, respectively, at endline (2014)]. We derived difference-in-difference impact estimates (DDEs), adjusting for geographic clustering, infant age, sex, differences in baseline characteristics, and differential change in characteristics over time. Results: Groups were similar at baseline. CF improvements were significantly greater in the intensive than in the nonintensive group [DDEs: 16.3, 14.7, 22.0, and 24.6 percentage points (pp) for minimum dietary diversity, minimum meal frequency, minimum acceptable diet, and consumption of iron-rich foods, respectively]. In the intensive group, CF practices were high: 50.4% for minimum acceptable diet, 63.8% for minimum diet diversity, 75.1% for minimum meal frequency, and 78.5% for consumption of iron-rich foods. Timely introduction of foods improved. Significant, nondifferential stunting declines occurred in intensive (6.2 pp) and nonintensive (5.2 pp) groups in children 24–47.9 mo. Conclusions: The intensive program substantially improved CF practices compared with the nonintensive program. Large-scale program delivery was feasible and, with the use of multiple platforms, reached 1.7 million households. Nondifferential impacts on stunting were likely due to rapid positive secular trends in Bangladesh

  10. Brief interventions to reduce Ecstasy use: a multi-site randomized controlled trial.

    PubMed

    Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan

    2014-11-01

    Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may

  11. Can Early Intervention Improve Maternal Well-Being? Evidence from a Randomized Controlled Trial

    PubMed Central

    Doyle, Orla; Delaney, Liam; O’Farrelly, Christine; Fitzpatrick, Nick; Daly, Michael

    2017-01-01

    Objective This study estimates the effect of a targeted early childhood intervention program on global and experienced measures of maternal well-being utilizing a randomized controlled trial design. The primary aim of the intervention is to improve children’s school readiness skills by working directly with parents to improve their knowledge of child development and parenting behavior. One potential externality of the program is well-being benefits for parents given its direct focus on improving parental coping, self-efficacy, and problem solving skills, as well as generating an indirect effect on parental well-being by targeting child developmental problems. Methods Participants from a socio-economically disadvantaged community are randomly assigned during pregnancy to an intensive 5-year home visiting parenting program or a control group. We estimate and compare treatment effects on multiple measures of global and experienced well-being using permutation testing to account for small sample size and a stepdown procedure to account for multiple testing. Results The intervention has no impact on global well-being as measured by life satisfaction and parenting stress or experienced negative affect using episodic reports derived from the Day Reconstruction Method (DRM). Treatment effects are observed on measures of experienced positive affect derived from the DRM and a measure of mood yesterday. Conclusion The limited treatment effects suggest that early intervention programs may produce some improvements in experienced positive well-being, but no effects on negative aspects of well-being. Different findings across measures may result as experienced measures of well-being avoid the cognitive biases that impinge upon global assessments. PMID:28095505

  12. Effectiveness of an intervention designed to optimize statins use: a primary prevention randomized clinical trial

    PubMed Central

    2014-01-01

    Background Although hypercholesterolemia is considered a cardiovascular risk factor, in isolation it is not necessarily sufficient cause for a cardiovascular event. To improve event prediction, cardiovascular risk calculators have been developed; the REGICOR calculator has been validated for use in our population. The objective of this project is to develop an intervention with general practitioners (GPs) and evaluate its impact on prescription adequacy of cholesterol-lowering drugs in primary prevention of cardiovascular disease and in controlling the costs associated with this disease. Methods This nonblinded, cluster-randomized clinical trial analyzes data from primary care electronic medical records (ECAP) and other databases. Inclusion criteria are patients aged 35 to 74 years with no known cardiovascular disease and a new prescription for cholesterol-lowering drugs during the 2-year study period. Dependent variables include the following: RETIRA, defined as new cholesterol-lowering drugs initiated during the year preceding the intervention, considered inadequate, and withdrawn during the study period; EVITA, defined as new cholesterol-lowering drugs initiated during the study period and considered inadequate; COST, defined as the total cost of inadequate new treatments prescribed; and REGISTER, defined as the recording of cardiovascular risk factors. Independent variables include the GP’s quality-of-care indicators and randomly assigned study group (intervention vs control), patient demographics, and clinical variables. Aggregated descriptive analysis will be done at the GP level and multilevel analysis will be performed to estimate the intervention effect, adjusted for individual and GP variables. Discussion The study objective is to generate evidence about the effectiveness of implementing feedback information programs directed to GPs in the context of Primary Care. The goal is to improve the prescription adequacy of lipid-lowering therapies for primary

  13. A Framework for Chaos Theory Career Counselling

    ERIC Educational Resources Information Center

    Pryor, Robert G. L.

    2010-01-01

    Theory in career development counselling provides a map that counsellors can use to understand and structure the career counselling process. It also provides a means to communicate this understanding and structuring to their clients as part of the counselling intervention. The chaos theory of careers draws attention to the complexity,…

  14. The Myth of Value Free Counseling.

    ERIC Educational Resources Information Center

    Kegley, John F.

    A counselor's values are inherent in all that he does with a client, ranging from selection of the counseling modality to the decision to terminate facilitative intervention. Value-free counseling is a myth, and recognition of this fact is the first step in arriving at a clear conception of what counseling can, or should, be. A counselor can be…

  15. Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome

    PubMed Central

    Dodson, William C.; Kris-Etherton, Penny M.; Kunselman, Allen R.; Stetter, Christy M.; Williams, Nancy I.; Gnatuk, Carol L.; Estes, Stephanie J.; Fleming, Jennifer; Allison, Kelly C.; Sarwer, David B.; Coutifaris, Christos; Dokras, Anuja

    2015-01-01

    Context: Lifestyle modification is recommended in women with polycystic ovary syndrome (PCOS) prior to conception but there are few randomized trials to support its implementation or benefit. Objective: This study aimed to determine the relative efficacy of preconception intervention on reproductive and metabolic abnormalities in overweight/obese women with PCOS. Design, Setting, and Participants: This was a randomized controlled trial of preconception and infertility treatment at Academic Health Centers in women with infertility due to PCOS, age 18–40 y and body mass index 27–42 kg/m2. Intervention: Women were randomly assigned to receive either 16 weeks of 1) continuous oral contraceptive pills (OCPs) (ethinyl estradiol 20 mcg/1 mg norethindrone acetate) (“OCP”); 2) lifestyle modification consisting of caloric restriction with meal replacements, weight loss medication (either sibutramine, or orlistat), and increased physical activity to promote a 7% weight loss (“Lifestyle”); or 3) combined treatment with both OCP and lifestyle modification (“Combined”). After preconception intervention, women underwent standardized ovulation induction with clomiphene citrate and timed intercourse for four cycles. Pregnancies were followed with trimester visits until delivery. Main Outcome Measures: Weight, ovulation, and live birth were measured. Results: We consented 216 and randomly assigned 149 women (Lifestyle: n = 50; OCP: n = 49; Combined: n = 50). We achieved significant weight loss with both Lifestyle (mean weight loss, −6.2%; 95% confidence interval (CI), −7.4–−5.0; and Combined (mean weight loss, −6.4%; 95% CI, −7.6–−5.2) compared with baseline and OCP (both P < .001). There was a significant increase in the prevalence of metabolic syndrome at the end of preconception treatment compared with baseline within OCP (odds ratio [OR, 2.47; 95% CI, 1.42–4.27) whereas no change in metabolic syndrome was detected in the Lifestyle (OR, 1.18; 95

  16. Cardiorespiratory fitness, cardiovascular workload and risk factors among cleaners; a cluster randomized worksite intervention

    PubMed Central

    2012-01-01

    Background Prevalence of cardiovascular risk factors is unevenly distributed among occupational groups. The working environment, as well as lifestyle and socioeconomic status contribute to the disparity and variation in prevalence of these risk factors. High physical work demands have been shown to increase the risk for cardiovascular disease and mortality, contrary to leisure time physical activity. High physical work demands in combination with a low cardiorespiratory fitness infer a high relative workload and an excessive risk for cardiovascular mortality. Therefore, the aim of this study is to examine whether a worksite aerobic exercise intervention will reduce the relative workload and cardiovascular risk factors by an increased cardiorespiratory fitness. Methods/design A cluster-randomized controlled trial is performed to evaluate the effect of the worksite aerobic exercise intervention on cardiorespiratory fitness and cardiovascular risk factors among cleaners. Cleaners are eligible if they are employed ≥ 20 hours/week, at one of the enrolled companies. In the randomization, strata are formed according to the manager the participant reports to. The clusters will be balanced on the following criteria: Geographical work location, gender, age and seniority. Cleaners are randomized to either I) a reference group, receiving lectures concerning healthy living, or II) an intervention group, performing worksite aerobic exercise “60 min per week”. Data collection will be conducted at baseline, four months and 12 months after baseline, at the worksite during working hours. The data collection will consist of a questionnaire-based interview, physiological testing of health and capacity-related measures, and objective diurnal measures of heart rate, physical activity and blood pressure. Primary outcome is cardiorespiratory fitness. Discussion Information is lacking about whether an improved cardiorespiratory fitness will affect the cardiovascular health

  17. A Randomized Intervention Study to Evaluate Whether Electronic Messaging Can Increase Human Papillomavirus Vaccine Completion and Knowledge among College Students

    ERIC Educational Resources Information Center

    Richman, Alice R.; Maddy, LaDonna; Torres, Essie; Goldberg, Ellen J.

    2016-01-01

    Objective: To evaluate an intervention aimed at increasing human papillomavirus (HPV) vaccine completion of the 3-dose series and knowledge. Participants: Two hundred sixty-four male and female US college students 18-26 years old who were receiving HPV vaccine dose 1. Methods: Students were randomly assigned to the intervention or control group.…

  18. To Wait in Tier 1 or Intervene Immediately: A Randomized Experiment Examining First Grade Response to Intervention (RTI) in Reading

    ERIC Educational Resources Information Center

    Al Otaiba, Stephanie; Connor, Carol M.; Folsom, Jessica S.; Wanzek, Jeanne; Greulich, Luana; Schatschneider, Christopher; Wagner, Richard K.

    2015-01-01

    This randomized control study compares the efficacy of two response-to-intervention (RTI) models: (1) Dynamic RTI, which immediately refers grade 1 students with the weakest skills to the most intensive intervention supports (Tier 2 or Tier 3); and (2) Typical RTI, which starts all students in Tier 1 and after 8 weeks, decides whether students who…

  19. Evaluation of a Randomized Intervention to Delay Sexual Initiation among Fifth-Graders Followed through the Sixth Grade

    ERIC Educational Resources Information Center

    Koo, Helen P.; Rose, Allison; El-Khorazaty, M. Nabil; Yao, Qing; Jenkins, Renee R.; Anderson, Karen M.; Davis, Maurice; Walker, Leslie R.

    2011-01-01

    US adolescents initiate sex at increasingly younger ages, yet few pregnancy prevention interventions for children as young as 10-12 years old have been evaluated. Sixteen Washington, DC schools were randomly assigned to intervention versus control conditions. Beginning in 2001/02 with fifth-grade students and continuing during the sixth grade,…

  20. Testing Mediators of Intervention Effects in Randomized Controlled Trials: An Evaluation of Two Eating Disorder Prevention Programs

    ERIC Educational Resources Information Center

    Stice, Eric; Presnell, Katherine; Gau, Jeff; Shaw, Heather

    2007-01-01

    The authors investigated mediators hypothesized to account for the effects of 2 eating disorder prevention programs using data from 355 adolescent girls who were randomized to a dissonance or a healthy weight intervention or an active control condition. The dissonance intervention produced significant reductions in outcomes (body…

  1. Brief Cognitive-Behavioral Depression Prevention Program for High-Risk Adolescents Outperforms Two Alternative Interventions: A Randomized Efficacy Trial

    ERIC Educational Resources Information Center

    Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.

    2008-01-01

    In this depression prevention trial, 341 high-risk adolescents (mean age = 15.6 years, SD = 1.2) with elevated depressive symptoms were randomized to a brief group cognitive-behavioral (CB) intervention, group supportive-expressive intervention, bibliotherapy, or assessment-only control condition. CB participants showed significantly greater…

  2. A Parent-Directed Language Intervention for Children of Low Socioeconomic Status: A Randomized Controlled Pilot Study

    ERIC Educational Resources Information Center

    Suskind, Dana L.; Leffel, Kristin R.; Graf, Eileen; Hernandez, Marc W.; Gunderson, Elizabeth A.; Sapolich, Shannon G.; Suskind, Elizabeth; Leininger, Lindsey; Goldin-Meadow, Susan; Levine, Susan C.

    2016-01-01

    We designed a parent-directed home-visiting intervention targeting socioeconomic status (SES) disparities in children's early language environments. A randomized controlled trial was used to evaluate whether the intervention improved parents' knowledge of child language development and increased the amount and diversity of parent talk.…

  3. Evaluation of a Brief Parent Intervention Teaching Coping-Promoting Behavior for the Infant Immunization Context: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Bustos, Theona; Jaaniste, Tiina; Salmon, Karen; Champion, G. David

    2008-01-01

    This study was designed to investigate whether a brief intervention encouraging parental coping-promoting talk within the treatment room would have beneficial effects on infant pain responses to an immunization injection. Infant-parent dyads were recruited from a 6-month immunization clinic and randomized to an intervention group (n = 25) or…

  4. A Preliminary Randomized Controlled Trial of Two Social Skills Interventions for Youth with High-Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Lerner, Matthew D.; Mikami, Amori Y.

    2012-01-01

    This study examined the effects of two social skills interventions, Sociodramatic Affective Relational Intervention (SDARI) and Skillstreaming, to compare their treatment mechanisms, social performance- and knowledge-training. A total of 13 youth with autism spectrum disorders were randomly assigned to 4 weeks of 1-day/week SDARI or…

  5. Mathematics Learned by Young Children in An Intervention Based on Learning Trajectories: A Large-Scale Cluster Randomized Trial

    ERIC Educational Resources Information Center

    Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.

    2011-01-01

    This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous…

  6. Promoting Healthy Beginnings: A Randomized Controlled Trial of a Preventive Intervention to Preserve Marital Quality During the Transition to Parenthood

    ERIC Educational Resources Information Center

    Schulz, Marc S.; Cowan, Carolyn Pape; Cowan, Philip A.

    2006-01-01

    Couples expecting their first child were randomly assigned to intervention (n = 28) and comparison groups (n = 38) to assess the efficacy of a couples intervention and examine marital satisfaction trajectories across the transition to parenthood. The primarily European American sample (M age = 30 years) completed assessments of marital…

  7. Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

    ERIC Educational Resources Information Center

    Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

    2010-01-01

    The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

  8. Non-Speech Oro-Motor Exercises in Post-Stroke Dysarthria Intervention: A Randomized Feasibility Trial

    ERIC Educational Resources Information Center

    Mackenzie, C.; Muir, M.; Allen, C.; Jensen, A.

    2014-01-01

    Background: There has been little robust evaluation of the outcome of speech and language therapy (SLT) intervention for post-stroke dysarthria. Non-speech oro-motor exercises (NSOMExs) are a common component of dysarthria intervention. A feasibility study was designed and executed, with participants randomized into two groups, in one of which…

  9. Randomized Controlled Trial for Early Intervention for Autism: A Pilot Study of the Autism 1-2-3 Project

    ERIC Educational Resources Information Center

    Wong, Virginia C. N.; Kwan, Queenie K.

    2010-01-01

    We piloted a 2-week "Autism-1-2-3" early intervention for children with autism and their parents immediately after diagnosis that targeted at (1) eye contact, (2) gesture and (3) vocalization/words. Seventeen children were randomized into the Intervention (n = 9) and Control (n = 8) groups. Outcome measures included the Autism Diagnostic…

  10. Telephone-Based Physical Activity Counseling for Major Depression in People with Multiple Sclerosis

    ERIC Educational Resources Information Center

    Bombardier, Charles H.; Ehde, Dawn M.; Gibbons, Laura E.; Wadhwani, Roini; Sullivan, Mark D.; Rosenberg, Dori E.; Kraft, George H.

    2013-01-01

    Objective: Physical activity represents a promising treatment for major depressive disorder (MDD) in people with multiple sclerosis (MS). We conducted a single-blind, two-arm randomized controlled trial comparing a 12-week physical activity counseling intervention delivered primarily by telephone (n = 44) to a wait-list control group (N = 48).…

  11. The spinal stenosis pedometer and nutrition lifestyle intervention (SSPANLI) randomized controlled trial protocol

    PubMed Central

    2013-01-01

    Background Because of symptoms, people with lumbar spinal stenosis (LSS) are often inactive, and this sedentary behaviour implies risk for diseases including obesity. Research has identified body mass index as the most powerful predictor of function in LSS. This suggests that function may be improved by targeting weight as a modifiable factor. An e-health lifestyle intervention was developed aimed at reducing fat mass and increasing physical activity in people with LSS. The main components of this intervention include pedometer-based physical activity promotion and nutrition education. Methods/Design The Spinal Stenosis Pedometer and Nutrition Lifestyle Intervention (SSPANLI) was developed and piloted with 10 individuals. The protocol for a randomized controlled trail comparing the SSPANLI intervention to usual non-surgical care follows. One hundred six (106) overweight or obese individuals with LSS will be recruited. Baseline and follow-up testing includes dual energy x-ray absorptiometry, blood draw, 3-day food record, 7-day accelerometry, questionnaire, maximal oxygen consumption, neurological exam, balance testing and a Self-Paced Walking Test. Intervention: During Week 1, the intervention group will receive a pedometer, and a personalized consultation with both a Dietitian and an exercise specialist. For 12 weeks participants will log on to the e-health website to access personal step goals, walking maps, nutrition videos, and motivational quotes. Participants will also have access to in-person Coffee Talk meetings every 3 weeks, and meet with the Dietitian and exercise specialist at week 6. The control group will proceed with usual care for the 12-week period. Follow-up testing will occur at Weeks 13 and 24. Discussion This lifestyle intervention has the potential to provide a unique, non-surgical management option for people with LSS. Through decreased fat mass and increased function, we may reduce risk for obesity, chronic diseases of inactivity, and pain

  12. Nutrition education intervention for dependent patients: protocol of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Malnutrition in dependent patients has a high prevalence and can influence the prognosis associated with diverse pathologic processes, decrease quality of life, and increase morbidity-mortality and hospital admissions. The aim of the study is to assess the effect of an educational intervention for caregivers on the nutritional status of dependent patients at risk of malnutrition. Methods/Design Intervention study with control group, randomly allocated, of 200 patients of the Home Care Program carried out in 8 Primary Care Centers (Spain). These patients are dependent and at risk of malnutrition, older than 65, and have caregivers. The socioeconomic and educational characteristics of the patient and the caregiver are recorded. On a schedule of 0–6–12 months, patients are evaluated as follows: Mini Nutritional Assessment (MNA), food intake, dentures, degree of dependency (Barthel test), cognitive state (Pfeiffer test), mood status (Yesavage test), and anthropometric and serum parameters of nutritional status: albumin, prealbumin, transferrin, haemoglobin, lymphocyte count, iron, and ferritin. Prior to the intervention, the educational procedure and the design of educational material are standardized among nurses. The nurses conduct an initial session for caregivers and then monitor the education impact at home every month (4 visits) up to 6 months. The North American Nursing Diagnosis Association (NANDA) methodology will be used. The investigators will study the effect of the intervention with caregivers on the patient’s nutritional status using the MNA test, diet, anthropometry, and biochemical parameters. Bivariate normal test statistics and multivariate models will be created to adjust the effect of the intervention. The SPSS/PC program will be used for statistical analysis. Discussion The nutritional status of dependent patients has been little studied. This study allows us to know nutritional risk from different points of view: diet

  13. An Internet-Based Intervention for Depression in Primary Care in Spain: A Randomized Controlled Trial

    PubMed Central

    Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier

    2016-01-01

    Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet

  14. Web-Based and Mobile Stress Management Intervention for Employees: A Randomized Controlled Trial

    PubMed Central

    Lehr, Dirk; Ebert, David Daniel; Berking, Matthias; Riper, Heleen

    2016-01-01

    Background Work-related stress is highly prevalent among employees and is associated with adverse mental health consequences. Web-based interventions offer the opportunity to deliver effective solutions on a large scale; however, the evidence is limited and the results conflicting. Objective This randomized controlled trial evaluated the efficacy of guided Web- and mobile-based stress management training for employees. Methods A total of 264 employees with elevated symptoms of stress (Perceived Stress Scale-10, PSS-10≥22) were recruited from the general working population and randomly assigned to an Internet-based stress management intervention (iSMI) or waitlist control group. The intervention (GET.ON Stress) was based on Lazarus’s transactional model of stress, consisted of seven sessions, and applied both well-established problem solving and more recently developed emotion regulation strategies. Participants also had the opportunity to request automatic text messages on their mobile phone along with the iSMI. Participants received written feedback on every completed session from an e-coach. The primary outcome was perceived stress (PSS-10). Web-based self-report assessments for both groups were scheduled at baseline, 7 weeks, and 6 months. At 12 months, an extended follow-up was carried out for the iSMI group only. Results An intention-to-treat analysis of covariance revealed significantly large effect differences between iSMI and waitlist control groups for perceived stress at posttest (F 1,261=58.08, P<.001; Cohen’s d=0.83) and at the 6-month follow-up (F 1,261=80.17, P<.001; Cohen’s d=1.02). The effects in the iSMI group were maintained at 12-month follow-up. Conclusions This Web- and mobile-based intervention has proven effective in reducing stress in employees in the long term. Internet-based stress management interventions should be further pursued as a valuable alternative to face-to-face interventions. Trial Registration German Clinical Trials

  15. Ethical practice and evaluation of interventions in crime and justice. The moral imperative for randomized trials.

    PubMed

    Weisburd, David

    2003-06-01

    In considering the ethical dilemmas associated with randomized experiments, scholars ordinarily focus on the ways in which randomization of treatments or interventions violates accepted norms of conduct of social science research more generally or evaluation of crime and justice questions more specifically. The weight of ethical judgment is thus put on experimental research to justify meeting ethical standards. In this article, it is argued that just the opposite should be true, and that in fact there is a moral imperative for the conduct of randomized experiments in crime and justice. That imperative develops from our professional obligation to provide valid answers to questions about the effectiveness of treatments, practices, and programs. It is supported by a statistical argument that makes randomized experiments the preferred method for ruling out alternative causes of the outcomes observed. Common objections to experimentation are reviewed and found overall to relate more to the failure to institutionalize experimentation than to any inherent limitations in the experimental method and its application in crime and justice settings. It is argued that the failure of crime and justice practitioners, funders, and evaluators to develop a comprehensive infrastructure for experimental evaluation represents a serious violation of professional standards.

  16. Randomized trial of a DVD intervention to improve readiness to self-manage joint pain.

    PubMed

    Elander, James; Robinson, Georgina; Morris, John

    2011-10-01

    A DVD (digital video disk) intervention to increase readiness to self-manage joint pain secondary to hemophilia was informed by a 2-phase, motivational-volitional model of readiness to self-manage pain, and featured the personal experiences of individuals with hemophilia. The DVD was evaluated in a randomized controlled trial in which 108 men with hemophilia completed measures of readiness to self-manage pain (Pain Stages of Change Questionnaire) before and 6 months after receiving the DVD plus information booklet (n=57) or just the booklet (n=51). The effect of the DVD was assessed by comparing changes in Pain Stages of Change Questionnaire scores (precontemplation, contemplation, and action/maintenance) between groups. The impact on pain coping, pain acceptance, and health-related quality of life was tested in secondary analyses. Repeated-measures analysis of variance, including all those with complete baseline and follow-up data regardless of use of the intervention, showed a significant, medium-sized, group×time effect on precontemplation, with reductions among the DVD group but not the booklet group. Significant use×time effects showed that benefits in terms of contemplation and action/maintenance were restricted to those who used the interventions at least once. The results show that low-intensity interventions in DVD format can improve the motivational impact of written information, and could be used to help prepare people with chronic pain for more intensive self-management interventions. The findings are consistent with a 2-phase, motivational-volitional model of pain self-management, and provide the first insights to our knowledge of readiness to self-manage pain in hemophilia.

  17. A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention’s effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders’ analysis are planned. Methods/design The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. Discussion The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life

  18. Cardiometabolic Risk Factor Response to a Lifestyle Intervention: A Randomized Trial

    PubMed Central

    Harrington, Deirdre M.; Champagne, Catherine M.; Broyles, Stephanie T.; Johnson, William D.; Tudor-Locke, Catrine

    2015-01-01

    Abstract Background: Strategies to increase adherence to national dietary and physical activity (PA) guidelines to improve the health in regions such as the Lower Mississippi Delta (LMD) of the United States are needed. Here we explore the cardiometabolic responses to an education and behavior change intervention among overweight and obese adults that adapted the 2010 Dietary Guidelines (DG), with and without a PA component. Methods: White and African American overweight and obese adults were randomized to a DG group (n=61) or a DG+PA group (n=60). Both groups received a 12-week dietary education and behavior change intervention, and the DG+PA group also received a PA education and behavior change intervention with a pedometer. Changes in individual risk factors (blood pressure, fasting glucose, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol) and a continuous cardiometabolic risk score were determined. General linear models compared mean changes between groups, adjusting for covariates. Results: No main effect of intervention group was found in completers (n=99) and those who engaged with ≥80% of the intervention (n=83) for individual risk factors or the continuous risk score. Pooling both groups, those with higher baseline risk factor values realized greater improvements in individual risk factors. Conclusions: Adapting DG did not produce any cardiometabolic benefits, even with a PA component. Although the sample was ostensibly healthy, they were all overweight to mildly obese (body mass index of 25–34.9 kg/m2) and participants with higher baseline risk factor values showed more improvements. Adherence to longer-term behavior change may elicit changes in risk profile, so this should be explored. PMID:25569324

  19. Breast-feeding counselling in a diarrhoeal disease hospital.

    PubMed Central

    Haider, R.; Islam, A.; Hamadani, J.; Amin, N. J.; Kabir, I.; Malek, M. A.; Mahalanabis, D.; Habte, D.

    1996-01-01

    Lactation counsellors were trained to advise mothers of partially breast-fed infants who were admitted to hospital because of diarrhoea, so that they could start exclusive breast-feeding during their hospital stay. Infants (n = 250) up to 12 weeks of age were randomized to intervention and control groups. Mothers in the intervention group were individually advised by the counsellors while mothers in the control group received only routine group health education. During follow-up at home by the counsellors a week later, only the mothers in the intervention group were counselled. All the mothers were evaluated for infant feeding practices at home two weeks after discharge. Among the 125 mother-infant pairs in each group, 60% of mothers in the intervention group were breast-feeding exclusively at discharge compared with only 6% in the control group (P < 0.001); two weeks later, these rates rose to 75% and 8% in the intervention and control groups, respectively (P < 0.001). However, 49% of mothers in the control group reverted back to bottle-feeding compared with 12% in the intervention group (P < 0.001). Thus, individual counselling had a positive impact on mothers to start exclusive breast-feeding during hospitalization and to continue the practice at home. Maternal and child health facilities should include lactation counselling as an integral part of their programme to improve infant feeding practices. PMID:8706233

  20. Interventions to Improve Medication Adherence among Older Adults: Meta-Analysis of Adherence Outcomes among Randomized Controlled Trials

    ERIC Educational Resources Information Center

    Conn, Vicki S.; Hafdahl, Adam R.; Cooper, Pamela S.; Ruppar, Todd M.; Mehr, David R.; Russell, Cynthia L.

    2009-01-01

    Purpose: This study investigated the effectiveness of interventions to improve medication adherence (MA) in older adults. Design and Methods: Meta-analysis was used to synthesize results of 33 published and unpublished randomized controlled trials. Random-effects models were used to estimate overall mean effect sizes (ESs) for MA, knowledge,…

  1. Randomized, Controlled Trial of the LEAP Model of Early Intervention for Young Children with Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Strain, Phillip S.; Bovey, Edward H.

    2011-01-01

    A clustered randomized design was used in which 28 inclusive preschool classrooms were randomly assigned to receive 2 years of training and coaching to fidelity in the LEAP (Learning Experiences and Alternative Program for Preschoolers and Their Parents) preschool model, and 28 inclusive classes were assigned to receive intervention manuals only.…

  2. Comparison of intervention fidelity between COPE TEEN and an attention-control program in a randomized controlled trial.

    PubMed

    Kelly, Stephanie A; Oswalt, Krista; Melnyk, Bernadette Mazurek; Jacobson, Diana

    2015-04-01

    Fidelity in implementing an intervention is critical to accurately determine and interpret the effects of an intervention. It is important to monitor the manner in which the behavioral intervention is implemented (e.g. adaptations, delivery as intended and dose). Few interventions are implemented with 100% fidelity. In this study, high school health teachers implemented the intervention. To attribute study findings to the intervention, it was vital to know to what degree the intervention was implemented. Therefore, the purposes of this study were to evaluate intervention fidelity and to compare implementation fidelity between the creating opportunities for personal empowerment (COPE) Healthy Lifestyles TEEN (thinking, emotions, exercise, and nutrition) program, the experimental intervention and Healthy Teens, an attention-control intervention, in a randomized controlled trial with 779 adolescents from 11 high schools in the southwest region of the United States. Thirty teachers participated in this study. Findings indicated that the attention-control teachers implemented their intervention with greater fidelity than COPE TEEN teachers. It is possible due to the novel intervention and the teachers' unfamiliarity with cognitive-behavioral skills building, COPE TEEN teachers had less fidelity. It is important to assess novel skill development prior to the commencement of experimental interventions and to provide corrective feedback during the course of implementation.

  3. Adapting an evidence-based intervention for HIV to avail access to testing and risk-reduction counseling for female victims of sexual violence in post-earthquake Haiti.

    PubMed

    Rahill, Guitele J; Joshi, Manisha; Hernandez, Anthony

    2016-01-01

    Haiti has the highest prevalence of HIV/AIDS in the Caribbean. Before the 2010 earthquake, Haitian women bore a disproportionate burden of HIV/AIDS, had lower HIV knowledge, less capacity to negotiate for safer sex, and limited access to HIV testing and risk-reduction (RR) counseling. Since 2010, there has been an increase in sexual violence against women, characterized by deliberate vaginal injuries by non-intimate partners, increasing victims' risk of sexually transmitted infections including HIV/AIDS. Needed is an adaptation of evidence-based interventions for HIV that include HIV testing and counseling for this stigmatized population. We reviewed several features of Centers for Disease Control and Prevention's 103 evidence-based interventions for HIV (e.g., measures used, participant risk characteristics, theoretical framework, outcome variables, and evidence tier) in an attempt to seek a feasibly adaptable evidence-based intervention for HIV that could be used for victims of sexual violence (VOSV). RESPECT, one of the reviewed evidence-based HIV interventions, comprises of one-on-one, client-focused HIV prevention/RR counseling, and RAPID HIV testing. Adapting RESPECT can enhance access to testing for Haitian VOSV and can influence their perceptions of HIV risk, and establishment of RR goals for future consensual intimate relations. Adapting and implementing RESPECT can increase uptake of evidence-based HIV interventions among Haitians and positively affect a region with high HIV prevalence and increased rates of sexual violence.

  4. Assessing the role of masculinity in the transmission of HIV: a systematic review to inform HIV risk reduction counseling interventions for men who have sex with men.

    PubMed

    Zeglin, Robert J

    2015-10-01

    HIV affects over 1.2 million people in the United States; a substantial number are men who have sex with men (MSM). Despite an abundance of literature evaluating numerous social/structural and individual risk factors associated with HIV for this population, relatively little is known regarding the individual-level role of masculinity in community-level HIV transmission risk. To address this gap, the current analysis systematically reviewed the masculinity and HIV literature for MSM. The findings of 31 sources were included. Seven themes were identified: (1) number of partners, (2) attitudes toward condoms, (3) drug use, (4) sexual positioning, (5) condom decision-making, (6) attitudes toward testing, and (7) treatment compliance. These factors, representing the enactment of masculine norms, potentiate the spread of HIV. The current article aligns these factors into a masculinity model of community HIV transmission. Opportunities for counseling interventions include identifying how masculinity informs a client's cognitions, emotions, and behaviors as well as adapting gender-transformative interventions to help create new conceptualizations of masculinity for MSM clients. This approach could reduce community-level HIV incidence.

  5. A Roadmap for Adapting an Evidence-Based HIV Prevention Intervention: Personal Cognitive Counseling (PCC) for Episodic Substance-Using Men Who Have Sex with Men

    PubMed Central

    Das, Moupali; DeMicco, Erin; Raiford, Jerris L.; Matheson, Tim; Shook, Alic; Antunez, Erin; Santos, Glenn-Milo; Dadasovich, Rand; Dilley, James W.; Colfax, Grant N.; Herbst, Jeffrey H.

    2015-01-01

    Episodic (less than weekly) drug use and binge drinking increase HIV-related sexual risk behaviors among men who have sex with men (MSM), yet no evidence-based interventions exist for these men. We describe an adaptation process of the Personalized Cognitive Counseling (PCC) intervention for utilization with high-risk, HIV-negative episodic, substance-using MSM. Participants (N=59) were racially diverse, and reported unprotected anal intercourse and concurrent binge drinking (85 %), use of poppers (36 %), methamphetamine (20 %) and cocaine (12 %). Semi-structured interviews with 20 episodic, substance-using MSM elicited sexual narratives for engaging in unprotected anal intercourse while using alcohol or drugs. Emergent qualitative themes were translated into self-justifications and included in a revised PCC self-justification elicitation instrument (SJEI). The adapted SJEI was pretested with 19 episodic, substance-using MSM, and the final adapted PCC was pilot-tested for acceptability and feasibility with 20 episodic, substance-using MSM. This process can be used as a roadmap for adapting PCC for other high-risk populations of MSM. PMID:23412947

  6. Diffusion of an Evidence-Based Smoking Cessation Intervention Through Facebook: A Randomized Controlled Trial

    PubMed Central

    Cobb, Nathan K.; Jacobs, Megan A.; Wileyto, Paul; Valente, Thomas

    2016-01-01

    Objectives. To examine the diffusion of an evidence-based smoking cessation application (“app”) through Facebook social networks and identify specific intervention components that accelerate diffusion. Methods. Between December 2012 and October 2013, we recruited adult US smokers (“seeds”) via Facebook advertising and randomized them to 1 of 12 app variants using a factorial design. App variants targeted components of diffusion: duration of use (t), “contagiousness” (β), and number of contacts (Z). The primary outcome was the reproductive ratio (R), defined as the number of individuals installing the app (“descendants”) divided by the number of a seed participant’s Facebook friends. Results. We randomized 9042 smokers. App utilization metrics demonstrated between-variant differences in expected directions. The highest level of diffusion (R = 0.087) occurred when we combined active contagion strategies with strategies to increase duration of use (incidence rate ratio = 9.99; 95% confidence interval = 5.58, 17.91; P < .001). Involving nonsmokers did not affect diffusion. Conclusions. The maximal R value (0.087) is sufficient to increase the numbers of individuals receiving treatment if applied on a large scale. Online interventions can be designed a priori to spread through social networks. PMID:27077358

  7. Effect of a physical conditioning versus health promotion intervention in dancers: a randomized controlled trial.

    PubMed

    Roussel, Nathalie A; Vissers, Dirk; Kuppens, Kevin; Fransen, Erik; Truijen, Steven; Nijs, Jo; De Backer, Wilfried

    2014-12-01

    Although dancing requires extensive physical exertion, dancers do not often train their physical fitness outside dance classes. Reduced aerobic capacity, lower muscle strength and altered motor control have been suggested as contributing factors for musculoskeletal injuries in dancers. This randomized controlled trial examined whether an intervention program improves aerobic capacity and explosive strength and reduces musculoskeletal injuries in dancers. Forty-four dancers were randomly allocated to a 4-month conditioning (i.e. endurance, strength and motor control training) or health promotion program (educational sessions). Outcome assessment was conducted by blinded assessors. When accounting for differences at baseline, no significant differences were observed between the groups following the intervention, except for the subscale "Pain" of the Short Form 36 Questionnaire (p = 0.03). Injury incidence rate and the proportion of injured dancers were identical in both groups, but dancers following the conditioning program had significant less low back injuries (p = 0.02). Supplementing regular dance training with a 4-month conditioning program does not lead to a significant increase in aerobic capacity or explosive strength in pre-professional dancers compared to a health promotion program without conditioning training, but leads to less reported pain. Further research should explore how additional training may be organized, taking into account the demanding dance schedule of pre-professional dancers. The trial is registered at ClinicalTrials.gov, number NCT01440153.

  8. Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

    PubMed Central

    2012-01-01

    Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance. PMID:22233221

  9. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. Methods/Design This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project

  10. Effect of Three Interventions on Contact Lens Comfort in Symptomatic Wearers: A Randomized Clinical Trial

    PubMed Central

    Navascues-Cornago, Maria; Morgan, Philip B.; Maldonado-Codina, Carole

    2015-01-01

    Purpose To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD) contact lens wearers. Methods A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a ‘scleral swish’; and no action (control). Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain) to 100 (excellent comfort) scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded. Results There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p<0.05). Comfort gradually decreased from 6 mins to 5 h after lens application for each group (p<0.0001) with no significant difference between groups over the 5-h period (p = 0.09). There was no significant difference in comfort 6 mins post-intervention for any group (all p>0.05). After the intervention, comfort continued to decline (p<0.0001) with slightly lower mean scores for the control group compared to the new lens group (p = 0.003). Change in comfort relative to pre-intervention (5 h) was similar for all groups (p = 0.81). There was no difference in comfort at 12 h between groups (p = 0.83). Conclusion This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather

  11. A yoga intervention for type 2 diabetes risk reduction: a pilot randomized controlled trial

    PubMed Central

    2014-01-01

    Background Type 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity. Methods This was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3–6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat. Results This study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight −0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference −4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI −0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking

  12. Intervention for homeless, substance abusing mothers: findings from a non-randomized pilot.

    PubMed

    Slesnick, Natasha; Erdem, Gizem

    2012-01-01

    Little empirically-based information is available regarding how best to intervene with substance-abusing homeless mothers. This study pilot-tested a comprehensive intervention with 15 homeless women and their 2- to 6-year-old children, recruited from a local family shelter. All participants were offered integrated intervention with three major components. The first component was housing which included 3 months of rental and utility assistance, and these services were not contingent upon women's abstinence from drugs or alcohol. The second and third components included 6 months of case management services and an evidence-based substance abuse treatment (Community Reinforcement Approach; CRA). Analysis revealed that women showed reductions in substance use (F(2,22) = 3.63; p < .05), homelessness (F(2,24) = 25.31; p < .001), and mental health problems (F(2,20) = 8.5; p < .01). Further, women reported reduced internalizing (F(2,22) = 4.08; p < .05) and externalizing problems (F(2,24) = 7.7; p = .01) among their children. The findings suggest that the intervention is a promising approach to meet the multiple needs of this vulnerable population. These positive outcomes support the need for future research to replicate the findings with a larger sample using a randomized design.

  13. Interference control training for PTSD: A randomized controlled trial of a novel computer-based intervention

    PubMed Central

    Bomyea, Jessica; Stein, Murray B.; Lang, Ariel J.

    2015-01-01

    Post-traumatic stress disorder (PTSD) is a chronic and debilitating condition characterized by persistent intrusive memories. Although effective treatments exist for PTSD, there is a need for development of alternative treatments. Diminished ability to control proactive interference may contribute to re-experiencing symptoms and may be a novel intervention target. The present study tested an intervention designed to modify proactive interference control. Forty-two women with PTSD were randomly assigned to a computerized cognitive training or a control condition. The impact of these programs on cognitive performance and symptoms was assessed. PTSD re-experiencing symptoms and interference control performance improved significantly more for individuals in the training group relative to those in the control group. Other PTSD and general distress symptoms improved equally over time in both groups. Cognitive training of this type may hold promise as a novel intervention for reducing PTSD symptoms, although the mechanism of action and implications for models of PTSD requires future study. PMID:26114901

  14. Battlemind debriefing and battlemind training as early interventions with soldiers returning from iraq: Randomization by platoon.

    PubMed

    Adler, Amy B; Bliese, Paul D; McGurk, Dennis; Hoge, Charles W; Castro, Carl Andrew

    2009-10-01

    Researchers have found that there is an increase in mental heath problems as a result of military-related traumatic events, and such problems increase in the months following return from combat. Nevertheless, researchers have not assessed the impact of early intervention efforts with this at-risk population. In the present study, the authors compared different early interventions with 2,297 U.S. soldiers following a year-long deployment to Iraq. Platoons were randomly assigned to standard postdeployment stress education, Battlemind debriefing, and small and large group Battlemind training. Results from a 4-month follow-up with 1,060 participants showed those with high levels of combat exposure who received Battlemind debriefing reported fewer posttraumatic stress symptoms, depression symptoms, and sleep problems than those in stress education. Small group Battlemind training participants with high combat exposure reported fewer posttraumatic stress symptoms and sleep problems than stress education participants. Compared to stress education participants, large group Battlemind training participants with high combat exposure reported fewer posttraumatic stress symptoms and lower levels of stigma and, regardless of combat exposure, reported fewer depression symptoms. Findings demonstrate that brief early interventions have the potential to be effective with at-risk occupational groups.

  15. Randomized controlled trial of parental responsiveness intervention for toddlers at high risk for autism.

    PubMed

    Kasari, Connie; Siller, Michael; Huynh, Linh N; Shih, Wendy; Swanson, Meghan; Hellemann, Gerhard S; Sugar, Catherine A

    2014-11-01

    This study tested the effects of a parent-mediated intervention on parental responsiveness with their toddlers at high risk for an autism spectrum disorder (ASD). Participants included caregivers and their 66 toddlers at high risk for ASD. Caregivers were randomized to 12 sessions of an individualized parent education intervention aimed at improving parental responsiveness or to a monitoring control group involving 4 sessions of behavioral support. Parental responsiveness and child outcomes were measured at three time points: at beginning and end of the 3-month treatment and at 12-months post-study entry. Parental responsiveness improved significantly in the treatment group but not the control group. However, parental responsiveness was not fully maintained at follow up. There were no treatment effects on child outcomes of joint attention or language. Children in both groups made significant developmental gains in cognition and language skills over one year. These results support parental responsiveness as an important intervention target given its general association with child outcomes in the extant literature; however, additional supports are likely needed to fully maintain the treatment effect and to affect child outcomes.

  16. Interventions employing mobile technology for overweight and obesity: an early systematic review of randomized controlled trials

    PubMed Central

    Bacigalupo, R; Cudd, P; Littlewood, C; Bissell, P; Hawley, M S; Buckley Woods, H

    2013-01-01

    Summary Obesity is a global epidemic with major healthcare implications and costs. Mobile technologies are potential interventions to promote weight loss. An early systematic review of this rapidly growing area of research was conducted. Electronic databases were searched for articles published between January 1998 and October 2011. Data sources included Medline, Embase and the Cochrane Central Register of Controlled Trials. Ongoing research was searched for using clinical trials databases and registers. Out of 174 articles retrieved, 21 met the inclusion criteria of randomized controlled trials (RCTs) on mobile technology interventions facilitating weight loss in overweight and obese adults with any other comparator. A narrative synthesis was undertaken. Seven articles were included and appraised using the Cochrane risk of bias tool: four presented a low risk of bias and three presented a high risk of bias. There is consistent strong evidence across the included multiple high-quality RCTs that weight loss occurs in the short-term because of mobile technology interventions, with moderate evidence for the medium-term. Recommendations for improving the reporting and quality of future trials are made including reporting weight loss in percent to meet clinical standards, and including features such as long-term follow-up, cost-effectiveness and patient acceptability. PMID:23167478

  17. A randomized clinical trial of the effectiveness of premarital intervention: moderators of divorce outcomes.

    PubMed

    Markman, Howard J; Rhoades, Galena K; Stanley, Scott M; Peterson, Kristina M

    2013-02-01

    This study examined the effects of premarital relationship intervention on divorce during the first 8 years of first marriage. Religious organizations were randomly assigned to have couples marrying through them complete the Prevention and Relationship Education Program (PREP) or their naturally occurring premarital services. Results indicated no differences in overall divorce rates between naturally occurring services (n = 44), PREP delivered by clergy at religious organizations (n = 66), or PREP delivered by professionals at a university (n = 83). Three moderators were also tested. Measured premaritally and before intervention, the level of negativity of couples' interactions moderated effects. Specifically, couples observed to have higher levels of negative communication in a video task were more likely to divorce if they received PREP than if they received naturally occurring services; couples with lower levels of premarital negative communication were more likely to remain married if they received PREP. A history of physical aggression in the current relationship before marriage and before intervention showed a similar pattern as a moderator, but the effect was only marginally significant. Family-of-origin background (parental divorce and/or aggression) was not a significant moderator of prevention effects across the two kinds of services. Implications for defining risk, considering divorce as a positive versus negative outcome, the practice of premarital relationship education, and social policy are discussed.

  18. Cost-effectiveness of interventions to prevent HIV and STDs among women: a randomized controlled trial.

    PubMed

    Ruger, Jennifer Prah; Abdallah, Arbi Ben; Ng, Nora Y; Luekens, Craig; Cottler, Linda

    2014-10-01

    Injection drug use is a leading transmission route of HIV and STDs, and disease prevention among drug users is an important public health concern. This study assesses cost-effectiveness of behavioral interventions for reducing HIV and STDs infections among injection drug-using women. Cost-effectiveness analysis was conducted from societal and provider perspectives for randomized trial data and Bernoullian model estimates of infections averted for three increasingly intensive interventions: (1) NIDA's standard intervention (SI); (2) SI plus a well woman exam (WWE); and (3) SI, WWE, plus four educational sessions (4ES). Trial results indicate that 4ES was cost-effective relative to WWE, which was dominated by SI, for most diseases. Model estimates, however, suggest that WWE was cost-effective relative to SI and dominated 4ES for all diseases. Trial and model results agree that WWE is cost-effective relative to SI per hepatitis C infection averted ($109 308 for in trial, $6 016 in model) and per gonorrhea infection averted ($9 461 in trial, $14 044 in model). In sensitivity analysis, trial results are sensitive to 5 % change in WWE effectiveness relative to SI for hepatitis C and HIV. In the model, WWE remained cost-effective or cost-saving relative to SI for HIV prevention across a range of assumptions. WWE is cost-effective relative to SI for preventing hepatitis C and gonorrhea. WWE may have similar effects as the costlier 4ES.

  19. Randomized controlled trials of interventions to prevent sexually transmitted infections: learning from the past to plan for the future.

    PubMed

    Wetmore, Catherine M; Manhart, Lisa E; Wasserheit, Judith N

    2010-01-01

    Globally, sexually transmitted infections (STIs) represent a significant source of morbidity and disproportionately impact the health of women and children. The number of randomized controlled trials testing interventions to prevent STIs has dramatically increased over time. To assess their impact, the authors conducted a systematic review of interventions to prevent sexual transmission or acquisition of STIs other than human immunodeficiency virus, published in the English-language, peer-reviewed literature through December 2009. Ninety-three papers reporting data from 74 randomized controlled trials evaluating 75 STI prevention interventions were identified. Eight intervention modalities were used: behavioral interventions (36% of interventions), vaginal microbicides (16%), vaccines (16%), treatment (11%), partner services (9%), physical barriers (5%), male circumcision (5%), and multicomponent (1%). Overall, 59% of interventions demonstrated efficacy in preventing infection with at least 1 STI. Treatment interventions and vaccines for viral STIs showed the most consistently positive effects. Male circumcision protected against viral STIs and possibly trichomoniasis. Almost two-thirds of behavioral interventions were effective, but the magnitude of effects ranged broadly. Partner services yielded similarly mixed results. In contrast, vaginal microbicides and physical barrier methods demonstrated few positive effects. Future STI prevention efforts should focus on enhancing adherence within interventions, integrating new technologies, ensuring sustainable behavior change, and conducting implementation research.

  20. Randomized Controlled Trials of Interventions to Prevent Sexually Transmitted Infections: Learning From the Past to Plan for the Future

    PubMed Central

    Wetmore, Catherine M.; Manhart, Lisa E.; Wasserheit, Judith N.

    2010-01-01

    Globally, sexually transmitted infections (STIs) represent a significant source of morbidity and disproportionately impact the health of women and children. The number of randomized controlled trials testing interventions to prevent STIs has dramatically increased over time. To assess their impact, the authors conducted a systematic review of interventions to prevent sexual transmission or acquisition of STIs other than human immunodeficiency virus, published in the English-language, peer-reviewed literature through December 2009. Ninety-three papers reporting data from 74 randomized controlled trials evaluating 75 STI prevention interventions were identified. Eight intervention modalities were used: behavioral interventions (36% of interventions), vaginal microbicides (16%), vaccines (16%), treatment (11%), partner services (9%), physical barriers (5%), male circumcision (5%), and multicomponent (1%). Overall, 59% of interventions demonstrated efficacy in preventing infection with at least 1 STI. Treatment interventions and vaccines for viral STIs showed the most consistently positive effects. Male circumcision protected against viral STIs and possibly trichomoniasis. Almost two-thirds of behavioral interventions were effective, but the magnitude of effects ranged broadly. Partner services yielded similarly mixed results. In contrast, vaginal microbicides and physical barrier methods demonstrated few positive effects. Future STI prevention efforts should focus on enhancing adherence within interventions, integrating new technologies, ensuring sustainable behavior change, and conducting implementation research. PMID:20519264

  1. Mindfulness-based Intervention for Female Adolescents with Chronic Pain: A Pilot Randomized Trial

    PubMed Central

    Chadi, Nicholas; McMahon, Audrey; Vadnais, Majorie; Malboeuf-Hurtubise, Catherine; Djemli, Anissa; Dobkin, Patricia L.; Lacroix, Jacques; Luu, Thuy Mai; Haley, Nancy

    2016-01-01

    Objective To test the feasibility of a randomized-controlled trial measuring the impact of an adapted mindfulness-based intervention (MBI) in female adolescents with chronic pain. Methods This was a single center, single-blind, prospective, experimental, longitudinal trial conducted in a pediatric tertiary care center. Participants had a history of chronic pain during at least three months. They were randomized into an intervention group or a wait-list control group. Both groups successively followed an adapted eight-week MBI designed specifically for adolescents with chronic pain. Pre-determined criteria were established to assess the feasibility, validity and acceptability of the study model. Data evaluating changes in quality of life, depression, anxiety, pain perception, psychological distress and salivary cortisol were collected throughout the 4-month study period. Results Nineteen female participants completed the study and had a mean age of 15.8 years (range 13.9 -17.8). Attrition rate was low (17%). Attendance to mindfulness sessions (84%) and compliance to study protocol (100%) were high. All participants reported a positive change in the way they coped with pain. No changes in quality of life, depression, anxiety, pain perception, and psychological distress were detected. Significant reductions in pre-and post-mindfulness session salivary cortisol levels were observed (p<0.001). Conclusions Mindfulness is a promising therapeutic approach for which limited data exist in adolescents with chronic pain. Our study indicates the feasibility of conducting such interventions in teenage girls. A large trial is needed to demonstrate the efficacy and bio-physiological impacts of MBIs in teenagers with chronic pain. PMID:27924146

  2. Early Parenteral Nutrition in Patients with Biliopancreatic Mass Lesions, a Prospective, Randomized Intervention Trial

    PubMed Central

    Krüger, Janine; Meffert, Peter J.; Vogt, Lena J.; Gärtner, Simone; Steveling, Antje; Kraft, Matthias; Mayerle, Julia; Lerch, Markus M.; Aghdassi, Ali A.

    2016-01-01

    Purpose Patients with biliopancreatic tumors frequently suffer from weight loss and cachexia. The in-hospital work-up to differentiate between benign and malignant biliopancreatic lesions requires repeated pre-interventional fasting periods that can aggravate this problem. We conducted a randomized intervention study to test whether routine in-hospital peripheral intravenous nutrition on fasting days (1000 ml/24 h, 700 kcal) has a beneficial effect on body weight and body composition. Material and Methods 168 patients were screened and 100 enrolled in the trial, all undergoing in-hospital work-up for biliopancreatic mass lesions and randomized to either intravenous nutrition or control. Primary endpoint was weight loss at time of hospital discharge; secondary endpoints were parameters determined by bioelectric impedance analysis and quality of life recorded by the EORTC questionnaire. Results Within three months prior to hospital admission patients had a median self-reported loss of 4.0 kg (25*th: -10.0 kg and 75*th* percentile: 0.0kg) of body weight. On a multivariate analysis nutritional intervention increased body weight by 1.7 kg (95% CI: 0.204; 3.210, p = 0.027), particularly in patients with malignant lesions (2.7 kg (95% CI: 0.71; 4.76, p < 0.01). Conclusions In a hospital setting, patients with suspected biliopancreatic mass lesions stabilized their body weight when receiving parenteral nutrition in fasting periods even when no total parenteral nutrition was required. Analysis showed that this effect was greatest in patients with malignant tumors. Further studies will be necessary to see whether patient outcome is affected as well. Trial Registration ClinicalTrials.gov NCT02670265 PMID:27861546

  3. Randomized Trial of a Hypnosis Intervention for Treatment of Hot Flashes Among Breast Cancer Survivors

    PubMed Central

    Elkins, Gary; Marcus, Joel; Stearns, Vered; Perfect, Michelle; Rajab, M. Hasan; Ruud, Christopher; Palamara, Lynne; Keith, Timothy

    2008-01-01

    Purpose Hot flashes are a significant problem for many breast cancer survivors. Hot flashes can cause discomfort, disrupted sleep, anxiety, and decreased quality of life. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. On the basis of previous case studies, this study was developed to evaluate the effect of a hypnosis intervention for hot flashes. Patients and Methods Sixty female breast cancer survivors with hot flashes were randomly assigned to receive hypnosis intervention (five weekly sessions) or no treatment. Eligible patients had to have a history of primary breast cancer without evidence of detectable disease and 14 or more weekly hot flashes for at least 1 month. The major outcome measure was a bivariate construct that represented hot flash frequency and hot flash score, which was analyzed by a classic sums and differences comparison. Secondary outcome measures were self-reports of interference of hot flashes on daily activities. Results Fifty-one randomly assigned women completed the study. By the end of the treatment period, hot flash scores (frequency × average severity) decreased 68% from baseline to end point in the hypnosis arm (P < .001). Significant improvements in self-reported anxiety, depression, interference of hot flashes on daily activities, and sleep were observed for patients who received the hypnosis intervention (P < .005) in comparison to the no treatment control group. Conclusion Hypnosis appears to reduce perceived hot flashes in breast cancer survivors and may have additional benefits such as reduced anxiety and depression, and improved sleep. PMID:18809612

  4. Mindfulness training improves attentional task performance in incarcerated youth: a group randomized controlled intervention trial

    PubMed Central

    Leonard, Noelle R.; Jha, Amishi P.; Casarjian, Bethany; Goolsarran, Merissa; Garcia, Cristina; Cleland, Charles M.; Gwadz, Marya V.; Massey, Zohar

    2013-01-01

    We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT) on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a quasi-experimental, group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16–18, to a CBT/MT intervention (youth n = 147) or an active control intervention (youth n = 117). Both arms received approximately 750 min of intervention in a small-group setting over a 3–5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. PMID:24265621

  5. The role of gender in a smoking cessation intervention: a cluster randomized clinical trial

    PubMed Central

    2011-01-01

    Background The prevalence of smoking in Spain is high in both men and women. The aim of our study was to evaluate the role of gender in the effectiveness of a specific smoking cessation intervention conducted in Spain. Methods This study was a secondary analysis of a cluster randomized clinical trial in which the randomization unit was the Basic Care Unit (family physician and nurse who care for the same group of patients). The intervention consisted of a six-month period of implementing the recommendations of a Clinical Practice Guideline. A total of 2,937 current smokers at 82 Primary Care Centers in 13 different regions of Spain were included (2003-2005). The success rate was measured by a six-month continued abstinence rate at the one-year follow-up. A logistic mixed-effects regression model, taking Basic Care Units as random-effect parameter, was performed in order to analyze gender as a predictor of smoking cessation. Results At the one-year follow-up, the six-month continuous abstinence quit rate was 9.4% in men and 8.5% in women (p = 0.400). The logistic mixed-effects regression model showed that women did not have a higher odds of being an ex-smoker than men after the analysis was adjusted for confounders (OR adjusted = 0.9, 95% CI = 0.7-1.2). Conclusions Gender does not appear to be a predictor of smoking cessation at the one-year follow-up in individuals presenting at Primary Care Centers. ClinicalTrials.gov Identifier NCT00125905. PMID:21605389

  6. Skin and needle hygiene intervention for injection drug users: Results from a randomized, controlled Stage I pilot trial

    PubMed Central

    Phillips, Kristina T.; Stein, Michael D.; Anderson, Bradley J.; Corsi, Karen F.

    2012-01-01

    A new skin and needle hygiene intervention, designed to reduce high-risk injection practices associated with bacterial and viral infections, was tested in a pilot, randomized controlled trial. Participants included 48 active heroin injectors recruited through street outreach and randomized to either the two-session intervention or an assessment-only condition (AO) and followed for six months. The primary outcome was skin and needle cleaning behavioral skills measured by videotaped demonstration. Secondary outcomes were high-risk injection practices, intramuscular injection, and bacterial infections. Intervention participants had greater improvements on the skin (d = 1.00) and needle cleaning demonstrations (d = .52) and larger reductions in high-risk injection practices (d = .32) and intramuscular injection (d = .29), with a lower incidence rate of bacterial infections (HR = .80), at 6-months compared to AO. The new intervention appears feasible and promising as a brief intervention to reduce bacterial and viral risks associated with drug injection. PMID:22341554

  7. Adaptation of a Counseling Intervention to Address Multiple Cancer Risk Factors among Overweight/Obese Latino Smokers

    ERIC Educational Resources Information Center

    Castro, Yessenia; Fernández, Maria E.; Strong, Larkin L.; Stewart, Diana W.; Krasny, Sarah; Hernandez Robles, Eden; Heredia, Natalia; Spears, Claire A.; Correa-Fernández, Virmarie; Eakin, Elizabeth; Resnicow, Ken; Basen-Engquist, Karen; Wetter, David W.

    2015-01-01

    More than 60% of cancer-related deaths in the United States are attributable to tobacco use, poor nutrition, and physical inactivity, and these risk factors tend to cluster together. Thus, strategies for cancer risk reduction would benefit from addressing multiple health risk behaviors. We adapted an evidence-based intervention grounded in social…

  8. Internet-Based Self-Help Career Assessments and Interventions: Challenges and Implications for Evidence-Based Career Counseling

    ERIC Educational Resources Information Center

    Gati, Itamar; Asulin-Peretz, Lisa

    2011-01-01

    A major characteristic of the 21st century with significant implications on career decision making is the growing prevalence of Information and Communication Technologies (ICTs). Challenges involving ICT-based self-assessment and self-help interventions aimed at facilitating career decision making are discussed. Specifically, this article focuses…

  9. The Effect of an Educational Intervention on the Level of Codependency and Emotional Intelligence among Graduate Counseling Students

    ERIC Educational Resources Information Center

    Belyea, Dianna L.

    2011-01-01

    The purpose of this study was to investigate the level of codependency and emotional intelligence before and after participating in an educational intervention for codependency at a workshop on substance abuse. The setting for the study was a substance abuse workshop that was an elective for graduate students who were enrolled in counseling…

  10. [Psychological counselling and motivational psychotherapy in the treatment of drug dependence: assessment of interventions with the CEDRO Lugar de Escucha Program].

    PubMed

    Rojas Valero, Milton; Espinoza Paul, Luis

    2008-01-01

    The objective of the present research is to assess perception of and levels of satisfaction with the Lugar de Escucha program, as well as its brief interventions using counseling and motivational sessions. The study is of a pre-experimental type, with a single-group pretest-posttest measurement design. The sample was made up of 128 participants (9.4% females and 90.6% males), aged 15 to 51 (mean= 23.65; standard deviation = 7.92), users of cannabis, cocaine base paste, cocaine, inhalants and alcohol who attended the program. Data collection was carried out using Attention Forms (FdA); the University of Rhode Island Change Assessment Scale (URICA); the Treatment Satisfaction Questionnaire (CST); and the Cases Follow-up Survey (ESC). In order to evaluate the effectiveness of the Lugar de Escucha Program, we assessed participants' motivational phases during the first interview and at referral, their level of satisfaction with the service received and the percentage of entrance to different treatment programs of the referred participants. The results on perception and satisfaction confirm a predominance of the program's strengths. With regard to the motivational phases, the findings show that the motivational induction interventions help to establish and maintain the patient's motivation for attitude change and for cessation of the abuse. In this sense, according to the findings, such interventions tend to be more effective when applied to patients in the Precontemplational and Contemplational phases. This suggests the need to work with more homogeneous groups, considering type of drugs, age and gender, and to use pre and post instruments. Likewise, the results suggest the need to classify patients in phases of change; such classification could be a useful tool for the improvement of treatment programs for drug users.

  11. Randomized Trial of a Cellular Phone-Enhanced Home Visitation Parenting Intervention

    PubMed Central

    Lefever, Jennifer Burke; Bigelow, Kathryn; Borkowski, John; Warren, Steven F.

    2013-01-01

    BACKGROUND AND OBJECTIVES: Although home visiting programs have been documented to improve parenting in high-risk families, their effectiveness is diminished when parents disengage from programs. Cellular phones offer an approach to promoting parent engagement and enhancing parenting outcomes. Our objective was to examine whether mothers in a parenting intervention, Planned Activities Training (PAT), or cellular phone-enhanced version (CPAT) of the intervention would demonstrate greater use of parenting strategies after treatment and at 6 months post-treatment compared with a wait-list control (WLC). METHODS: A sample of 371 low-income mothers and their 3.5- to 5.5-year-old children were randomly assigned to condition and assessed at pre-test, post-intervention, and 6 months post-intervention. Treatment efficacy was evaluated through observations of mother-child interactions as well as maternal interviews about depression, parenting stress, and child behaviors. RESULTS: Mothers receiving PAT and CPAT demonstrated more frequent use of parenting strategies and engaged in more responsive parenting than mothers in the WLC. Mothers receiving CPAT used more PAT parenting strategies than mothers in the other 2 groups and experienced greater reductions in depression and stress. Children of mothers receiving PAT and CPAT demonstrated higher rates of positive engagement, and children of CPAT mothers demonstrated higher levels of adaptive behaviors than children in the WLC. Importantly, changes in parenting, depression, and stress predicted positive child behaviors. CONCLUSIONS: PAT and CPAT conditions improved parenting strategies and child engagement and reduced children’s challenging behaviors. The addition of cellular phones to a home visiting program enhanced maternal responsivity and reduced depression and stress. PMID:24187120

  12. Interventions for atopic dermatitis in dogs: a systematic review of randomized controlled trials.

    PubMed

    Olivry, Thierry; Foster, Aiden P; Mueller, Ralf S; McEwan, Neil A; Chesney, Christopher; Williams, Hywel C

    2010-02-01

    The objective of this systematic review, which was performed following the guidelines of the Cochrane collaboration, was to assess the effects of interventions for treatment of atopic dermatitis (AD) in dogs. Citations identified from three databases (MEDLINE, Thomson's Science Citation Index Expanded and CAB Abstracts) and trials published by December 2007 were selected. Proceedings books from the major veterinary dermatology international congresses were hand searched for relevant citations. The authors selected randomized controlled trials (RCTs), published from January 1980 to December 2007, which reported the efficacy of topical or systemic interventions for treatment or prevention of canine AD. Studies had to report assessments of either pruritus or skin lesions, or both. Studies were selected and data extracted by two reviewers, with discrepancies resolved by a third arbitrator. Missing data were requested from study authors of recently published trials. Pooling of results and meta-analyses were performed for studies reporting similar interventions and outcome measures. A total of 49 RCTs were selected, which had enrolled 2126 dogs. This review found some evidence of efficacy of topical tacrolimus (3 RCTs), topical triamcinolone (1), oral glucocorticoids (5), oral ciclosporin (6), subcutaneous recombinant gamma-interferon (1) and subcutaneous allergen-specific immunotherapy (3) to decrease pruritus and/or skin lesions of AD in dogs. One high-quality RCT showed that an oral essential fatty acid supplement could reduce prednisolone consumption by approximately half. Additional RCTs of high design quality must be performed to remedy previous flaws and to test interventions for prevention of flares of this disease.

  13. Rehabilitating Walking Speed Poststroke With Treadmill-Based Interventions: A Systematic Review of Randomized Controlled Trials

    PubMed Central

    Charalambous, Charalambos C.; Bonilha, Heather Shaw; Kautz, Steven A.; Gregory, Chris M.; Bowden, Mark G.

    2015-01-01

    Background In the past several years, several randomized controlled trials (RCTs) have been reported regarding the efficacy of treadmill-based walking-specific rehabilitation programs, either individually (TT) or combined with body weight support (BWSTT), over control group therapies poststroke. No clear consensus exists as to whether treadmill-based interventions are superior in rehabilitating walking speed (WS) poststroke. Objective To review published RCTs examining TT and BWSTT poststroke and describe the effects on improving and retaining WS. Methods A systematic literature search in computerized databases was conducted to identify RCTs whose methodological quality was assessed with PEDro. Pre- and post-WS, change in WS, functional outcomes, and follow-up speed were extracted and calculated from each study. Additionally, statistical results of each study were examined, and the intragroup and intergroup effect sizes (ESintra and ESinter, respectively) were calculated. Results All studies (8 TT; 7 BWSTT) met the inclusion criteria, and their methodological quality was generally good, with a mean PEDro score 6.9/10. Of the 15 studies, 8 studies (4 TT; 4 BWSTT) reported intragroup significant increases of WS, whereas only 4 (4 TT) found superiority of treadmill interventions. Nine studies demonstrated large ESintra (4 TT; 5 BWSTT), yet only 3 showed large ESinter (1 TT; 2 BWSTT). Four studies (2 TT and 2 BWSTT) reported retention of gains in WS, regardless of intervention. Conclusions Treadmill-based interventions poststroke may increase and retain WS, but their universal superiority to other control group therapies has failed to be established. PMID:23764885

  14. Counseling Exceptional Individuals and Their Families: A Systems Perspective

    ERIC Educational Resources Information Center

    Thomas, Volker; Ray, Karen E.

    2006-01-01

    This article presents three models of counseling exceptional students from a systems perspective. The authors present their definition of counseling, the goals of counseling, and the counseling relationship from a systems perspective. Each model is described, including assessment and intervention techniques appropriate for working with children,…

  15. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial – Cell phone Intervention for You (CITY)

    PubMed Central

    Batch, Bryan C.; Tyson, Crystal; Bagwell, Jacqueline; Corsino, Leonor; Intille, Stephen; Lin, Pao-Hwa; Lazenka, Tony; Bennett, Gary; Bosworth, Hayden B.; Voils, Corrine; Grambow, Steven; Sutton, Aziza; Bordogna, Rachel; Pangborn, Matthew; Schwager, Jenifer; Pilewski, Kate; Caccia, Carla; Burroughs, Jasmine; Svetkey, Laura P.

    2014-01-01

    Background The obesity epidemic has spread to young adults, leading to significant public health implications later in adulthood. Intervention in early adulthood may be an effective public health strategy for reducing the long-term health impact of the epidemic. Few weight loss trials have been conducted in young adults. It is unclear what weight loss strategies are beneficial in this population. Purpose To describe the design and rationale of the NHLBI-sponsored Cell Phone Intervention for You (CITY) study, which is a single center, randomized three-arm trial that compares the impact on weight loss of 1) a behavioral intervention that is delivered almost entirely via cell phone technology (Cell Phone group); and 2) a behavioral intervention delivered mainly through monthly personal coaching calls enhanced by self-monitoring via cell phone (Personal Coaching group), each compared to; 3) a usual care, advice-only control condition. Methods A total of 365 community-dwelling overweight/obese adults aged 18–35 years were randomized to receive one of these three interventions for 24 months in parallel group design. Study personnel assessing outcomes were blinded to group assignment. The primary outcome is weight change at 12 months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. Conclusions If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. PMID:24462568

  16. A pilot clustered randomized control trial evaluating the efficacy of a network-based HIV peer-education intervention targeting men who have sex with men in Hong Kong, China.

    PubMed

    Lau, Joseph T F; Tsui, Hi Yi; Lau, Mason M C

    2013-01-01

    HIV is a serious health threat among men who have sex with men (MSM). A 2-month pilot network-based peer intervention was conducted among Chinese MSM in Hong Kong. Eight MSM peer educators were randomized into the Intervention or the Control Groups and recruited 36 and 33 peers to join the program, respectively. The educators of the Intervention Group delivered standardized and theory-based preventive messages to their peers via daily social interactions. The Control Group received education materials. Baseline between-group differences were non-significant. At post-intervention, intervened participants were more likely than controlled participants to intend to use condoms consistently during anal sex with men in the next 6 months [94.4% versus 60.6%; Relative Risk (RR): 1.56 (95% Confidence Interval (CI): 1.17, 2.08)] and to perceive behavioral control over taking up voluntary HIV testing and counseling [97.2% versus 72.7%; RR: 1.34 (95% CI: 1.08, 1.66)]. Large scale randomized trials are warranted.

  17. Pilot and Feasibility Test of a Mobile Health-Supported Behavioral Counseling Intervention for Weight Management Among Breast Cancer Survivors

    PubMed Central

    Quintiliani, Lisa M; Mann, Devin M; Puputti, Marissa; Quinn, Emily; Bowen, Deborah J

    2016-01-01

    Background Health behavior and weight management interventions for cancer survivors have the potential to prevent future cancer recurrence and improve long-term health; however, their translation can be limited if the intervention is complex and involves high participant burden. Mobile health (mHealth) offers a delivery modality to integrate interventions into daily life routines. Objective The objective of this study was to evaluate the effects of a one-group trial with a pre-post evaluation design on engagement (use and acceptability), physiological (weight), behavioral (diet and physical activity), and other secondary outcomes. Methods The 10-week intervention consisted of mHealth components (self-monitoring of selected diet behaviors via daily text messages, wireless devices to automatically track weight and steps) and 4 motivational interviewing–based technology-assisted phone sessions with a nonprofessionally trained counselor. Participants were overweight breast cancer survivors who had completed treatment and owned a smartphone. Weight was measured objectively; diet and physical activity were measured with brief self-reported questionnaires. Results Ten women participated; they had a mean age of 59 years (SD 6), 50% belonged to a racial or ethnic minority group, 50% had some college or less, and 40% reported using Medicaid health insurance. Engagement was high: out of 70 days in total, the mean number of days recording steps via the wristband pedometer was 64 (SD 7), recording a weight via the scale was 45 (SD 24), and responding to text messages was 60 (SD 13); 100% of participants completed all 4 calls with the counselor. Most (90%) were very likely to participate again and recommend the program to others. Mean weight in pounds decreased (182.5 to 179.1, mean change −3.38 [SD 7.67]), fruit and vegetable daily servings increased (2.89 to 4.42, mean change 1.53 [SD 2.82]), and self-reported moderate physical activity increased in metabolic equivalent of

  18. Effectiveness of a cognitive behavioral intervention in patients with medically unexplained symptoms: cluster randomized trial

    PubMed Central

    2012-01-01

    Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain). The number of patients required is 242 (121 in each arm), all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions) and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity of the symptoms, improve

  19. Cell phone Intervention for You (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology

    PubMed Central

    Svetkey, LP; Batch, BC; Lin, P-H; Intille, SS; Corsino, L; Tyson, CC; Bosworth, HB; Grambow, SC; Voils, C; Loria, C; Gallis, JA; Schwager, J; Bennett, GB

    2015-01-01

    Objectives To determine the effect on weight of two Mobile technology-based (mHealth) behavioral weight loss interventions in young adults. Methods Randomized, controlled comparative effectiveness trial in 18–35 year olds with BMI ≥ 25 kg/m2 (overweight/obese), with participants randomized to 24 months of mHealth intervention delivered by interactive smartphone application on a cell phone (CP); personal coaching enhanced by smartphone self-monitoring (PC); or Control. Results The 365 randomized participants had mean baseline BMI of 35 kg/m2. Final weight was measured in 86% of participants. CP was not superior to Control at any measurement point. PC participants lost significantly more weight than Controls at 6 months (net effect −1.92 kg [CI −3.17, −0.67], p=0.003), but not at 12 and 24 months. Conclusions Despite high intervention engagement and study retention, the inclusion of behavioral principles and tools in both interventions, and weight loss in all treatment groups, CP did not lead to weight loss and PC did not lead to sustained weight loss relative to control. Although mHealth solutions offer broad dissemination and scalability, the CITY results sound a cautionary note concerning intervention delivery by mobile applications. Effective intervention may require the efficiency of mobile technology, the social support and human interaction of personal coaching, and an adaptive approach to intervention design. Trial Registration ClinicalTrials.gov Identifier NCT01092364. https://clinicaltrials.gov/ct2/show/NCT01092364?term=Cell+phone+intervention+for+you&rank=3 PMID:26530929

  20. Effectiveness of a primary care based complex intervention to promote self-management in patients presenting psychiatric symptoms: study protocol of a cluster-randomized controlled trial

    PubMed Central

    2014-01-01

    Background Anxiety, Depression and Somatoform (ADSom) disorders are highly prevalent in primary care. Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners (GPs). Furthermore, the management of these patients is restricted by the high patient turnover rates in primary care practices, especially in the German health care system. In order to address this problem, we implement a complex, low-threshold intervention by an Advanced Practice Nurse (APN) using a mixture of case management and counseling techniques to promote self-management in these patients. Here we present the protocol of the “Self-Management Support for Anxiety, Depression and Somatoform Disorders in Primary Care” (SMADS)-Study. Methods/Design The study is designed as a cluster-randomized controlled trial, comparing an intervention and a control group of 10 primary care practices in each case. We will compare the effectiveness of the intervention applied by an APN with usual GP-care. A total of 340 participants will be enrolled in the study, 170 in either arm. We use the Patient Health Questionnaire-German version (PHQ-D) as a screening tool for psychiatric symptoms, including patients with a score above 5 on any of the three symptom scales. The primary outcome is self-efficacy, measured by the General Self-Efficacy Scale (GSE), here used as a proxy for self-management. As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life. Outcome assessments will be applied 8 weeks and 12 months after the baseline assessment. Discussion The SMADS-study evaluates a complex, low threshold intervention for ambulatory patients presenting ADSom-symptoms, empowering them to better manage their condition, as well as improving their motivation to engage in self-help and health-seeking behaviour. The benefit of the intervention will be substantiated, when patients can enhance

  1. The Treatment Advocacy Program: A Randomized Controlled Trial of a Peer-Led Safer Sex Intervention for HIV-Infected Men Who Have Sex with Men

    ERIC Educational Resources Information Center

    McKirnan, David J.; Tolou-Shams, Marina; Courtenay-Quirk, Cari

    2010-01-01

    Objective: Primary care may be an effective venue for delivering behavioral interventions for sexual safety among HIV-positive men who have sex with men (MSM); however, few studies show efficacy for such an approach. We tested the efficacy of the Treatment Advocacy Program (TAP), a 4-session, primary-care-based, individual counseling intervention…

  2. A Randomized Controlled Pilot Study of an HIV Risk-Reduction Intervention for Sub-Saharan African University Students

    PubMed Central

    Heeren, G. Anita; Jemmott, John B.; Ngwane, Zolani; Mandeya, Andrew; Tyler, Joanne C.

    2012-01-01

    This pilot study used a randomized controlled trial to test the efficacy of an HIV risk-reduction intervention for university students in Eastern Cape Province, South Africa. Randomly selected second-year students were randomized to one of two interventions based on social cognitive theory and qualitative research: HIV risk-reduction, targeting sexual-risk behaviors; health-promotion control, targeting health behaviors unrelated to sexual risks. Participants completed behavioral assessments via audio computer-assisted self-interviewing pre-intervention, 6, and 12 months post intervention, with 97.2% retained at 12-month follow-up. Averaged over the 2 follow-ups, HIV risk-reduction intervention participants reported less unprotected vaginal intercourse and more frequent condom use than control participants, with greater efficacy in non-South Africans than South Africans. Positive changes were also observed on theoretical mediators of condom use that the intervention targeted. Interventions based on social cognitive theory integrated with qualitative information from the population may reduce sexual risk behaviors among university students in sub-Saharan Africa. PMID:22246515

  3. Sex effects in cocaine using methadone patients randomized to contingency management interventions

    PubMed Central

    Burch, Ashley E.; Rash, Carla J.; Petry, Nancy M.

    2015-01-01

    Contingency management (CM) is an effective treatment for promoting cocaine abstinence in patients receiving methadone maintenance. However, few studies have examined the effect of sex on treatment outcomes in this population. This study evaluated the impact of sex on longest duration of abstinence (LDA) and percent negative urine samples in 323 cocaine-using methadone patients from four randomized clinical trials comparing CM to standard methadone care. Overall, women had better treatment outcomes compared to men, demonstrated by an increase in both LDA and percentages of negative samples. Patients receiving CM also had significantly higher LDA and percentages of negative samples compared to patients receiving standard care, but sex by treatment condition effects were not significant. These data suggest that cocaine using methadone patients who are women have better substance use outcomes than men in interventions that regularly monitor cocaine use, and CM is equally efficacious regardless of sex. PMID:26237326

  4. Reducing School Mobility: A Randomized Trial of a Relationship-Building Intervention

    PubMed Central

    Fiel, Jeremy E.; Haskins, Anna R.; López Turley, Ruth N.

    2013-01-01

    Student turnover has many negative consequences for students and schools, and the high mobility rates of disadvantaged students may exacerbate inequality. Scholars have advised schools to reduce mobility by building and improving relationships with and among families, but such efforts are rarely tested rigorously. A cluster-randomized field experiment in 52 predominantly Hispanic elementary schools in San Antonio, TX, and Phoenix, AZ, tested whether student mobility in early elementary school was reduced through Families and Schools Together (FAST), an intervention that builds social capital among families, children, and schools. FAST failed to reduce mobility overall but substantially reduced the mobility of Black students, who were especially likely to change schools. Improved relationships among families help explain this finding. PMID:25346541

  5. A Randomized Trial of Brief Interventions for Problem and Pathological Gamblers

    PubMed Central

    Petry, Nancy M.; Weinstock, Jeremiah; Ledgerwood, David; Morasco, Benjamin

    2009-01-01

    Limited research exists regarding methods for reducing problem gambling. Problem gamblers (N=180) were randomly assigned to: assessment only control, 10 minutes of Brief Advice, 1 session of motivational enhancement therapy (MET), or 1 session of MET plus 3 sessions of cognitive-behavioral therapy (CBT). Gambling was assessed at baseline, 6 weeks later, and a 9-month follow-up. Relative to assessment only, Brief Advice was the only condition that significantly decreased gambling between baseline and week 6, and it was associated with clinically significant reductions in gambling at month 9. Between week 6 and month 9, MET+CBT evidenced significantly reduced gambling on one index compared to the control condition. These results suggest the efficacy of a very brief intervention for reducing gambling among problem and pathological gamblers not actively seeking gambling treatment. PMID:18377127

  6. A postdeployment expressive writing intervention for military couples: a randomized controlled trial.

    PubMed

    Baddeley, Jenna L; Pennebaker, James W

    2011-10-01

    The current study tested the effectiveness of a brief expressive writing intervention on the marital adjustment of 102 military couples recently reunited following a deployment to Iraq or Afghanistan. Active duty soldiers and their spouses were randomly assigned to write about either their relationship or a nonemotional topic on 3 occasions on a single day. The resulting design included 4 couple-level writing topic conditions: soldier-expressive/spouse-expressive, soldier-expressive/spouse-control, soldier-control/spouse-expressive, and soldier-control/spouse-control. Participants completed marital adjustment measures before writing, 1 month, and 6 months after writing. When soldiers, but not spouses, did expressive writing, couples increased in marital satisfaction over the next month, particularly if the soldier had had high combat exposure.

  7. An eight month randomized controlled exercise intervention alters resting state synchrony in overweight children.

    PubMed

    Krafft, C E; Pierce, J E; Schwarz, N F; Chi, L; Weinberger, A L; Schaeffer, D J; Rodrigue, A L; Camchong, J; Allison, J D; Yanasak, N E; Liu, T; Davis, C L; McDowell, J E

    2014-01-03

    Children with low aerobic fitness have altered brain function compared to higher-fit children. This study examined the effect of an 8-month exercise intervention on resting state synchrony. Twenty-two sedentary, overweight (body mass index ≥85th percentile) children 8-11 years old were randomly assigned to one of two after-school programs: aerobic exercise (n=13) or sedentary attention control (n=9). Before and after the 8-month programs, all subjects participated in resting state functional magnetic resonance imaging scans. Independent components analysis identified several networks, with four chosen for between-group analysis: salience, default mode, cognitive control, and motor networks. The default mode, cognitive control, and motor networks showed more spatial refinement over time in the exercise group compared to controls. The motor network showed increased synchrony in the exercise group with the right medial frontal gyrus compared to controls. Exercise behavior may enhance brain development in children.

  8. Randomized Controlled Trial: Multimodal Anxiety and Social Skill Intervention for Adolescents with Autism Spectrum Disorder

    PubMed Central

    White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence

    2012-01-01

    Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was high, and therapist fidelity was high. A 16% improvement in ASD social impairment (within-group effect size = 1.18) was observed on a parent-reported scale. Although anxiety symptoms declined by 26%, the change was not statistically significant. These findings suggest MASSI is a feasible treatment program and further evaluation is warranted. PMID:22735897

  9. Event Rates in Randomized Clinical Trials Evaluating Cardiovascular Interventions and Devices.

    PubMed

    Mahmoud, Karim D; Lennon, Ryan J; Holmes, David R

    2015-08-01

    Randomized clinical trials (RCTs) are considered the gold standard for evidence-based medicine. However, an accurate estimation of the event rate is crucial for their ability to test clinical hypotheses. Overestimation of event rates reduces the required sample size but can compromise the statistical power of the RCT. Little is known about the prevalence, extent, and impact of overestimation of event rates. The latest RCTs on 10 preselected topics in the field of cardiovascular interventions and devices were selected, and actual primary event rates in the control group were compared with their respective event rate estimations. We also assessed what proportion of the nonsignificant RCTs was truly able to exclude a relevant treatment effect. A total of 27 RCTs randomizing 19,436 patients were included. The primary event rate in the control group was overestimated in 20 of the 27 RCTs (74.1%) resulting in a substantial relative difference between observed and estimated event rates (mean -22.9%, 95% confidence interval -33.5% to -12.2%; median -16.3%, 95% confidence interval -30.3% to -6.5%). Event rates were particularly overestimated in RCTs on biodegradable polymer drug-eluting coronary stents and renal artery stenting. Of the 14 single end point superiority trials with nonsignificant results, only 3 (21.4%) actually resulted in truly negative conclusions. In conclusion, event rates in RCTs evaluating cardiovascular interventions and devices are frequently overestimated. This under-reported phenomenon has fundamental impact on the design of RCTs and can have an adverse impact on the statistical power of these trials to answer important questions about therapeutic strategies.

  10. Web Intervention for Adolescents Affected by Disaster: Population-Based Randomized Controlled Trial

    PubMed Central

    Ruggiero, Kenneth J.; Price, Matthew; Adams, Zachary; Stauffacher, Kirstin; McCauley, Jenna; Danielson, Carla Kmett; Knapp, Rebecca; Hanson, Rochelle F.; Davidson, Tatiana M.; Amstadter, Ananda B.; Carpenter, Matthew J.; Saunders, Benjamin E.; Kilpatrick, Dean G.; Resnick, Heidi S.

    2015-01-01

    Objective To assess the efficacy of Bounce Back Now (BBN), a modular, web-based intervention for disaster-affected adolescents and their parents. Method A population-based randomized controlled trial used address-based sampling to enroll 2,000 adolescents and parents from communities affected by tornadoes in Joplin, MO, and Alabama. Data collection via baseline and follow-up semi-structured telephone interviews was completed between September 2011 and August 2013. All families were invited to access the BBN study web portal irrespective of mental health status at baseline. Families who accessed the web portal were assigned randomly to 3 groups: (1) BBN, which featured modules for adolescents and parents targeting adolescents’ mental health symptoms; (2) BBN plus additional modules targeting parents’ mental health symptoms; or (3) assessment only. The primary outcomes were adolescent symptoms of posttraumatic stress disorder (PTSD) and depression. Results Nearly 50% of families accessed the web portal. Intent-to-treat analyses revealed time × condition interactions for PTSD symptoms (B=−0.24, SE=0.08, p<.01) and depressive symptoms (B=−0.23, SE=0.09, p<.01). Post-hoc comparisons revealed fewer PTSD and depressive symptoms for adolescents in the experimental vs. control conditions at 12-month follow-up (PTSD: B=−0.36, SE=0.19, p=.06; depressive symptoms: B=−0.42, SE=0.19, p=0.03). A time × condition interaction also was found favoring the BBN vs. BBN + parent self-help condition for PTSD symptoms (B=0.30, SE=0.12, p=.02), but not depressive symptoms (B=0.12, SE=0.12, p=.33). Conclusion Results supported the feasibility and initial efficacy of BBN as a scalable disaster mental health intervention for adolescents. Technology-based solutions have tremendous potential value if found to reduce the mental health burden of disasters. PMID:26299292

  11. Multifaceted Intervention to Prevent Venous Thromboembolism in Patients Hospitalized for Acute Medical Illness: A Multicenter Cluster-Randomized Trial

    PubMed Central

    Roy, Pierre-Marie; Rachas, Antoine; Meyer, Guy; Le Gal, Grégoire; Durieux, Pierre; El Kouri, Dominique; Honnart, Didier; Schmidt, Jeannot; Legall, Catherine; Hausfater, Pierre; Chrétien, Jean-Marie; Mottier, Dominique

    2016-01-01

    Background Misuse of thromboprophylaxis may increase preventable complications for hospitalized medical patients. Objectives To assess the net clinical benefit of a multifaceted intervention in emergency wards (educational lectures, posters, pocket cards, computerized clinical decision support systems and, where feasible, electronic reminders) for the prevention of venous thromboembolism. Patients/Methods Prospective cluster-randomized trial in 27 hospitals. After a pre-intervention period, centers were randomized as either intervention (n = 13) or control (n = 14). All patients over 40 years old, admitted to the emergency room, and hospitalized in a medical ward were included, totaling 1,402 (712 intervention and 690 control) and 15,351 (8,359 intervention and 6,992 control) in the pre-intervention and intervention periods, respectively. Results Symptomatic venous thromboembolism or major bleeding (primary outcome) occurred at 3 months in 3.1% and 3.2% of patients in the intervention and control groups, respectively (adjusted odds ratio: 1.02 [95% confidence interval: 0.78–1.34]). The rates of thromboembolism (1.9% vs. 1.9%), major bleedings (1.2% vs. 1.3%), and mortality (11.3% vs. 11.1%) did not differ between the groups. Between the pre-intervention and intervention periods, the proportion of patients who received prophylactic anticoagulant treatment more steeply increased in the intervention group (from 35.0% to 48.2%: +13.2%) than the control (40.7% to 44.1%: +3.4%), while the rate of adequate thromboprophylaxis remained stable in both groups (52.4% to 50.9%: -1.5%; 49.1% to 48.8%: -0.3%). Conclusions Our intervention neither improved adequate prophylaxis nor reduced the rates of clinical events. New strategies are required to improve thromboembolism prevention for hospitalized medical patients. Trial Registration ClinicalTrials.gov NCT01212393 PMID:27227406

  12. Behavioral Weight Loss and Physical Activity Intervention in Obese Adults with Asthma. A Randomized Trial

    PubMed Central

    Strub, Peg; Xiao, Lan; Lavori, Philip W.; Camargo, Carlos A.; Wilson, Sandra R.; Gardner, Christopher D.; Buist, A. Sonia; Haskell, William L.; Lv, Nan

    2015-01-01

    Rationale: The effect of weight loss on asthma in obese adults warrants rigorous investigation. Objectives: To examine an evidence-based, practical, and comprehensive lifestyle intervention targeting modest weight loss and increased physical activity for asthma control. Methods: The trial randomized 330 obese adults with uncontrolled asthma to receive usual care enhanced with a pedometer, a weight scale, information about existing weight management services at the participating clinics, and an asthma education DVD, or with these tools plus the 12-month intervention. Measurements and Main Results: The primary outcome was change in Asthma Control Questionnaire (ACQ) scores from baseline to 12 months. Participants (mean [SD] age, 47.6 [12.4] yr) were 70.6% women, 20.0% non-Hispanic black, 20.3% Hispanic/Latino, and 8.2% Asian/Pacific Islander. At baseline, they were obese (mean [SD] body mass index, 37.5 [5.9] kg/m2) and had uncontrolled asthma (Asthma Control Test score, 15.1 [3.8]). Compared with control subjects, intervention participants achieved significantly greater mean weight loss (±SE) (intervention, −4.0 ± 0.8 kg vs. control, −2.1 ± 0.8 kg; P = 0.01) and increased leisure-time activity (intervention, 418.2 ± 110.6 metabolic equivalent task–min/wk vs. control, 178.8 ± 109.1 metabolic equivalent task–min/wk; P = 0.05) at 12 months. But between-treatment mean (±SE) differences were not significant for ACQ changes (intervention, –0.3 ± 0.1 vs. control, –0.2 ± 0.1; P = 0.92) from baseline (mean [SD], 1.4 [0.8]), nor for any other clinical asthma outcomes (e.g., spirometric results and asthma exacerbations). Among all participants regardless of treatment assignment, weight loss of 10% or greater was associated with a Cohen d effect of 0.76 and with 3.78 (95% confidence interval, 1.72–8.31) times the odds of achieving clinically significant reductions (i.e., ≥0.5) on ACQ as stable weight (<3% loss or gain from

  13. An Evidence-Based Practice Educational Intervention for Athletic Trainers: A Randomized Controlled Trial

    PubMed Central

    Welch, Cailee E.; Van Lunen, Bonnie L.; Hankemeier, Dorice A.

    2014-01-01

    Context: As evidence-based practice (EBP) becomes a necessity in athletic training, Web-based modules have been developed and made available to the National Athletic Trainers' Association membership as a mechanism to educate athletic trainers (ATs) on concepts of EBP. Objective: To assess the effect of an educational intervention on enhancing knowledge of EBP among ATs. Design: Randomized controlled trial. Setting: Web-based modules and knowledge assessment. Patients or Other Participants: A total of 164 of 473 ATs (34.7% response rate), including professional athletic training students, graduate students, clinical preceptors, educators, and clinicians, were randomized into a control group (40 men, 42 women) or experimental group (33 men, 49 women). Intervention(s): Ten Web-based modules were developed that covered concepts involved in the EBP process. Both groups completed the Evidence-Based Practice Knowledge Assessment before and after the intervention phase. During the intervention phase, the experimental group had access to the Web-based modules for 4 weeks, whereas the control group had no direct responsibilities for the investigation. The knowledge assessment consisted of 60 multiple choice questions pertaining to concepts presented in the 10 modules. Test-retest reliability was determined to be good (intraclass correlation coefficient [2,1] = 0.726, 95% confidence interval = 0.605, 0.814). Main Outcome Measure(s): Independent variables consisted of group (control, experimental) and time (preassessment, postassessment). Knowledge scores were tabulated by awarding 1 point for each correct answer (maximum = 60). Between-group and within-group differences were calculated using a 2 × 2 repeated-measures analysis of variance (P ≤ .05), post hoc t tests, and Hedges g effect size with 95% confidence intervals. Results: We found a group × time interaction (F1,162 = 26.29, P < .001). No differences were identified between the control (30.12 ± 5.73) and

  14. Results of a large-scale randomized behavior change intervention on road safety in Kenya

    PubMed Central

    Habyarimana, James; Jack, William

    2015-01-01

    Road accidents kill 1.3 million people each year, most in the developing world. We test the efficacy of evocative messages, delivered on stickers placed inside Kenyan matatus, or minibuses, in reducing road accidents. We randomize the intervention, which nudges passengers to complain to their drivers directly, across 12,000 vehicles and find that on average it reduces insurance claims rates of matatus by between one-quarter and one-third and is associated with 140 fewer road accidents per year than predicted. Messages promoting collective action are especially effective, and evocative images are an important motivator. Average maximum speeds and average moving speeds are 1–2 km/h lower in vehicles assigned to treatment. We cannot reject the null hypothesis of no placebo effect. We were unable to discern any impact of a complementary radio campaign on insurance claims. Finally, the sticker intervention is inexpensive: we estimate the cost-effectiveness of the most impactful stickers to be between $10 and $45 per disability-adjusted life-year saved. PMID:26261326

  15. Randomized controlled evaluation of an early intervention to prevent post-rape psychopathology.

    PubMed

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J; Kilpatrick, Dean

    2007-10-01

    A randomized between-group design was used to evaluate the efficacy of a video intervention to reduce post-traumatic stress disorder (PTSD) and other mental health problems, implemented prior to the forensic medical examination conducted within 72 h post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) aged 15 years or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with a prior rape history relative to scores among women with a prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior rape history who were in the video relative to the standard care condition. Small effects indicating higher PTSD and Beck Anxiety Inventory (BAI) scores among women without a prior rape history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a videoxprior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms.

  16. Randomized Controlled Evaluation of an Early Intervention to Prevent Post-Rape Psychopathology

    PubMed Central

    Resnick, Heidi; Acierno, Ron; Waldrop, Angela E.; King, Lynda; King, Daniel; Danielson, Carla; Ruggiero, Kenneth J.; Kilpatrick, Dean

    2007-01-01

    A randomized between-group design was used to evaluate efficacy of a video intervention to reduce PTSD and other mental health problems, implemented prior to the forensic medical exam conducted within 72 hours post-sexual assault. Participants were 140 female victims of sexual assault (68 video/72 nonvideo) ages 15 or older. Assessments were targeted for 6 weeks (Time 1) and 6 months (Time 2) post-assault. At Time 1, the intervention was associated with lower scores on measures of PTSD and depression among women with prior rape history relative to scores among women with prior rape history in the standard care condition. At Time 2, depression scores were also lower among those with a prior history who were in the video relative to standard care condition. Small effects indicating higher PTSD and BAI scores among women without a prior history in the video condition were observed at Time 1. Accelerated longitudinal growth curve analysis indicated a video x prior rape history interaction for PTSD, yielding four patterns of symptom trajectory over time. Women with a prior rape history in the video condition generally maintained the lowest level of symptoms. PMID:17585872

  17. Evaluation of a preventive intervention for child anxiety in two randomized attention-control school trials.

    PubMed

    Miller, Lynn D; Laye-Gindhu, Aviva; Liu, Yan; March, John S; Thordarson, Dana S; Garland, E Jane

    2011-05-01

    The present research examined the effectiveness of a cognitive-behavioral therapy (CBT) based intervention program, FRIENDS, for children from grades 4 to 6, using random assignment at the school-level and an attention-control design in two longitudinal studies. The first study targeted children with anxiety symptoms (N=191, mean age=10.1) as screened with self, parent, and teacher-reports; the second study took a universal approach with full classrooms of children participating (N=253, mean age=9.8). The results showed no intervention effect in both studies, with children's anxiety symptoms decreasing over time regardless of whether they were in the story-reading (attention control) or FRIENDS condition. The findings also indicated that girls reported a higher level of anxiety than boys and children in higher grades reported lower anxiety relative to younger children in both studies. In addition, similar patterns were found using a subgroup of children with high-anxiety symptoms from both studies.

  18. The selection and design of control conditions for randomized controlled trials of psychological interventions.

    PubMed

    Mohr, David C; Spring, Bonnie; Freedland, Kenneth E; Beckner, Victoria; Arean, Patricia; Hollon, Steven D; Ockene, Judith; Kaplan, Robert

    2009-01-01

    The randomized controlled trial (RCT) provides critical support for evidence-based practice using psychological interventions. The control condition is the principal method of removing the influence of unwanted variables in RCTs. There is little agreement or consistency in the design and construction of control conditions. Because control conditions have variable effects, the results of RCTs can depend as much on control condition selection as on the experimental intervention. The aim of this paper is to present a framework for the selection and design of control conditions for these trials. Threats to internal validity arising from modern RCT methodology are reviewed and reconsidered. The strengths and weaknesses of several categories of control conditions are examined, including the ones that are under experimental control, the ones that are under the control of clinical service providers, and no-treatment controls. Considerations in the selection of control conditions are discussed and several recommendations are proposed. The aim of this paper is to begin to define principles by which control conditions can be selected or developed in a manner that can assist both investigators and grant reviewers.

  19. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol

    PubMed Central

    Rubio-Valera, Maria; Serrano-Blanco, Antoni; Travé, Pere; Peñarrubia-María, M Teresa; Ruiz, Mar; Pujol, Marian March

    2009-01-01

    Background Treatment of depression, the most prevalent and costly mental disorder, needs to be improved. Non-concordance with clinical guidelines and non-adherence can limit the efficacy of pharmacological treatment of depression. Through pharmaceutical care, pharmacists can improve patients' compliance and wellbeing. The aim of this study is to evaluate the effectiveness and cost-effectiveness of a community pharmacist intervention developed to improve adherence and outcomes of primary care patients with depression. Methods/design A randomized controlled trial, with 6-month follow-up, comparing patients receiving a pharmaceutical care support programme in primary care with patients receiving usual care. The total sample comprises 194 patients (aged between 18 and 75) diagnosed with depressive disorder in a primary care health centre in the province of Barcelona (Spain). Subjects will be asked for written informed consent in order to participate in the study. Diagnosis will be confirmed using the SCID-I. The intervention consists of an educational programme focused on improving knowledge about medication, making patients aware of the importance of compliance, reducing stigma, reassuring patients about side-effects and stressing the importance of carrying out general practitioners' advice. Measurements will take place at baseline, and after 3 and 6 months. Main outcome measure is compliance with antidepressants. Secondary outcomes include; clinical severity of depression (PHQ-9), anxiety (STAI-S), health-related quality of life (EuroQol-5D), satisfaction with the treatment received, side-effects, chronic physical conditions and socio-demographics. The use of healthcare and social care services will be assessed with an adapted version of the Client Service Receipt Inventory (CSRI). Discussion This trial will provide valuable information for health professionals and policy makers on the effectiveness and cost-effectiveness of a pharmaceutical intervention programme in

  20. Randomized controlled trial to compare growth parameters and nutrient adequacy in children with picky eating behaviors who received nutritional counseling with or without an oral nutritional supplement.

    PubMed

    Sheng, Xiaoyang; Tong, Meiling; Zhao, Dongmei; Leung, Ting Fan; Zhang, Feng; Hays, Nicholas P; Ge, John; Ho, Wing Man; Northington, Robert; Terry, Donna L; Yao, Manjiang

    2014-01-01

    In this study, changes in growth parameters and nutrient intake were compared in Chinese children (ages 30-60 months) with picky eating (PE) behaviors and weight-for-height ≤25th percentile, who were randomized to receive nutrition counseling alone (NC; n = 76) or with a nutritional milk supplement (NC + NS; n = 77) for 120 days. Increases in weight-for-height z-scores were significantly greater in the NC + NS group at days 30 and 90 and over the entire study period (all P < 0.05), but not at day 120. Increases in weight-for-age z-scores were significantly greater in the NC + NS group at day 90 (P = 0.025) and over the entire study period (P = 0.046). Mean intakes of energy, protein, carbohydrate, docosahexaenoic acid, arachidonic acid, calcium, phosphorous, iron, zinc, and vitamins A, C, D, E, and B6 were significantly higher in the NC + NS group at days 60 and 120 (all P < 0.01). Thus, in young children with PE behaviors, nutritional supplementation given as an adjunct to NC resulted in greater improvements in nutrient intake compared with NC alone. Growth parameters differed between groups at several timepoints during the study, but not at day 120.

  1. Randomized Controlled Trial to Compare Growth Parameters and Nutrient Adequacy in Children with Picky Eating Behaviors Who Received Nutritional Counseling With or Without an Oral Nutritional Supplement

    PubMed Central

    Sheng, Xiaoyang; Tong, Meiling; Zhao, Dongmei; Leung, Ting Fan; Zhang, Feng; Hays, Nicholas P; Ge, John; Ho, Wing Man; Northington, Robert; Terry, Donna L; Yao, Manjiang

    2014-01-01

    In this study, changes in growth parameters and nutrient intake were compared in Chinese children (ages 30–60 months) with picky eating (PE) behaviors and weight-for-height ≤25th percentile, who were randomized to receive nutrition counseling alone (NC; n = 76) or with a nutritional milk supplement (NC + NS; n = 77) for 120 days. Increases in weight-for-height z-scores were significantly greater in the NC + NS group at days 30 and 90 and over the entire study period (all P < 0.05), but not at day 120. Increases in weight-for-age z-scores were significantly greater in the NC + NS group at day 90 (P = 0.025) and over the entire study period (P = 0.046). Mean intakes of energy, protein, carbohydrate, docosahexaenoic acid, arachidonic acid, calcium, phosphorous, iron, zinc, and vitamins A, C, D, E, and B6 were significantly higher in the NC + NS group at days 60 and 120 (all P < 0.01). Thus, in young children with PE behaviors, nutritional supplementation given as an adjunct to NC resulted in greater improvements in nutrient intake compared with NC alone. Growth parameters differed between groups at several timepoints during the study, but not at day 120. PMID:25342910

  2. One Year Effects of a Workplace Integrated Care Intervention for Workers with Rheumatoid Arthritis: Results of a Randomized Controlled Trial.

    PubMed

    van Vilsteren, M; Boot, C R L; Twisk, J W R; Steenbeek, R; Voskuyl, A E; van Schaardenburg, D; Anema, J R

    2017-03-01

    Purpose To evaluate the effectiveness of a workplace integrated care intervention on at-work productivity loss in workers with rheumatoid arthritis (RA) compared to usual care. Methods In this randomized controlled trial, 150 workers with RA were randomized into either the intervention or control group. The intervention group received an integrated care and participatory workplace intervention. Outcome measures were the Work Limitations Questionnaire, Work Instability Scale for RA, pain, fatigue and quality of life (RAND 36). Participants filled out a questionnaire at baseline, and after 6 and 12 months. We performed linear mixed models to analyse the outcomes. Results Participants were on average 50 years of age, and mostly female. After 12 months, no significant intervention effect was found on at-work productivity loss. We also found no significant intervention effects on any of the secondary outcomes. Conclusions We did not find evidence for the effectiveness of our workplace integrated care intervention after 12 months of follow up. Future studies should focus on investigating the intervention in groups of workers with severe limitations in work functioning, and an unstable work situation.

  3. Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

    PubMed Central

    2011-01-01

    Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI) or Health Education Intervention Augmentation (HEI). Both groups will receive TAU (i.e., usual care). The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions, although other

  4. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention

    PubMed Central

    2013-01-01

    Introduction Tamoxifen and raloxifene are chemopreventive drugs that can reduce women's relative risk of primary breast cancer by 50%; however, most women eligible for these drugs have chosen not to take them. The reasons for low uptake may be related to women's knowledge or attitudes towards the drugs. We aimed to examine the impact of an online breast cancer chemoprevention decision aid (DA) on informed intentions and decisions of women at high risk of breast cancer. Methods We conducted a randomized clinical trial, assessing the effect of a DA about breast cancer chemoprevention on informed choices about chemoprevention. Women (n = 585), 46- to 74-years old old, completed online baseline, post-test, and three-month follow-up questionnaires. Participants were randomly assigned to either an intervention group, a standard control group that answered questions about chemoprevention at baseline, or a three-month control group that did not answer questions about chemoprevention at baseline. The main outcome measures were whether women's intentions and decisions regarding chemoprevention drugs were informed, and whether women who viewed the DA were more likely to make informed decisions than women who did not view the DA, using a dichotomous composite variable 'informed choice' (yes/no) to classify informed decisions as those reflecting sufficient knowledge and concordance between a woman's decision and relevant attitudes. Results Analyses showed that more intervention than standard control participants (52.7% versus 5.9%) made informed decisions at post-test, P <0.001. At the three-month follow-up, differences in rates of informed choice between intervention (16.9%) and both control groups (11.8% and 8.0%) were statistically non-significant, P = 0.067. Conclusions The DA increased informed decision making about breast cancer chemoprevention, although the impact on knowledge diminished over time. This study was not designed to determine how much knowledge decision

  5. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials

    PubMed Central

    Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M.; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G.; Liu, Tasnuva M.; Margevicius, Seunghee; Miller, Dawn M.; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D.

    2016-01-01

    Purpose Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. Patients and Methods A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient’s barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Results Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. Conclusion These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was

  6. An Intervention Targeting Service Providers and Clients for Methadone Maintenance Treatment in China: A Cluster-randomized Trial

    PubMed Central

    Li, Li; Wu, Zunyou; Liang, Li-Jung; Lin, Chunqing; Zhang, Linglin; Guo, Sam; Rou, Keming; Li, Jianhua

    2012-01-01

    Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and 3-, 6-, and 9-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, methadone maintenance therapy knowledge, perceived job-related stigma, and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved methadone maintenance therapy knowledge, provider-client interaction, and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared to the standard care group. Conclusions The methadone maintenance therapy CARE intervention targeting providers in methadone maintenance clinics can improve providers’ treatment knowledge and their interaction with clients. The intervention can also reduce clients’ drug using behavior through motivational interviewing sessions conducted by trained providers. PMID:22788780

  7. Impact of a peer-counseling intervention on breastfeeding practices in different socioeconomic strata: results from the equity analysis of the PROMISE-EBF trial in Uganda

    PubMed Central

    Eide, Kristiane Tislevoll; Fadnes, Lars Thore; Engebretsen, Ingunn Marie Stadskleiv; Onarheim, Kristine Husøy; Wamani, Henry; Tumwine, James K.; Norheim, Ole Frithjof

    2016-01-01

    Background Undernutrition is highly prevalent among infants in Uganda. Optimal infant feeding practices may improve nutritional status, health, and survival among children. Objective Our study evaluates the socioeconomic distribution of exclusive breastfeeding (EBF) and growth outcomes among infants included in a trial, which promoted EBF by peer counselors in Uganda. Design Twenty-four clusters comprising one to two communities in Uganda were randomized into intervention and control arms, including 765 mother-infant pairs (PROMISE-EBF trial, 200608, ClinicalTrials.gov no. NCT00397150). Intervention clusters received the promotion of EBF by peer counselors in addition to standard care. Breastfeeding and growth outcomes were compared according to wealth quintiles and intervention/control arms. Socioeconomic inequality in breastfeeding and growth outcomes were measured using the concentration index 12 and 24 weeks postpartum. We used the decomposition of the concentration index to identify factors contributing to growth inequality at 24 weeks. Results EBF was significantly concentrated among the poorest in the intervention group at 24 weeks postpartum, concentration index −0.060. The control group showed a concentration of breastfeeding among the richest part of the population, although not statistically significant. Stunting, wasting, and underweight were similarly significantly concentrated among the poorest in the intervention group and the total population at 24 weeks, but showing non-significant concentrations for the control group. Conclusion This study shows that EBF can be successfully promoted among the poor. In addition, socioeconomic inequality in growth outcomes starts early in infancy, but the breastfeeding intervention was not strong enough to counteract this influence. PMID:27473676

  8. Impact of a peer-counseling intervention on breastfeeding practices in different socioeconomic strata: results from the equity analysis of the PROMISE-EBF trial in Uganda.

    PubMed

    Eide, Kristiane Tislevoll; Fadnes, Lars Thore; Engebretsen, Ingunn Marie Stadskleiv; Onarheim, Kristine Husøy; Wamani, Henry; Tumwine, James K; Norheim, Ole Frithjof

    2016-01-01

    Background Undernutrition is highly prevalent among infants in Uganda. Optimal infant feeding practices may improve nutritional status, health, and survival among children. Objective Our study evaluates the socioeconomic distribution of exclusive breastfeeding (EBF) and growth outcomes among infants included in a trial, which promoted EBF by peer counselors in Uganda. Design Twenty-four clusters comprising one to two communities in Uganda were randomized into intervention and control arms, including 765 mother-infant pairs (PROMISE-EBF trial, 200608, ClinicalTrials.gov no. NCT00397150). Intervention clusters received the promotion of EBF by peer counselors in addition to standard care. Breastfeeding and growth outcomes were compared according to wealth quintiles and intervention/control arms. Socioeconomic inequality in breastfeeding and growth outcomes were measured using the concentration index 12 and 24 weeks postpartum. We used the decomposition of the concentration index to identify factors contributing to growth inequality at 24 weeks. Results EBF was significantly concentrated among the poorest in the intervention group at 24 weeks postpartum, concentration index -0.060. The control group showed a concentration of breastfeeding among the richest part of the population, although not statistically significant. Stunting, wasting, and underweight were similarly significantly concentrated among the poorest in the intervention group and the total population at 24 weeks, but showing non-significant concentrations for the control group. Conclusion This study shows that EBF can be successfully promoted among the poor. In addition, socioeconomic inequality in growth outcomes starts early in infancy, but the breastfeeding intervention was not strong enough to counteract this influence.

  9. The Empowering Role of Mobile Apps in Behavior Change Interventions: The Gray Matters Randomized Controlled Trial

    PubMed Central

    Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C

    2016-01-01

    Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly

  10. Effects of group sexual counseling on the traditional perceptions and attitudes of Iranian pregnant women

    PubMed Central

    Navidian, Ali; Rigi, Shahindokht Navabi; Soltani, Parvin

    2016-01-01

    Background Marital relationships may fluctuate due to physical and psychological changes during pregnancy. This study aimed to investigate the effect of group sexual counseling on the traditional perceptions and attitudes of pregnant women. Methods This was a quasiexperimental intervention study. Among the pregnant women who were referred to health care centers in Zahedan, Iran, in 2015 for routine care during pregnancy, 100 individuals were chosen and randomly categorized into two groups: intervention (n=50) and control (n=50). Variables were the participant’s attitudes and beliefs on sexual activity during pregnancy. The data were collected during pregnancy using the Sexual Activities and Attitudes Questionnaire. The questionnaire was completed before and 6 weeks after five sessions of group sexual counseling. Data were analyzed using SPSS software (Version 20) with descriptive and analytical statistics. Results The mean of score changes for sexual attitudes and traditional perceptions in the intervention group was significantly higher than that in the control group (P<0.0001). Analysis of covariance also showed that the mean score of the participant’s traditional perceptions and sexual attitudes in both groups was significantly different after the group sexual counseling. Discussion Due to the positive effect of group sexual counseling on improving the attitudes of pregnant women about sexual issues and reframing the traditional perceptions over sexual activities during pregnancy, it is recommended that this educational intervention should be integrated into counseling and prenatal care for pregnant women. PMID:27366105

  11. School-Based Randomized Controlled Trial of an HIV/STD Risk-Reduction Intervention for South African Adolescents

    PubMed Central

    Jemmott, John B.; Jemmott, Loretta S.; O’Leary, Ann; Ngwane, Zolani; Icard, Larry D.; Bellamy, Scarlett L.; Jones, Shasta F.; Landis, J. Richard; Heeren, G. Anita; Tyler, Joanne C.; Makiwane, Monde B.

    2015-01-01

    Objectives We tested the efficacy of a school-based HIV/STD risk-reduction intervention for South African adolescents. Design A cluster-randomized controlled design, with assessments of self-reported sexual behavior collected pre-intervention and 3, 6, and 12 months post-intervention. Setting Primary schools in a large Black township and a neighboring rural settlement in Eastern Cape Province, South Africa. Participants 9 of 17 matched-pairs of schools were randomly selected. Grade 6 learners with parent/guardian consent were eligible. Interventions Two 6-session interventions based on behavior-change theories and qualitative research: HIV/STD risk-reduction intervention targeted sexual-risk behaviors; attention-matched health-promotion control intervention targeted health issues unrelated to sexual behavior. Main Outcome Measures The primary outcome was self-report of unprotected vaginal intercourse in the previous 3 months averaged over the 3 follow-ups. Secondary outcomes were other sexual behaviors. Results A total of 1,057 (94.5%) of 1,118 eligible learners (mean age = 12.4 years) participated, with 96.7% retained at the 12-month follow-up. Generalized estimating equations analyses, adjusting for clustering from 18 schools, revealed that averaged over the 3 follow-ups a significantly smaller percentage of HIV/STD risk-reduction intervention participants reported having unprotected vaginal intercourse (OR = 0.51; 95% CI, 0.30-0.85), vaginal intercourse (OR = 0.62; 95% CI, 0.42-0.94), and multiple sexual partners (OR = 0.50; 95% CI, 0.28-0.89), when adjusted for baseline prevalences, compared with health-promotion control participants. Conclusions This is the first large-scale community-level randomized intervention trial to obtain significant effects on HIV/STD sexual-risk behavior among South African adolescents in the earliest stages of entry into sexual activity. PMID:20921349

  12. Alcohol Screening and Brief Intervention in a College Student Health Center: A Randomized Controlled Trial*

    PubMed Central

    Schaus, James F.; Sole, Mary Lou; McCoy, Thomas P.; Mullett, Natalie; O'Brien, Mary Claire

    2009-01-01

    Objective: This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students who screened positive for high-risk drinking. Method: Between November 2005 and August 2006, 8,753 students who presented as new patients to the health service at a large public university were screened for high-risk drinking, and 2,484 students (28%) screened positive on the 5/4 gender-specific high-risk drinking question (i.e., five or more drinks per occasion for men and four or more for women). Students who screened positive for high-risk drinking and consented to participate (N = 363; 52% female) were randomly assigned either to a control group (n = 182) or to an experimental group (n = 181). Participants in the experimental group received two brief intervention sessions that were founded in motivational interviewing techniques and delivered by four specially trained providers within the student health center. Data on alcohol use and related harms were obtained from a Web-based Healthy Lifestyle Questionnaire, 30-day Timeline Followback alcohol-use diaries, the Rutgers Alcohol Problem Index (RAPI), and eight items from the Drinker Inventory of Consequences-2L. Results: Repeated measures analysis showed that, compared with the control group (C), the intervention group (I) had significant reductions in typical estimated blood alcohol concentration (BAC) (C = .071 vs I = .057 at 3 months; C = .073 vs I = .057 at 6 months), peak BAC (C = .142 vs I = .112 at 3 months; C = .145 vs I = .108 at 6 months), peak number of drinks per sitting (C = 8.03 vs I = 6.87 at 3 months; C = 7.98 vs I = 6.52 at 6 months), average number of drinks per week (C = 9.47 vs I = 7.33 at 3 months; C = 8.90 vs I = 6.16 at 6 months), number of drunk episodes in a typical week (C = 1.24 vs I = 0.85 at 3 months; C = 1.10 vs I = 0.71 at 6 months), number of times taken foolish risks (C = 2.24 vs I = 1.12 at 3 months), and RAPI

  13. Promoting healthy beginnings: a randomized controlled trial of a preventive intervention to preserve marital quality during the transition to parenthood.

    PubMed

    Schulz, Marc S; Cowan, Carolyn Pape; Cowan, Philip A

    2006-02-01

    Couples expecting their first child were randomly assigned to intervention (n=28) and comparison groups (n=38) to assess the efficacy of a couples intervention and examine marital satisfaction trajectories across the transition to parenthood. The primarily European American sample (M age=30 years) completed assessments of marital satisfaction at 5 points from the final trimester of pregnancy to 66 months postpartum. Growth curve analyses indicated a normative linear decline in marital satisfaction. Intervention participants experienced significantly less decline than comparison participants, providing support for the efficacy of the intervention. Comparable childless couples (n=13) did not show a decline in marital satisfaction. The results suggest that early family transitions that strain couple relationships provide critical opportunities for preventive interventions to strengthen marriage.

  14. Parent-Targeted Mobile Phone Intervention to Increase Physical Activity in Sedentary Children: Randomized Pilot Trial

    PubMed Central

    Marker, Arwen M; Allen, H Raymond; Machtmes, Ryan; Han, Hongmei; Johnson, William D; Schuna Jr, John M; Broyles, Stephanie T; Tudor-Locke, Catrine; Church, Timothy S

    2014-01-01

    Background Low levels of moderate-to-vigorous physical activity are associated with adverse health consequences. Objective The intent of the study was to determine the feasibility and efficacy of a 12-week physical activity promotion program targeting children, which was delivered to parents through mobile phones. Methods Potential participants were recruited through advertisements placed in the newspaper, local hospitals and schools, and an email listserv. Sedentary children aged 6-10 years were randomly assigned to a minimal (MIG) or intensive (IIG) intervention group. Parents in the MIG were given a goal to increase (within 1 month) and maintain their child’s activity at 6000 pedometer steps/day above their baseline levels and to monitor their child’s steps daily. Parents in the IIG were given the same steps/day and monitoring goals, in addition to text messages and articles containing additional behavioral strategies (based on the Social Cognitive Theory) designed to promote their child’s physical activity. The intervention components were delivered via mobile phone. Anthropometrics, body composition, and questionnaires were administered in a clinic. Children wore a New Lifestyles pedometer (NL-1000) each day throughout the intervention and parents were to monitor their child’s step counts daily. Results Out of 59 children who screened for the study, a total of 27 children (mean age 8.7, SD 1.4 years; 56%, 15/27 female; 59%, 16/27 African American) were enrolled and completed the study. Overall, 97.90% (2220/2268; 98.20%, 1072/1092 for MIG; 97.60%, 1148/1176 for IIG) of expected step data were successfully entered by the parent or study coordinator. Parents in the MIG and IIG were sent approximately 7 and 13 text messages per week, respectively, averaged over the course of the study. IIG parents accessed an average of 6.1 (SD 4.4) articles over the course of the intervention and accessed a fewer number of articles in the last month compared to the first

  15. Male partner antenatal attendance and HIV testing in eastern Uganda: a randomized facility-based intervention trial

    PubMed Central

    2011-01-01

    Background The objective of the study was to evaluate the effect of a written invitation letter to the spouses of new antenatal clinic attendees on attendance by couples and on male partner acceptance of HIV testing at subsequent antenatal clinic visits. Methods The trial was conducted with 1060 new attendees from October 2009 to February 2010 in an antenatal clinic at Mbale Regional Referral Hospital, Mbale District, eastern Uganda. The intervention comprised an invitation letter delivered to the spouses of new antenatal attendees, while the control group received an information letter, a leaflet, concerning antenatal care. The primary outcome measure was the proportion of pregnant women who attended antenatal care with their male partners during a follow-up period of four weeks. Eligible pregnant women were randomly assigned to the intervention or non-intervention groups using a randomization sequence, which was computer generated utilizing a random sequence generator (RANDOM ORG) that employed a simple randomization procedure. Respondents, health workers and research assistants were masked to group assignments. Results The trial was completed with 530 women enrolled in each group. Participants were analyzed as originally assigned (intention to treat). For the primary outcome, the percentage of trial participants who attended the antenatal clinic with their partners were 16.2% (86/530) and 14.2% (75/530) in the intervention and non-intervention groups, respectively (OR = 1.2; 95% CI: 0.8, 1.6). For the secondary outcome, most of the 161 male partners attended the antenatal clinic; 82 of 86 (95%) in the intervention group and 68 of 75 (91%) in the non-intervention group were tested for HIV (OR = 2.1; 95% CI: 0.6 to 7.5). Conclusions The effect of the intervention and the control on couple antenatal attendance was similar. In addition, the trial demonstrated that a simple intervention, such as a letter to the spouse, could increase couple antenatal clinic

  16. Effects of a Mail and Telephone Intervention on Breast Health Behaviors

    ERIC Educational Resources Information Center

    Bowen, Deborah J.; Powers, Diane

    2010-01-01

    This study evaluated a mail and telephone intervention to improve breast health behaviors while maintaining quality of life. Women recruited from the general public were randomized to a stepped-intensity intervention consisting of mailings, telephone calls, and counseling (if requested or appropriate given a woman's genetic risk for breast cancer)…

  17. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial

    PubMed Central

    2016-01-01

    Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance

  18. Computer assisted electromagnetic navigation improves accuracy in computed tomography guided interventions: A prospective randomized clinical trial

    PubMed Central

    2017-01-01

    Purpose To assess the accuracy and usability of an electromagnetic navigation system designed to assist Computed Tomography (CT) guided interventions. Materials and methods 120 patients requiring a percutaneous CT intervention (drainage, biopsy, tumor ablation, infiltration, sympathicolysis) were included in this prospective randomized trial. Nineteen radiologists participated. Conventional procedures (CT group) were compared with procedures assisted by a navigation system prototype using an electromagnetic localizer to track the position and orientation of a needle holder (NAV group). The navigation system displays the needle path in real-time on 2D reconstructed CT images extracted from the 3D CT volume. The regional ethics committee approved this study and all patients gave written informed consent. The main outcome was the distance between the planned trajectory and the achieved needle trajectory calculated from the initial needle placement. Results 120 patients were analyzable in intention-to-treat (NAV: 60; CT: 60). Accuracy improved when the navigation system was used: distance error (in millimeters: median[P25%; P75%]) with NAV = 4.1[2.7; 9.1], vs. with CT = 8.9[4.9; 15.1] (p<0.001). After the initial needle placement and first control CT, fewer subsequent CT acquisitions were necessary to reach the target using the navigation system: NAV = 2[2; 3]; CT = 3[2; 4] (p = 0.01). Conclusion The tested system was usable in a standard clinical setting and provided significant improvement in accuracy; furthermore, with the help of navigation, targets could be reached with fewer CT control acquisitions. PMID:28296957

  19. Reduction of the body burden of PCBs and DDE by dietary intervention in a randomized trial.

    PubMed

    Jandacek, Ronald J; Heubi, James E; Buckley, Donna D; Khoury, Jane C; Turner, Wayman E; Sjödin, Andreas; Olson, James R; Shelton, Christie; Helms, Kim; Bailey, Tina D; Carter, Shirley; Tso, Patrick; Pavuk, Marian

    2014-04-01

    Serum polychlorinated biphenyls (PCBs) in Anniston, AL, residents have been associated with hypertension and diabetes. There have been no systematic interventions to reduce PCB body burdens in Anniston or other populations. Our objective was to determine the efficacy of 15 g/day of dietary olestra to reduce PCBs in Anniston residents. Blood PCBs and 1,1-bis-(4-chlorophenyl)-2,2-dichloroethene were measured at baseline and 4-month intervals in a double-blind, placebo-controlled, 1-year trial. Participants with elevated serum PCBs were randomized into two groups of 14 and received potato crisps made with olestra or vegetable oil (VO). Elimination rates during the study period were compared with 5-year prestudy rates. Eleven participants in the olestra group and 12 in the VO group completed the study. Except for one participant in the VO group, reasons for dropout were unrelated to treatments. The elimination rate of 37 non-coplanar PCB congeners during the 1-year trial was faster during olestra consumption compared to the pretrial period (-0.0829 ± 0.0357 and -0.00864 ± 0.0116 year(-1), respectively; P=.04), but not during VO consumption (-0.0413 ± 0.0408 and -0.0283 ± 0.0096 year(-1), respectively; P=.27). The concentration of PCBs in two olestra group participants decreased by 27% and 25% during the trial. There was no significant time by group interaction in change from baseline. However, group main effects for total PCBs and PCB 153 were of borderline significance. This pilot study has demonstrated that olestra can safely reduce body burdens of PCBs and supports a larger intervention trial that may also determine whether reduction in PCBs will reduce the risk of hypertension and diabetes.

  20. Treatment Sequencing for Childhood ADHD: A Multiple-Randomization Study of Adaptive Medication and Behavioral Interventions.

    PubMed

    Pelham, William E; Fabiano, Gregory A; Waxmonsky, James G; Greiner, Andrew R; Gnagy, Elizabeth M; Pelham, William E; Coxe, Stefany; Verley, Jessica; Bhatia, Ira; Hart, Katie; Karch, Kathryn; Konijnendijk, Evelien; Tresco, Katy; Nahum-Shani, Inbal; Murphy, Susan A

    2016-01-01

    Behavioral and pharmacological treatments for children with attention deficit/hyperactivity disorder (ADHD) were evaluated to address whether endpoint outcomes are better depending on which treatment is initiated first and, in case of insufficient response to initial treatment, whether increasing dose of initial treatment or adding the other treatment modality is superior. Children with ADHD (ages 5-12, N = 146, 76% male) were treated for 1 school year. Children were randomized to initiate treatment with low doses of either (a) behavioral parent training (8 group sessions) and brief teacher consultation to establish a Daily Report Card or (b) extended-release methylphenidate (equivalent to .15 mg/kg/dose bid). After 8 weeks or at later monthly intervals as necessary, insufficient responders were rerandomized to secondary interventions that either increased the dose/intensity of the initial treatment or added the other treatment modality, with adaptive adjustments monthly as needed to these secondary treatments. The group beginning with behavioral treatment displayed significantly lower rates of observed classroom rule violations (the primary outcome) at study endpoint and tended to have fewer out-of-class disciplinary events. Further, adding medication secondary to initial behavior modification resulted in better outcomes on the primary outcomes and parent/teacher ratings of oppositional behavior than adding behavior modification to initial medication. Normalization rates on teacher and parent ratings were generally high. Parents who began treatment with behavioral parent training had substantially better attendance than those assigned to receive training following medication. Beginning treatment with behavioral intervention produced better outcomes overall than beginning treatment with medication.

  1. Reducing the Risk of Internalizing Symptoms among High-risk Hispanic Youth through a Family Intervention: A Randomized Controlled Trial.

    PubMed

    Perrino, Tatiana; Pantin, Hilda; Huang, Shi; Brincks, Ahnalee; Brown, C Hendricks; Prado, Guillermo

    2016-03-01

    Familias Unidas is an intervention that has been found to be efficacious in preventing and reducing substance use, sexual risk, and problem behaviors among Hispanic youth. While it does not specifically target youth internalizing symptoms, the intervention works to strengthen parenting and family factors associated with reduced risk of internalizing symptoms (i.e., depression, anxiety symptoms). This study examines the effects of Familias Unidas on internalizing symptoms among high-risk youth, as well as the role of family level factors in the intervention's effects. A total of 242 12-17-year-old Hispanic youth with a history of delinquency and their primary caregivers were recruited from the school and juvenile justice systems, and randomly assigned to the Familias Unidas intervention or community practice control. A linear latent growth model was used to examine intervention effects on the trajectory of adolescent internalizing symptoms from baseline to 6 and 12 months post-baseline. Results show that the Familias Unidas intervention was more efficacious than control in reducing youth internalizing symptoms. Baseline youth externalizing and internalizing symptoms did not moderate the intervention's effects on the trajectory of youth internalizing symptoms. While parent-adolescent communication did not significantly moderate the intervention's effects, changes in parent-adolescent communication mediated the intervention's effects on internalizing symptoms, showing stronger intervention effects for youth starting with poorer communication. Findings indicate that the Familias Unidas intervention can reduce internalizing symptoms among high-risk Hispanic youth, and that improving parent-youth communication, a protective family factor, may be one of the mechanisms by which the intervention influences youth internalizing symptoms.

  2. A Web-Based Sexual Violence Bystander Intervention for Male College Students: Randomized Controlled Trial

    PubMed Central

    Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan

    2014-01-01

    Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (P<.001), greater knowledge of effective consent (P<.001), less rape myths (P<.001), greater empathy for rape victims (P<.001), less negative date rape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P

  3. Genetic Counseling

    PubMed Central

    Reid, Kathryn J.; Sakati, Nadia; Prichard, Lorraine L.; Schneiderman, Lawrence J.; Jones, Oliver W.; Dixson, Barbara K.

    1976-01-01

    The geographic distribution of County Health Department clinic facilities in the state of California has made it readily possible to establish a regionalized program for genetic counseling services, using public health nurses as a major source of case-finding. From both consumer and health professional standpoints, regionalized satellite genetic counseling clinics have been successful, and in particular, the effectiveness of public health nurses in identifying clinical genetic problems is readily apparent. Long-term follow-up reinforcement of genetic counseling appears to be an important conclusion from these studies. It is our suggestion that reinforcement of counseling would best be accomplished through the health team member (physician, nurse and so forth) following the patient or family rather than through the consulting geneticist. PMID:946335

  4. Cangrelor for patients undergoing percutaneous coronary intervention: evidence from a meta-analysis of randomized trials.

    PubMed

    Sardar, Partha; Nairooz, Ramez; Chatterjee, Saurav; Mushiyev, Savi; Pekler, Gerald; Visco, Ferdinand

    2014-07-01

    Cangrelor is a new parenteral adenosine diphosphate P2Y12 receptor inhibitor with rapid, profound and reversible inhibition of platelet activity. The aim of this meta-analysis was to evaluate efficacy and safety of this new agent in patients undergoing percutaneous coronary intervention (PCI). We searched PubMed, Cochrane Library, EMBASE, Web of Science and CINAHL databases from the inception through April 2013. Randomized controlled trials (RCTs) comparing cangrelor with control (clopidogrel/placebo) were selected. We used the random-effects models to calculate the risk ratio. The primary efficacy outcome was risk of myocardial infarction, and the primary safety outcome was TIMI major bleeding at 48 h. Three RCTs included a total of 25,107 participants. Effects of Cangrelor were not different against comparators for myocardial infarction (MI) (Risk ratio [RR] 0.94, 95% confidence interval [CI] 0.78-1.13) and all-cause mortality (RR 0.72, 95% CI 0.36-1.43). However, cangrelor significantly reduced the risk of ischemia-driven revascularization (RR 0.72, 95% CI 0.52-0.98), stent thrombosis (RR 0.60, 95% CI 0.44-0.82) and Q wave MI (RR 0.53, 95% CI 0.30-0.92) without causing extra major bleeding (Thrombolysis in Myocardial infarction criteria) and severe or life-threatening bleeding (Global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries criteria). Separate analysis against only clopidogrel also showed similar findings except Q wave MI outcome. Use of cangrelor during PCI might reduce the risk of ischemia-driven revascularization and stent thrombosis, without causing extra major bleeding.

  5. Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial.