The efficacy of early language intervention in mainstream school settings: a randomized controlled trial.

PubMed

Fricke, Silke; Burgoyne, Kelly; Bowyer-Crane, Claudine; Kyriacou, Maria; Zosimidou, Alexandra; Maxwell, Liam; Lervåg, Arne; Snowling, Margaret J; Hulme, Charles

2017-10-01

Oral language skills are a critical foundation for literacy and more generally for educational success. The current study shows that oral language skills can be improved by providing suitable additional help to children with language difficulties in the early stages of formal education. We conducted a randomized controlled trial with 394 children in England, comparing a 30-week oral language intervention programme starting in nursery (N = 132) with a 20-week version of the same programme starting in Reception (N = 133). The intervention groups were compared to an untreated waiting control group (N = 129). The programmes were delivered by trained teaching assistants (TAs) working in the children's schools/nurseries. All testers were blind to group allocation. Both the 20- and 30-week programmes produced improvements on primary outcome measures of oral language skill compared to the untreated control group. Effect sizes were small to moderate (20-week programme: d = .21; 30-week programme: d = .30) immediately following the intervention and were maintained at follow-up 6 months later. The difference in improvement between the 20-week and 30-week programmes was not statistically significant. Neither programme produced statistically significant improvements in children's early word reading or reading comprehension skills (secondary outcome measures). This study provides further evidence that oral language interventions can be delivered successfully by trained TAs to children with oral language difficulties in nursery and Reception classes. The methods evaluated have potentially important policy implications for early education. © 2017 Association for Child and Adolescent Mental Health.

Brain research to ameliorate impaired neurodevelopment--home-based intervention trial (BRAIN-HIT).

PubMed

Wallander, Jan L; McClure, Elizabeth; Biasini, Fred; Goudar, Shivaprasad S; Pasha, Omrana; Chomba, Elwyn; Shearer, Darlene; Wright, Linda; Thorsten, Vanessa; Chakraborty, Hrishikesh; Dhaded, Sangappa M; Mahantshetti, Niranjana S; Bellad, Roopa M; Abbasi, Zahid; Carlo, Waldemar

2010-04-30

This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential

Indicated Prevention and Early Intervention for Childhood Anxiety: A Randomized Trial with Caucasian and Hispanic/Latino Youth

ERIC Educational Resources Information Center

Pina, Armando A.; Zerr, Argero A.; Villalta, Ian K.; Gonzales, Nancy A.

2012-01-01

Objective: This trial of a randomized indicated anxiety prevention and early intervention explored initial program effects as well as the role of ethnicity and language on measured outcomes. Method: A total of 88 youth (M = 10.36 years; 45 girls, 52 Latino) received 1 of 2 protocols with varying degrees of parent involvement, and response was…

Seven Elements Important to Successful Implementation of Early Literacy Intervention

ERIC Educational Resources Information Center

Foorman, Barbara; Dombek, Jennifer; Smith, Kevin

2016-01-01

The objective of this article is to describe seven elements important to successful implementation of early literacy intervention. The seven elements are drawn from research as well as from the authors' recent randomized controlled trial of effective early literacy interventions in kindergarten through second grade in 55 schools across Florida.…

SPIRIT advance care planning intervention in early stage dementias: An NIH stage I behavioral intervention development trial.

PubMed

Song, Mi-Kyung; Ward, Sandra E; Hepburn, Kenneth; Paul, Sudeshna; Shah, Raj C; Morhardt, Darby J

2018-06-02

People in the early stages of Alzheimer's disease and related dementias (ADRD) are encouraged to engage in advance care planning (ACP) while they are still competent to appoint a surrogate decision maker and meaningfully participate in ACP discussions with the surrogate. In this NIH Stage I behavioral intervention development trial, we will adapt and test an efficacious ACP intervention, SPIRIT (Sharing Patient's Illness Representation to Increase Trust), with people with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. We will first adapt SPIRIT (in person) to target people with mild dementia and their surrogates through a process of modification-pretesting-refinement using stakeholders (persons with mild dementia, family caregivers, and clinicians) and experts, including adapting the delivery mode to interactive web-based videoconference format (SPIRIT-remote). Then in a 3-group RCT with 120 patient-surrogate dyads, we will evaluate the feasibility and acceptability of SPIRIT in-person and SPIRIT remote, and preliminary efficacy of SPIRIT compared to usual care on preparedness outcomes for end-of-life decision making (dyad congruence on goals of care, patient decisional conflict, and surrogate decision-making confidence) shortly after the intervention. This Stage I research of SPIRIT will generate valuable insights regarding how to improve ACP for people with mild dementia who will progress to an advanced stage of the disease in the foreseeable future. ClinicalTrials.gov NCT03311711, Registered 10/12/2017. Copyright © 2018. Published by Elsevier Inc.

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

Internet-based early intervention to prevent posttraumatic stress disorder in injury patients: randomized controlled trial.

PubMed

Mouthaan, Joanne; Sijbrandij, Marit; de Vries, Giel-Jan; Reitsma, Johannes B; van de Schoot, Rens; Goslings, J Carel; Luitse, Jan S K; Bakker, Fred C; Gersons, Berthold P R; Olff, Miranda

2013-08-13

not support the efficacy of the Trauma TIPS Internet-based early intervention in the prevention of PTSD symptoms for an unselected population of injury patients. Moreover, uptake was relatively low since one-fifth of individuals did not log in to the intervention. Future research should therefore focus on innovative strategies to increase intervention usage, for example, adding gameplay, embedding it in a blended care context, and targeting high-risk individuals who are more likely to benefit from the intervention. International Standard Randomized Controlled Trial Number (ISRCTN): 57754429; http://www.controlled-trials.com/ISRCTN57754429 (Archived by WebCite at http://webcitation.org/6FeJtJJyD).

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

PubMed

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's developmental

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�

A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

ERIC Educational Resources Information Center

Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

2006-01-01

Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

A 3-arm randomized controlled trial on the effects of dance movement intervention and exercises on elderly with early dementia.

PubMed

Ho, Rainbow Tin Hung; Cheung, Jacob Kai Ki; Chan, Wai Chi; Cheung, Irene Kit Man; Lam, Linda Chiu Wah

2015-10-19

Dementia is characterized by a progressive decline and deterioration of brain regions such as memory, spatial navigation and language, along with disturbances in daily functioning. Non-pharmacological interventions that offer a holistic approach by targeting cognitive functioning, prognosis and the psychological and social effects of dementia require rigorous investigation. The well-established benefits of physical activity for cognitive functioning and psychological support in dementia have been observed with dance-movement intervention. There is substantial evidence that dance-movement interventions provide emotional and social advantages. Thus, a randomized controlled trial (RCT) is planned to investigate the positive effects of a dance movement intervention, compared with mild physical exercise, on the physical and psychological well-being of elderly Chinese individuals with early dementia. A 3-arm RCT with waitlist control design will be used in this study. Two hundred and one elderly participants with very mild to mild dementia will be screened and randomized into the following groups: (i) dance movement based intervention, (ii) stretching and exercise intervention and (iii) no intervention waitlist-control group. The two intervention groups will receive a 1-h intervention, twice a week, for 12 weeks. The participants will be assessed four times over the course of 12 months: baseline before randomization, post-intervention (3 months), 6 months from baseline and 12 months from baseline. The primary outcomes will be compared between assessment points and between groups on neuropsychiatric symptoms, psychosocial well-being and cognitive and daily functioning. Secondary outcomes will assess the changes in salivary cortisol levels and their relationships with the primary outcome measures. This study will provide substantial evidence of the efficacy of a dance-movement-based intervention in slowing down dementia progression, due to its ability to act as a

The Effects of Centralised and Specialised Intervention in the Early Course of Severe Unipolar Depressive Disorder: A Randomised Clinical Trial

PubMed Central

Hansen, Hanne Vibe; Christensen, Ellen Margrethe; Dam, Henrik; Gluud, Christian; Wetterslev, Jørn; Kessing, Lars Vedel

2012-01-01

Background Little is known on whether centralised and specialised combined pharmacological and psychological intervention in the early phase of severe unipolar depression improve prognosis. The aim of the present study was to assess the benefits and harms of centralised and specialised secondary care intervention in the early course of severe unipolar depression. Methods A randomised multicentre trial with central randomisation and blinding in relation to the primary outcome comparing a centralised and specialised outpatient intervention program with standard decentralised psychiatric treatment. The interventions were offered at discharge from first, second, or third hospitalisation due to a single depressive episode or recurrent depressive disorder. The primary outcome was time to readmission to psychiatric hospital. The data on re-hospitalisation was obtained from the Danish Psychiatric Central Register. The secondary and tertiary outcomes were severity of depressive symptoms according to the Major Depression Inventory, adherence to medical treatment, and satisfaction with treatment according to the total score on the Verona Service Satisfaction Scale-Affective Disorder (VSSS-A). These outcomes were assessed using questionnaires one year after discharge from hospital. Results A total of 268 patients with unipolar depression were included. There was no significant difference in the time to readmission (unadjusted hazard ratio 0.89, 95% confidence interval 0.60 to 1.32; log rank: χ2 = 0.3, d.f. = 1, p = 0.6); severity of depressive symptoms (mood disorder clinic: median 21.6, quartiles 9.7–31.2 versus standard treatment: median 20.2, quartiles 10.0–29.8; p = 0.7); or the prevalence of patients in antidepressant treatment (73.9% versus 80.0%, p = 0.2). Centralised and specialised secondary care intervention resulted in significantly higher satisfaction with treatment (131 (SD 31.8) versus 107 (SD 25.6); p<0.001). Conclusions Centralised and

Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

PubMed Central

2012-01-01

Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

A Randomized Controlled Trial of the First Step to Success Early Intervention: Demonstration of Program Efficacy Outcomes in a Diverse, Urban School District

ERIC Educational Resources Information Center

Walker, Hill M.; Seeley, John R.; Small, Jason; Severson, Herbert H.; Graham, Bethany A.; Feil, Edward G.; Serna, Loretta; Golly, Annemieke M.; Forness, Steven R.

2009-01-01

This article reports on a randomized controlled trial of the First Step to Success early intervention that was conducted over a 4-year period in Albuquerque Public Schools. First Step is a selected intervention for students in Grades 1 through 3 with externalizing behavior problems, and it addresses secondary prevention goals and objectives. It…

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial.

PubMed

Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-06-01

with cardiovascular disease, 79% for those with chronic kidney disease, 70% for those aged ≥75 years, 55% for women, and 61% for minorities. As recruitment was observed to lag behind expectations, additional clinics were included and inclusion criteria were broadened, keeping event rates and trial power in mind. As overall recruitment improved, a greater focus on subgroup recruitment was implemented. Systolic Blood Pressure Intervention Trial met its overall projected recruitment goal using diverse, locally adapted enrollment strategies to specifically target persons with cardiovascular disease, chronic kidney disease, ≥75 years old, women, and minority subgroups. The trial exceeded its recruitment goal for minorities but found it a challenge to meet the competing demands of the targeted goals for recruiting into the remaining four subgroups. Important lessons include the imperative to monitor the recruitment process carefully, decide early to add new clinics or modify inclusion and exclusion criteria if recruitment lags, and consider limiting enrollment to subgroups only. We found benefit in using multiple recruitment sources simultaneously; mass mailing produced the largest number of participants, but referrals resulted in the greater randomization yield. © The Author(s) 2016.

Early Intervention.

ERIC Educational Resources Information Center

Nathanson, Jeanne H., Ed.

1992-01-01

This theme issue focuses on early intervention. The four articles presented on this theme are: (1) "Deaf Infants, Hearing Mothers: A Research Report" (Kathryn P. Meadow-Orlans, and others), reporting findings on effects of auditory loss on early development; (2) "Maintaining Involvement of Inner City Families in Early Intervention Programs through…

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)…

Interventions to promote cancer awareness and early presentation: systematic review

PubMed Central

Austoker, J; Bankhead, C; Forbes, L J L; Atkins, L; Martin, F; Robb, K; Wardle, J; Ramirez, A J

2009-01-01

Background: Low cancer awareness contributes to delay in presentation for cancer symptoms and may lead to delay in cancer diagnosis. The aim of this study was to review the evidence for the effectiveness of interventions to raise cancer awareness and promote early presentation in cancer to inform policy and future research. Methods: We searched bibliographic databases and reference lists for randomised controlled trials of interventions delivered to individuals, and controlled or uncontrolled studies of interventions delivered to communities. Results: We found some evidence that interventions delivered to individuals modestly increase cancer awareness in the short term and insufficient evidence that they promote early presentation. We found limited evidence that public education campaigns reduce stage at presentation of breast cancer, malignant melanoma and retinoblastoma. Conclusions: Interventions delivered to individuals may increase cancer awareness. Interventions delivered to communities may promote cancer awareness and early presentation, although the evidence is limited. PMID:19956160

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

A systematic review of early intensive intervention for autism spectrum disorders.

PubMed

Warren, Zachary; McPheeters, Melissa L; Sathe, Nila; Foss-Feig, Jennifer H; Glasser, Allison; Veenstra-Vanderweele, Jeremy

2011-05-01

Early intensive behavioral and developmental interventions for young children with autism spectrum disorders (ASDs) may enhance developmental outcomes. To systematically review evidence regarding such interventions for children aged 12 and younger with ASDs. We searched Medline, PsycINFO, and ERIC (Education Resources Information Center) from 2000 to May 2010. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two reviewers independently extracted data regarding participant and intervention characteristics, assessment techniques, and outcomes and assigned overall quality and strength-of-evidence ratings using predetermined criteria. Thirty-four unique studies met inclusion criteria. Seventeen studies were case series; 2 were randomized controlled trials. We rated 1 study as good quality, 10 as fair quality, and 23 as poor quality. The strength of the evidence overall ranged from insufficient to low. Studies of University of California Los Angeles/Lovaas-based interventions and variants reported clinically significant gains in language and cognitive skills in some children, as did 1 randomized controlled trial of an early intensive developmental intervention approach (the Early Start Denver Model). Specific parent-training approaches yielded gains in short-term language function and some challenging behaviors. Data suggest that subgroups of children displayed more prominent gains across studies, but participant characteristics associated with greater gains are not well understood. Studies of Lovaas-based approaches and early intensive behavioral intervention variants and the Early Start Denver Model resulted in some improvements in cognitive performance, language skills, and adaptive behavior skills in some young children with ASDs, although the literature is limited by methodologic concerns.

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.

Moderators of Intervention Effects on Parenting Practices in a Randomized Controlled Trial in Early Childhood

PubMed Central

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

2013-01-01

Objective 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. Method Ninety-two preschool-age children (Mean 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. Results 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. Conclusions Consideration of moderators of preventive intervention effects on parenting provides important information about intervention impact in families experiencing multiple barriers to engagement and effective parenting. Findings suggest that parents with diminished psychological resources are just as likely to benefit. Family-centered, group-based intervention is promising for strengthening parenting among the highest risk families. PMID:24063291

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

Impact of a child stimulation intervention on early child development in rural Peru: a cluster randomised trial using a reciprocal control design

PubMed Central

Hartinger, Stella Maria; Lanata, Claudio Franco; Hattendorf, Jan; Wolf, Jennyfer; Gil, Ana Isabel; Obando, Mariela Ortiz; Noblega, Magaly; Verastegui, Hector; Mäusezahl, Daniel

2017-01-01

Objective Stimulation in early childhood can alleviate adverse effects of poverty. In a community-randomised trial, we implemented 2 home-based interventions, each serving as an attention control for the other. One group received an integrated household intervention package (IHIP), whereas the other group received an early child development (ECD) intervention. The primary objective of the study was to evaluate the effect of IHIP on diarrhoea and respiratory infections, the details of which are described elsewhere. Here, we present the impact of the ECD intervention on early childhood development indicators. Methods In this non-blinded community-randomised trial, an ECD intervention, adapted from the Peruvian government's National Wawa Wasi ECD programme, was implemented in 25 rural Peruvian Andean communities. We enrolled 534 children aged 6–35 months, from 50 communities randomised 1:1 into ECD and IHIP communities. In ECD communities, trained fieldworkers instructed mothers every 3 weeks over the 12 months study, to stimulate and interact with their children and to use standard programme toys. IHIP communities received an improved stove and hygiene promotion. Using a nationally validated ECD evaluation instrument, all children were assessed at baseline and 12 months later for overall performance on age-specific developmental milestones which fall into 7 developmental domains. Findings At baseline, ECD-group and IHIP-group children performed similarly in all domains. After 12 months, data from 258 ECD-group and 251 IHIP-group children could be analysed. The proportion of children scoring above the mean in their specific age group was significantly higher in the ECD group in all domains (range: 12–23%-points higher than IHIP group). We observed the biggest difference in fine motor skills (62% vs 39% scores above the mean, OR: 2.6, 95% CI 1.7 to 3.9). Conclusions The home-based ECD intervention effectively improved child development overall across

Implementing an early childhood school-based mental health promotion intervention in low-resource Ugandan schools: study protocol for a cluster randomized controlled trial.

PubMed

Huang, Keng-Yen; Nakigudde, Janet; Calzada, Esther; Boivin, Michael J; Ogedegbe, Gbenga; Brotman, Laurie Miller

2014-12-01

study will produce important information regarding the value of an evidence-based early intervention, and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings. This trial was registered with ClinicalTrials.gov (registration number: NCT097115) on 15 May 2013.

Early Intervention for Preterm Infants and Their Mothers: A Systematic Review.

PubMed

Zhang, Xin; Kurtz, Melissa; Lee, Shih-Yu; Liu, Huaping

2014-11-18

This systematic review evaluates the efficacy of various early interventions on maternal emotional outcomes, mother-infant interaction, and subsequent infant outcomes during neonatal intensive care unit admission and postdischarge. Key interventions associated with outcomes in both the neonatal intensive care unit and postdischarge (ie, home) settings are summarized. A comprehensive search of peer-reviewed randomized controlled trials involving early interventions for infants and their mother published between 1993 and 2013 in the electronic databases PubMed, CINAHL, EMBASE, PsychINFO, and Cochrane was undertaken. Methodological quality was assessed using the PEDro scale to evaluate internal and external validity of the study. Twelve randomized controlled trials were included in the review, and all used some form of parenting education. The interventions had limited effects on maternal stress and mother-infant interaction and positive effects on maternal anxiety, depressive symptoms, and maternal coping. There were positive effects on infants' short-term outcomes for length of stay and breast-feeding rate. Positive and clinically meaningful effects of early interventions were seen in some physiological/psychological outcomes of mothers and preterm infants. It is important for nurses to foster close mother-infant contact and increase maternal competence during and after the infant's hospitalization period.

Social recovery therapy in combination with early intervention services for enhancement of social recovery in patients with first-episode psychosis (SUPEREDEN3): a single-blind, randomised controlled trial.

PubMed

Fowler, David; Hodgekins, Jo; French, Paul; Marshall, Max; Freemantle, Nick; McCrone, Paul; Everard, Linda; Lavis, Anna; Jones, Peter B; Amos, Tim; Singh, Swaran; Sharma, Vimal; Birchwood, Max

2018-01-01

Provision of early intervention services has increased the rate of social recovery in patients with first-episode psychosis; however, many individuals have continuing severe and persistent problems with social functioning. We aimed to assess the efficacy of early intervention services augmented with social recovery therapy in patients with first-episode psychosis. The primary hypothesis was that social recovery therapy plus early intervention services would lead to improvements in social recovery. We did this single-blind, phase 2, randomised controlled trial (SUPEREDEN3) at four specialist early intervention services in the UK. We included participants who were aged 16-35 years, had non-affective psychosis, had been clients of early intervention services for 12-30 months, and had persistent and severe social disability, defined as engagement in less than 30 h per week of structured activity. Participants were randomly assigned (1:1), via computer-generated randomisation with permuted blocks (sizes of four to six), to receive social recovery therapy plus early intervention services or early intervention services alone. Randomisation was stratified by sex and recruitment centre (Norfolk, Birmingham, Lancashire, and Sussex). By necessity, participants were not masked to group allocation, but allocation was concealed from outcome assessors. The primary outcome was time spent in structured activity at 9 months, as measured by the Time Use Survey. Analysis was by intention to treat. This trial is registered with ISRCTN, number ISRCTN61621571. Between Oct 1, 2012, and June 20, 2014, we randomly assigned 155 participants to receive social recovery therapy plus early intervention services (n=76) or early intervention services alone (n=79); the intention-to-treat population comprised 154 patients. At 9 months, 143 (93%) participants had data for the primary outcome. Social recovery therapy plus early intervention services was associated with an increase in structured

Early food for future health: a randomized controlled trial evaluating the effect of an eHealth intervention aiming to promote healthy food habits from early childhood.

PubMed

Helle, Christine; Hillesund, Elisabet Rudjord; Omholt, Mona Linge; Øverby, Nina Cecilie

2017-09-20

Childhood overweight and obesity is a global public health challenge. Primary prevention initiatives targeting parents have been called for to encourage a positive feeding environment and healthy eating habits that may lay a good foundation for future health. At the same time, there is a need for interventions which combine accessibility and scalability with cost effectiveness. Today's parents are extensive Internet-users, but only a few randomized controlled trials have investigated the use of Internet to promote healthy eating habits in early childhood. In Early Food for Future Health we have developed and will evaluate an Internet-based tool for parents of children between 6 and 12 months, aiming to increase knowledge about infant nutrition and foster protective feeding behavior. During springtime 2016, parents of children aged between 3 and 5 months were recruited through Norwegian child health centres and announcements on Facebook. After completing the baseline questionnaire, 718 parents were individually randomized to intervention- or control group. The intervention group received monthly emails with links to an age-appropriate web-site when their child was between 6 and 12 months. The control group received ordinary care from the child health centres. The data-collection is ongoing. All participants will be followed up at ages 12 and possibly 24 and 48 months, with questionnaires relating to eating behaviour and feeding practices, food variety and diet quality. Providing guidance and counseling to parents of infants is an important task for health authorities and the public child health services. Early Food for Future health is an intervention focusing on promoting early healthy food-habits which may prevent childhood overweight and obesity. If proven to be effective, Early Food for Future Health can be used by parents and public health nurses for supplementary guidance on feeding practices and diet. This study has the potential to provide greater

Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial.

PubMed

Beentjes, Titus A A; van Gaal, Betsie G I; Goossens, Peter J J; Schoonhoven, Lisette

2016-01-19

E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial. We developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities. We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The

Integrating nutrition and early child-development interventions among infants and preschoolers in rural India.

PubMed

Fernandez-Rao, Sylvia; Hurley, Kristen M; Nair, Krishnapillai Madhavan; Balakrishna, Nagalla; Radhakrishna, Kankipati V; Ravinder, Punjal; Tilton, Nicholas; Harding, Kimberly B; Reinhart, Greg A; Black, Maureen M

2014-01-01

This article describes the development, design, and implementation of an integrated randomized double-masked placebo-controlled trial (Project Grow Smart) that examines how home/preschool fortification with multiple micronutrient powder (MNP) combined with an early child-development intervention affects child development, growth, and micronutrient status among infants and preschoolers in rural India. The 1-year trial has an infant phase (enrollment age: 6-12 months) and a preschool phase (enrollment age: 36-48 months). Infants are individually randomized into one of four groups: placebo, placebo plus early learning, MNP alone, and MNP plus early learning (integrated intervention), conducted through home visits. The preschool phase is a cluster-randomized trial conducted in Anganwadi centers (AWCs), government-run preschools sponsored by the Integrated Child Development System of India. AWCs are randomized into MNP or placebo, with the MNP or placebo mixed into the children's food. The evaluation examines whether the effects of the MNP intervention vary by the quality of the early learning opportunities and communication within the AWCs. Study outcomes include child development, growth, and micronutrient status. Lessons learned during the development, design, and implementation of the integrated trial can be used to guide large-scale policy and programs designed to promote the developmental, educational, and economic potential of children in developing countries. © 2013 New York Academy of Sciences.

A Novel Early Intervention for Preschool Depression: Findings from a Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Luby, Joan; Lenze, Shannon; Tillman, Rebecca

2012-01-01

Background: Validation for depression in preschool children has been established; however, to date no empirical investigations of interventions for the early onset disorder have been conducted. Based on this and the modest efficacy of available treatments for childhood depression, the need for novel early interventions has been emphasized. Large…

The CIRCuiTS study (Implementation of cognitive remediation in early intervention services): protocol for a randomised controlled trial.

PubMed

Wykes, Til; Joyce, Eileen; Velikonja, Tjasa; Watson, Andrew; Aarons, Gregory; Birchwood, Max; Cella, Matteo; Dopson, Sue; Fowler, David; Greenwood, Kathy; Johnson, Sonia; McCrone, Paul; Perez, Jesus; Pickles, Andrew; Reeder, Clare; Rose, Diana; Singh, Swaran; Stringer, Dominic; Taylor, Matthew; Taylor, Rumina; Upthegrove, Rachel

2018-03-15

Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience

Academic Performance of Subsequent Schools and Impacts of Early Interventions: Evidence from a Randomized Controlled Trial in Head Start Settings

PubMed Central

Zhai, Fuhua; Raver, C. Cybele; Jones, Stephanie M.

2012-01-01

The role of subsequent school contexts in the long-term effects of early childhood interventions has received increasing attention, but has been understudied in the literature. Using data from the Chicago School Readiness Project (CSRP), a cluster-randomized controlled trial conducted in Head Start programs, we investigate whether the intervention had differential effects on academic and behavioral outcomes in kindergarten if children attended high- or low-performing schools subsequent to the preschool intervention year. To address the issue of selection bias, we adopt an innovative method, principal score matching, and control for a set of child, mother, and classroom covariates. We find that exposure to the CSRP intervention in the Head Start year had significant effects on academic and behavioral outcomes in kindergarten for children who subsequently attended high-performing schools, but no significant effects on children attending low-performing schools. Policy implications of the findings are discussed. PMID:22773872

Early Educational Intervention, Early Cumulative Risk, and the Early Home Environment as Predictors of Young Adult Outcomes Within a High-Risk Sample

PubMed Central

Pungello, Elizabeth P.; Kainz, Kirsten; Burchinal, Margaret; Wasik, Barbara H.; Sparling, Joseph J.; Ramey, Craig T.; Campbell, Frances A.

2009-01-01

The extent to which early educational intervention, early cumulative risk, and the early home environment were associated with young adult outcomes was investigated in a sample of 139 young adults (age 21) from high-risk families enrolled in randomized trials of early intervention. Positive effects of treatment were found for education attainment, attending college, and skilled employment; negative effects of risk were found for education attainment, graduating high school, being employed and avoiding teen parenthood. The home mediated the effects of risk for graduating high school, but not being employed or teen parenthood. Evidence for moderated mediation was found for educational attainment; the home mediated the association between risk and educational attainment for the control group, but not the treated group. PMID:20331676

Cost-effectiveness of early intervention in first-episode psychosis: economic evaluation of a randomised controlled trial (the OPUS study).

PubMed

Hastrup, Lene Halling; Kronborg, Christian; Bertelsen, Mette; Jeppesen, Pia; Jorgensen, Per; Petersen, Lone; Thorup, Anne; Simonsen, Erik; Nordentoft, Merete

2013-01-01

Information about the cost-effectiveness of early intervention programmes for first-episode psychosis is limited. To evaluate the cost-effectiveness of an intensive early-intervention programme (called OPUS) (trial registration NCT00157313) consisting of enriched assertive community treatment, psychoeducational family treatment and social skills training for individuals with first-episode psychosis compared with standard treatment. An incremental cost-effectiveness analysis of a randomised controlled trial, adopting a public sector perspective was undertaken. The mean total costs of OPUS over 5 years (€123,683, s.e. = 8970) were not significantly different from that of standard treatment (€148,751, s.e. = 13073). At 2-year follow-up the mean Global Assessment of Functioning (GAF) score in the OPUS group (55.16, s.d. = 15.15) was significantly higher than in standard treatment group (51.13, s.d. = 15.92). However, the mean GAF did not differ significantly between the groups at 5-year follow-up (55.35 (s.d. = 18.28) and 54.16 (s.d. = 18.41), respectively). Cost-effectiveness planes based on non-parametric bootstrapping showed that OPUS was less costly and more effective in 70% of the replications. For a willingness-to-pay up to €50,000 the probability that OPUS was cost-effective was more than 80%. The incremental cost-effectiveness analysis showed that there was a high probability of OPUS being cost-effective compared with standard treatment.

A cluster randomised trial of effectiveness of educational intervention in primary health care on early childhood caries.

PubMed

Mohebbi, S Z; Virtanen, J I; Vahid-Golpayegani, M; Vehkalahti, M M

2009-01-01

Early childhood caries (ECC) remains a serious problem in several developing and developed countries. This cluster randomised trial evaluated the impact of a 6-month educational intervention on ECC. The trial targeted 12- to 15-month-old children (n = 242) and their mothers in Tehran, Iran, visiting 18 public health centres, randomly selected and assigned to two intervention groups and one control group. At baseline, each mother was interviewed and each child underwent a dental examination of all teeth for the number of decayed teeth (dt) and of upper central incisors for the number of teeth with enamel caries (de). All mothers in the two intervention groups (A and B) received oral health instructions from the vaccination staff. In addition, group A received extra reminders. The outcome was defined as increments in the number of teeth with dt or de, as percentages of children developing new dt or de, and as the number needed to treat (NNT). No new de appeared in group A, the mean de increment in group B was 0.2 (SD = 0.6), and in the controls, it was 0.4 (SD = 0.7) (p < 0.05). The percentages of children developing new de were 0, 14, and 26%, respectively. No differences in dt increments were found. Regarding de, NNT for group A was 4 and for B 9; the figures for dt were 13 and 17, respectively. In conclusion, oral health education given to mothers by general health staff is a valuable tool to prevent caries in infants and toddlers. 2009 S. Karger AG, Basel.

Coping with Accident Reactions (CARE) early intervention programme for preventing traumatic stress reactions in young injured children: study protocol for two randomised controlled trials.

PubMed

De Young, Alexandra C; Haag, Ann-Christin; Kenardy, Justin A; Kimble, Roy M; Landolt, Markus A

2016-07-28

Accidental injury represents the most common type of traumatic event experienced by children under the age of 6 years. Around 10-30 % of young injured children will go on to develop post-traumatic stress disorder (PTSD) and other co-morbid conditions. Parents of injured children are also at risk of PTSD, and this is associated with short- and long-term consequences for their children's physical and psychological recovery. Despite the significance of this problem, to date, the mental health needs of injured young children have been neglected. One reason for this is due to the uncertainty and considerable debate around how to best provide early psychological intervention to traumatised children and adults. To address these gaps, researchers and psychologists in Australia and Switzerland have developed the Coping with Accident Reactions (CARE) programme, which is a two-session early intervention designed to prevent persistent PTSD reactions in young injured children screened as 'at risk'. Two separate international studies are being conducted to evaluate the effectiveness and feasibility of this programme. The study design for the two proposed studies will employ a randomised controlled trial design and children (aged 1-6 years) who are screened as at risk for PTSD 1 week after an unintentional injury, and their parents will be randomised to either (1) CARE intervention or (2) treatment as usual. Assessment will be completed at baseline (2 weeks) and 3 and 6 months post-injury. This international collaboration provides an excellent opportunity to test the benefit of screening and providing early intervention to young children in two different countries and settings. It is expected that outcomes from this research will lead to significant original contributions to the scientific evidence base and clinical treatment and recovery of very young injured children. The Australian study was registered with the Australian New Zealand Clinical Trials Registry ( ACTRN

Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies

PubMed Central

Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken

2015-01-01

In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology. PMID:26155878

Trials of Intervention Principles: Evaluation Methods for Evolving Behavioral Intervention Technologies.

PubMed

Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken

2015-07-08

In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.

Impact of a child stimulation intervention on early child development in rural Peru: a cluster randomised trial using a reciprocal control design.

PubMed

Hartinger, Stella Maria; Lanata, Claudio Franco; Hattendorf, Jan; Wolf, Jennyfer; Gil, Ana Isabel; Obando, Mariela Ortiz; Noblega, Magaly; Verastegui, Hector; Mäusezahl, Daniel

2017-03-01

Stimulation in early childhood can alleviate adverse effects of poverty. In a community-randomised trial, we implemented 2 home-based interventions, each serving as an attention control for the other. One group received an integrated household intervention package (IHIP), whereas the other group received an early child development (ECD) intervention. The primary objective of the study was to evaluate the effect of IHIP on diarrhoea and respiratory infections, the details of which are described elsewhere. Here, we present the impact of the ECD intervention on early childhood development indicators. In this non-blinded community-randomised trial, an ECD intervention, adapted from the Peruvian government's National Wawa Wasi ECD programme, was implemented in 25 rural Peruvian Andean communities. We enrolled 534 children aged 6-35 months, from 50 communities randomised 1:1 into ECD and IHIP communities. In ECD communities, trained fieldworkers instructed mothers every 3 weeks over the 12 months study, to stimulate and interact with their children and to use standard programme toys. IHIP communities received an improved stove and hygiene promotion. Using a nationally validated ECD evaluation instrument, all children were assessed at baseline and 12 months later for overall performance on age-specific developmental milestones which fall into 7 developmental domains. At baseline, ECD-group and IHIP-group children performed similarly in all domains. After 12 months, data from 258 ECD-group and 251 IHIP-group children could be analysed. The proportion of children scoring above the mean in their specific age group was significantly higher in the ECD group in all domains (range: 12-23%-points higher than IHIP group). We observed the biggest difference in fine motor skills (62% vs 39% scores above the mean, OR: 2.6, 95% CI 1.7 to 3.9). The home-based ECD intervention effectively improved child development overall across domains and separately by investigated domain

Early Behavioral Intervention Is Associated with Normalized Brain Activity in Young Children with Autism

ERIC Educational Resources Information Center

Dawson, Geraldine; Jones, Emily J. H.; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J.; Webb, Sara J.

2012-01-01

Objective: A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Method:…

Do Early Intervention Programmes Improve Cognitive and Motor Outcomes for Preterm Infants after Discharge? A Systematic Review

ERIC Educational Resources Information Center

Orton, Jane; Spittle, Alicia; Doyle, Lex; Anderson, Peter; Boyd, Roslyn

2009-01-01

Aim: The aim of this study was to review the effects of early developmental intervention after discharge from hospital on motor and cognitive development in preterm infants. Method: Randomized controlled trials (RCTs) or quasi-RCTs of early developmental intervention programmes for preterm infants in which motor or cognitive outcomes were reported…

The Effectiveness of Early Intervention.

ERIC Educational Resources Information Center

Guralnick, Michael J., Ed.

This book reviews research on the effectiveness of early intervention for children with disabilities or who are at risk. Program factors for children at risk and with disabilities, the effects of early intervention on different types of disabilities, and the outcomes of early intervention are explored. Chapters include: "Second-Generation Research…

Early Behavioral Intervention Is Associated With Normalized Brain Activity in Young Children With Autism

PubMed Central

Dawson, Geraldine; Jones, Emily J.H.; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J.; Webb, Sara J.

2013-01-01

Objective A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Method Forty-eight 18- to 30-month-old children with autism spectrum disorder were randomized to receive the ESDM or referral to community intervention for 2 years. After the intervention (age 48 to 77 months), EEG activity (event-related potentials and spectral power) was measured during the presentation of faces versus objects. Age-matched typical children were also assessed. Results The ESDM group exhibited greater improvements in autism symptoms, IQ, language, and adaptive and social behaviors than the community intervention group. The ESDM group and typical children showed a shorter Nc latency and increased cortical activation (decreased α power and increased θ power) when viewing faces, whereas the community intervention group showed the opposite pattern (shorter latency event-related potential [ERP] and greater cortical activation when viewing objects). Greater cortical activation while viewing faces was associated with improved social behavior. Conclusions This was the first trial to demonstrate that early behavioral intervention is associated with normalized patterns of brain activity, which is associated with improvements in social behavior, in young children with autism spectrum disorder. PMID:23101741

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial

PubMed Central

2012-01-01

Background Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in ‘real-world’ services. Methods/Design The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers’ patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrolment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms’ severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible

Interventions in randomised controlled trials in surgery: issues to consider during trial design.

PubMed

Blencowe, Natalie S; Brown, Julia M; Cook, Jonathan A; Metcalfe, Chris; Morton, Dion G; Nicholl, Jon; Sharples, Linda D; Treweek, Shaun; Blazeby, Jane M

2015-09-04

Until recently, insufficient attention has been paid to the fact that surgical interventions are complex. This complexity has several implications, including the way in which surgical interventions are described and delivered in trials. In order for surgeons to adopt trial findings, interventions need to be described in sufficient detail to enable accurate replication; however, it may be permissible to allow some aspects to be delivered according to local practice. Accumulating work in this area has identified the need for general guidance on the design of surgical interventions in trial protocols and reports. Key issues to consider when designing surgical interventions include the identification of each surgical intervention and their components, who will deliver the interventions, and where and how the interventions will be standardised and monitored during the trial. The trial design (pragmatic and explanatory), comparator and stage of innovation may also influence the extent of detail required. Thoughtful consideration of surgical interventions in this way may help with the interpretation of trial results and the adoption of successful interventions into clinical practice.

The Cool Little Kids randomised controlled trial: population-level early prevention for anxiety disorders.

PubMed

Bayer, Jordana K; Rapee, Ronald M; Hiscock, Harriet; Ukoumunne, Obioha C; Mihalopoulos, Cathrine; Clifford, Susan; Wake, Melissa

2011-01-05

The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms. This trial addresses gaps

Early intervention to protect the mother-infant relationship following postnatal depression: study protocol for a randomised controlled trial.

PubMed

Milgrom, Jeannette; Holt, Charlene

2014-10-03

postnatal depression group treatment programme. Primary outcome measures are the Parenting Stress Index (self-report measure) and the Parent-child Early Relational Assessment (observational measure coded by a blinded observer). Measurements are taken at baseline, after the postnatal depression programme, post-HUGS/Playtime, and at 6 months post-HUGS/Playtime. This research addresses the need for specific treatment for mother-infant interactional difficulties following postnatal depression. There is a need to investigate interventions in randomised trials to prevent detrimental effects on child development and make available evidence-based treatments. Australia and New Zealand Clinical Trials Register: ACTRN12612001110875. Date Registered: 17 October 2012.

A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov.

PubMed

Bell, Stuart A; Tudur Smith, Catrin

2014-11-26

To provide a comprehensive characterisation of rare disease clinical trials registered in ClinicalTrials.gov, and compare against characteristics of trials in non-rare diseases. Registry based study of ClinicalTrials.gov registration entries. The ClinicalTrials.gov registry comprised 133,128 studies registered to September 27, 2012. By annotating medical subject heading descriptors to condition terms we could identify rare and non-rare disease trials. A total of 24,088 Interventional trials registered after January 1, 2006, conducted in the United States, Canada and/or the European Union were categorised as rare or non-rare. Characteristics of the respective trials were extracted and summarised with comparative statistics calculated where appropriate. Characteristics of interventional trials reported in the database categorised by rare and non-rare conditions to allow comparison. Of the 24,088 trials categorised 2,759 (11.5%) were classified as rare disease trials and 21,329 (88.5%) related to non-rare conditions. Despite the limitations of the database we found that rare disease trials differed to non-rare disease trials across all characteristics that we examined. Rare disease trials enrolled fewer participants (median 29 vs. 62), were more likely to be single arm (63.0% vs. 29.6%), non-randomised (64.5% vs. 36.1%) and open label (78.7% vs. 52.2%). A higher proportion of rare disease trials were terminated early (13.7% vs. 6.3%) and proportionally fewer rare disease studies were actively pursuing, or waiting to commence, enrolment (15.9% vs. 38.5%). Rare disease interventional trials differ from those in non-rare conditions with notable differences in enrolment, design, blinding and randomisation. However, clinical trials should aim to implement the highest trial design standards possible, regardless of whether diseases are rare or not.

The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

PubMed Central

2011-01-01

Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms

Early Diagnosis and Early Intervention in Cerebral Palsy

PubMed Central

Hadders-Algra, Mijna

2014-01-01

This paper reviews the opportunities and challenges for early diagnosis and early intervention in cerebral palsy (CP). CP describes a group of disorders of the development of movement and posture, causing activity limitation that is attributed to disturbances that occurred in the fetal or infant brain. Therefore, the paper starts with a summary of relevant information from developmental neuroscience. Most lesions underlying CP occur in the second half of gestation, when developmental activity in the brain reaches its summit. Variations in timing of the damage not only result in different lesions but also in different neuroplastic reactions and different associated neuropathologies. This turns CP into a heterogeneous entity. This may mean that the best early diagnostics and the best intervention methods may differ for various subgroups of children with CP. Next, the paper addresses possibilities for early diagnosis. It discusses the predictive value of neuromotor and neurological exams, neuroimaging techniques, and neurophysiological assessments. Prediction is best when complementary techniques are used in longitudinal series. Possibilities for early prediction of CP differ for infants admitted to neonatal intensive care and other infants. In the former group, best prediction is achieved with the combination of neuroimaging and the assessment of general movements, in the latter group, best prediction is based on carefully documented milestones and neurological assessment. The last part reviews early intervention in infants developing CP. Most knowledge on early intervention is based on studies in high-risk infants without CP. In these infants, early intervention programs promote cognitive development until preschool age; motor development profits less. The few studies on early intervention in infants developing CP suggest that programs that stimulate all aspects of infant development by means of family coaching are most promising. More research is urgently needed

Early behavioral intervention is associated with normalized brain activity in young children with autism.

PubMed

Dawson, Geraldine; Jones, Emily J H; Merkle, Kristen; Venema, Kaitlin; Lowy, Rachel; Faja, Susan; Kamara, Dana; Murias, Michael; Greenson, Jessica; Winter, Jamie; Smith, Milani; Rogers, Sally J; Webb, Sara J

2012-11-01

A previously published randomized clinical trial indicated that a developmental behavioral intervention, the Early Start Denver Model (ESDM), resulted in gains in IQ, language, and adaptive behavior of children with autism spectrum disorder. This report describes a secondary outcome measurement from this trial, EEG activity. Forty-eight 18- to 30-month-old children with autism spectrum disorder were randomized to receive the ESDM or referral to community intervention for 2 years. After the intervention (age 48 to 77 months), EEG activity (event-related potentials and spectral power) was measured during the presentation of faces versus objects. Age-matched typical children were also assessed. The ESDM group exhibited greater improvements in autism symptoms, IQ, language, and adaptive and social behaviors than the community intervention group. The ESDM group and typical children showed a shorter Nc latency and increased cortical activation (decreased α power and increased θ power) when viewing faces, whereas the community intervention group showed the opposite pattern (shorter latency event-related potential [ERP] and greater cortical activation when viewing objects). Greater cortical activation while viewing faces was associated with improved social behavior. This was the first trial to demonstrate that early behavioral intervention is associated with normalized patterns of brain activity, which is associated with improvements in social behavior, in young children with autism spectrum disorder. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

A Trial of an iPad™ Intervention Targeting Social Communication Skills in Children with Autism

ERIC Educational Resources Information Center

Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen

2016-01-01

This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of…

Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: the baby milk intervention and trial.

PubMed

Lakshman, Rajalakshmi; Griffin, Simon; Hardeman, Wendy; Schiff, Annie; Kinmonth, Ann Louise; Ong, Ken K

2014-01-01

We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.

Effects of healthcare professional delivered early feeding interventions on feeding practices and dietary intake: A systematic review.

PubMed

Matvienko-Sikar, Karen; Toomey, Elaine; Delaney, Lisa; Harrington, Janas; Byrne, Molly; Kearney, Patricia M

2018-04-01

Childhood obesity is a global public health challenge. Parental feeding practices, such as responsive feeding, are implicated in the etiology of childhood obesity. This systematic review aimed to examine of effects of healthcare professional-delivered early feeding interventions, on parental feeding practices, dietary intake, and weight outcomes for children up to 2 years. The role of responsive feeding interventions was also specifically examined. Databases searched included: CINAHL, the Cochrane Library, EMBASE, Medline, PubMed, PsycINFO, and Maternity and Infant Care. participants are parents of children ≤2 years; intervention includes focus on early child feeding to prevent overweight and obesity; intervention delivered by healthcare professionals. Sixteen papers, representing 10 trials, met inclusion criteria for review. Six interventions included responsive feeding components. Interventions demonstrated inconsistent effects on feeding practices, dietary intake, and weight outcomes. Findings suggest some reductions in pressure to eat and infant consumption of non-core beverages. Responsive feeding based interventions demonstrate greater improvements in feeding approaches, and weight outcomes. The findings of this review highlight the importance of incorporating responsive feeding in healthcare professional delivered early feeding interventions to prevent childhood obesity. Observed inconsistencies across trials may be explained by methodological limitations. Copyright © 2017 Elsevier Ltd. All rights reserved.

A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'

PubMed Central

Sgandurra, Giuseppina; Lorentzen, Jakob; Inguaggiato, Emanuela; Bartalena, Laura; Beani, Elena; Cecchi, Francesca; Dario, Paolo; Giampietri, Matteo; Greisen, Gorm; Herskind, Anna; Nielsen, Jens Bo; Rossi, Giuseppe; Cioni, Giovanni

2017-01-01

CareToy system is an innovative tele-rehabilitative tool, useful in providing intensive, individualized, home-based, family-centred Early Intervention (EI) in infants. Our aim was to evaluate, through a Randomized Clinical Trial (RCT) study, the effects of CareToy intervention on early motor and visual development in preterm infants. 41 preterm infants (range age: 3.0–5.9 months of corrected age) were enrolled and randomized into two groups, CareToy and Standard Care. 19 infants randomized in CareToy group performed a 4-week CareToy program, while 22 allocated to control group completed 4 weeks of Standard Care. Infant Motor Profile (IMP) was primary outcome measure, Alberta Infant Motor Scale (AIMS) and Teller Acuity Cards were secondary ones. Assessments were carried out at baseline (T0) and at the end of CareToy training or Standard Care period (T1). T1 was the primary endpoint. After RCT phase, 17 infants from control group carried out a 4-week CareToy program, while 18 infants from the CareToy group continued with Standard Care. At the end of this phase, infants were re-assessed at T2. In RCT phase, delta IMP total score and variation and performance sub-domains were significantly higher (P<0.050) in CareToy group if compared to Standard Care group. Similar results were found for Teller Acuity Cards, while no differences between groups were found for AIMS. No differences were found in any outcome measure results (T2-T0), between infants who started CareToy training before or after one month of standard care. This RCT study confirms the results of a previous pilot study, indicating that CareToy system can provide effective home-based EI. Trial Registration: This trial has been registered at www.clinicaltrials.gov (Identifier NCT01990183). PMID:28328946

Systematic review of interventional sickle cell trials registered in ClinicalTrials.gov.

PubMed

Lebensburger, Jeffrey D; Hilliard, Lee M; Pair, Lauren E; Oster, Robert; Howard, Thomas H; Cutter, Gary R

2015-12-01

The registry ClinicalTrials.gov was created to provide investigators and patients an accessible database of relevant clinical trials. To understand the state of sickle cell disease clinical trials, a comprehensive review of all 174 "closed," "interventional" sickle cell trials registered at ClinicalTrials.gov was completed in January 2015. The majority of registered sickle cell disease clinical trials listed an academic center as the primary sponsor and were an early phase trial. The primary outcome for sickle cell disease trials focused on pain (23%), bone marrow transplant (BMT) (13%), hydroxyurea (8%), iron overload (8%), and pulmonary hypertension (8%). A total of 52 trials were listed as terminated or withdrawn, including 25 (14% of all trials) terminated for failure to enroll participants. At the time of this review, only 19 trials uploaded results and 29 trials uploaded a manuscript in the ClinicalTrials.gov database. A systematic review of pubmed.gov revealed that only 35% of sickle cell studies completed prior to 2014 resulted in an identified manuscript. In comparison, of 80 thalassemia trials registered in ClinicalTrials.gov, four acknowledged failure to enroll participants as a reason for trial termination or withdrawal, and 48 trials (60%) completed prior to 2014 resulted in a currently identified manuscript. ClinicalTrials.gov can be an important database for investigators and patients with sickle cell disease to understand the current available research trials. To enhance the validity of the website, investigators must update their trial results and upload trial manuscripts into the database. This study, for the first time, quantifies outcomes of sickle cell disease trials and provides support to the belief that barriers exist to successful completion, publication, and dissemination of sickle cell trial results. © The Author(s) 2015.

Long-Term Maternal Effects of Early Childhood Intervention: Findings from the Infant Health and Development Program (IHDP)

ERIC Educational Resources Information Center

Martin, Anne; Brooks-Gunn, Jeanne; Klebanov, Pamela; Buka, Stephen L.; McCormick, Marie C.

2008-01-01

The Infant Health and Development Program (IHDP) was a randomized clinical trial of early intervention services for low birth weight, premature infants. Mothers and infants received services for 3 years beginning at neonatal discharge. At the intervention's conclusion, mothers in the intervention group who had lighter (less than 2001 g) birth…

Getting inside acupuncture trials - Exploring intervention theory and rationale

PubMed Central

2011-01-01

Background Acupuncture can be described as a complex intervention. In reports of clinical trials the mechanism of acupuncture (that is, the process by which change is effected) is often left unstated or not known. This is problematic in assisting understanding of how acupuncture might work and in drawing together evidence on the potential benefits of acupuncture. Our aim was to aid the identification of the assumed mechanisms underlying the acupuncture interventions in clinical trials by developing an analytical framework to differentiate two contrasting approaches to acupuncture (traditional acupuncture and Western medical acupuncture). Methods Based on the principles of realist review, an analytical framework to differentiate these two contrasting approaches was developed. In order to see how useful the framework was in uncovering the theoretical rationale, it was applied to a set of trials of acupuncture for fatigue and vasomotor symptoms, identified from a wider literature review of acupuncture and early stage breast cancer. Results When examined for the degree to which a study demonstrated adherence to a theoretical model, two of the fourteen selected studies could be considered TA, five MA, with the remaining seven not fitting into any recognisable model. When examined by symptom, five of the nine vasomotor studies, all from one group of researchers, are arguably in the MA category, and two a TA model; in contrast, none of the five fatigue studies could be classed as either MA or TA and all studies had a weak rationale for the chosen treatment for fatigue. Conclusion Our application of the framework to the selected studies suggests that it is a useful tool to help uncover the therapeutic rationale of acupuncture interventions in clinical trials, for distinguishing between TA and MA approaches and for exploring issues of model validity. English language acupuncture trials frequently fail to report enough detail relating to the intervention. We advocate using

34 CFR 303.11 - Early intervention program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 34 Education 2 2010-07-01 2010-07-01 false Early intervention program. 303.11 Section 303.11... AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND... intervention program. As used in this part, early intervention program means the total effort in a State that...

34 CFR 303.11 - Early intervention program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 34 Education 2 2011-07-01 2010-07-01 true Early intervention program. 303.11 Section 303.11... AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND... intervention program. As used in this part, early intervention program means the total effort in a State that...

It's Hard to Get from Here to There: Early Intervention for Rural Young Children in Arkansas

ERIC Educational Resources Information Center

Marsh, Carolyn; Casey, Patrick H.

2006-01-01

The Kids First program at the University of Arkansas Medical School (UAMS) is an outgrowth of the Infant Health and Development Program, a randomized trial of an early intervention approach for premature, low birth weight children, which showed that intensive intervention had significant initial benefits in the cognitive development and behavior…

Early Intervention in Psychosis

PubMed Central

McGorry, Patrick D.

2015-01-01

Abstract Early intervention for potentially serious disorder is a fundamental feature of healthcare across the spectrum of physical illness. It has been a major factor in the reductions in morbidity and mortality that have been achieved in some of the non-communicable diseases, notably cancer and cardiovascular disease. Over the past two decades, an international collaborative effort has been mounted to build the evidence and the capacity for early intervention in the psychotic disorders, notably schizophrenia, where for so long deep pessimism had reigned. The origins and rapid development of early intervention in psychosis are described from a personal and Australian perspective. This uniquely evidence-informed, evidence-building and cost-effective reform provides a blueprint and launch pad to radically change the wider landscape of mental health care and dissolve many of the barriers that have constrained progress for so long. PMID:25919380

A randomized controlled trial of two primary school intervention strategies to prevent early onset tobacco smoking.

PubMed

Storr, Carla L; Ialongo, Nicholas S; Kellam, Sheppard G; Anthony, James C

2002-03-01

In this article, we examine the impact of two universal, grade 1 preventive interventions on the onset of tobacco smoking as assessed in early adolescence. The classroom-centered (CC) intervention was designed to reduce the risk for tobacco smoking by enhancing teachers' behavior management skills in first grade and, thereby, reducing child attention problems and aggressive and shy behavior-known risk behaviors for later substance use. The family-school partnership (FSP) intervention targeted these early risk behaviors via improvements in parent-teacher communication and parents' child behavior management strategies. A cohort of 678 urban, predominately African-American, public school students were randomly assigned to one of three Grade 1 classrooms at entrance to primary school (age 6). One classroom featured the CC intervention, a second the FSP intervention, and the third served as a control classroom. Six years later, 81% of the students completed audio computer-assisted self-interviews. Relative to controls, a modest attenuation in the risk of smoking initiation was found for students who had been assigned to either the CC or FSP intervention classrooms (26% versus 33%) (adjusted relative risk for CC/control contrast=0.57, 95% confidence interval (CI), 0.34-0.96; adjusted relative risk for FSP/control contrast=0.69, 95% CI, 0.50-0.97). Results lend support to targeting the early antecedent risk behaviors for tobacco smoking.

Treatment strategies in the acute therapy of migraine: stratified care and early intervention.

PubMed

D'Amico, D; Moschiano, F; Usai, S; Bussone, G

2006-05-01

Various treatment strategies have been proposed to help clinicians provide the most effective acute treatment for migraine patients. Stratified care is based on the concept that the most appropriate initial treatment can be prescribed after evaluation of each patient's headache characteristics. The results of a large multicentre trial showed that when patients were stratified according to disability grade, clinical outcomes were significantly better than with step-care approaches. Prospective studies have shown that treating migraines with triptans when pain is mild (early intervention) considerably increases success rates for endpoints (pain-free at 2 h, sustained pain-free state) for which triptans had relatively poor efficacy in pivotal trials, and which contribute most to patient satisfaction. Stratified care and early treatment are also cost-effective. However these strategies are not suitable for all patients. Stratified care may be rendered difficult by medication contraindications and changes in attack characteristics over time. Early triptan intervention carries a risk of medication overuse and might not be indicated in patients with lack of pain progression. Successful implementation of both strategies requires that physicians are well informed, and that they elicit an exhaustive headache history from each patient.

Early Intervention in Bipolar Disorder.

PubMed

Vieta, Eduard; Salagre, Estela; Grande, Iria; Carvalho, André F; Fernandes, Brisa S; Berk, Michael; Birmaher, Boris; Tohen, Mauricio; Suppes, Trisha

2018-05-01

Bipolar disorder is a recurrent disorder that affects more than 1% of the world population and usually has its onset during youth. Its chronic course is associated with high rates of morbidity and mortality, making bipolar disorder one of the main causes of disability among young and working-age people. The implementation of early intervention strategies may help to change the outcome of the illness and avert potentially irreversible harm to patients with bipolar disorder, as early phases may be more responsive to treatment and may need less aggressive therapies. Early intervention in bipolar disorder is gaining momentum. Current evidence emerging from longitudinal studies indicates that parental early-onset bipolar disorder is the most consistent risk factor for bipolar disorder. Longitudinal studies also indicate that a full-blown manic episode is often preceded by a variety of prodromal symptoms, particularly subsyndromal manic symptoms, therefore supporting the existence of an at-risk state in bipolar disorder that could be targeted through early intervention. There are also identifiable risk factors that influence the course of bipolar disorder, some of them potentially modifiable. Valid biomarkers or diagnosis tools to help clinicians identify individuals at high risk of conversion to bipolar disorder are still lacking, although there are some promising early results. Pending more solid evidence on the best treatment strategy in early phases of bipolar disorder, physicians should carefully weigh the risks and benefits of each intervention. Further studies will provide the evidence needed to finish shaping the concept of early intervention. AJP AT 175 Remembering Our Past As We Envision Our Future April 1925: Interpretations of Manic-Depressive Phases Earl Bond and G.E. Partridge reviewed a number of patients with manic-depressive illness in search of a unifying endo-psychic conflict. They concluded that understanding either phase of illness was "elusive" and

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data From the Efficacy Trial for Lunch Is in the Bag.

PubMed

Roberts-Gray, Cindy; Sweitzer, Sara J; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E; Briley, Margaret E; Hoelscher, Deanna M

2017-08-01

A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the Lunch Is in the Bag intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). To examine the utility of structuring the trial's process evaluation to forecast use, sustainability, and readiness of the intervention for wider dissemination and implementation. Pretrial, the research team simulated user experience to forecast use of the intervention. Multiattribute evaluation of user experience measured during the trial assessed use and sustainability of the intervention. Thematic analysis of posttrial interviews with users evaluated sustained use and readiness for wider dissemination. Moderate use was forecast by the research team. Multiattribute evaluation of activity logs, surveys, and observations during the trial indicated use consistent with the forecast except that prevalence of parents reading the newsletters was greater (83% vs. 50%) and hearing their children talk about the classroom was less (4% vs. 50%) than forecast. Early care and education center-level likelihood of sustained use was projected to be near zero. Posttrial interviews indicated use was sustained at zero centers. Structuring the efficacy trial's process evaluation as a progression of assessments of user experience produced generally accurate forecasts of use and sustainability of the intervention at the trial sites. This approach can assist interpretation of trial outcomes, aid decisions about dissemination of the intervention, and contribute to translational science for improving health.

Comparison of usual podiatric care and early physical therapy intervention for plantar heel pain: study protocol for a parallel-group randomized clinical trial

PubMed Central

2013-01-01

Background A significant number of individuals suffer from plantar heel pain (PHP) and many go on to have chronic symptoms and continued disability. Persistence of symptoms adds to the economic burden of PHP and cost-effective solutions are needed. Currently, there is a wide variation in treatment, cost, and outcomes of care for PHP with limited information on the cost-effectiveness and comparisons of common treatment approaches. Two practice guidelines and recent evidence of effective physical therapy intervention are available to direct treatment but the timing and influence of physical therapy intervention in the multidisciplinary management of PHP is unclear. The purpose of this investigation is to compare the outcomes and costs associated with early physical therapy intervention (ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in individuals with PHP. Methods A parallel-group, block-randomized clinical trial will compare ePT and uPOD. Both groups will be seen initially by a podiatrist before allocation to a group that will receive physical therapy intervention consisting primarily of manual therapy, exercise, and modalities, or podiatric care consisting primarily of a stretching handout, medication, injections, and orthotics. Treatment in each group will be directed by practice guidelines and a procedural manual, yet the specific intervention for each participant will be selected by the treating provider. Between-group differences in the Foot and Ankle Ability Measure 6 months following the initial visit will be the primary outcome collected by an independent investigator. In addition, differences in the European Quality of Life – Five Dimensions, Numeric Pain Rating Scale, Global Rating of Change (GROC), health-related costs, and cost-effectiveness at 6 weeks, 6 months, and 1 year will be compared between groups. The association between successful outcomes based on GROC score and participant expectations of recovery

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults.

PubMed

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S; Adams, Marc A

2015-09-11

Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults' PA compared to the static intervention components. Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message-based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants' daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently active and are overweight or obese. WalkIT is one of

An efficacy trial of brief lifestyle intervention delivered by generalist community nurses (CN SNAP trial).

PubMed

Laws, Rachel A; Chan, Bibiana C; Williams, Anna M; Davies, Gawaine Powell; Jayasinghe, Upali W; Fanaian, Mahnaz; Harris, Mark F

2010-02-23

Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP) are the main behavioural risk factors for chronic disease. Primary health care (PHC) has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison) group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1) telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2) nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3) semi-structured interviews/focus with nurses, managers and clients in 'early intervention' sites to explore the

Challenges and Limitations in Early Intervention

ERIC Educational Resources Information Center

Hadders-Algra, Mijna

2011-01-01

Research over the past three decades has shown that early intervention in infants biologically at risk of developmental disorders, irrespective of the presence of a brain lesion, is associated with improved cognitive development in early childhood without affecting motor development. However, at present it is unknown whether early intervention is…

Early Interventions: Keys to Successful Readers.

ERIC Educational Resources Information Center

Jeffreys, JoAnn; Spang, Joan

This action research outlines an early reading intervention project for improving students' reading skills and promoting the implementation of early reading intervention programs. The targeted population includes first and second grade students in one school located in the suburbs of a major city in Illinois. The problem of early reading…

A randomized trial examining the effects of parent engagement on early language and literacy: the Getting Ready intervention.

PubMed

Sheridan, Susan M; Knoche, Lisa L; Kupzyk, Kevin A; Edwards, Carolyn Pope; Marvin, Christine A

2011-06-01

Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children's language use (d=1.11), reading (d=1.25), and writing skills (d=0.93). Significant intervention effects on children's direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child's development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment's effects. Copyright © 2011 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

A Randomized Trial Examining the Effects of Parent Engagement on Early Language and Literacy: The Getting Ready Intervention

PubMed Central

Knoche, Lisa L.; Kupzyk, Kevin A.; Edwards, Carolyn Pope; Marvin, Christine A.

2011-01-01

Language and literacy skills established during early childhood are critical for later school success. Parental engagement with children has been linked to a number of adaptive characteristics in preschoolers including language and literacy development, and family-school collaboration is an important contributor to school readiness. This study reports the results of a randomized trial of a parent engagement intervention designed to facilitate school readiness among disadvantaged preschool children, with a particular focus on language and literacy development. Participants included 217 children, 211 parents, and 29 Head Start teachers in 21 schools. Statistically significant differences in favor of the treatment group were observed between treatment and control participants in the rate of change over 2 academic years on teacher reports of children’s language use (d = 1.11), reading (d = 1.25), and writing skills (d = .93). Significant intervention effects on children’s direct measures of expressive language were identified for a subgroup of cases where there were concerns about a child’s development upon entry into preschool. Additionally, other child and family moderators revealed specific variables that influenced the treatment’s effects. PMID:21640249

The Walking Interventions Through Texting (WalkIT) Trial: Rationale, Design, and Protocol for a Factorial Randomized Controlled Trial of Adaptive Interventions for Overweight and Obese, Inactive Adults

PubMed Central

Hurley, Jane C; Hollingshead, Kevin E; Todd, Michael; Jarrett, Catherine L; Tucker, Wesley J; Angadi, Siddhartha S

2015-01-01

Background Walking is a widely accepted and frequently targeted health promotion approach to increase physical activity (PA). Interventions to increase PA have produced only small improvements. Stronger and more potent behavioral intervention components are needed to increase time spent in PA, improve cardiometabolic risk markers, and optimize health. Objective Our aim is to present the rationale and methods from the WalkIT Trial, a 4-month factorial randomized controlled trial (RCT) in inactive, overweight/obese adults. The main purpose of the study was to evaluate whether intensive adaptive components result in greater improvements to adults’ PA compared to the static intervention components. Methods Participants enrolled in a 2x2 factorial RCT and were assigned to one of four semi-automated, text message–based walking interventions. Experimental components included adaptive versus static steps/day goals, and immediate versus delayed reinforcement. Principles of percentile shaping and behavioral economics were used to operationalize experimental components. A Fitbit Zip measured the main outcome: participants’ daily physical activity (steps and cadence) over the 4-month duration of the study. Secondary outcomes included self-reported PA, psychosocial outcomes, aerobic fitness, and cardiorespiratory risk factors assessed pre/post in a laboratory setting. Participants were recruited through email listservs and websites affiliated with the university campus, community businesses and local government, social groups, and social media advertising. Results This study has completed data collection as of December 2014, but data cleaning and preliminary analyses are still in progress. We expect to complete analysis of the main outcomes in late 2015 to early 2016. Conclusions The Walking Interventions through Texting (WalkIT) Trial will further the understanding of theory-based intervention components to increase the PA of men and women who are healthy, insufficiently

The Benefits of Early Book Sharing (BEBS) for child cognitive and socio-emotional development in South Africa: study protocol for a randomised controlled trial.

PubMed

Dowdall, Nicholas; Cooper, Peter J; Tomlinson, Mark; Skeen, Sarah; Gardner, Frances; Murray, Lynne

2017-03-09

Children in low and middle-income countries (LMICs) are at risk for problems in their cognitive, social and behavioural development. Factors such as a lack of cognitive stimulation, harsh parenting practices, and severe and persistent aggression in early childhood are central to the genesis of these problems. Interventions that target the intersection between early childhood development, parenting, and early violence prevention are required in order to meaningfully address these problems. We are conducting a randomised controlled trial to evaluate a parenting intervention for caregivers of children aged between 23 and 27 months, designed to promote child cognitive and socioemotional development in Khayelitsha, a low-income peri-urban township in South Africa. Families are randomly allocated to a book-sharing intervention group or to a wait-list control group. In the intervention, we train caregivers in supportive book-sharing with young children. Training is carried out in small groups over a period of 8 weeks. Data are collected at baseline, post intervention and at 6 months post intervention. In addition to targeting child cognitive development, the intervention aims to improve child socioemotional functioning. The Benefits of Early Book Sharing (BEBS) trial aims to evaluate the impact of an early parenting intervention on several key risk factors for the development of violence, including aspects of parenting and child cognition, prosocial behaviour, aggression, and socioemotional functioning. The study is being carried out in a LMIC where violence constitutes a major social and health burden. Since the intervention is brief and, with modest levels of training, readily deliverable in LMIC contexts, a demonstration that it is of benefit to both child cognitive and socioemotional development would be of significance. The BEBS trial is registered on the International Standard Randomised Controlled Trial Number database, registration number ISRCTN71109104

Study protocol: an early intervention program to improve motor outcome in preterm infants: a randomized controlled trial and a qualitative study of physiotherapy performance and parental experiences

PubMed Central

2012-01-01

Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age). Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist) are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences with the intervention

A phase II study in advanced cancer patients to evaluate the early transition to palliative care (the PREPArE trial): protocol study for a randomized controlled trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Siqueira, Milena Ruas; da Rosa, Luciana de Toledo Bernardes; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2015-04-12

Previous studies have demonstrated the benefit of early integration of palliative care (PC) in oncology. However, patients continue to receive late referrals to PC even in comprehensive cancer centers. Patients and health professionals may perceive PC as 'a place to die,' and this stigma is a barrier to timely referrals and to patient acceptance of treatment. The primary objective is to evaluate the feasibility of psychosocial intervention and PC in patients with advanced cancer. The patients will be submitted to a series of brief psychosocial interventions that are based on cognitive behavioral therapy, and patient acceptance and satisfaction will be assessed. In addition, the impact of these interventions on depressive symptoms will be evaluated. A randomized, open-label, phase II trial with two intervention arms and a control group will be conducted. Patients who are started on palliative chemotherapy and who meet the inclusion criteria will be enrolled. The study participants will be recruited from the outpatient oncology clinics at Barretos Cancer Hospital and will be randomized into one of the following three treatment arms: Arm A, which will include five weekly psychosocial interventions based on CBT in combination with early PC; Arm B, which will include early PC only; and Arm C, which will include standard oncologic care. The Hospital Anxiety and Depression Scale (HADS), the Patient Health Questionnaire (PHQ-9), the Edmonton Symptom Assessment System (ESAS-br), the Family Satisfaction with End-of-Life Care (FAMCARE)-Patient scale, and the Disease Understanding Protocol will be used for data collection. The patients will answer these questionnaires at baseline and 45, 90, 120 and 180 days after randomization. Despite evidence of the positive impact of early PC, it is often provided to patients only at later stages. The inadequate awareness and stigmatization of PC as a place to die are barriers that complicate the early referral. Patients with advanced

The uses of outcome measures within multidisciplinary early childhood intervention services: a systematic review.

PubMed

Calder, Samuel; Ward, Roslyn; Jones, Megan; Johnston, Jenelle; Claessen, Mary

2017-07-18

Purpose of the article: To review the use of outcome measures, across the domains of activity, participation, and environment, within multidisciplinary early childhood intervention services. A systematic literature search was undertaken that included four electronic databases: Medline, CINAHL, EMBASE, and the Cochrane Library and Cochrane Database of Systematic Review. Inclusion criteria were age 0-24 months, having or at risk of a developmental disability, in receipt of multidisciplinary early childhood intervention services, and included outcome measures across all domains of the International Classification of Functioning-Child & Youth (ICF-CY). Only peer-reviewed journal articles were considered. Eligible studies were coded using the Oxford Levels of Evidence. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) Scale for randomised controlled trials and the QualSyst for non-randomised control trials. Of the total of 5764 records identified, 10 were considered to meet inclusion criteria. Fourteen outcome measures were identified, addressing the domains of activity, participation, and environment. Of these, eight have been recommended in the early intervention literature. While the methodological quality of the 10 studies varied, these papers make a contribution to the body of research that acknowledges the role of routine and enriched environments. Implications for Rehabilitation Core practice elements of multidisciplinary early childhood intervention services indicate it is necessary to select outcome measures framed within the International Classification of Functioning-Child & Youth to inform clinical decision-making for measuring intervention effectiveness across the domains of activity, participation and environment. Of the identified measures, three (Canadian Occupational Performance Measure, Pediatric Evaluation of Disability Inventory, and Goal Attainment Scaling) are well-established and identified in the literature as

Early Intervention for Symptomatic Youth at Risk for Bipolar Disorder: A Randomized Trial of Family-Focused Therapy

PubMed Central

Miklowitz, David J.; Schneck, Christopher D.; Singh, Manpreet K.; Taylor, Dawn O.; George, Elizabeth L.; Cosgrove, Victoria E.; Howe, Meghan E.; Dickinson, L. Miriam; Garber, Judy; Chang, Kiki D.

2012-01-01

Objective Depression and brief periods of (hypo)mania are linked to an increased risk of progression to bipolar I or II disorder (BD) in children of bipolar parents. This randomized trial examined the effects of a 4-month family-focused therapy (FFT) program on the 1-year course of mood symptoms in youth at high familial risk for BD, and explored its comparative benefits among youth in families with high vs. low expressed emotion (EE). Method Participants were 40 youth (mean 12.3 ± 2.8 years, range 9–17) with BD not otherwise specified, major depressive disorder, or cyclothymic disorder who had a first-degree relative with BD I or II and active mood symptoms (Young Mania Rating Scale [YMRS] > 11 or Child Depression Rating Scale > 29). Participants were randomly allocated to FFT–High Risk version (FFT-HR; 12 sessions of psychoeducation and training in communication and problem-solving skills) or an education control (EC; 1–2 family sessions). Results Youth in FFT-HR had more rapid recovery from their initial mood symptoms (hazard ratio = 2.69, p = .047), more weeks in remission, and a more favorable trajectory of YMRS scores over 1 year than youth in EC. The magnitude of treatment effect was greater among youth in high-EE (vs. low-EE) families. Conclusions FFT-HR may hasten and help sustain recovery from mood symptoms among youth at high risk for BD. Longer follow-up will be necessary to determine if early family intervention has downstream effects that contribute to the delay or prevention of full manic episodes in vulnerable youth. Clinical trial registration information—Early Family-Focused Treatment for Youth at Risk for Bipolar Disorder; http://www.clinicaltrials.gov/; NCT00943085. PMID:23357439

Early Literacy Instruction and Intervention

PubMed Central

Al Otaiba, Stephanie; Foorman, Barbara

2014-01-01

The purpose of this paper is to describe the efficacy of early literacy interventions and to discuss possible roles for volunteer tutors in helping prevent reading difficulties within the Response to Intervention process. First, we describe a landmark study that evaluated the impact of primary classroom instruction on reducing the proportion of students at risk for reading failure, and a more recent series of studies exploring the effects of individualizing classroom reading instruction based on students’ initial skills. Second, we review studies of more intensive early intervention to demonstrate how these interventions substantially reduce the proportion of students at risk. Third, we examine effective tutoring models that utilize volunteers. Finally, we discuss the potential role of community tutors in supporting primary classroom instruction and secondary interventions. PMID:25221452

The feasibility and benefit of a brief psychosocial intervention in addition to early palliative care in patients with advanced cancer to reduce depressive symptoms: a pilot randomized controlled clinical trial.

PubMed

do Carmo, Thamires Monteiro; Paiva, Bianca Sakamoto Ribeiro; de Oliveira, Cleyton Zanardo; Nascimento, Maria Salete de Angelis; Paiva, Carlos Eduardo

2017-08-23

The aim of this study was to assess the feasibility and potential benefit of a brief psychosocial intervention based on cognitive-behavioral therapy performed in addition to early palliative care (PC) in the reduction of depressive symptoms among patients with advanced cancer. An open-label randomized phase II clinical trial with two intervention arms and one control group. Patients with advanced cancer starting palliative chemotherapy and who met the selection criteria were included. The participants were randomly allocated to three arms: arm A, five weekly sessions of psychosocial intervention combined with early PC; arm B, early PC only; and arm C, standard cancer treatment. Feasibility was investigated by calculating rates (%) of inclusion, attrition, and contamination (% of patients from Arm C that received PC). Scores of depression (primary aim), anxiety, and quality of life were measured at baseline and 45, 90, 120, and 180 days after randomization. From the total of 613 screened patients (10.3% inclusion rate), 19, 22, and 22 patients were allocated to arms A, B, and C, respectively. Contamination and attrition rates (180 days) were 31.8% and 38.0%, respectively. No interaction between the arms and treatments were found. Regarding effect sizes, there was a moderate benefit in arm A over arms B and C in emotional functioning (-0.66 and -0.61, respectively) but a negative effect of arm A over arm C in depression (-0.74). Future studies to be conducted with this population group need to revise the eligibility criteria and make them less restrictive. In addition, the need for arm C is questioned due to high contamination rate. The designed psychosocial intervention was not able to reduce depressive symptoms when combined with early PC. Further studies are warrant to evaluate the intervention on-demand and in subgroups of high risk of anxiety/depression. Clinical Trials identifier NCT02133274 . Registered May 6, 2014.

Effectiveness of Multipurpose Unit Early Classroom Intervention Program for 4-5-Year-Old Children

ERIC Educational Resources Information Center

Celebioglu Morkoc, Ozlem; Aktan Acar, Ebru

2014-01-01

This research examined the effectiveness of Multipurpose Unit Early Classroom Intervention Program (MUECIP) prepared for 4-5-year-old (48-60 months) children whose development is at risk because of their families' socioeconomic conditions. The research adopted a preliminary test-final test control group trial model. The research participants were…

Community-based interventions to optimize early childhood development in low resource settings.

PubMed

Maulik, P K; Darmstadt, G L

2009-08-01

Interventions targeting the early childhood period (0 to 3 years) help to improve neuro-cognitive functioning throughout life. Some of the more low cost, low resource-intensive community practices for this age-group are play, reading, music and tactile stimulation. This research was conducted to summarize the evidence regarding the effectiveness of such strategies on child development, with particular focus on techniques that may be transferable to developing countries and to children at risk of developing secondary impairments. PubMed, PsycInfo, Embase, ERIC, CINAHL and Cochrane were searched for studies involving the above strategies for early intervention. Reference lists of these studies were scanned and other studies were incorporated based on snow-balling. Overall, 76 articles corresponding to 53 studies, 24 of which were randomized controlled trials, were identified. Sixteen of those studies were from low- and middle-income countries. Play and reading were the two commonest interventions and showed positive impact on intellectual development of the child. Music was evaluated primarily in intensive care settings. Kangaroo Mother Care, and to a lesser extent massage, also showed beneficial effects. Improvement in parent-child interaction was common to all the interventions. Play and reading were effective interventions for early childhood interventions in low- and middle-income countries. More research is needed to judge the effectiveness of music. Kangaroo Mother Care is effective for low birth weight babies in resource poor settings, but further research is needed in community settings. Massage is useful, but needs more rigorous research prior to being advocated for community-level interventions.

Explaining high and low performers in complex intervention trials: a new model based on diffusion of innovations theory.

PubMed

McMullen, Heather; Griffiths, Chris; Leber, Werner; Greenhalgh, Trisha

2015-05-31

Complex intervention trials may require health care organisations to implement new service models. In a recent cluster randomised controlled trial, some participating organisations achieved high recruitment, whereas others found it difficult to assimilate the intervention and were low recruiters. We sought to explain this variation and develop a model to inform organisational participation in future complex intervention trials. The trial included 40 general practices in a London borough with high HIV prevalence. The intervention was offering a rapid HIV test as part of the New Patient Health Check. The primary outcome was mean CD4 cell count at diagnosis. The process evaluation consisted of several hundred hours of ethnographic observation, 21 semi-structured interviews and analysis of routine documents (e.g., patient leaflets, clinical protocols) and trial documents (e.g., inclusion criteria, recruitment statistics). Qualitative data were analysed thematically using--and, where necessary, extending--Greenhalgh et al.'s model of diffusion of innovations. Narrative synthesis was used to prepare case studies of four practices representing maximum variety in clinicians' interest in HIV (assessed by level of serological testing prior to the trial) and performance in the trial (high vs. low recruiters). High-recruiting practices were, in general though not invariably, also innovative practices. They were characterised by strong leadership, good managerial relations, readiness for change, a culture of staff training and available staff time ('slack resources'). Their front-line staff believed that patients might benefit from the rapid HIV test ('relative advantage'), were emotionally comfortable administering it ('compatibility'), skilled in performing it ('task issues') and made creative adaptations to embed the test in local working practices ('reinvention'). Early experience of a positive HIV test ('observability') appeared to reinforce staff commitment to recruiting

EHLS at School: school-age follow-up of the Early Home Learning Study cluster randomized controlled trial.

PubMed

Westrupp, Elizabeth M; Bennett, Clair; Cullinane, Meabh; Hackworth, Naomi J; Berthelsen, Donna; Reilly, Sheena; Mensah, Fiona K; Gold, Lisa; Bennetts, Shannon K; Levickis, Penny; Nicholson, Jan M

2018-05-02

Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the parent

Intervention fidelity in primary care complex intervention trials: qualitative study using telephone interviews of patients and practitioners.

PubMed

Dyas, Jane V; Togher, Fiona; Siriwardena, A Niroshan

2014-01-01

Treatment fidelity has previously been defined as the degree to which a treatment or intervention is delivered to participants as intended. Underreporting of fidelity in primary care randomised controlled trials (RCTs) of complex interventions reduces our confidence that findings are due to the treatment or intervention being investigated, rather than unknown confounders. We aimed to investigate treatment fidelity (for the purpose of this paper, hereafter referred to as intervention fidelity), of an educational intervention delivered to general practice teams and designed to improve the primary care management of insomnia. We conducted telephone interviews with patients and practitioners participating in the intervention arm of the trial to explore trial fidelity. Qualitative analysis was undertaken using constant comparison and a priori themes (categories): 'adherence to the delivery of the intervention', 'patients received and understood intervention' and 'patient enactment'. If the intervention protocol was not adhered to by the practitioner then patient receipt, understanding and enactment levels were reduced. Recruitment difficulties in terms of the gap between initially being recruited into the study and attending an intervention consultation also reduced the effectiveness of the intervention. Patient attributes such as motivation to learn and engage contributed to the success of the uptake of the intervention. Qualitative methods using brief telephone interviews are an effective way of collecting the depth of data required to assess intervention fidelity. Intervention fidelity monitoring should be an important element of definitive trial design. ClinicalTrials. gov id isrctn 55001433 - www.controlled-trials.com/isrctn55001433.

How completely are physiotherapy interventions described in reports of randomised trials?

PubMed

Yamato, Tiê P; Maher, Chris G; Saragiotto, Bruno T; Hoffmann, Tammy C; Moseley, Anne M

2016-06-01

Incomplete descriptions of interventions are a common problem in reports of randomised controlled trials. To date no study has evaluated the completeness of the descriptions of physiotherapy interventions. To evaluate the completeness of the descriptions of physiotherapy interventions in a random sample of reports of randomised controlled trials (RCTs). A random sample of 200 reports of RCTs from the PEDro database. We included full text papers, written in English, and reporting trials with two arms. We included trials evaluating any type of physiotherapy interventions and subdisciplines. The methodological quality was evaluated using the PEDro scale and completeness of intervention description using the Template for Intervention Description and Replication (TIDieR) checklist. The proportion and 95% confidence interval were calculated for intervention and control groups, and used to present the relationship between completeness and methodological quality, and subdisciplines. Completeness of intervention reporting in physiotherapy RCTs was poor. For intervention groups, 46 (23%) trials did not describe at least half of the items. Reporting was worse for control groups, 149 (75%) trials described less than half of the items. There was no clear difference in the completeness across subdisciplines or methodological quality. Our sample were restricted to trials published in English in 2013. Descriptions of interventions in physiotherapy RCTs are typically incomplete. Authors and journals should aim for more complete descriptions of interventions in physiotherapy trials. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Randomised trial of early diet in preterm babies and later intelligence quotient

PubMed Central

Lucas, A; Morley, R; Cole, T J

1998-01-01

Objectives To determine whether perinatal nutrition influences cognitive function at 7½-8 years in children born preterm. Design Randomised, blinded nutritional intervention trial. Blinded follow up at 7½-8 years. Setting Intervention phase in two neonatal units; follow up in a clinic or school setting. Subjects 424 preterm infants who weighed under 1850 g at birth; 360 of those who survived were tested at 7½-8 years. Interventions Standard infant formula versus nutrient enriched preterm formula randomly assigned as sole diet (trial A) or supplements to maternal milk (trial B) fed for a mean of 1 month. Main outcome measures Intelligence quotient (IQ) at 7½-8 years with abbreviated Weschler intelligence scale for children (revised). Results There was a major sex difference in the impact of diet. At 7½-8 years boys previously fed standard versus preterm formula as sole diet had a 12.2 point disadvantage (95% confidence interval 3.7 to 20.6; P<0.01) in verbal IQ. In those with highest intakes of trial diets corresponding figures were 9.5 point disadvantage and 14.4 point disadvantage in overall IQ (1.2 to 17.7; P<0.05) and verbal IQ (5.7 to 23.2; P<0.01). Consequently, more infants fed term formula had low verbal IQ (<85): 31% versus 14% for both sexes (P=0.02) and 47% versus 13% in boys P=0.009). There was a higher incidence of cerebral palsy in those fed term formula; exclusion of such children did not alter the findings. Conclusions Preterm infants are vulnerable to suboptimal early nutrition in terms of their cognitive performance—notably, language based skills—at 7½-8 years, when cognitive scores are highly predictive of adult ones. Our data on cerebral palsy generate a new hypothesis that suboptimal nutritional management during a critical or plastic early period of rapid brain growth could impair functional compensation in those sustaining an earlier brain insult. Cognitive function, notably in males, may be permanently impaired by suboptimal

A Literature Review of Early Intervention.

ERIC Educational Resources Information Center

Panitch, Melanie

This review of the literature on early childhood intervention with special needs children provides a Canadian perspective on theory, models, program development, effects, and training. After an introductory chapter, the second chapter identifies theoretical influences on early childhood intervention, including the work of Piaget, Bronfenbrenner,…

Ethics and Early Intervention: Toward More Relationship-Focused Interventions.

ERIC Educational Resources Information Center

Able-Boone, Harriet

1996-01-01

The ethical issues surrounding early intervention services to young children with disabilities are discussed. The conflict between parental autonomy and paternalistic interventions is evaluated. Value-based intervention decisions, such as parent choice of alternative therapies, refusal of services, and family-centered versus child-centered care,…

Enhancing the early home learning environment through a brief group parenting intervention: study protocol for a cluster randomised controlled trial.

PubMed

Nicholson, Jan M; Cann, Warren; Matthews, Jan; Berthelsen, Donna; Ukoumunne, Obioha C; Trajanovska, Misel; Bennetts, Shannon K; Hillgrove, Tessa; Hamilton, Victoria; Westrupp, Elizabeth; Hackworth, Naomi J

2016-06-02

The quality of the home learning environment has a significant influence on children's language and communication skills during the early years with children from disadvantaged families disproportionately affected. This paper describes the protocol and participant baseline characteristics of a community-based effectiveness study. It evaluates the effects of 'smalltalk', a brief group parenting intervention (with or without home coaching) on the quality of the early childhood home learning environment. The study comprises two cluster randomised controlled superiority trials (one for infants and one for toddlers) designed and conducted in parallel. In 20 local government areas (LGAs) in Victoria, Australia, six locations (clusters) were randomised to one of three conditions: standard care (control); smalltalk group-only program; or smalltalk plus (group program plus home coaching). Programs were delivered to parents experiencing socioeconomic disadvantage through two existing age-based services, the maternal and child health service (infant program, ages 6-12 months), and facilitated playgroups (toddler program, ages 12-36 months). Outcomes were assessed by parent report and direct observation at baseline (0 weeks), post-intervention (12 weeks) and follow-up (32 weeks). Primary outcomes were parent verbal responsivity and home activities with child at 32 weeks. Secondary outcomes included parenting confidence, parent wellbeing and children's communication, socio-emotional and general development skills. Analyses will use intention-to-treat random effects ("multilevel") models to account for clustering. Across the 20 LGAs, 986 parents of infants and 1200 parents of toddlers enrolled and completed baseline measures. Eighty four percent of families demonstrated one or more of the targeted risk factors for poor child development (low income; receives government benefits; single, socially isolated or young parent; culturally or linguistically diverse background). This

The EHDI and Early Intervention Connection

ERIC Educational Resources Information Center

Nelson, Lauri; Bradham, Tamala S.; Houston, K. Todd

2011-01-01

State coordinators of early hearing detection and intervention (EHDI) programs completed a strengths, weaknesses, opportunities, and threats, or SWOT, analysis that examined 12 areas within state EHDI programs. For the early intervention focus question, 48 coordinators listed 273 items, and themes were identified within each SWOT category. A…

34 CFR 303.12 - Early intervention service provider.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Early intervention service provider. 303.12 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.12 Early intervention service...

34 CFR 303.11 - Early intervention service program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Early intervention service program. 303.11 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.11 Early intervention service...

34 CFR 303.12 - Early intervention service provider.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Early intervention service provider. 303.12 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.12 Early intervention service...

34 CFR 303.11 - Early intervention service program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Early intervention service program. 303.11 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.11 Early intervention service...

34 CFR 303.11 - Early intervention service program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Early intervention service program. 303.11 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.11 Early intervention service...

34 CFR 303.12 - Early intervention service provider.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Early intervention service provider. 303.12 Section 303... EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR INFANTS AND TODDLERS WITH DISABILITIES General Definitions Used in This Part § 303.12 Early intervention service...

Developments in early intervention for psychosis in Hong Kong.

PubMed

Wong, G H Y; Hui, C L M; Wong, D Y; Tang, J Y M; Chang, W C; Chan, S K W; Lee, E H M; Xu, J Q; Lin, J J X; Lai, D C; Tam, W; Kok, J; Chung, D W S; Hung, S F; Chen, E Y H

2012-09-01

The year 2011 marked the 10-year milestone of early intervention for psychosis in Hong Kong. Since 2001, the landscape of early psychosis services has changed markedly in Hong Kong. Substantial progress has been made in the areas of early intervention service implementation, knowledge generation, and public awareness promotion. Favourable outcomes attributable to the early intervention service are supported by solid evidence from local clinical research studies; early intervention service users showed improved functioning, ameliorated symptoms, and decreased hospitalisation and suicide rates. Continued development of early intervention in Hong Kong over the decade includes the introduction and maturation of several key platforms, such as the Hospital Authority Early Assessment Service for Young People with Psychosis programme, the Psychosis Studies and Intervention Unit by the University of Hong Kong, the Hong Kong Early Psychosis Intervention Society, the Jockey Club Early Psychosis Project, and the postgraduate Psychological Medicine (Psychosis Studies) programme. In this paper, we reviewed some of the major milestones in local service development with reference to features of the Hong Kong mental health system. We describe chronologically the implementation and consolidation of public early intervention services as well as recent progresses in public awareness work that are tied in with knowledge generation and transfer, and outline the prospects for early intervention in the next decade and those that follow.

Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research.

PubMed

Poduska, Jeanne; Kellam, Sheppard; Brown, C Hendricks; Ford, Carla; Windham, Amy; Keegan, Natalie; Wang, Wei

2009-09-02

While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD), aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC). Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. NCT00257088.

High-Quality Foster Care Mitigates Callous-Unemotional Traits Following Early Deprivation in Boys: A Randomized Controlled Trial.

PubMed

Humphreys, Kathryn L; McGoron, Lucy; Sheridan, Margaret A; McLaughlin, Katie A; Fox, Nathan A; Nelson, Charles A; Zeanah, Charles H

2015-12-01

Callous-unemotional (CU) traits in childhood are a developmental precursor to psychopathy, yet the origins and etiology of CU traits are not known. We examined CU traits among 12-year-old children exposed to severe early deprivation and evaluated whether a high-quality foster care intervention mitigated the development of high levels of CU traits. Participants were from the Bucharest Early Intervention Project, a randomized controlled trial of foster care for children in institutions. Children were recruited from institutions in Bucharest, Romania, along with age- and sex-matched children who were never institutionalized. Children raised in institutional settings were randomized (mean age = 22 months) to either a foster care group (n = 68) or a care-as-usual group (n = 68). CU traits were assessed at age 12.75 years in available participants from the randomized trial (n = 95) and children who were never institutionalized (n = 50). Children who experienced institutional rearing as young children had significantly higher levels of CU traits in early adolescence compared to children who were never institutionalized. Intent-to-treat analysis indicated that, among boys, CU traits were significantly lower among those who received the foster care intervention compared to those randomized to care as usual. Caregiver responsiveness to distress, but not caregiver warmth, mediated the intervention effect on CU traits in boys. These findings provide the first evidence to date that psychosocial intervention can prevent the onset of CU traits. Although severe early deprivation predicted higher levels of CU traits, high-quality foster care that emphasized responsive caregiving reduced the impact of deprivation on CU trait development for boys. The Bucharest Early Intervention Project; http://clinicaltrials.gov; NCT00747396. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial.

PubMed

Rogers, Sally J; Estes, Annette; Lord, Catherine; Vismara, Laurie; Winter, Jamie; Fitzpatrick, Annette; Guo, Mengye; Dawson, Geraldine

2012-10-01

This study was carried out to examine the efficacy of a 12-week, low-intensity (1-hour/wk of therapist contact), parent-delivered intervention for toddlers at risk for autism spectrum disorders (ASD) aged 14 to 24 months and their families. A randomized controlled trial involving 98 children and families was carried out in three different sites investigating the efficacy of a parent delivery of the Early Start Denver model (P-ESDM), which fosters parental use of a child-centered responsive interaction style that embeds many teaching opportunities into play, compared to community treatment as usual. Assessments were completed at baseline and 12 weeks later, immediately after the end of parent coaching sessions. There was no effect of group assignment on parent-child interaction characteristics or on any child outcomes. Both groups of parents improved interaction skills, and both groups of children demonstrated progress. Parents receiving P-ESDM demonstrated significantly stronger working alliances with their therapists than did the community group. Children in the community group received significantly more intervention hours than those in the P-ESDM group. For the group as a whole, both younger child age at the start of intervention and a greater number of intervention hours were positively related to the degree of improvement in children's behavior for most variables. Parent-implemented intervention studies for early ASD thus far have not demonstrated the large effects seen in intensive-treatment studies. Evidence that both younger age and more intervention hours positively affect developmental rates has implications for clinical practice, service delivery, and public policy. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Community-led trials: Intervention co-design in a cluster randomised controlled trial.

PubMed

Andersson, Neil

2017-05-30

In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

"Dosage" Decisions for Early Intervention Services

ERIC Educational Resources Information Center

Kuhn, Miriam; Marvin, Christine A.

2016-01-01

Part C of the Individuals With Disabilities Education Improvement Act (IDEA) of 2004 requires early intervention teams craft individualized and effective plans to meet the needs of young children with special needs and their families (Küpper, 2012). Many early intervention teams, however, may struggle to follow a process that results in…

Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY).

PubMed

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

2014-03-01

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. 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. 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 24 [corrected] months. We hypothesize that each active intervention will cause more weight loss than the usual care condition. Study completion is anticipated in 2014. If effective, implementation of the CITY interventions could mitigate the alarming rates of obesity in young adults through promotion of weight loss. ClinicalTrial.gov: NCT01092364. Published by Elsevier Inc.

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results

Parent-Mediated Intervention for One-Year-Olds Screened as At-Risk for Autism Spectrum Disorder: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Watson, Linda R.; Crais, Elizabeth R.; Baranek, Grace T.; Turner-Brown, Lauren; Sideris, John; Wakeford, Linn; Kinard, Jessica; Reznick, J. Steven; Martin, Katrina L.; Nowell, Sallie W.

2017-01-01

Theoretically, interventions initiated with at-risk infants prior to the point in time a definitive autism spectrum disorder (ASD) diagnosis can be made will improve outcomes. Pursuing this idea, we tested the efficacy of a parent-mediated early intervention called Adapted Responsive Teaching (ART) via a randomized controlled trial with 87…

Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

PubMed

Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

2018-03-05

The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and

Designing Clinical Trials of Interventions for Mobility Disability: Results from the Lifestyle Interventions and Independence for Elders Pilot (LIFE-P) Trial

PubMed Central

Espeland, Mark A.; Gill, Thomas M.; Guralnik, Jack; Miller, Michael E.; Fielding, Roger; Newman, Anne B.; Pahor, Marco

2008-01-01

Background Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Methods Results are described from a pilot clinical trial in which 424 volunteers aged 70–89 years were randomly assigned to one of two interventions -- physical activity or a healthy aging education program -- and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in ≤10 seconds, a physical performance battery, and a questionnaire focused on physical function. Results Changes in all four outcomes were inter-related over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e. appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A four-year trial based on the outcome of 400 meter walk is projected to require N = 962 to 2,234 to detect an intervention effect of 30% to 20% with 90% power. Conclusions Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400 meter walk as their primary outcome. PMID:18000143

Designing clinical trials of interventions for mobility disability: results from the lifestyle interventions and independence for elders pilot (LIFE-P) trial.

PubMed

Espeland, Mark A; Gill, Thomas M; Guralnik, Jack; Miller, Michael E; Fielding, Roger; Newman, Anne B; Pahor, Marco

2007-11-01

Clinical trials to assess interventions for mobility disability are critically needed; however, data for efficiently designing such trials are lacking. Results are described from a pilot clinical trial in which 424 volunteers aged 70-89 years were randomly assigned to one of two interventions-physical activity or a healthy aging education program-and followed for a planned minimum of 12 months. We evaluated the longitudinal distributions of four standardized outcomes to contrast how they may serve as primary outcomes of future clinical trials: ability to walk 400 meters, ability to walk 4 meters in < or =10 seconds, a physical performance battery, and a questionnaire focused on physical function. Changes in all four outcomes were interrelated over time. The ability to walk 400 meters as a dichotomous outcome provided the smallest sample size projections (i.e., appeared to be the most efficient outcome). It loaded most heavily on the underlying latent variable in structural equation modeling with a weight of 80%. A 4-year trial based on the outcome of the 400-meter walk is projected to require N = 962-2234 to detect an intervention effect of 30%-20% with 90% power. Future clinical trials of interventions designed to influence mobility disability may have greater efficiency if they adopt the ability to complete a 400-meter walk as their primary outcome.

A randomized controlled trial evaluating a low-intensity interactive online parenting intervention, Triple P Online Brief, with parents of children with early onset conduct problems.

PubMed

Baker, Sabine; Sanders, Matthew R; Turner, Karen M T; Morawska, Alina

2017-04-01

This randomized controlled trial examined the efficacy of Triple P Online Brief, a low-intensity online positive parenting program for parents of children with early onset disruptive behavior problems. Two hundred parents with 2-9-year-old children displaying early onset disruptive behavior difficulties were randomly assigned to either the intervention condition (n = 100) or a Waitlist Control group (n = 100). At 8-week post-assessment, parents in the intervention group displayed significantly less use of ineffective parenting strategies and significantly more confidence in dealing with a range of behavior concerns. These effects were maintained at 9-month follow-up assessment. A delayed effect was found for child behavior problems, with parents in the intervention group reporting significantly fewer and less frequent child behavior problems at follow-up, but not at post-assessment. All effect sizes were in the small to medium range. There were no significant improvements in observed negative parent and child behavior. No change was seen for parents' adjustment, anger, or conflict over parenting. Consumer satisfaction ratings for the program were high. A brief, low-intensity parenting program delivered via the Internet can bring about significant improvements in parenting and child behavior. Copyright © 2017 Elsevier Ltd. All rights reserved.

Integrating technology into complex intervention trial processes: a case study.

PubMed

Drew, Cheney J G; Poile, Vincent; Trubey, Rob; Watson, Gareth; Kelson, Mark; Townson, Julia; Rosser, Anne; Hood, Kerenza; Quinn, Lori; Busse, Monica

2016-11-17

Trials of complex interventions are associated with high costs and burdens in terms of paperwork, management, data collection, validation, and intervention fidelity assessment occurring across multiple sites. Traditional data collection methods rely on paper-based forms, where processing can be time-consuming and error rates high. Electronic source data collection can potentially address many of these inefficiencies, but has not routinely been used in complex intervention trials. Here we present the use of an on-line system for managing all aspects of data handling and for the monitoring of trial processes in a multicentre trial of a complex intervention. We custom built a web-accessible software application for the delivery of ENGAGE-HD, a multicentre trial of a complex physical therapy intervention. The software incorporated functionality for participant randomisation, data collection and assessment of intervention fidelity. It was accessible to multiple users with differing levels of access depending on required usage or to maintain blinding. Each site was supplied with a 4G-enabled iPad for accessing the system. The impact of this system was quantified through review of data quality and collation of feedback from site coordinators and assessors through structured process interviews. The custom-built system was an efficient tool for collecting data and managing trial processes. Although the set-up time required was significant, using the system resulted in an overall data completion rate of 98.5% with a data query rate of 0.1%, the majority of which were resolved in under a week. Feedback from research staff indicated that the system was highly acceptable for use in a research environment. This was a reflection of the portability and accessibility of the system when using the iPad and its usefulness in aiding accurate data collection, intervention fidelity and general administration. A combination of commercially available hardware and a bespoke online database

Long-Term Outcomes of Early Intervention in 6-Year-Old Children With Autism Spectrum Disorder

PubMed Central

Estes, Annette; Munson, Jeffrey; Rogers, Sally J.; Greenson, Jessica; Winter, Jamie; Dawson, Geraldine

2015-01-01

Objective We prospectively examine evidence for the sustained effects of early intervention based on a follow-up study of 39 children with ASD who began participation in a randomized clinical trial testing the effectiveness of the Early Start Denver Model (ESDM) at age 18–30 months. The intervention, conducted at a high level of intensity in-home for 2 years, showed evidence of efficacy immediately posttreatment. Method This group of children was assessed at age 6, two years after the intervention ended, across multiple domains of functioning by clinicians naïve to previous intervention group status. Results The ESDM group, on average, maintained gains made in early intervention during the 2-year follow-up period in overall intellectual ability, adaptive behavior, symptom severity, and challenging behavior. No group differences in core autism symptoms were found immediately posttreatment; however, two years later, the ESDM group demonstrated improved core autism symptoms and adaptive behavior as compared with the community-intervention-as-usual (COM) group. The two groups were not significantly different in terms of intellectual functioning at age 6. The two groups received equivalent intervention hours during the original study, but the ESDM group received fewer hours during the follow-up period. Conclusion These results provide evidence that gains from early intensive intervention are maintained 2 years later. Notably, core autism symptoms improved in the ESDM group over the follow-up period relative to the COM group. This improvement occurred at the same time the ESDM group received significantly fewer services. This is the first study to examine the role of early ESDM behavioral intervention initiated below 30 months of age in altering the longer term developmental course of autism. PMID:26088663

Long-Term Outcomes of Early Intervention in 6-Year-Old Children With Autism Spectrum Disorder.

PubMed

Estes, Annette; Munson, Jeffrey; Rogers, Sally J; Greenson, Jessica; Winter, Jamie; Dawson, Geraldine

2015-07-01

We prospectively examined evidence for the sustained effects of early intervention based on a follow-up study of 39 children with ASD who began participation in a randomized clinical trial testing the effectiveness of the Early Start Denver Model (ESDM) at age 18 to 30 months. The intervention, conducted at a high level of intensity in-home for 2 years, showed evidence of efficacy immediately posttreatment. This group of children was assessed at age 6 years, 2 years after the intervention ended, across multiple domains of functioning by clinicians naive to previous intervention group status. The ESDM group, on average, maintained gains made in early intervention during the 2-year follow-up period in overall intellectual ability, adaptive behavior, symptom severity, and challenging behavior. No group differences in core autism symptoms were found immediately posttreatment; however, 2 years later, the ESDM group demonstrated improved core autism symptoms and adaptive behavior as compared with the community-intervention-as-usual (COM) group. The 2 groups were not significantly different in terms of intellectual functioning at age 6 years. Both groups received equivalent intervention hours during the original study, but the ESDM group received fewer hours during the follow-up period. These results provide evidence that gains from early intensive intervention are maintained 2 years later. Notably, core autism symptoms improved in the ESDM group over the follow-up period relative to the COM group. This improvement occurred at the same time that the ESDM group received significantly fewer services. This is the first study to examine the role of early ESDM behavioral intervention initiated at less than 30 months of age in altering the longer-term developmental course of autism. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Multifaceted intervention to decrease the rate of severe postpartum haemorrhage: the PITHAGORE6 cluster-randomised controlled trial

PubMed Central

Deneux-Tharaux, Catherine; Dupont, Corinne; Colin, C.; Rabilloud, Muriel; Touzet, S.; Lansac, Jacques; Harvey, Thierry; Tessier, Véronique; Chauleur, C.; Pennehouat, G.; Morin, X.; Bouvier-Colle, Marie-Hélène; Rudigoz, René

2010-01-01

Objective Decreasing the prevalence of severe postpartum haemorrhages (PPH) is a major obstetrical challenge. These are often considered to be associated with substandard initial care. Strategies to increase the appropriateness of early management of PPH must be assessed. We tested the hypothesis that a multifaceted intervention aimed at increasing the translation into practice of a protocol for early management of PPH, would reduce the incidence of severe PPH. Design Cluster-randomised trial Population 106 maternity units in 6 French regions Methods Maternity units were randomly assigned to receive the intervention, or to have the protocol passively disseminated. The intervention combined outreach visits to discuss the protocol in each local context, reminders, and peer reviews of severe cases, and was implemented in each maternity hospital by a team pairing an obstetrician and a midwife. Main outcome measures The primary outcome was the incidence of severe PPH, defined as a composite of one or more of: transfusion, embolisation, surgical procedure, transfer to intensive care, peripartum haemoglobin delta of 4 g/dl or more, death. The main secondary outcomes were PPH management practices. Results The mean rate of severe PPH was 1.64% (SD0.80) in the intervention units and 1.65% (SD0.96) in control units; difference not significant. Some elements of PPH management were applied more frequently in intervention units –help from senior staff (p=0.005)-, or tended to – second line pharmacological treatment (p=0.06), timely blood test (p=0.09). Conclusion This educational intervention did not affect the rate of severe PPH as compared to control units, although it improved some practices. Trial registration: ClinicalTrials.gov NCT 00344929 PMID:20573150

Infusing Early Childhood Mental Health into Early Intervention Services

ERIC Educational Resources Information Center

Grabert, John C.

2009-01-01

This article describes the process of enhancing early childhood mental health awareness and skills in non-mental health staff. The author describes a pilot training model, conducted the U.S. Army's Early Intervention Services, that involved: (a) increasing early childhood mental health knowledge through reflective readings, (b) enhancing…

Early detection and intervention for attention-deficit/hyperactivity disorder.

PubMed

Sonuga-Barke, Edmund J S; Koerting, Johanna; Smith, Elizabeth; McCann, Donna C; Thompson, Margaret

2011-04-01

Attention-deficit/hyperactivity disorder (ADHD) is a high-cost/high-burden disorder. Early detection and intervention may prevent or ameliorate the development of the disorder and reduce its long-term impact. In this article, we set out a rationale for an early detection and intervention program. First, we highlight the costs of the condition and second, we discuss the limitations of the current treatments. We then outline the potential value of an early detection and intervention program. We review evidence on predictors of poor outcomes for early ADHD signs and discuss how these might allow us to target early intervention more cost-effectively. We then examine potential barriers to engagement with at-risk samples. This leads to a discussion of possible intervention approaches and how these could be improved. Finally, we describe the Program for Early Detection and Intervention for ADHD (PEDIA), a 5-year program of research supported by the UK National Institute for Health Research and conducted at the University of Southampton (Southampton, UK), which aims to develop and evaluate a strategy for early intervention.

Lidcombe Program Webcam Treatment for Early Stuttering: A Randomized Controlled Trial.

PubMed

Bridgman, Kate; Onslow, Mark; O'Brian, Susan; Jones, Mark; Block, Susan

2016-10-01

Webcam treatment is potentially useful for health care in cases of early stuttering in which clients are isolated from specialized treatment services for geographic and other reasons. The purpose of the present trial was to compare outcomes of clinic and webcam deliveries of the Lidcombe Program treatment (Packman et al., 2015) for early stuttering. The design was a parallel, open plan, noninferiority randomized controlled trial of the standard Lidcombe Program treatment and the experimental webcam Lidcombe Program treatment. Participants were 49 children aged 3 years 0 months to 5 years 11 months at the start of treatment. Primary outcomes were the percentage of syllables stuttered at 9 months postrandomization and the number of consultations to complete Stage 1 of the Lidcombe Program. There was insufficient evidence of a posttreatment difference of the percentage of syllables stuttered between the standard and webcam Lidcombe Program treatments. There was insufficient evidence of a difference between the groups for typical stuttering severity measured by parents or the reported clinical relationship with the treating speech-language pathologist. This trial confirmed the viability of the webcam Lidcombe Program intervention. It appears to be as efficacious and economically viable as the standard, clinic Lidcombe Program treatment.

A randomised controlled trial for overweight and obese parents to prevent childhood obesity--Early STOPP (STockholm Obesity Prevention Program).

PubMed

Sobko, Tanja; Svensson, Viktoria; Ek, Anna; Ekstedt, Mirjam; Karlsson, Håkan; Johansson, Elin; Cao, Yingting; Hagströmer, Maria; Marcus, Claude

2011-05-18

Overweight and obesity have a dramatic negative impact on children's health not only during the childhood but also throughout the adult life. Preventing the development of obesity in children is therefore a world-wide health priority. There is an obvious urge for sustainable and evidenced-based interventions that are suitable for families with young children, especially for families with overweight or obese parents. We have developed a prevention program, Early STOPP, combating multiple obesity-promoting behaviors such unbalanced diet, physical inactivity and disturbed sleeping patterns. We also aim to evaluate the effectiveness of the early childhood obesity prevention in a well-characterized population of overweight or obese parents. This protocol outlines methods for the recruitment phase of the study. This randomized controlled trial (RCT) targets overweight and/or obese parents with infants, recruited from the Child Health Care Centers (CHCC) within the Stockholm area. The intervention starts when infants are one year of age and continues until they are six and is regularly delivered by a trained coach (dietitian, physiotherapist or a nurse). The key aspects of Early STOPP family intervention are based on Swedish recommendations for CHCC, which include advices on healthy food choices and eating patterns, increasing physical activity/reducing sedentary behavior and regulating sleeping patterns. The Early STOPP trial design addresses weaknesses of previous research by recruiting from a well-characterized population, defining a feasible, theory-based intervention and assessing multiple measurements to validate and interpret the program effectiveness. The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge, this longitudinal RCT is the first attempt to demonstrate whether an early, long-term, targeted health promotion program focusing on healthy eating, physical activity/reduced sedentary behaviors and normalizing

Reporting of Telehealth-Delivered Dietary Intervention Trials in Chronic Disease: Systematic Review.

PubMed

Warner, Molly M; Kelly, Jaimon T; Reidlinger, Dianne P; Hoffmann, Tammy C; Campbell, Katrina L

2017-12-11

Telehealth-delivered dietary interventions are effective for chronic disease management and are an emerging area of clinical practice. However, to apply interventions from the research setting in clinical practice, health professionals need details of each intervention component. The aim of this study was to evaluate the completeness of intervention reporting in published dietary chronic disease management trials that used telehealth delivery methods. Eligible randomized controlled trial publications were identified through a systematic review. The completeness of reporting of experimental and comparison interventions was assessed by two independent assessors using the Template for Intervention Description and Replication (TIDieR) checklist that consists of 12 items including intervention rationale, materials used, procedures, providers, delivery mode, location, when and how much intervention delivered, intervention tailoring, intervention modifications, and fidelity. Where reporting was incomplete, further information was sought from additional published material and through email correspondence with trial authors. Within the 37 eligible trials, there were 49 experimental interventions and 37 comparison interventions. One trial reported every TIDieR item for their experimental intervention. No publications reported every item for the comparison intervention. For the experimental interventions, the most commonly reported items were location (96%), mode of delivery (98%), and rationale for the essential intervention elements (96%). Least reported items for experimental interventions were modifications (2%) and intervention material descriptions (39%) and where to access them (20%). Of the 37 authors, 14 responded with further information, and 8 could not be contacted. Many details of the experimental and comparison interventions in telehealth-delivered dietary chronic disease management trials are incompletely reported. This prevents accurate interpretation of trial

AIMS baby movement scale application in high-risk infants early intervention analysis.

PubMed

Wang, Y; Shi, J-P; Li, Y-H; Yang, W-H; Tian, Y-J; Gao, J; Li, S-J

2016-05-01

We investigated the application of Alberta Infant Motor Scale (AIMS) in screening motor development delay in the follow-up of high-risk infants who were discharged from NICU, to explain the state of infants' motor development and propose early individualized intervention. The study design was a randomized, single-blind trial by selecting patients between April 2015 and November 2015 in our hospital, children nerve recovery branch clinics and 77 cases of high-risk infants. We randomly divided the patients into observation group (39 cases) and control group (38 cases). To evaluate the application with AIMS, observation group was based on evaluation results for the first time to give rehabilitation training plan making, early intervention, control group according to the growth and development milestone in order to guide parents to take family training interval of 3 months. While comparing the two groups of high-risk infants before the intervention, the months of age, gender, risk factors, it was found that the AIMS scores, each position AIMS scores did not show a significant difference in percentile (p>0.05). There was also no significant difference between two groups in the seat and stand AIMS scores before and after intervention (p>0.05). However, the comparison of two groups of high-risk infants after intervention in comparison showed that the observation group supine AIMS scores and AIMS scores were significantly higher than the control group (p<0.05). Prone position AIMS scores observation group was also significantly higher than that of the control group (p<0.01). The corresponding percentile for two groups after the intervention of AIMS scores was less than 10% of cases, which was significantly lower in the observation group (p<0.01). AIMS can predict the development delay in high-risk infants, for improving the early hypernymic diagnosis and intervention.

Hormone Therapy Improves Femur Geometry Among Ethnically Diverse Postmenopausal Participants in the Women's Health Initiative Hormone Intervention Trials

PubMed Central

Chen, Zhao; Beck, Thomas J; Cauley, Jane A; Lewis, Cora E; LaCroix, Andrea; Bassford, Tamsen; Wu, Guanglin; Sherrill, Duane; Going, Scott

2008-01-01

Loss of bone strength underlies osteoporotic fragility fractures. We hypothesized that hormone interventions significantly improve the structural geometry of proximal femur cross-sections. Study participants were from the Women's Health Initiative hormone intervention trials: either the conjugated equine estrogen (CEE) only (N placebo = 447, N CEE = 422) trial or the estrogen (E) plus progestin (P) (N placebo = 441, N E+P = 503) trial, who were 50–79 yr old at baseline and were followed up to 6 yr. BMD scans by DXA were conducted at baseline, year 1, year 3, and year 6. Femur geometry was derived from hip DXA scans using the hip structural analysis (HSA) method. Mixed effects models with the intent-to-treat analysis approach were used. There were no significant differences in treatment effects between the E-alone and the E + P trial, so the analyses were conducted with participants combined from both trials. Treatment benefits (p < 0.05) on femur geometry were observed as early as 1 yr after the intervention. From baseline to year 6, section modulus (a measure of maximum bending stress) was preserved, and buckling ratio (an index of cortical instability under compression) was reduced by hormone interventions (p < 0.05); the differences in the percent changes from baseline to year 6 between women on hormone intervention versus women on placebo were 2.3–3.6% for section modulus and –5.3% to – 4.3% for buckling ratio. Hormone interventions led to favorable changes in femur geometry, which may help explain the reduced fracture risk observed in hormone interventions. PMID:18665788

34 CFR 303.112 - Availability of early intervention services.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Availability of early intervention services. 303.112... SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR... System Minimum Components of A Statewide System § 303.112 Availability of early intervention services...

34 CFR 303.112 - Availability of early intervention services.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Availability of early intervention services. 303.112... SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR... System Minimum Components of A Statewide System § 303.112 Availability of early intervention services...

34 CFR 303.112 - Availability of early intervention services.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Availability of early intervention services. 303.112... SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION PROGRAM FOR... System Minimum Components of A Statewide System § 303.112 Availability of early intervention services...

Qualitative "trial-sibling" studies and "unrelated" qualitative studies contributed to complex intervention reviews.

PubMed

Noyes, Jane; Hendry, Margaret; Lewin, Simon; Glenton, Claire; Chandler, Jackie; Rashidian, Arash

2016-06-01

To compare the contribution of "trial-sibling" and "unrelated" qualitative studies in complex intervention reviews. Researchers are using qualitative "trial-sibling" studies undertaken alongside trials to provide explanations to understand complex interventions. In the absence of qualitative "trial-sibling" studies, it is not known if qualitative studies "unrelated" to trials are helpful. Trials, "trial-sibling," and "unrelated" qualitative studies looking at three health system interventions were identified. We looked for similarities and differences between the two types of qualitative studies, such as participants, intervention delivery, context, study quality and reporting, and contribution to understanding trial results. Reporting was generally poor in both qualitative study types. We detected no substantial differences in participant characteristics. Interventions in qualitative "trial-sibling" studies were delivered using standardized protocols, whereas interventions in "unrelated" qualitative studies were delivered in routine care. Qualitative "trial-sibling" studies alone provided insufficient data to develop meaningful transferrable explanations beyond the trial context, and their limited focus on immediate implementation did not address all phenomena of interest. Together, "trial-sibling" and "unrelated" qualitative studies provided larger, richer data sets across contexts to better understand the phenomena of interest. Findings support inclusion of "trial-sibling" and "unrelated" qualitative studies to explore complexity in complex intervention reviews. Copyright © 2016 Elsevier Inc. All rights reserved.

Reporting Quality of Social and Psychological Intervention Trials: A Systematic Review of Reporting Guidelines and Trial Publications

PubMed Central

Grant, Sean P.; Mayo-Wilson, Evan; Melendez-Torres, G. J.; Montgomery, Paul

2013-01-01

Background Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. Objective/Design We conducted a two-part study that reviewed (1) reporting guidelines for and (2) the reporting quality of social and psychological intervention trials. Data Sources (1) To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2) To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. Eligibility (1) Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2) Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. Results (1) We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2) Our review of trials (n = 239) revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information) and abstracts (55%); information about blinding (15%), sequence generation (23%), and allocation concealment (17%); and details about actual delivery of experimental (43%) and control interventions (34%), participant uptake (25%), and service environment (28%). Only 11 of 40 journals referenced reporting guidelines in “Instructions to Authors.” Conclusion Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely

Development of an internet version of the Lidcombe Program of early stuttering intervention: A trial of Part 1.

PubMed

Van Eerdenbrugh, Sabine; Packman, Ann; Onslow, Mark; O'brian, Sue; Menzies, Ross

2018-04-01

There is evidence that access to treatment for early stuttering is not available for all who need it. An internet version of the Lidcombe Program for early stuttering (Internet-LP) has been developed to deal with this shortfall. The LP is suitable for such development because it is delivered by parents in the child's everyday environment, with training by a speech-language pathologist. A Phase I trial of Internet-LP Part 1, comprising parent training, is reported here. Eight parents of pre-schoolers who stutter were recruited and six completed the trial. Post-trial assessment indicated that the parents scored well for identifying and measuring stuttering and for knowledge about conducting practice sessions, including how to present verbal contingencies during practice sessions. The results prompted minor adjustments to Part 1 and guided the construction of Part 2, which instructs parents during the remainder of the treatment process.

Non-pharmacological Interventions for Adults with Mild Cognitive Impairment and Early Stage Dementia: An Updated Scoping Review

PubMed Central

Rodakowski, Juleen; Saghafi, Ester; Butters, Meryl A.; Skidmore, Elizabeth R.

2015-01-01

The purpose of this scoping review was to examine the science related to non-pharmacological interventions designed to slow decline for older adults with Mild Cognitive Impairment or early-stage dementia. We reviewed 32 unique randomized controlled trials that employed cognitive training (remediation or compensation approaches), physical exercise, or psychotherapeutic interventions that were published before November 2014. Evidence suggests that cognitive training focused on remediation and physical exercise interventions may promote small improvements in selected cognitive abilities. Cognitive training focused on compensation interventions and selected psychotherapeutic interventions may influence how cognitive changes impact daily living. However, confidence in these findings is limited due methodological limitations. To better assess the value of non-pharmacological interventions for this population, we recommend: 1) adoption of universal criteria for “early stage cognitive decline” among studies, 2) adherence to guidelines for the conceptualization, operationalization, and implementation of complex interventions, 3) consistent characterization of the impact of interventions on daily life, and 3) long-term follow-up of clinical outcomes to assess maintenance and meaningfulness of reported effects over time. PMID:26070444

Goal-oriented cognitive rehabilitation in early-stage dementia: study protocol for a multi-centre single-blind randomised controlled trial (GREAT)

PubMed Central

2013-01-01

Background Preliminary evidence suggests that goal-oriented cognitive rehabilitation (CR) may be a clinically effective intervention for people with early-stage Alzheimer’s disease, vascular or mixed dementia and their carers. This study aims to establish whether CR is a clinically effective and cost-effective intervention for people with early-stage dementia and their carers. Methods/design In this multi-centre, single-blind randomised controlled trial, 480 people with early-stage dementia, each with a carer, will be randomised to receive either treatment as usual or cognitive rehabilitation (10 therapy sessions over 3 months, followed by 4 maintenance sessions over 6 months). We will compare the effectiveness of cognitive rehabilitation with that of treatment as usual with regard to improving self-reported and carer-rated goal performance in areas identified as causing concern by people with early-stage dementia; improving quality of life, self-efficacy, mood and cognition of people with early-stage dementia; and reducing stress levels and ameliorating quality of life for carers of participants with early-stage dementia. The incremental cost-effectiveness of goal-oriented cognitive rehabilitation compared to treatment as usual will also be examined. Discussion If the study confirms the benefits and cost-effectiveness of cognitive rehabilitation, it will be important to examine how the goal-oriented cognitive rehabilitation approach can most effectively be integrated into routine health-care provision. Our aim is to provide training and develop materials to support the implementation of this approach following trial completion. Trial registration Current Controlled Trials ISRCTN21027481 PMID:23710796

Employment and educational outcomes in early intervention programmes for early psychosis: a systematic review.

PubMed

Bond, G R; Drake, R E; Luciano, A

2015-10-01

Young adults with early psychosis want to pursue normal roles - education and employment. This paper summarises the empirical literature on the effectiveness of early intervention programmes for employment and education outcomes. We conducted a systematic review of employment/education outcomes for early intervention programmes, distinguishing three programme types: (1) those providing supported employment, (2) those providing unspecified vocational services and (3) those without vocational services. We summarised findings for 28 studies. Eleven studies evaluated early intervention programmes providing supported employment. In eight studies that reported employment outcomes separately from education outcomes, the employment rate during follow-up for supported employment patients was 49%, compared with 29% for patients receiving usual services. The two groups did not differ on enrolment in education. In four controlled studies, meta-analysis showed that the employment rate for supported employment participants was significantly higher than for control participants, odds ratio = 3.66 [1.93-6.93], p < 0.0001. Five studies (four descriptive and one quasi-experimental) of early intervention programmes evaluating unspecified vocational services were inconclusive. Twelve studies of early intervention programmes without vocational services were methodologically heterogeneous, using diverse methods for evaluating vocational/educational outcomes and precluding a satisfactory meta-analytic synthesis. Among studies with comparison groups, 7 of 11 (64%) reported significant vocational/education outcomes favouring early intervention over usual services. In early intervention programmes, supported employment moderately increases employment rates but not rates of enrolment in education. These improvements are in addition to the modest effects early programmes alone have on vocational/educational outcomes compared with usual services.

Frameworks for Proof-of-Concept Clinical Trials of Interventions That Target Fundamental Aging Processes

PubMed Central

Justice, Jamie; Miller, Jordan D.; Newman, John C.; Hashmi, Shahrukh K.; Halter, Jeffrey; Austad, Steve N.; Barzilai, Nir

2016-01-01

Therapies targeted at fundamental processes of aging may hold great promise for enhancing the health of a wide population by delaying or preventing a range of age-related diseases and conditions—a concept dubbed the “geroscience hypothesis.” Early, proof-of-concept clinical trials will be a key step in the translation of therapies emerging from model organism and preclinical studies into clinical practice. This article summarizes the outcomes of an international meeting partly funded through the NIH R24 Geroscience Network, whose purpose was to generate concepts and frameworks for early, proof-of-concept clinical trials for therapeutic interventions that target fundamental processes of aging. The goals of proof-of-concept trials include generating preliminary signals of efficacy in an aging-related disease or outcome that will reduce the risk of conducting larger trials, contributing data and biological samples to support larger-scale research by strategic networks, and furthering a dialogue with regulatory agencies on appropriate registration indications. We describe three frameworks for proof-of-concept trials that target age-related chronic diseases, geriatric syndromes, or resilience to stressors. We propose strategic infrastructure and shared resources that could accelerate development of therapies that target fundamental aging processes. PMID:27535966

Case Study in Ethics of Research: The Bucharest Early Intervention Project

PubMed Central

Zeanah, Charles H.; Fox, Nathan A.; Nelson, Charles A.

2014-01-01

The Bucharest Early Intervention Project is the first ever randomized controlled trial of foster care as an alternative to institutional care for young abandoned children. This paper examines ethical issues in the conceptualization and implementation of the study, which involved American investigators conducting research in another country, as well as vulnerable participants. We organize discussion of ethical questions about the study around several key issues. These include the nature and location of the vulnerable study population, the social value of conducting the study, risks and benefits of participating in the study to participants, and the post-trial obligations of the investigators. In discussing how these questions were addressed as the study was designed and after it was initiated, we describe our attempts to wed sound scientific practices with meaningful ethical protections for participants. PMID:22373763

Structuring Process Evaluation to Forecast Use and Sustainability of an Intervention: Theory and Data from the Efficacy Trial for "Lunch Is in the Bag"

ERIC Educational Resources Information Center

Roberts-Gray, Cindy; Sweitzer, Sara J.; Ranjit, Nalini; Potratz, Christa; Rood, Magdalena; Romo-Palafox, Maria Jose; Byrd-Williams, Courtney E.; Briley, Margaret E.; Hoelscher, Deanna M.

2017-01-01

Background: A cluster-randomized trial at 30 early care and education centers (Intervention = 15, waitlist Control = 15) showed the "Lunch Is in the Bag" intervention increased parents' packing of fruits, vegetables, and whole grains in their preschool children's bag lunches (parent-child dyads = 351 Intervention, 282 Control). Purpose:…

Use and Appreciation of a Tailored Self-Management eHealth Intervention for Early Cancer Survivors: Process Evaluation of a Randomized Controlled Trial.

PubMed

Kanera, Iris Maria; Willems, Roy A; Bolman, Catherine A W; Mesters, Ilse; Zambon, Victor; Gijsen, Brigitte Cm; Lechner, Lilian

2016-08-23

A fully automated computer-tailored Web-based self-management intervention, Kanker Nazorg Wijzer (KNW [Cancer Aftercare Guide]), was developed to support early cancer survivors to adequately cope with psychosocial complaints and to promote a healthy lifestyle. The KNW self-management training modules target the following topics: return to work, fatigue, anxiety and depression, relationships, physical activity, diet, and smoking cessation. Participants were guided to relevant modules by personalized module referral advice that was based on participants’ current complaints and identified needs. The aim of this study was to evaluate the adherence to the module referral advice, examine the KNW module use and its predictors, and describe the appreciation of the KNW and its predictors. Additionally, we explored predictors of personal relevance. This process evaluation was conducted as part of a randomized controlled trial. Early cancer survivors with various types of cancer were recruited from 21 Dutch hospitals. Data from online self-report questionnaires and logging data were analyzed from participants allocated to the intervention condition. Chi-square tests were applied to assess the adherence to the module referral advice, negative binominal regression analysis was used to identify predictors of module use, multiple linear regression analysis was applied to identify predictors of the appreciation, and ordered logistic regression analysis was conducted to explore possible predictors of perceived personal relevance. From the respondents (N=231; mean age 55.6, SD 11.5; 79.2% female [183/231]), 98.3% (227/231) were referred to one or more KNW modules (mean 2.9, SD 1.5), and 85.7% (198/231) of participants visited at least one module (mean 2.1, SD 1.6). Significant positive associations were found between the referral to specific modules (range 1-7) and the use of corresponding modules. The likelihoods of visiting modules were higher when respondents were referred to

Overview of Play: Its Uses and Importance in Early Intervention/Early Childhood Special Education

ERIC Educational Resources Information Center

Lifter, Karin; Foster-Sanda, Suzanne; Arzamarski, Caley; Briesch, Jacquelyn; McClure, Ellen

2011-01-01

Play is a natural activity of early childhood, which has great relevance to the fields of early intervention, early childhood special education, and early childhood education. Within these fields, ongoing tensions persist in how play is described and used. These tensions compromise activities of assessment, intervention, and curriculum development…

A Very Early Rehabilitation Trial after stroke (AVERT): a Phase III, multicentre, randomised controlled trial.

PubMed

Langhorne, Peter; Wu, Olivia; Rodgers, Helen; Ashburn, Ann; Bernhardt, Julie

2017-09-01

Mobilising patients early after stroke [early mobilisation (EM)] is thought to contribute to the beneficial effects of stroke unit care but it is poorly defined and lacks direct evidence of benefit. We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke. We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation. The trial took place in 56 acute stroke units in five countries. We included adult patients with a first or recurrent stroke who met physiological inclusion criteria. Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke. The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis. Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation. We recruited 2104 (UK, n  = 610; Australasia, n  = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p  < 0.0001] earlier, with an additional three (95% CI 3.0 to 3.5; p  < 0.0001) mobilisation sessions per day. Fewer patients in the VEM group ( n  = 480, 46%) had a favourable outcome than in the UC group ( n  = 525, 50%) (adjusted odds ratio 0.73, 95% CI 0.59 to 0.90; p  = 0.004). Results were consistent between Australasian and UK settings. There were no statistically significant differences in secondary outcomes at 3 months and QoL at 12 months. Dose-response analysis found a consistent pattern of an improved odds of efficacy and safety outcomes in

Harms, benefits, and the nature of interventions in pragmatic clinical trials.

PubMed

Ali, Joseph; Andrews, Joseph E; Somkin, Carol P; Rabinovich, C Egla

2015-10-01

To produce evidence capable of informing healthcare decision making at all critical levels, pragmatic clinical trials are diverse both in terms of the type of intervention (medical, behavioral, and/or technological) and the target of intervention (patients, clinicians, and/or healthcare system processes). Patients and clinicians may be called on to participate as designers, investigators, intermediaries, or subjects of pragmatic clinical trials. Other members of the healthcare team, as well as the healthcare system itself, also may be affected directly or indirectly before, during, or after study implementation. This diversity in the types and targets of pragmatic clinical trial interventions has brought into focus the need to consider whether existing ethics and regulatory principles, policies, and procedures are appropriate for pragmatic clinical trials. Specifically, further examination is needed to identify how the types and targets of pragmatic clinical trial interventions may influence the assessment of net potential risk, understood as the balance of potential harms and benefits. In this article, we build on scholarship seeking to align ethics and regulatory requirements with potential research risks and propose an approach to the assessment of net risks that is sensitive to the diverse nature of pragmatic clinical trial interventions. We clarify the potential harms, burdens, benefits, and advantages of common types of pragmatic clinical trial interventions and discuss implications for patients, clinicians, and healthcare systems. © The Author(s) 2015.

Embedded Professional Development and Classroom-Based Early Reading Intervention: Early Diagnostic Reading Intervention through Coaching

ERIC Educational Resources Information Center

Amendum, Steven J.

2014-01-01

The purpose of the current mixed-methods study was to investigate a model of professional development and classroom-based early reading intervention implemented by the 1st-grade teaching team in a large urban/suburban school district in the southeastern United States. The intervention provided teachers with ongoing embedded professional…

Early Nutrition and Physical Activity Interventions in Childhood Cancer Survivors

PubMed Central

Zhang, Fang Fang; Kelly, Michael J.; Must, Aviva

2017-01-01

Purpose of review Childhood cancer survivors experience excessive weight gain early in treatment. Lifestyle interventions need to be initiated early in cancer care to prevent the early onset of obesity and cardiovascular disease (CVD). We reviewed the existing literature on early lifestyle interventions in childhood cancer survivors and consider implications for clinical care. Recent findings Few lifestyle interventions focus on improving nutrition in childhood cancer survivors. A consistent effect on reducing obesity and CVD risk factors is not evident from the limited number of studies with heterogeneous intervention characteristics, although interventions with a longer duration and follow-up show more promising trends. Summary Future lifestyle interventions should be of a longer duration and include a nutrition component. Interventions with a longer duration and follow-up are needed to assess the timing and sustainability of the intervention effect. Lifestyle interventions introduced early in cancer care are both safe and feasible. PMID:28455678

Ethical Challenges of Randomized Violence Intervention Trials: Examining the SHARE intervention in Rakai, Uganda

PubMed Central

Wagman, Jennifer A.; Paul, Amy; Namatovu, Fredinah; Ssekubugu, Robert; Nalugoda, Fred

2016-01-01

Objective We identify complexities encountered, including unanticipated crossover between trial arms and inadequate ‘standard of care’ violence services, during a cluster randomized trial (CRT) of a community-level intimate partner violence (IPV) and HIV prevention intervention in Uganda. Methods Concepts in public health ethics - beneficence, social value of research, fairness, standard of care, and researcher responsibilities for post-trial benefits - are used to critically reflect on lessons learned and guide discussion on practical and ethical challenges of violence intervention CRTs. Results Existing ethical guidelines provide incomplete guidance for responding to unexpected crossover in CRTs providing IPV services. We struggled to balance duty of care with upholding trial integrity, and identifying and providing appropriate standard of care. While we ultimately offered short-term IPV services to controls, we faced additional challenges related to sustaining services beyond the ‘short-term’ and post-trial. Conclusion Studies evaluating community-level violence interventions, including those combined with HIV reduction strategies, are limited yet critical for developing evidence-based approaches for effectively preventing IPV. Although CRTs are a promising design, further guidance is needed to implement trials that avoid introducing tensions between validity of findings, researchers’ responsibilities to protect participants, and equitable distribution of CRT benefits. PMID:27453794

Velocardiofacial Syndrome and Early Intervention Providers: Recommendations for Intervention

ERIC Educational Resources Information Center

Boyer, Valerie E.; Fullman, Leah I.; Bruns, Deborah A.

2012-01-01

Velocardiofacial syndrome (VCFS), the most common microdeletion syndrome, is increasingly diagnosed in young children because of advances in diagnostic testing. The result is an increase in the number of young children with VCFS referred for early intervention (EI) services. We describe early development of children with VCFS and strategies to…

Microrandomized trials: An experimental design for developing just-in-time adaptive interventions.

PubMed

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

2015-12-01

This article presents an experimental design, the microrandomized 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. Microrandomized 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. The article describes the microrandomized 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. Microrandomized trials enable causal modeling of proximal effects of the randomized intervention components and assessment of time-varying moderation of those effects. Microrandomized 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. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Testosterone reactivity to provocation mediates the effect of early intervention on aggressive behavior.

PubMed

Carré, Justin M; Iselin, Anne-Marie R; Welker, Keith M; Hariri, Ahmad R; Dodge, Kenneth A

2014-05-01

We tested the hypotheses that the Fast Track intervention program for high-risk children would reduce adult aggressive behavior and that this effect would be mediated by decreased testosterone responses to social provocation. Participants were a subsample of males from the full trial sample, who during kindergarten had been randomly assigned to the 10-year Fast Track intervention or to a control group. The Fast Track program attempted to develop children's social competencies through child social-cognitive and emotional-coping skills training, peer-relations coaching, academic tutoring, and classroom management, as well as training for parents to manage their child's behavior. At a mean age of 26 years, participants responded to laboratory provocations. Results indicated that, relative to control participants, men assigned to the intervention demonstrated reduced aggression and testosterone reactivity to social provocations. Moreover, reduced testosterone reactivity mediated the effect of intervention on aggressive behavior, which provides evidence for an enduring biological mechanism underlying the effect of early psychosocial intervention on aggressive behavior in adulthood.

The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants

PubMed Central

Zelkowitz, Phyllis; Feeley, Nancy; Shrier, Ian; Stremler, Robyn; Westreich, Ruta; Dunkley, David; Steele, Russell; Rosberger, Zeev; Lefebvre, Francine; Papageorgiou, Apostolos

2008-01-01

on the efficacy of a brief, skills-based intervention to reduce anxiety and increase sensitivity in mothers of very low birthweight infants. A brief intervention of this nature may be more readily implemented as part of standard neonatal intensive care than broad-based, multi-component interventions. By intervening early, we aim to optimize developmental outcomes in these high risk infants. Trial Registration Current Controlled Trials ISRCTN00918472 The Cues and Care Trial: A randomized controlled trial of an intervention to reduce maternal anxiety and improve developmental outcomes in very low birthweight infants PMID:18822128

Simulations for designing and interpreting intervention trials in infectious diseases.

PubMed

Halloran, M Elizabeth; Auranen, Kari; Baird, Sarah; Basta, Nicole E; Bellan, Steven E; Brookmeyer, Ron; Cooper, Ben S; DeGruttola, Victor; Hughes, James P; Lessler, Justin; Lofgren, Eric T; Longini, Ira M; Onnela, Jukka-Pekka; Özler, Berk; Seage, George R; Smith, Thomas A; Vespignani, Alessandro; Vynnycky, Emilia; Lipsitch, Marc

2017-12-29

Interventions in infectious diseases can have both direct effects on individuals who receive the intervention as well as indirect effects in the population. In addition, intervention combinations can have complex interactions at the population level, which are often difficult to adequately assess with standard study designs and analytical methods. Herein, we urge the adoption of a new paradigm for the design and interpretation of intervention trials in infectious diseases, particularly with regard to emerging infectious diseases, one that more accurately reflects the dynamics of the transmission process. In an increasingly complex world, simulations can explicitly represent transmission dynamics, which are critical for proper trial design and interpretation. Certain ethical aspects of a trial can also be quantified using simulations. Further, after a trial has been conducted, simulations can be used to explore the possible explanations for the observed effects. Much is to be gained through a multidisciplinary approach that builds collaborations among experts in infectious disease dynamics, epidemiology, statistical science, economics, simulation methods, and the conduct of clinical trials.

Community-based early intervention for language delay: a preliminary investigation.

PubMed

Ciccone, Natalie; Hennessey, Neville; Stokes, Stephanie F

2012-01-01

A trial parent-focused early intervention (PFEI) programme for children with delayed language development is reported in which current research evidence was translated and applied within the constraints of available of clinical resources. The programme, based at a primary school, was run by a speech-language pathologist with speech-language pathology students. To investigate the changes in child language development and parent and child interactions following attendance at the PFEI. Eighteen parents and their children attended six, weekly group sessions in which parents were provided with strategies to maximize language learning in everyday contexts. Pre- and post-programme assessments of vocabulary size and measures of parent-child interaction were collected. Parents and children significantly increased their communicative interactions from pre- to post-treatment. Children's expressive vocabulary size and language skills increased significantly. Large-effect sizes were observed. The positive outcomes of the intervention programme contribute to the evidence base of intervention strategies and forms of service delivery for children at risk of language delay. © 2012 Royal College of Speech and Language Therapists.

Recruitment strategies and challenges in a large intervention trial: Systolic Blood Pressure Intervention Trial (SPRINT)

PubMed Central

Ramsey, Thomas M; Snyder, Joni K; Lovato, Laura C; Roumie, Christianne L; Glasser, Steven P; Cosgrove, Nora M; Olney, Christine M; Tang, Rocky H; Johnson, Karen C; Still, Carolyn H; Gren, Lisa H; Childs, Jeffery C; Crago, Osa L; Summerson, John H; Walsh, Sandy M; Perdue, Letitia H; Bankowski, Denise M; Goff, David C

2016-01-01

Background The Systolic Blood Pressure Intervention Trial (SPRINT) is a multicenter, randomized clinical trial of 9,361 participants with hypertension who are ≥ 50 years old. The trial is designed to evaluate the effect of intensive systolic blood pressure control (systolic blood pressure goal <120 mm Hg) compared to standard control (systolic blood pressure goal <140 mm Hg) on cardiovascular events using commonly prescribed antihypertensive medications and lifestyle modification. Objective To describe the recruitment strategies and lessons learned during recruitment of the SPRINT cohort and five targeted participant subgroups: pre-existing cardiovascular disease, pre-existing chronic kidney disease, age ≥ 75 years, women, and minorities. Methods In collaboration with the National Institutes of Health Project Office and SPRINT Coordinating Center, five Clinical Center Networks oversaw clinical site selection, recruitment, and trial activities. Recruitment began November 8, 2010 and ended March 15, 2013 (about 28 months). Various recruitment strategies were used, including mass mailing, brochures, referrals from healthcare providers or friends, posters, newspaper ads, radio ads, and electronic medical record searches. Results Recruitment was scheduled to last 24 months to enroll a target of 9,250 participants; in just over 28 months, the trial enrolled 9,361 participants. The trial screened 14,692 volunteers, with 33% of initial screens originating from the use of mass mailing lists. Screening results show that participants also responded to recruitment efforts through referral by SPRINT staff, healthcare providers, or friends (45%); brochures or posters placed in clinic waiting areas (15%); and television, radio, newspaper, internet ads, or toll-free numbers (8%). The overall recruitment yield (number randomized /number screened) was 64% (9,361 randomized /14,692 screened), 77% for those with cardiovascular disease, 79% for those with chronic kidney disease, 70

Nutrition Intervention Trials in Linxian, China

Cancer.gov

Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population

Alzheimer's disease prevention: from risk factors to early intervention.

PubMed

Crous-Bou, Marta; Minguillón, Carolina; Gramunt, Nina; Molinuevo, José Luis

2017-09-12

Due to the progressive aging of the population, Alzheimer's disease (AD) is becoming a healthcare burden of epidemic proportions for which there is currently no cure. Disappointing results from clinical trials performed in mild-moderate AD dementia combined with clear epidemiological evidence on AD risk factors are contributing to the development of primary prevention initiatives. In addition, the characterization of the long asymptomatic stage of AD is allowing the development of intervention studies and secondary prevention programmes on asymptomatic at-risk individuals, before substantial irreversible neuronal dysfunction and loss have occurred, an approach that emerges as highly relevant.In this manuscript, we review current strategies for AD prevention, from primary prevention strategies based on identifying risk factors and risk reduction, to secondary prevention initiatives based on the early detection of the pathophysiological hallmarks and intervention at the preclinical stage of the disease. Firstly, we summarize the evidence on several AD risk factors, which are the rationale for the establishment of primary prevention programmes as well as revising current primary prevention strategies. Secondly, we review the development of public-private partnerships for disease prevention that aim to characterize the AD continuum as well as serving as platforms for secondary prevention trials. Finally, we summarize currently ongoing clinical trials recruiting participants with preclinical AD or a higher risk for the onset of AD-related cognitive impairment.The growing body of research on the risk factors for AD and its preclinical stage is favouring the development of AD prevention programmes that, by delaying the onset of Alzheimer's dementia for only a few years, would have a huge impact on public health.

Clinical outcomes of an early intervention program for preschool children with Autism Spectrum Disorder in a community group setting.

PubMed

Eapen, Valsamma; Crnčec, Rudi; Walter, Amelia

2013-01-07

Available evidence indicates that early intervention programs, such as the Early Start Denver Model (ESDM), can positively affect key outcomes for children with Autism Spectrum Disorder (ASD). However, programs involving resource intensive one-to-one clinical intervention are not readily available or deliverable in the community, resulting in many children with ASD missing out on evidence-based intervention during their early and most critical preschool years. This study evaluated the effectiveness of the ESDM for preschool-aged children with ASD using a predominantly group-based intervention in a community child care setting. Participants were 26 children (21 male) with ASD with a mean age of 49.6 months. The ESDM, a comprehensive early intervention program that integrates applied behaviour analysis with developmental and relationship-based approaches, was delivered by trained therapists during the child's attendance at a child care centre for preschool-aged children with ASD. Children received 15-20 hours of group-based, and one hour of one-to-one, ESDM intervention per week. The average intervention period was ten months. Outcome measures were administered pre- and post-intervention, and comprised a developmental assessment - the Mullen Scales of Early Learning (MSEL); and two parent-report questionnaires - the Social Communication Questionnaire (SCQ) and Vineland Adaptive Behaviours Scales-Second Edition (VABS-II). Statistically significant post-intervention improvements were found in children's performance on the visual reception, receptive language and expressive language domains of the MSEL in addition to their overall intellectual functioning, as assessed by standardised developmental quotients. Parents reported significant increases in their child's receptive communication and motor skills on the VABS-II, and a significant decrease in autism-specific features on the SCQ. These effects were of around medium size, and appeared to be in excess of what may

A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

PubMed Central

2012-01-01

Background Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. Design A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures

A randomized trial to investigate the effects of pre-natal and infant nutritional supplementation on infant immune development in rural Gambia: the ENID trial: Early Nutrition and Immune Development.

PubMed

Moore, Sophie E; Fulford, Anthony Jc; Darboe, Momodou K; Jobarteh, Modou Lamin; Jarjou, Landing M; Prentice, Andrew M

2012-10-11

Recent observational research indicates that immune development may be programmed by nutritional exposures early in life. Such findings require replication from trials specifically designed to assess the impact of nutritional intervention during pregnancy on infant immune development. The current trial seeks to establish: (a) which combination of protein-energy (PE) and multiple-micronutrient (MMN) supplements would be most effective; and (b) the most critical periods for intervention in pregnancy and infancy, for optimal immune development in infancy. The ENID Trial is a 2 x 2 x 2 factorial randomized, partially blind trial to assess whether nutritional supplementation to pregnant women (from < 20 weeks gestation to term) and their infants (from 6 to 12 months of age) can enhance infant immune development. Eligible pregnant women from the West Kiang region of The Gambia (pregnancy dated by ultrasound examination) are randomized on entry to 4 intervention groups (Iron-folate (FeFol = standard care), multiple micronutrients (MMN), protein-energy (PE), PE + MMN). Women are visited at home weekly for supplement administration and morbidity assessment and seen at MRC Keneba at 20 and 30 weeks gestation for a detailed antenatal examination, including ultrasound. At delivery, cord blood and placental samples are collected, with detailed infant anthropometry collected within 72 hours. Infants are visited weekly thereafter for a morbidity questionnaire. From 6 to 12 months of age, infants are further randomized to a lipid-based nutritional supplement, with or without additional MMN. The primary outcome measures of this study are thymic development during infancy, and antibody response to vaccination. Measures of cellular markers of immunity will be made in a selected sub-cohort. Subsidiary studies to the main trial will additionally assess the impact of supplementation on infant growth and development to 24 months of age. The proposed trial is designed to test whether

Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

ERIC Educational Resources Information Center

Putwain, David W.; Pescod, Marc

2018-01-01

The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

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…

Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

PubMed

Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

2016-01-01

Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline

34 CFR 303.126 - Early intervention services in natural environments.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 34 Education 2 2012-07-01 2012-07-01 false Early intervention services in natural environments...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... Statewide System Minimum Components of A Statewide System § 303.126 Early intervention services in natural...

34 CFR 303.126 - Early intervention services in natural environments.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 34 Education 2 2014-07-01 2013-07-01 true Early intervention services in natural environments. 303...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... Statewide System Minimum Components of A Statewide System § 303.126 Early intervention services in natural...

34 CFR 303.126 - Early intervention services in natural environments.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 34 Education 2 2013-07-01 2013-07-01 false Early intervention services in natural environments...) OFFICE OF SPECIAL EDUCATION AND REHABILITATIVE SERVICES, DEPARTMENT OF EDUCATION EARLY INTERVENTION... Statewide System Minimum Components of A Statewide System § 303.126 Early intervention services in natural...

Webcam delivery of the Lidcombe program for early stuttering: a phase I clinical trial.

PubMed

O'Brian, Sue; Smith, Kylie; Onslow, Mark

2014-06-01

The Lidcombe Program is an operant treatment for early stuttering shown with meta-analysis to have a favorable odds ratio. However, many clients are unable to access the treatment because of distance and lifestyle factors. In this Phase I trial, we explored the potential efficacy, practicality, and viability of an Internet webcam Lidcombe Program service delivery model. Participants were 3 preschool children who stuttered and their parents, all of whom received assessment and treatment using webcam in their homes with no clinic attendance. At 6 months post-Stage 1 completion, all children were stuttering below 1.0% syllables stuttered. The webcam intervention was acceptable to the parents and appeared to be practical and viable, with only occasional audiovisual problems. At present, there is no reason to doubt that a webcam-delivered Lidcombe Program will be shown with clinical trials to have comparable efficacy with the clinic version. Webcam-delivered Lidcombe Program intervention is potentially efficacious, is practical and viable, and requires further exploration with comparative clinical trials and a qualitative study of parent and caregiver experiences.

Combining child social skills training with a parent early intervention program for inhibited preschool children.

PubMed

Lau, Elizabeth X; Rapee, Ronald M; Coplan, Robert J

2017-10-01

Previous studies have demonstrated the efficacy of early intervention for anxiety in preschoolers through parent-education. The current study evaluated a six-session early intervention program for preschoolers at high risk of anxiety disorders in which a standard educational program for parents was supplemented by direct training of social skills to the children. Seventy-two children aged 3-5 years were selected based on high behavioural inhibition levels and concurrently having a parent with high emotional distress. Families were randomly assigned to either the intervention group, which consisted of six parent-education group sessions and six child social skills training sessions, or waitlist. After six months, families on waitlist were offered treatment consisting of parent-education only. Relative to waitlist, children in the combined condition showed significantly fewer clinician-rated anxiety disorders and diagnostic severity and maternal (but not paternal) reported anxiety symptoms and life interference at six months. Mothers also reported less overprotection. These gains were maintained at 12-month follow-up. Parent only education following waitlist produced similar improvements among children. Quasi-experimental comparison between combined and parent-only interventions indicated greater reductions from combined intervention according to clinician reports, but no significant differences on maternal reports. Results suggest that this brief early intervention program for preschoolers with both parent and child components significantly reduces risk and disorder in vulnerable children. The inclusion of a child component might have the potential to increase effects over parent-only intervention. However, future support for this conclusion through long-term, randomised controlled trials is needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Developing a Reporting Guideline for Social and Psychological Intervention Trials

PubMed Central

Mayo-Wilson, Evan; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Grant, Sean

2013-01-01

Understanding randomized controlled trials of complex social and psychological interventions requires a detailed description of the interventions tested and the methods used to evaluate them. However, randomized controlled trial reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. We explain how reporting guidelines have improved the quality of reports in medicine, and describe the ongoing development of a new reporting guideline for randomized controlled trials: an extension of the Consolidated Standards of Reporting Trials for social and psychological interventions. We invite readers to participate in the project by visiting our Web site, to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/consort-study). PMID:23947317

Early Intervention for Children with Disabilities: The Australian Experience.

ERIC Educational Resources Information Center

Pieterse, Moira, Ed.; And Others

A collection of papers on the Australian experience with early intervention for children with disabilities gives regional overviews, describes specific intervention programs, and discusses a variety of issues. Overviews are given of early intervention in Australia in general, New South Wales, Victoria, Queensland, South Australia, Western…

Five years of specialised early intervention versus two years of specialised early intervention followed by three years of standard treatment for patients with a first episode psychosis: randomised, superiority, parallel group trial in Denmark (OPUS II).

PubMed

Albert, Nikolai; Melau, Marianne; Jensen, Heidi; Emborg, Charlotte; Jepsen, Jens Richardt Mollegaard; Fagerlund, Birgitte; Gluud, Christian; Mors, Ole; Hjorthøj, Carsten; Nordentoft, Merete

2017-01-12

To compare the effects of five years of specialised early intervention (SEI) treatment for first episode schizophrenia spectrum disorder with the standard two years of SEI plus three years of treatment as usual. Randomised, superiority, parallel group trial with blinded outcome assessment. Randomisation was centralised and computerised with concealed randomisation sequence carried out at an external site. Participants were recruited from six OPUS teams in Denmark between 2009 and 2012. OPUS teams provide SEI treatment to all patients diagnosed with a schizophrenia spectrum disorder in Denmark. 400 participants (51% women) with a mean age of 25.6 (standard deviation 4.3) were randomised to five years of SEI (experimental intervention; n=197) or to two years of SEI plus three years of treatment as usual (control; n=203). OPUS treatment consists of three core elements-modified assertive community treatment, family involvement, and social skill training-with a patient-case manager ratio of no more than 12:1. For participants randomised to five years of OPUS treatment, the treatment was largely unchanged. Participants randomised to the control group were mostly referred to community health centres after two years of SEI treatment. Follow-up assessments were conducted five years after start of OPUS treatment. Primary outcome was negative symptoms measured on the scale for assessment of negative symptoms (avolition-apathy, anhedonia, alogia, and affective blunting). Secondary outcomes were remission of both negative and psychotic symptoms, psychotic symptoms, suicidal ideation, substance abuse, compliance with medical treatment, adherence with treatment, client satisfaction, days in hospital care, and labour market affiliation. Levels of negative symptoms did not differ between the intervention group and control group (1.72 v 1.81 points; estimated mean difference -0.10 (95% confidence interval -0.33 to 0.13), P=0.39). Participants receiving five years of OPUS treatment

12 CFR 1024.39 - Early intervention requirements for certain borrowers.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 8 2014-01-01 2014-01-01 false Early intervention requirements for certain... SETTLEMENT PROCEDURES ACT (REGULATION X) Mortgage Servicing § 1024.39 Early intervention requirements for... of the user, the revised text is set forth as follows: § 1024.39 Early intervention requirements for...

EARLY INTERVENTIONS FOR PTSD: A REVIEW

PubMed Central

Kearns, Megan C.; Ressler, Kerry J.; Zatzick, Doug; Rothbaum, Barbara Olasov

2013-01-01

The high prevalence of trauma exposure and subsequent negative consequences for both survivors and society as a whole emphasize the need for secondary prevention of posttraumatic stress disorder. However, clinicians and relief workers remain limited in their ability to intervene effectively in the aftermath of trauma and alleviate traumatic stress reactions that can lead to chronic PTSD. The scientific literature on early intervention for PTSD is reviewed, including early studies on psychological debriefing, pharmacological, and psychosocial interventions aimed at preventing chronic PTSD. Studies on fear extinction and memory consolidation are discussed in relation to PTSD prevention and the potential importance of immediate versus delayed intervention approaches and genetic predictors are briefly reviewed. Preliminary results from a modified prolonged exposure intervention applied within hours of trauma exposure in an emergency room setting are discussed, along with considerations related to intervention reach and overall population impact. Suggestions for future research are included. Prevention of PTSD, although currently not yet a reality, remains an exciting and hopeful possibility with current research approaches translating work from the laboratory to the clinic. PMID:22941845

Early intervention influences positively quality of life as reported by prematurely born children at age nine and their parents; a randomized clinical trial.

PubMed

Landsem, Inger Pauline; Handegård, Bjørn Helge; Ulvund, Stein Erik; Kaaresen, Per Ivar; Rønning, John A

2015-02-22

The Tromsø Intervention Study on Preterms evaluates an early, sensitizing intervention given to parents of prematurely born children (birth-weight < 2000 g). The current study investigated the potential influence of the intervention on children's self-reported and parental proxy-reported quality of life (QoL) at children's age of nine. Participants were randomized to either intervention (PI, n = 72) or preterm control (PC, n = 74) in the neonatal care unit, while healthy term-born infants were recruited to a term reference group (TR, n = 75). The intervention was a modified version of the Mother-Infant Transaction Program, and comprised eight one-hour sessions during the last week before discharge and four home visits at 1, 2, 4 and 12 weeks post-discharge. The two control groups received care in accordance with written guidelines drawn up at the hospital. Participants and parents reported QoL independently on the Kinder Lebensqualität Fragebogen (KINDL) questionnaire. Differences between groups were analyzed by SPSS; Linear Mixed Models and parent-child agreement were analyzed and compared by intra-class correlations within each group. On average, children in all groups reported high levels of well-being. The PI children reported better physical well-being than the PC children (p = 0.002). In all other aspects of QoL both the PI and the PC children reported at similar levels as the term reference group. PI parents reported better emotional wellbeing (p = 0.05) and a higher level of contentment in school (p = 0.003) compared with PC parents. Parent-child agreement was significantly weaker in the PI group than in the PC group on dimensions such as emotional well-being and relationships with friends (p < 0.05). PI parents reported QoL similar to parents of terms on all aspects except the subscale self-esteem, while PC parents generally reported moderately lower QoL than TR parents. This early intervention appears to have generated

Impact of Early Intervention on Psychopathology, Crime, and Weil-Being at Age 25

PubMed Central

2015-01-01

Objective This randomized controlled trial tested the efficacy of early intervention to prevent adult psychopathology and improve well-being in early-starting conduct-problem children. Method Kindergarteners (N=9,594) in three cohorts (1991–1993) at 55 schools in four communities were screened for conduct problems, yielding 979 early starters. A total of 891 (91%) consented (51% African American, 47% European American; 69% boys). Children were randomly assigned by school cluster to a 10-year intervention or control. The intervention goal was to develop social competencies in children that would carry them throughout life, through social skills training, parent behavior-management training with home visiting, peer coaching, reading tutoring, and classroom social-emotional curricula. Manualization and supervision ensured program fidelity. Ninety-eight percent participated during grade 1, and 80% continued through grade 10. At age 25, arrest records were reviewed (N=817,92%), and condition-blinded adults psychiatrically interviewed participants (N=702; 81% of living participants) and a peer (N=535) knowledgeable about the participant. Results Intent-to-treat logistic regression analyses indicated that 69% of participants in the control arm displayed at least one externalizing, internalizing, or substance abuse psychiatric problem (based on self- or peer interview) at age 25, in contrast with 59% of those assigned to intervention (odds ratio=0.59, CI=0.43–0.81; number needed to treat=8). This pattern also held for self-interviews, peer interviews, scores using an “and” rule for self- and peer reports, and separate tests for externalizing problems, internalizing problems, and substance abuse problems, as well as for each of three cohorts, four sites, male participants, female participants, African Americans, European Americans, moderate-risk, and high-risk subgroups. Intervention participants also received lower severity-weighted violent (standardized estimate

Effectiveness of a School-Based Early Intervention CBT Group Programme for Children with Anxiety Aged 5-7 Years

ERIC Educational Resources Information Center

Ruocco, Sylvia; Gordon, Jocelynne; McLean, Louise A.

2016-01-01

Early manifestations of anxiety in childhood confer significant distress and life interference. This study reports on the first controlled trial of the "Get Lost Mr. Scary" programme, a Cognitive Behavioural Therapy group intervention for children with anxiety aged 5-7 years. Participants were 134 children (65 males and 69 females) drawn…

Stopping randomized trials early for benefit: a protocol of the Study Of Trial Policy Of Interim Truncation-2 (STOPIT-2)

PubMed Central

Briel, Matthias; Lane, Melanie; Montori, Victor M; Bassler, Dirk; Glasziou, Paul; Malaga, German; Akl, Elie A; Ferreira-Gonzalez, Ignacio; Alonso-Coello, Pablo; Urrutia, Gerard; Kunz, Regina; Culebro, Carolina Ruiz; da Silva, Suzana Alves; Flynn, David N; Elamin, Mohamed B; Strahm, Brigitte; Murad, M Hassan; Djulbegovic, Benjamin; Adhikari, Neill KJ; Mills, Edward J; Gwadry-Sridhar, Femida; Kirpalani, Haresh; Soares, Heloisa P; Elnour, Nisrin O Abu; You, John J; Karanicolas, Paul J; Bucher, Heiner C; Lampropulos, Julianna F; Nordmann, Alain J; Burns, Karen EA; Mulla, Sohail M; Raatz, Heike; Sood, Amit; Kaur, Jagdeep; Bankhead, Clare R; Mullan, Rebecca J; Nerenberg, Kara A; Vandvik, Per Olav; Coto-Yglesias, Fernando; Schünemann, Holger; Tuche, Fabio; Chrispim, Pedro Paulo M; Cook, Deborah J; Lutz, Kristina; Ribic, Christine M; Vale, Noah; Erwin, Patricia J; Perera, Rafael; Zhou, Qi; Heels-Ansdell, Diane; Ramsay, Tim; Walter, Stephen D; Guyatt, Gordon H

2009-01-01

Background Randomized clinical trials (RCTs) stopped early for benefit often receive great attention and affect clinical practice, but pose interpretational challenges for clinicians, researchers, and policy makers. Because the decision to stop the trial may arise from catching the treatment effect at a random high, truncated RCTs (tRCTs) may overestimate the true treatment effect. The Study Of Trial Policy Of Interim Truncation (STOPIT-1), which systematically reviewed the epidemiology and reporting quality of tRCTs, found that such trials are becoming more common, but that reporting of stopping rules and decisions were often deficient. Most importantly, treatment effects were often implausibly large and inversely related to the number of the events accrued. The aim of STOPIT-2 is to determine the magnitude and determinants of possible bias introduced by stopping RCTs early for benefit. Methods/Design We will use sensitive strategies to search for systematic reviews addressing the same clinical question as each of the tRCTs identified in STOPIT-1 and in a subsequent literature search. We will check all RCTs included in each systematic review to determine their similarity to the index tRCT in terms of participants, interventions, and outcome definition, and conduct new meta-analyses addressing the outcome that led to early termination of the tRCT. For each pair of tRCT and systematic review of corresponding non-tRCTs we will estimate the ratio of relative risks, and hence estimate the degree of bias. We will use hierarchical multivariable regression to determine the factors associated with the magnitude of this ratio. Factors explored will include the presence and quality of a stopping rule, the methodological quality of the trials, and the number of total events that had occurred at the time of truncation. Finally, we will evaluate whether Bayesian methods using conservative informative priors to "regress to the mean" overoptimistic tRCTs can correct observed

Methodological Issues in Trials of Complementary and Alternative Medicine Interventions

PubMed Central

Sikorskii, Alla; Wyatt, Gwen; Victorson, David; Faulkner, Gwen; Rahbar, Mohammad Hossein

2010-01-01

Background Complementary and alternative medicine (CAM) use is widespread among cancer patients. Information on safety and efficacy of CAM therapies is needed for both patients and health care providers. Well-designed randomized clinical trials (RCTs) of CAM therapy interventions can inform both clinical research and practice. Objectives To review important issues that affect the design of RCTs for CAM interventions. Methods Using the methods component of the Consolidated Standards for Reporting Trials (CONSORT) as a guiding framework, and a National Cancer Institute-funded reflexology study as an exemplar, methodological issues related to participants, intervention, objectives, outcomes, sample size, randomization, blinding, and statistical methods were reviewed. Discussion Trials of CAM interventions designed and implemented according to appropriate methodological standards will facilitate the needed scientific rigor in CAM research. Interventions in CAM can be tested using proposed methodology, and the results of testing will inform nursing practice in providing safe and effective supportive care and improving the well-being of patients. PMID:19918155

IQ at age 12 following a history of institutional care: Findings from the Bucharest Early Intervention Project

PubMed Central

Almas, Alisa N.; Degnan, Kathryn A.; Nelson, Charles A.; Zeanah, Charles H.; Fox, Nathan A.

2016-01-01

Young children removed from institutions and placed into foster care or adoptive homes have been shown to experience significant gains in IQ relative to children who remain in institutions. Less is known about the long-term impact of severe early deprivation on development in late childhood. Data are presented from a follow-up of children at 12 years of age in the Bucharest Early Intervention Project, a randomized clinical trial of foster care for institutionally reared children. One hundred and seven of the original 136 children in the study were tested with the WISC IV. Results revealed continued benefit from the intervention through age 12, with 12-year-old children placed in foster care scoring significantly higher on full scale IQ compared to their peers who received prolonged institutional care. Longitudinal IQ data revealed two IQ profiles from early to late childhood. Attachment security emerged as a significant predictor of a profile of stable, typical IQ scores over time. We demonstrate the continued importance of foster care intervention and the negative effects of severe, early psychosocial deprivation on IQ into late childhood. PMID:27709994

IQ at age 12 following a history of institutional care: Findings from the Bucharest Early Intervention Project.

PubMed

Almas, Alisa N; Degnan, Kathryn A; Nelson, Charles A; Zeanah, Charles H; Fox, Nathan A

2016-11-01

Young children removed from institutions and placed into foster care or adoptive homes have been shown to experience significant gains in IQ relative to children who remain in institutions. Less is known about the long-term impact of severe early deprivation on development in late childhood. Data are presented from a follow-up of children at 12 years of age in the Bucharest Early Intervention Project, a randomized clinical trial of foster care for institutionally reared children. Of the original 136 children in the study, 107 were tested with the Wechsler Intelligence Scale for Children-IV. Results revealed continued benefit from the intervention through age 12, with 12-year-old children placed in foster care scoring significantly higher on full-scale IQ compared to their peers who received prolonged institutional care. Longitudinal IQ data revealed 2 IQ profiles from early to late childhood. Attachment security emerged as a significant predictor of a profile of stable, typical IQ scores over time. We demonstrate the continued importance of foster care intervention and the negative effects of severe, early psychosocial deprivation on IQ into late childhood. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial.

PubMed

Lin, Pao-Hwa; Intille, Stephen; Bennett, Gary; Bosworth, Hayden B; Corsino, Leonor; Voils, Corrine; Grambow, Steven; Lazenka, Tony; Batch, Bryan C; Tyson, Crystal; Svetkey, Laura P

2015-12-01

The obesity epidemic has spread to young adults, and obesity is a significant risk factor for cardiovascular disease. The prominence and increasing functionality of mobile phones may provide an opportunity to deliver longitudinal and scalable weight management interventions in young adults. The aim of this article is to describe the design and development of the intervention tested in the Cell Phone Intervention for You study and to highlight the importance of adaptive intervention design that made it possible. The Cell Phone Intervention for You study was a National Heart, Lung, and Blood Institute-sponsored, controlled, 24-month randomized clinical trial comparing two active interventions to a usual-care control group. Participants were 365 overweight or obese (body mass index≥25 kg/m2) young adults. Both active interventions were designed based on social cognitive theory and incorporated techniques for behavioral self-management and motivational enhancement. Initial intervention development occurred during a 1-year formative phase utilizing focus groups and iterative, participatory design. During the intervention testing, adaptive intervention design, where an intervention is updated or extended throughout a trial while assuring the delivery of exactly the same intervention to each cohort, was employed. The adaptive intervention design strategy distributed technical work and allowed introduction of novel components in phases intended to help promote and sustain participant engagement. Adaptive intervention design was made possible by exploiting the mobile phone's remote data capabilities so that adoption of particular application components could be continuously monitored and components subsequently added or updated remotely. The cell phone intervention was delivered almost entirely via cell phone and was always-present, proactive, and interactive-providing passive and active reminders, frequent opportunities for knowledge dissemination, and multiple tools

No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial.

PubMed

Schoeps, Anja; Nebié, Eric; Fisker, Ane Baerent; Sié, Ali; Zakane, Alphonse; Müller, Olaf; Aaby, Peter; Becher, Heiko

2018-04-05

Non-specific effects (NSEs) of vaccines have increasingly gained attention in recent years. Recent studies suggest that live vaccines, such as measles vaccine (MV), have beneficial effects on health, while inactivated vaccines, such as the diphtheria-tetanus-pertussis (DTP) vaccine, may have harmful effects. If this is the case, it should improve child health to move MV closer to the last vaccination with DTP. The objective of this study was to investigate the NSEs of an additional early dose of MV on hospitalization or mortality. Children were randomized to receive either the standard MV at 9 months (control) or an additional early dose of MV 4 weeks after the third dose of DTP-containing Pentavalent vaccine and the standard MV at 9 months (intervention). In this analysis of a secondary outcome in the trial, we investigated the effect of the intervention on a composite endpoint of over-night hospitalization with or without recovery, or death without previous hospitalization, in children between 4.5 and 36 months of age in the Nouna HDSS in Burkina Faso. We used Cox proportional hazards regression with repeated events and time since study enrolment as underlying time-scale. Among 2258 children in the intervention and 2238 children in the control group we observed a total of 464 episodes of hospitalization or mortality. There was no difference between intervention and control group (HR = 1.00, 95% Confidence Interval (CI) 0.83-1.20). Results from the per-protocol and intention-to-treat analysis were similar. Although no significant, results suggest a possible beneficial effect of early MV in children that had not been exposed to an OPV campaign after enrolment (HR = 0.83, 95% CI 0.55-1.29). We did not detect any effect of early MV on subsequent hospitalization or mortality. However, possible effects of early MV could have been obscured by NSEs of the frequent OPV campaigns. Registration: The trial was registered at ClinicalTrials.gov, NCT01644721

Mapping the Early Intervention System in Ontario, Canada

ERIC Educational Resources Information Center

Underwood, Kathryn

2012-01-01

This study documents the wide range of early intervention services across the province of Ontario. The services are mapped across the province showing geographic information as well as the scope of services (clinical, family-based, resource support, etc.), the range of early intervention professionals, sources of funding and the populations served…

Early Intervention for Families and Children Experiencing Homelessness

ERIC Educational Resources Information Center

Hurley, Jennifer J.; Looby, Winnie; Goodrum, Ashley R.; Campbell, Elizabeth M.; Bonti, Gregg K.; Raymon, Becca A.; Condon, Rebecca; Schwaeber, Sami E.; Mauceri, Melina E.; Bourne, Erin M.; Callahan, Elizabeth D.; Hardy, Danielle L.; Mathews, Pamela

2018-01-01

Early intervention (EI) services are provided for families and children at risk for or with developmental delays. Early intervention includes services that are provided in the natural environment as mandated by the Individuals with Disabilities Education Act (IDEA; 2004). The natural environment is where children and families would naturally spend…

Mathematical Difficulty: Does Early Intervention Enhance Mathematical Performance?

ERIC Educational Resources Information Center

Graham, Jennifer

2008-01-01

The need to ask educators about their opinions on the subject to what extent early intervention methods enhance mathematical performance is long overdue. The purpose of this quantitative research is to examine the extent to which teachers agree that early intervention methods enhance the mathematical performance of students with mathematical…

Early elementary school intervention to reduce conduct problems: a randomized trial with Hispanic and non-Hispanic children.

PubMed

Barrera, Manuel; Biglan, Anthony; Taylor, Ted K; Gunn, Barbara K; Smolkowski, Keith; Black, Carol; Ary, Dennis V; Fowler, Rollen C

2002-06-01

Children's aggressive behavior and reading difficulties during early elementary school years are risk factors for adolescent problem behaviors such as delinquency, academic failure, and substance use. This study determined if a comprehensive intervention that was designed to address both of these risk factors could affect teacher, parent, and observer measures of internalizing and externalizing problems. European American (n = 116) and Hispanic (n = 168) children from 3 communities who were selected for aggressiveness or reading difficulties were randomly assigned to an intervention or no-intervention control condition. Intervention families received parent training, and their children received social behavior interventions and supplementary reading instruction over a 2-year period. At the end of intervention, playground observations showed that treated children displayed less negative social behavior than controls. At the end of a 1-year follow-up, treated children showed less teacher-rated internalizing and less parent-rated coercive and antisocial behavior than controls. The study's limitations and implications for prevention are discussed.

Early phase drugs and biologicals clinical trials on worldwide leading causes of death: a descriptive analysis.

PubMed

Dal-Ré, Rafael

2011-06-01

To describe the global effort targeting the major causes of mortality in terms of "open" early phase clinical trials with drugs and biologicals. Sixteen of the 20 leading causes of death were chosen; 9 of these were also amongst the top 10 causes of death in low-income countries. Studies were identified from the ClinicalTrials.gov database and included phase 1 and/or 2 "interventional" "open" trials, i.e. those recruiting or about to start recruitment. Trials were considered in terms of sponsorship [industry, universities and other organisations (UNO), and US federal agencies (NIH included)], genders and age groups included, and whether they were conducted with drugs and/or biologicals. The search was performed in March 2010. A total of 2,298 (824 phase 1; 1,474 phase 2) trials were retrieved. Of these, 67% were on trachea, bronchus, and lung cancers (25%); diabetes mellitus (15%); colon and rectum cancers (14%); and HIV/AIDS (12%). In contrast, only 4% were trials on diarrhoeal disease, nephrosis and nephritis, liver cirrhosis, and prematurity and low birth weight. UNO were the first source of funding. Fifty-two percent of phase 1 non-cancer trials were on healthy volunteers. Twenty-nine percent of all trials were co-funded. There were 4.6 times as many drug trials as those with biologicals. Only 7% were conducted with a combination of drugs and biologicals, the majority (78%) on cancers. Discrimination in terms of gender or age group was not observed. Four of the 16 diseases considered represented 2/3 of early phase trials. Cancers were a top priority for all sponsors. Increasing attention should be given to conditions with current and projected global high mortality rates that had few "open" early phase trials.

Three controlled trials of interventions to increase recruitment to a randomized controlled trial of mobile phone based smoking cessation support.

PubMed

Free, Caroline; Hoile, Elizabeth; Robertson, Steven; Knight, Rosemary

2010-06-01

Recruitment is a major challenge for trials but there is little evidence regarding interventions to increase trial recruitment. We report three controlled trials of interventions to increase recruitment to the Txt2stop trial. To evaluate: Trial 1. The impact on registrations of a text message regarding an online registration facility; Trial 2. The impact on randomizations of sending pound5 with a covering letter to those eligible to join the trial; Trial 3. The impact on randomizations of text messages containing quotes from existing participants. Single blind controlled trials with allocation concealment. Trial 1: A text message regarding our new online registration facility; Trial 2: A letter with pound5 enclosed; Trial 3: A series of four text messages containing quotes from participants. The control group in each trial received standard Txt2stop procedures. Trial 1: 3.6% (17/470) of the intervention group and 1.1% (5/467) of the control group registered for the trial, risk difference 2.5% (95% CI 0.6-4.5). 0% (0/ 470) of the intervention group and 0.2% (1/467) of the control group registered successfully online, risk difference -0.2 (95% CI -0.6-0.2); Trial 2: 4.5% (11/246) of the intervention group and 0.4% (1/245) of the control group were randomized into the Txt2stop trial, risk difference 4.0% (95% CI 1.4-6.7); Trial 3: 3.5% (14/405) of the intervention group and 0% (0/406) of the control group were randomized into the Txt2stop trial, risk difference 3.5 (95% CI 1.7-5.2). There were no baseline data available for trial 1. Allocation of participant IDs in trials 2 and 3 were systematic. Sending a text message about an online registration facility increased registrations to Txt2stop, but did not increase online registrations. Sending a pound5 reimbursement for participants' time and sending text messages containing quotes from existing participants increased randomizations into the Txt2stop trial. Clinical Trials 2010; 7: 265-273. http://ctj.sagepub.com.

Determinants of high and low attendance to diet and exercise interventions among overweight and obese older adults. Results from the arthritis, diet, and activity promotion trial.

PubMed

van Gool, Coen H; Penninx, Brenda W J H; Kempen, Gertrudis I J M; Miller, Gary D; van Eijk, Jacques Th M; Pahor, Marco; Messier, Stephen P

2006-06-01

Determinants of adherence to lifestyle regimens are ill understood. Attendance to intervention sessions is crucial for patients to acquire knowledge and skills regarding the core elements of an intervention. Therefore, we explored demographic, health-related, and social determinants of high and low attendance to diet and exercise sessions among overweight and obese patients with knee osteoarthritis (> or = 60 years; N = 206). The Arthritis, Diet, and Activity Promotion Trial was an 18-month randomized controlled trial on the effectiveness of dietary weight loss and exercise interventions. We conducted chi-square and t-tests, and logistic regression analyses on categories of short- and long-term attendance to intervention sessions. Over the 18-month duration of the study, 60.7% (+/- 28.5) of diet sessions, and 53.2% (+/- 29.0) of exercise sessions were attended. Not being married, low social participation, and single intervention randomization predicted high attendance to diet sessions during months 1-4. Exercising at home, and single intervention randomization predicted high attendance to exercise sessions during months 5-18. High attendance to sessions early in the intervention was a significant determinant of high session attendance thereafter. Offering people a choice where to exercise, and stimulating early intervention session attendance can be effective in improving long-term attendance to both interventions. Several determinants we found may be amenable to change to enhance intervention adherence of future randomized controlled trials involving dietary weight loss and/or physical exercise.

Student Preparation for Professional Practice in Early Intervention

ERIC Educational Resources Information Center

Francois, Jennifer R.; Coufal, Kathy L.; Subramanian, Anu

2015-01-01

The preparation of students for professional practice in the field of early intervention has changed as a result of mandates through Part C, Individuals With Disabilities Education Act (IDEA). The purpose of this survey research was to describe the knowledge and skill areas, specific to early intervention, included in pre-professional curricula…

Discerning the Future of Early Childhood Intervention.

ERIC Educational Resources Information Center

Zigler, Edward; Berman, Winnie

1983-01-01

Examines the recent history of early childhood intervention efforts; discusses principles that guided the formation of intervention programs in the 1960s and 1970s; describes the Head Start program and lessons learned from its development; considers issues in evaluating intervention programs; and presents suggestions for future directions in early…

Effects of Parent-Implemented Early Start Denver Model Intervention on Chinese Toddlers with Autism Spectrum Disorder: A Non-Randomized Controlled Trial.

PubMed

Zhou, Bingrui; Xu, Qiong; Li, Huiping; Zhang, Ying; Wang, Yi; Rogers, Sally J; Xu, Xiu

2018-04-01

To evaluate the effects of a 26-week, high-intensity, parent-implemented Early Start Denver Model (P-ESDM) intervention on developmental outcomes, severity of autism spectrum disorder (ASD), and parental stress of ASD toddlers in China. Subjects in P-ESDM group (n = 23) were recruited from 1.5- to 2.5-year-old toddlers who were screened positive in Xuhui and Minhang Districts and were diagnosed with ASD. A community (comparison) group of age-matched toddlers with ASD (n = 20) was recruited from other areas. Subjects of the P-ESDM group attended 1.5-hr parent coaching per week for 26 weeks, and those in the community group received interventions available from communities. Assessments were conducted at baseline (T1) and 26 weeks later (T2). After adjusting for baseline differences between the two groups, P-ESDM group demonstrated greater improvement than the community group in general development, especially in Language domain. Neither group demonstrated significant change in ASD severity, but the P-ESDM group showed greater improvement in social affect, parent-reported social communication and symbolic play than community group did. Finally, parents in P-ESDM group experienced decreased parenting stress while those in community group showed an opposite trend, though the differences did not reach significant association with the P-ESDM intervention. Chinese toddlers with ASD receiving 26 weeks of P-ESDM via regular coaching sessions showed significant greater improvement than those receiving community interventions in multiple aspects of development including social communications. These findings add support to the importance of providing early screening, diagnosis, and immediate referral for evidence-based interventions to improve outcome of young children with ASD. Autism Res 2018, 11: 654-666. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. The development of early screening and diagnosis of autism spectrum disorder (ASD) in

Early detection versus primary prevention in the PLCO flexible sigmoidoscopy screening trial: Which has the greatest impact on mortality?

PubMed

Doroudi, Maryam; Schoen, Robert E; Pinsky, Paul F

2017-12-15

Screening for colorectal cancer (CRC) with flexible sigmoidoscopy (FS) has been shown to reduce CRC mortality. The current study examined whether the observed mortality reduction was due primarily to the prevention of incident CRC via removal of adenomatous polyps or to the early detection of cancer and improved survival. The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial randomized 154,900 men and women aged 55 to 74 years. Individuals underwent FS screening at baseline and at 3 or 5 years versus usual care. CRC-specific survival was analyzed using Kaplan-Meier curves and proportional hazards modeling. The authors estimated the percentage of CRC deaths averted by early detection versus primary prevention using a model that applied intervention arm survival rates to CRC cases in the usual-care arm and vice versa. A total of 1008 cases of CRC in the intervention arm and 1291 cases of CRC in the usual-care arm were observed. Through 13 years of follow-up, there was no significant difference noted between the trial arms with regard to CRC-specific survival for all CRC (68% in the intervention arm vs 65% in the usual-care arm; P =.16) or proximal CRC (68% vs 62%, respectively; P = .11) cases; however, survival in distal CRC cases was found to be higher in the intervention arm compared with the usual-care arm (77% vs 66%; P<.0001). Within each arm, symptom-detected cases had significantly worse survival compared with screen-detected cases. Overall, approximately 29% to 35% of averted CRC deaths were estimated to be due to early detection and 65% to 71% were estimated to be due to primary prevention. CRC-specific survival was similar across arms in the PLCO trial, suggesting a limited role for early detection in preventing CRC deaths. Modeling suggested that approximately two-thirds of avoided deaths were due to primary prevention. Future CRC screening guidelines should emphasize primary prevention via the identification and removal of precursor

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

Poor description of non-pharmacological interventions: analysis of consecutive sample of randomised trials

PubMed Central

Erueti, Chrissy; Glasziou, Paul P

2013-01-01

Objectives To evaluate the completeness of descriptions of non-pharmacological interventions in randomised trials, identify which elements are most frequently missing, and assess whether authors can provide missing details. Design Analysis of consecutive sample of randomised trials of non-pharmacological interventions. Data sources and study selection All reports of randomised trials of non-pharmacological interventions published in 2009 in six leading general medical journals; 133 trial reports, with 137 interventions, met the inclusion criteria. Data collection Using an eight item checklist, two raters assessed the primary full trial report, plus any reference materials, appendices, or websites. Questions about missing details were emailed to corresponding authors, and relevant items were then reassessed. Results Of 137 interventions, only 53 (39%) were adequately described; this was increased to 81 (59%) by using 63 responses from 88 contacted authors. The most frequently missing item was the “intervention materials” (47% complete), but it also improved the most after author response (92% complete). Whereas some authors (27/70) provided materials or further information, other authors (21/70) could not; their reasons included copyright or intellectual property concerns, not having the materials or intervention details, or being unaware of their importance. Although 46 (34%) trial interventions had further information or materials readily available on a website, many were not mentioned in the report, were not freely accessible, or the URL was no longer functioning. Conclusions Missing essential information about interventions is a frequent, yet remediable, contributor to the worldwide waste in research funding. If trial reports do not have a sufficient description of interventions, other researchers cannot build on the findings, and clinicians and patients cannot reliably implement useful interventions. Improvement will require action by funders, researchers

Early Intervention: Key Issues from Research.

ERIC Educational Resources Information Center

Fraser, Helen

1998-01-01

As the preschool and early years of schooling were becoming the focus of increasing attention, the Scottish Office Education and Industry Department commissioned a review of United Kingdom and international literature on the use of early intervention schemes for disadvantaged students. The resulting review presents evidence on the most appropriate…

Promoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10™ problem: a randomised control trial

PubMed Central

2014-01-01

Background This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of ‘360 degree marketing’ on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children’s knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections. Methods/Design This cluster-randomised trial will be conducted with 300, 4 to 5 year-old children attending pre-school. Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating, active play and sustainability consciousness and deliver this to their pre-school class. Children will be interviewed about their knowledge of healthy eating, active play and the sustainability consequences of their food and toy selections. Parents will complete an Eating and Physical Activity Questionnaire rating their children’s food preferences, digital media viewing and physical activity habits. All measures will be administered at baseline, the end of the intervention and 6 months post intervention. Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group. Discussion This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children’s healthy eating, active play, and sustainability consciousness. The significance of the early childhood period, for young children’s learning about healthy eating, active play and sustainability, is now unquestioned. The specific

Internet-Delivered Parenting Program for Prevention and Early Intervention of Anxiety Problems in Young Children: Randomized Controlled Trial.

PubMed

Morgan, Amy J; Rapee, Ronald M; Salim, Agus; Goharpey, Nahal; Tamir, Elli; McLellan, Lauren F; Bayer, Jordana K

2017-05-01

The Cool Little Kids parenting group program is an effective intervention for preventing anxiety disorders in young children who are at risk because of inhibited temperament. The program has six group sessions delivered by trained psychologists to parents of 3- to 6-year-old children. An online adaptation (Cool Little Kids Online) has been developed to overcome barriers to its wide dissemination in the community. This study tested the efficacy of Cool Little Kids Online in a randomized controlled trial. A total of 433 parents of a child aged 3 to 6 years with an inhibited temperament were randomized to the online parenting program or to a 24-week waitlist. The online program has 8 interactive modules providing strategies that parents can implement with their child to manage their child's avoidant coping, reduce parental overprotection, and encourage child independence. Parents were provided telephone consultation support with a psychologist when requested. Parents completed self-report questionnaires at baseline and at 12 and 24 weeks after baseline. The intervention group showed significantly greater improvement over time in child anxiety symptoms compared to the control group (d = 0.38). The intervention group also showed greater reductions in anxiety life interference (ds = 0.33-0.35) and lower rates of anxiety disorders than the control group (40% versus 54%), but there were minimal effects on broader internalizing symptoms or overprotective parenting. Results provide empirical support for the efficacy of online delivery of the Cool Little Kids program. Online dissemination may improve access to an evidence-based prevention program for child anxiety disorders. Clinical trial registration information-Randomised Controlled Trial of Cool Little Kids Online: A Parenting Program to Prevent Anxiety Problems in Young Children; http://www.anzctr.org.au/; 12615000217505. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc

Music intervention during daily weaning trials-A 6 day prospective randomized crossover trial.

PubMed

Liang, Zhan; Ren, Dianxu; Choi, JiYeon; Happ, Mary Beth; Hravnak, Marylyn; Hoffman, Leslie A

2016-12-01

To examine the effect of patient-selected music intervention during daily weaning trials for patients on prolonged mechanical ventilation. Using a crossover repeated measures design, patients were randomized to music vs no music on the first intervention day. Provision of music was alternated for 6 days, resulting in 3 music and 3 no music days. During weaning trials on music days, data were obtained for 30min prior to music listening and continued for 60min while patients listened to selected music (total 90min). On no music days, data were collected for 90min. Outcome measures were heart rate (HR), respiratory rate (RR), oxygen saturation (SpO 2 ), blood pressure (BP), dyspnea and anxiety assessed with a visual analog scale (VAS-D, VAS-A) and weaning duration (meanh per day on music and non-music days). Of 31 patients randomized, 23 completed the 6-day intervention. When comparisons were made between the 3 music and 3 no music days, there were significant decreases in RR and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). A multivariate mixed-effects model analysis that included patients who completed ≥2 days of the intervention (n=28) demonstrated significant decreases in HR, RR, VAS-A, and VAS-D and a significant increase in daily weaning duration on music days (p<0.05). Providing patient selected music during daily weaning trials is a simple, low-cost, potentially beneficial intervention for patients on prolonged mechanical ventilation. Further study is indicated to test ability of this intervention to promote weaning success and benefits earlier in the weaning process. Copyright © 2016 Elsevier Ltd. All rights reserved.

Early intervention for psychotic disorders: Real-life implementation in Hong Kong.

PubMed

Wong, Gloria H Y; Hui, Christy L M; Tang, Jennifer Y M; Chang, Wing-Chung; Chan, Sherry K W; Xu, Jia-Qi; Lin, Jessie J X; Lai, Dik-Chee; Tam, Wendy; Kok, Joy; Chung, Dicky; Hung, S F; Chen, Eric Y H

2012-03-01

Hong Kong is among the first few cities in Asia to have implemented early intervention for psychosis in 2001. Substantial changes in psychosis service have since taken place. We reviewed available outcome data in Hong Kong, with reference to the philosophy of early intervention in psychosis, discussing experience and lessons learned from the implementation process, and future opportunities and challenges. Data accumulated in the past decade provided evidence for the benefits and significance of early intervention programmes: patients under the care of early intervention service showed improved functioning, milder symptoms, and fewer hospitalizations and suicides. Early intervention is more cost-effective compared with standard care. Stigma and misconception remains an issue, and public awareness campaigns are underway. In recent years, a critical mass is being formed, and Hong Kong has witnessed the unfolding of public service extension, new projects and organizations, and increasing interest from the community. Several major platforms are in place for coherent efforts, including the public Early Assessment Service for Young people with psychosis (EASY) programme, the Psychosis Studies and Intervention (PSI) research unit, the independent Hong Kong Early Psychosis Intervention Society (EPISO), the Jockey Club Early Psychosis (JCEP) project, and the postgraduate Psychological Medicine (Psychosis Studies) programme. The first decade of early intervention work has been promising; consolidation and further development is needed on many fronts of research, service and education. Copyright © 2012 Elsevier B.V. All rights reserved.

Preventing Obesity Across Generations: Evidence for Early Life Intervention.

PubMed

Haire-Joshu, Debra; Tabak, Rachel

2016-01-01

To prevent the intergenerational transfer of obesity and end the current epidemic, interventions are needed across the early life stages, from preconception to prenatal to infancy through the age of 2 years. The foundation for obesity is laid in early life by actions and interactions passed from parent to child that have long-lasting biologic and behavioral consequences. The purpose of this paper is to examine the best evidence about (a) factors in parents and offspring that promote obesity during the early life stages, (b) the social determinants and dimensions of obesity in early life, (c) promising and effective interventions for preventing obesity in early life, and (d) opportunities for future research into strategies to disrupt the intergenerational cycle of obesity that begins early in life. The pathway for halting the intergenerational obesity epidemic requires the discovery and development of evidence-based interventions that can act across multiple dimensions of influence on early life.

Preventing Obesity Across Generations: Evidence for Early Life Intervention

PubMed Central

Haire-Joshu, Debra; Tabak, Rachel

2017-01-01

To prevent the intergenerational transfer of obesity and end the current epidemic, interventions are needed across the early life stages, from preconception to prenatal to infancy through the age of 2 years. The foundation for obesity is laid in early life by actions and interactions passed from parent to child that have long-lasting biologic and behavioral consequences. The purpose of this paper is to examine the best evidence about (a) factors in parents and offspring that promote obesity during the early life stages, (b) the social determinants and dimensions of obesity in early life, (c) promising and effective interventions for preventing obesity in early life, and (d) opportunities for future research into strategies to disrupt the intergenerational cycle of obesity that begins early in life. The pathway for halting the intergenerational obesity epidemic requires the discovery and development of evidence-based interventions that can act across multiple dimensions of influence on early life. PMID:26989828

A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.

PubMed

Herrman, Helen; Humphreys, Cathy; Halperin, Stephen; Monson, Katherine; Harvey, Carol; Mihalopoulos, Cathrine; Cotton, Susan; Mitchell, Penelope; Glynn, Tony; Magnus, Anne; Murray, Lenice; Szwarc, Josef; Davis, Elise; Havighurst, Sophie; McGorry, Patrick; Tyano, Sam; Kaplan, Ida; Rice, Simon; Moeller-Saxone, Kristen

2016-12-07

Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. Australian New Zealand Clinical Trials Registry ACTRN12615000501549 . Retrospectively registered 19 May 2015.

Intervention Effects on Foster Preschoolers’ Attachment-Related Behaviors From a Randomized Trial

PubMed Central

Fisher, Philip A.; Kim, Hyoun K.

2008-01-01

This study examines change in attachment-related behaviors among foster preschoolers participating in a randomized trial of the Multidimensional Treatment Foster Care Program for Preschoolers (MTFC-P). Measures of secure, resistant, and avoidant behaviors were collected using a caregiver-report diary at 3-month intervals during the 12 months following a new foster placement. Children randomly assigned to the MTFC-P intervention condition (n = 57) showed significant increases in secure behavior and significant decreases in avoidant behavior relative to children assigned to a regular foster care condition (n = 60). Both groups showed significant decreases in resistant behavior over time. Analyses also revealed a significant interaction between treatment condition and age at first foster placement on change in secure behavior. Results are discussed in terms of the importance of early intervention and prevention services for foster preschoolers. PMID:17340186

Inadequate reporting of concomitant drug treatment in cardiovascular interventional head-to-head trials.

PubMed

Mahfoud, Felix; Böhm, Michael; Baumhäkel, Magnus

2012-04-01

Optimal revascularization strategy is still under debate in patients with coronary artery disease, particularly due to the results of the Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial. Although medical prevention has been clearly shown to be beneficial in coronary artery disease, it has been suggested that patients were significantly undertreated with evidence-based medications for cardiovascular protection. The purpose of the study was to evaluate concomitant medical treatment in cardiovascular interventional head-to-head trials comparing coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). A systematic search of the literature regarding documentation and reports of medical treatment in cardiovascular interventional head-to-head trials with more than 500 patients comparing CABG and PCI was performed. Systematic research of the literature identified 2106 articles of potential interest. After review and selection, only 3 trials reported on medical treatment. Baseline medication was reported in the RITA (Randomized Intervention Treatment of Angina), CABRI (Coronary Angioplasty versus Bypass Revascularisation Investigation), and SYNTAX trials, and follow-up data were provided by the CABRI and SYNTAX 3-year trials only. Poor reporting of medical treatment at discharge might reflect an underestimation of secondary prevention in patients undergoing cardiac surgery or interventional procedures in head-to-head interventional trials. Thus, discussion of optimal revascularization procedure has to remain open, even in terms of concomitant medical treatment of patients. © 2012 Wiley Periodicals, Inc.

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

Interventions for hyperthyroidism pre-pregnancy and during pregnancy.

PubMed

Earl, Rachel; Crowther, Caroline A; Middleton, Philippa

2013-11-19

Women with hyperthyroidism in pregnancy have increased risks of miscarriage, stillbirth, preterm birth, and intrauterine growth restriction; and they can develop severe pre-eclampsia or placental abruption. To identify interventions used in the management of hyperthyroidism pre-pregnancy or during pregnancy and to ascertain the impact of these interventions on important maternal, fetal, neonatal and childhood outcomes. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (30 September 2013). We planned to include randomised controlled trials, quasi-randomised controlled trials, and cluster-randomised trials comparing antithyroid interventions for hyperthyroidism pre-pregnancy or during pregnancy with another intervention or no intervention (placebo or no treatment). Two review authors assessed trial eligibility and planned to assess trial quality and extract the data independently. No trials were included in the review. As we did not identify any eligible trials, we are unable to comment on implications for practice, although early identification of hyperthyroidism before pregnancy may allow a woman to choose radioactive iodine therapy or surgery before planning to have a child. Designing and conducting a trial of antithyroid interventions for pregnant women with hyperthyroidism presents formidable challenges. Not only is hyperthyroidism a relatively rare condition, both of the two main drugs used have potential for harm, one for the mother and the other for the child. More observational research is required about the potential harms of methimazole in early pregnancy and about the potential liver damage from propylthiouracil.

Engaging participants in a complex intervention trial in Australian General Practice

PubMed Central

Perkins, David; Harris, Mark F; Tan, Jocelyn; Christl, Bettina; Taggart, Jane; Fanaian, Mahnaz

2008-01-01

Background The paper examines the key issues experienced in recruiting and retaining practice involvement in a large complex intervention trial in Australian General Practice. Methods Reflective notes made by research staff and telephone interviews with staff from general practices which expressed interest, took part or withdrew from a trial of a complex general practice intervention. Results Recruitment and retention difficulties were due to factors inherent in the demands and context of general practice, the degree of engagement of primary care organisations (Divisions of General Practice), perceived benefits by practices, the design of the trial and the timing and complexity of data collection. Conclusion There needs to be clearer articulation to practices of the benefits of the research to participants and streamlining of the design and processes of data collection and intervention to fit in with their work practices. Ultimately deeper engagement may require additional funding and ongoing participation through practice research networks. Trial Registration Current Controlled Trials ACTRN12605000788673 PMID:18700984

Design of control-group conditions in clinical trials of behavioral interventions.

PubMed

Lindquist, Ruth; Wyman, Jean F; Talley, Kristine M C; Findorff, Mary J; Gross, Cynthia R

2007-01-01

To review considerations in the design of placebo (attention) control conditions for community-based clinical trials of health behavior change interventions and to provide practical strategies for the design of control conditions. A well-designed control condition is an essential component of a clinical trial to foster the unambiguous interpretation of study findings. Pitfalls in the design of control conditions in clinical trials of behavioral interventions are identified and strategies to address them are offered. Types of control conditions that have been used in fall prevention trials are described, along with their strengths and weaknesses. The control condition used in the recent fall evaluation and prevention program (FEPP) was designed to overcome limitations of previous trial designs; it is provided to illustrate how to apply specific design principles. Pitfalls in the design of behavioral intervention studies may be avoided with the application of sound design principles. The FEPP active control condition can be used as a model in the design of future studies.

Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis

PubMed Central

Gurung, Vinita; Williamson, Catherine; Chappell, Lucy; Chambers, Jenny; Briley, Annette; Pipkin, Fiona Broughton; Thornton, Jim

2009-01-01

Background Obstetric cholestasis (OC) is a serious problem in pregnancy. It affects about 4500 women per year in the UK. Affected women develop itching and occasionally jaundice. More importantly, the condition is associated with premature delivery, fetal distress and is believed to be an important cause of stillbirth. However, even now, there is no clear evidence as to whether the most popular treatment, a drug called ursodeoxycholic acid is beneficial to the baby, or even if it is safe in pregnancy. Nor do we know whether planned early delivery of the baby at 37–38 weeks, another popular treatment, does more good than harm. A randomised trial to evaluate both ursodeoxycholic acid and timed delivery is needed but will be complicated and expensive. We plan a preliminary study, Pilot study for a trial of ursodeoxycholic acid and/or early delivery for obstetric cholestasis (Acronym PITCH- Pregnancy Intervention Trial in Cholestasis) trial, to evaluate the feasibility of a larger trial. The trial is funded by the NHS Research for Patient Benefit (RfPB) Programme. Methods PITCH is a multi-centre, double blinded, randomised, controlled, factorial design trial. The trial is being run in six UK centres and women with obstetric cholestasis will be recruited for eighteen months. In this pilot trial we aim to collect data to finalise the design for the main trial. This will include measuring trial recruitment rate, including recruitment to each factorial comparison separately. We will also measure the spectrum of disease among recruits and non-recruits and compliance with the four possible treatment allocations. We will use these data to design the main trial. Discussion The ultimate aim of the main trial is to enable clinicians to manage this condition more effectively. If it transpires that ursodeoxycholic acid and early delivery are both safe and effective then steps will be taken to ensure that all women with OC who could benefit from them receives this treatment

Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial

PubMed Central

Attanasio, Orazio P; Fernández, Camila; Grantham-McGregor, Sally M; Meghir, Costas; Rubio-Codina, Marta

2014-01-01

Objective To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children’s development, growth, and hemoglobin levels. Design Cluster randomized controlled trial, using a 2×2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control. Setting 96 municipalities in Colombia, located across eight of its 32 departments. Participants 1420 children aged 12-24 months and their primary carers. Intervention Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months. Main outcome measures Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention. Results Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels. Conclusions Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children’s cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood

Diabetes Intervention Accentuating Diet and Enhancing Metabolism (DIADEM-I): a randomised controlled trial to examine the impact of an intensive lifestyle intervention consisting of a low-energy diet and physical activity on body weight and metabolism in early type 2 diabetes mellitus: study protocol for a randomized controlled trial.

PubMed

Taheri, Shahrad; Chagoury, Odette; Zaghloul, Hadeel; Elhadad, Sara; Ahmed, Salma Hayder; Omar, Omar; Payra, Sherryl; Ahmed, Salma; El Khatib, Neda; Amona, Rasha Abou; El Nahas, Katie; Bolton, Matthew; Chaar, Henem; Suleiman, Noor; Jayyousi, Amin; Zirie, Mahmoud; Janahi, Ibrahim; Elhag, Wahiba; Alnaama, Abdulla; Zainel, Abduljaleel; Hassan, Dahlia; Cable, Tim; Charlson, Mary; Wells, Martin; Al-Hamaq, Abdulla; Al-Abdulla, Samya; Abou-Samra, Abdul Badi

2018-05-21

Type 2 diabetes mellitus (T2DM) and obesity are syndemic and will have a significant impact on affected individuals and healthcare services worldwide. Evidence shows that T2DM remission can be achieved with significant weight loss in those who are younger with early diabetes and requiring fewer medications for glycaemic control. DIADEM-I aims to examine the impact of an intensive lifestyle intervention (ILI) using a low-energy diet (LED) meal replacement approach combined with physical activity in younger individuals with early T2DM. The planned study is an ongoing, non-blinded, pragmatic, randomised controlled, parallel-group trial examining the impact of an LED-based ILI on body weight and diabetes remission in younger (18-50 years) T2DM individuals with early diabetes (≤ 3-year duration). The ILI will be compared to usual medical care (UMC). The primary outcome will be weight loss at 12 months. Other key outcomes of interest include diabetes remission, glycaemic control, diabetes complications, cardiovascular health, physical activity, mental health, and quality of life. It is planned for the study to include 138 subjects for assessment of the primary outcome. Safety will be assessed throughout. If DIADEM-I demonstrates a clinically significant effect for younger individuals with early T2DM, it will inform clinical guidelines and services of the future for management of T2DM. ISRCTN: ISRCTN20754766 (date assigned: 7 June 2017); ClinicalTrials.gov, ID: NCT03225339 Registered on 26 June 2017.

Improving early childhood care and development, HIV-testing, treatment and support, and nutrition in Mokhotlong, Lesotho: study protocol for a cluster randomized controlled trial.

PubMed

Tomlinson, Mark; Skeen, Sarah; Marlow, Marguerite; Cluver, Lucie; Cooper, Peter; Murray, Lynne; Mofokeng, Shoeshoe; Morley, Nathene; Makhetha, Moroesi; Gordon, Sarah; Esterhuizen, Tonya; Sherr, Lorraine

2016-11-09

Since 1990, the lives of 48 million children under the age of 5 years have been saved because of increased investments in reducing child mortality. However, despite these unprecedented gains, 250 million children younger than 5 years in low- and middle-income countries (LMIC) cannot meet their developmental potential due to poverty, poor health and nutrition, and lack of necessary stimulation and care. Lesotho has high levels of poverty, HIV, and malnutrition, all of which affect child development outcomes. There is a unique opportunity to address these complex issues through the widespread network of informal preschools in rural villages in the country, which provide a setting for inclusive, integrated Early Childhood Care and Development (ECCD) and HIV and nutrition interventions. We are conducting a cluster randomised controlled trial in Mokhotlong district, Lesotho, to evaluate a newly developed community-based intervention program to integrate HIV-testing and treatment services, ECCD, and nutrition education for caregivers with children aged 1-5 years living in rural villages. Caregivers and their children are randomly assigned by village to intervention or control condition. We select, train, and supervise community health workers recruited to implement the intervention, which consists of nine group-based sessions with caregivers and children over 12 weeks (eight weekly sessions, and a ninth top-up session 1 month later), followed by a locally hosted community health outreach day event. Group-based sessions focus on using early dialogic book-sharing to promote cognitive development and caregiver-child interaction, health-related messages, including motivation for HIV-testing and treatment uptake for young children, and locally appropriate nutrition education. All children aged 1-5 years and their primary caregivers living in study villages are eligible for participation. Caregivers and their children will be interviewed and assessed at baseline, after

The Effectiveness of Early Educational Interventions in the Emergency Department to Reduce Incidence or Severity of Postconcussion Syndrome Following a Concussion: A Systematic Review.

PubMed

Eliyahu, Leeor; Kirkland, Scott; Campbell, Sandy; Rowe, Brian H

2016-05-01

Concussions or mild traumatic brain injury are a major public health concern accounting for 85% of all brain injuries. Postconcussion syndrome (PCS) has been found to affect between 15 and 25% of patients with concussion 1 year after the initial injury. The goal of this review is to assess the effectiveness of early educational information or interventions provided in the emergency department on the onset and/or severity of PCS. A comprehensive literature search strategy involving seven electronic databases was developed. A grey literature search of Google Scholar, recent conference proceedings in emergency medicine, bibliographies of included studies, and clinical trial registries was also performed. The citation list was reviewed independently by two reviewers; no restrictions on publication status or language of publication were applied. The Cochrane risk-of-bias tool and the Newcastle-Ottawa scale were used to assess quality. From 1,325 citations retrieved, four RCTs and one controlled clinical trial met inclusion criteria. Interventions identified in these studies included: educational information sheets, with or without telephone or in-person follow-up, and one study on bed rest. While rarely requested, one study offered referrals and additional treatment, if needed. None of the studies were deemed to be high quality. Heterogeneity among outcome reporting, follow-up dates and interventions used precluded a pooled analysis. Overall, only two of the five included studies involving adult patients receiving early educational interventions reported a significant improvement in PCS symptoms. No reduction in PCS symptoms was found in the study on bed rest interventions. Limited evidence exists regarding the effectiveness of early educational interventions following concussion. Standardization of the interventions, outcome measures, and follow-up periods would make quantitative comparisons more valid. Moreover, higher-quality research in the field of early

Effectiveness of very early workplace interventions to reduce sickness absence: a systematic review of the literature and meta-analysis.

PubMed

Vargas-Prada, Sergio; Demou, Evangelia; Lalloo, Drushca; Avila-Palencia, Ione; Sanati, Kaveh A; Sampere, Maite; Freer, Kerry; Serra, Consol; Macdonald, Ewan B

2016-07-01

The aim of this review was to investigate the effectiveness of workplace return-to-work (RTW) interventions delivered at very early stages (<15 days) of sickness absence (SA). A systematic literature search was conducted in PubMed, Health Management Information Consortium (HMIC), Cochrane library database, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsychInfo and Embase. Using pre-established criteria, independent pairs of researchers carried out the study selection, quality appraisal and data extraction. Workplace interventions before day 15 of SA, were included. Primary outcome measures included rates of and time until RTW, productivity loss, and recurrences of SA. We found limited available evidence on the benefits of "very early" workplace interventions in terms of RTW after a SA episode compared to usual care. Only three randomized controlled trials classed as high or intermediate quality were identified. Early part-time sick leave together with appropriate job modifications led to a reduction in the duration and recurrence of SA. There is evidence of benefit of intervening during the first two weeks of SA for musculoskeletal disorders. Our review has identified a lack of evidence from the literature at this time point to support "very early" intervention compared to usual care. The methodological design of the studies, notably the extent and timing of usual care provided and variable compliance/crossover between groups could however explain the lack of demonstrated benefit. Consensus is required on the definition of "early" and "very early" interventions, and further research is recommended to improve understanding of the factors influencing when and how best to intervene for maximum gain.

Early Intervention and AAC: What a Difference 30 Years Makes.

PubMed

Romski, MaryAnn; Sevcik, Rose A; Barton-Hulsey, Andrea; Whitmore, Ani S

2015-01-01

This article provides an overview of early intervention and AAC over the 30-year period since the founding of the journal Augmentative and Alternative Communication in 1985. It discusses the global context for early intervention and addresses issues pertaining to young children from birth to 6 years of age. It provides a narrative review and synthesis of the evidence base in AAC and early intervention. Finally, it provides implications for practice and future research directions.

Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis.

PubMed

Nagpal, Anjali; Choy, Fong Chan; Howell, Stuart; Hillier, Susan; Chan, Fiona; Hamilton-Bruce, Monica A; Koblar, Simon A

2017-08-30

Stem cells have demonstrated encouraging potential as reparative therapy for patients suffering from post-stroke disability. Reperfusion interventions in the acute phase of stroke have shown significant benefit but are limited by a narrow window of opportunity in which they are beneficial. Thereafter, rehabilitation is the only intervention available. The current review summarises the current evidence for use of stem cell therapies in stroke from early-phase clinical trials. The safety and feasibility of administering different types of stem cell therapies in stroke seem to be reasonably proven. However, the effectiveness needs still to be established through bigger clinical trials with more pragmatic clinical trial designs that address the challenges raised by the heterogeneous nature of stroke per se, as well those due to unique characteristics of stem cells as therapeutic agents.

A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

PubMed Central

Fitzpatrick, Bridie; Watson, Nicholas; Cotmore, Richard; Wilson, Philip; Donaldson, Julia; Boyd, Kathleen; Zeanah, Charles; Norrie, John; Messow, Martina; Turner, Fiona; Irving, Susan

2013-01-01

Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home) is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child's neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510). PMID:24023537

A trial of an iPad™ intervention targeting social communication skills in children with autism

PubMed Central

Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O’Hare, Anne; Pain, Helen; McConachie, Helen

2015-01-01

This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent–child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad™ apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains. PMID:26503990

Promoting equity through integrated early child development and nutrition interventions.

PubMed

Black, Maureen M; Dewey, Kathryn G

2014-01-01

Sustainable development, a foundation of the post-2015 global agenda, depends on healthy and productive citizens. The origins of adult health begin early in life, stemming from genetic-environmental interactions that include adequate nutrition and opportunities for responsive learning. Inequities associated with inadequate nutrition and early learning opportunities can undermine children's health and development, thereby compromising their productivity and societal contributions. Transactional theory serves as a useful framework for examining the associations that link early child development and nutrition because it emphasizes the interplay that occurs between children and the environment, mediated through caregiver interactions. Although single interventions targeting early child development or nutrition can be effective, there is limited evidence on the development, implementation, evaluation, and scaling up of integrated interventions. This manuscript introduces a special edition of papers on six topics central to integrated child development/nutrition interventions: (1) review of integrated interventions; (2) methods and topics in designing integrated interventions; (3) economic considerations related to integrated interventions; (4) capacity-building considerations; (5) examples of integrated interventions; and (6) policy implications of integrated interventions. Ensuring the health and development of infants and young children through integrated child development/nutrition interventions promotes equity, a critical component of sustainable development. © 2014 New York Academy of Sciences.

Teaching Caregivers in Early Intervention

ERIC Educational Resources Information Center

Sawyer, Brook E.; Campbell, Philippa H.

2017-01-01

The overarching research aim of this study was to examine learning opportunities available for caregivers during early intervention sessions. Of specific interest were providers' purposeful (i.e., explicit) teaching behaviors and opportunities from which caregivers might learn incidentally. Relations between teaching behaviors, caregiver…

The NOURISH randomised control trial: positive feeding practices and food preferences in early childhood - a primary prevention program for childhood obesity.

PubMed

Daniels, Lynne A; Magarey, Anthea; Battistutta, Diana; Nicholson, Jan M; Farrell, Ann; Davidson, Geoffrey; Cleghorn, Geoffrey

2009-10-14

Primary prevention of childhood overweight is an international priority. In Australia 20-25% of 2-8 year olds are already overweight. These children are at substantially increased the risk of becoming overweight adults, with attendant increased risk of morbidity and mortality. Early feeding practices determine infant exposure to food (type, amount, frequency) and include responses (eg coercion) to infant feeding behaviour (eg. food refusal). There is correlational evidence linking parenting style and early feeding practices to child eating behaviour and weight status. A focus on early feeding is consistent with the national focus on early childhood as the foundation for life-long health and well being. The NOURISH trial aims to implement and evaluate a community-based intervention to promote early feeding practices that will foster healthy food preferences and intake and preserve the innate capacity to self-regulate food intake in young children. This randomised controlled trial (RCT) aims to recruit 820 first-time mothers and their healthy term infants. A consecutive sample of eligible mothers will be approached postnatally at major maternity hospitals in Brisbane and Adelaide. Initial consent will be for re-contact for full enrolment when the infants are 4-7 months old. Individual mother- infant dyads will be randomised to usual care or the intervention. The intervention will provide anticipatory guidance via two modules of six fortnightly parent education and peer support group sessions, each followed by six months of regular maintenance contact. The modules will commence when the infants are aged 4-7 and 13-16 months to coincide with establishment of solid feeding, and autonomy and independence, respectively. Outcome measures will be assessed at baseline, with follow up at nine and 18 months. These will include infant intake (type and amount of foods), food preferences, feeding behaviour and growth and self-reported maternal feeding practices and parenting

Early intervention for alcohol problems

PubMed Central

Skinner, Harvey A.; Holt, Stephen

1983-01-01

Despite awareness of the wide variety of clinical and laboratory abnormalities associated with alcohol abuse, drinking problems often remain undetected in clinical practice. There is increasing evidence that problem drinking can be successfully treated by brief intervention. The general practitioner is in a good position to identify patients who drink excessively, and to intervene with brief counselling at an early stage when prognosis is more favourable. A practical strategy is described for diagnosis and intervention that could be readily implemented in clinical practice. PMID:6361249

Developing a Reporting Guideline for Social and Psychological Intervention Trials

ERIC Educational Resources Information Center

Grant, Sean; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Mayo-Wilson, Evan

2013-01-01

Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting…

Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

PubMed

Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

2017-01-01

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

Economic Evaluation Plan (EEP) for A Very Early Rehabilitation Trial (AVERT): An international trial to compare the costs and cost-effectiveness of commencing out of bed standing and walking training (very early mobilization) within 24 h of stroke onset with usual stroke unit care.

PubMed

Sheppard, Lauren; Dewey, Helen; Bernhardt, Julie; Collier, Janice M; Ellery, Fiona; Churilov, Leonid; Tay-Teo, Kiu; Wu, Olivia; Moodie, Marj

2016-06-01

A key objective of A Very Early Rehabilitation Trial is to determine if the intervention, very early mobilisation following stroke, is cost-effective. Resource use data were collected to enable an economic evaluation to be undertaken and a plan for the main economic analyses was written prior to the completion of follow up data collection. To report methods used to collect resource use data, pre-specify the main economic evaluation analyses and report other intended exploratory analyses of resource use data. Recruitment to the trial has been completed. A total of 2,104 participants from 56 stroke units across three geographic regions participated in the trial. Resource use data were collected prospectively alongside the trial using standardised tools. The primary economic evaluation method is a cost-effectiveness analysis to compare resource use over 12 months with health outcomes of the intervention measured against a usual care comparator. A cost-utility analysis is also intended. The primary outcome in the cost-effectiveness analysis will be favourable outcome (modified Rankin Scale score 0-2) at 12 months. Cost-utility analysis will use health-related quality of life, reported as quality-adjusted life years gained over a 12 month period, as measured by the modified Rankin Scale and the Assessment of Quality of Life. Outcomes of the economic evaluation analysis will inform the cost-effectiveness of very early mobilisation following stroke when compared to usual care. The exploratory analysis will report patterns of resource use in the first year following stroke. © 2016 World Stroke Organization.

Improving understanding of clinical trial procedures among low literacy populations: an intervention within a microbicide trial in Malawi

PubMed Central

2012-01-01

Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124) obtained low scores (lower than 75%) on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18) and intervention arms (n=18). The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75%) during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001). Conclusions Potential trial

Using and Providing Services: Case Studies in Early Intervention.

ERIC Educational Resources Information Center

McWilliam, Robin; Tocci, Lynn; Sideris, John; Harbin, Gloria

A case study approach was used to examine the complexities of service utilization in early intervention with infants, toddlers, and young children with disabilities. Seventy-two families of children (ages birth to 4) participating in nine early intervention programs in three states (Colorado, North Carolina, and Pennsylvania) and their service…

Multimodal MRI for early diabetic mild cognitive impairment: study protocol of a prospective diagnostic trial.

PubMed

Yu, Ying; Sun, Qian; Yan, Lin-Feng; Hu, Yu-Chuan; Nan, Hai-Yan; Yang, Yang; Liu, Zhi-Cheng; Wang, Wen; Cui, Guang-Bin

2016-08-24

Type 2 diabetes mellitus (T2DM) is a risk factor for dementia. Mild cognitive impairment (MCI), an intermediary state between normal cognition and dementia, often occurs during the prodromal diabetic stage, making early diagnosis and intervention of MCI very important. Latest neuroimaging techniques revealed some underlying microstructure alterations for diabetic MCI, from certain aspects. But there still lacks an integrated multimodal MRI system to detect early neuroimaging changes in diabetic MCI patients. Thus, we intended to conduct a diagnostic trial using multimodal MRI techniques to detect early diabetic MCI that is determined by the Montreal Cognitive Assessment (MoCA). In this study, healthy controls, prodromal diabetes and diabetes subjects (53 subjects/group) aged 40-60 years will be recruited from the physical examination center of Tangdu Hospital. The neuroimaging and psychometric measurements will be repeated at a 0.5 year-interval for 2.5 years' follow-up. The primary outcome measures are 1) Microstructural and functional alterations revealed with multimodal MRI scans including structure magnetic resonance imaging (sMRI), resting state functional magnetic resonance imaging (rs-fMRI), diffusion kurtosis imaging (DKI), and three-dimensional pseudo-continuous arterial spin labeling (3D-pCASL); 2) Cognition evaluation with MoCA. The second outcome measures are obesity, metabolic characteristics, lifestyle and quality of life. The study will provide evidence for the potential use of multimodal MRI techniques with psychometric evaluation in diagnosing MCI at prodromal diabetic stage so as to help decision making in early intervention and improve the prognosis of T2DM. This study has been registered to ClinicalTrials.gov ( NCT02420470 ) on April 2, 2015 and published on July 29, 2015.

Prediction of motivational impairment: 12-month follow-up of the randomized-controlled trial on extended early intervention for first-episode psychosis.

PubMed

Chang, W C; Kwong, V W Y; Chan, G H K; Jim, O T T; Lau, E S K; Hui, C L M; Chan, S K W; Lee, E H M; Chen, E Y H

2017-03-01

Amotivation is prevalent in first-episode psychosis (FEP) patients and is a major determinant of functional outcome. Prediction of amotivation in the early stage of psychosis, however, is under-studied. We aimed to prospectively examine predictors of amotivation in FEP patients in a randomized-controlled trial comparing a 1-year extension of early intervention (Extended EI, 3-year EI) with step-down psychiatric care (SC, 2-year EI). One hundred sixty Chinese patents were recruited from a specialized EI program for FEP in Hong Kong after they have completed this 2-year EI service, randomly allocated to Extended EI or SC, and followed up for 12 months. Assessments on premorbid adjustment, onset profiles, baseline symptom severity and treatment characteristics were conducted. Data analysis was based on 156 subjects who completed follow-up assessments. Amotivation at 12-month follow-up was associated with premorbid adjustment, allocated treatment condition, and levels of positive symptoms, disorganization, amotivation, diminished expression (DE) and depression at study intake. Hierarchical multiple regression analysis revealed that Extended EI and lower levels of DE independently predicted better outcome on 12-month amotivation. Our findings indicate a potentially critical therapeutic role of an extended specialized EI on alleviating motivational impairment in FEP patients. The longer-term effect of Extended EI on amotivation merits further investigation. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

Guideline for Early Interventions

DTIC Science & Technology

2006-04-01

desensitization and reprocessing ( EMDR ) as a early mental health intervention, following mass violence and disasters, is a treatment of choice over other...village. Military operations take place under the eye of the world and are surrounded by high political attention. International missions far exceed...consistently reduce risks of later post-traumatic stress disorder or related adjustment difficulties. • There is no evidence that eye movement

Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial.

PubMed

Attanasio, Orazio P; Fernández, Camila; Fitzsimons, Emla O A; Grantham-McGregor, Sally M; Meghir, Costas; Rubio-Codina, Marta

2014-09-29

To assess the effectiveness of an integrated early child development intervention, combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia, for children's development, growth, and hemoglobin levels. Cluster randomized controlled trial, using a 2 × 2 factorial design, with municipalities assigned to one of four groups: psychosocial stimulation, micronutrient supplementation, combined intervention, or control. 96 municipalities in Colombia, located across eight of its 32 departments. 1420 children aged 12-24 months and their primary carers. Psychosocial stimulation (weekly home visits with play demonstrations), micronutrient sprinkles given daily, and both combined. All delivered by female community leaders for 18 months. Cognitive, receptive and expressive language, and fine and gross motor scores on the Bayley scales of infant development-III; height, weight, and hemoglobin levels measured at the baseline and end of intervention. Stimulation improved cognitive scores (adjusted for age, sex, testers, and baseline levels of outcomes) by 0.26 of a standard deviation (P=0.002). Stimulation also increased receptive language by 0.22 of a standard deviation (P=0.032). Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions. No intervention affected height, weight, or hemoglobin levels. Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children's cognitive development. We found no effect of supplementation on developmental or health outcomes. Moreover, supplementation did not interact with stimulation. The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development.Trial registration Current Controlled trials ISRCTN18991160. © Attanasio et al 2014.

A Consumer's Guide To Outcomes in Early Childhood Intervention.

ERIC Educational Resources Information Center

Accreditation Council on Services for People with Disabilities, Landover, MD.

This collection of 21 suggested outcome measures for early childhood intervention services is designed to assist families in evaluating the quality of early intervention services they receive. The measures apply to all types of service and support program models for children with various developmental delays and/or disabilities and their families.…

Cluster-Randomized Controlled Trial Evaluating the Effectiveness of Computer-Assisted Intervention Delivered by Educators for Children with Speech Sound Disorders

ERIC Educational Resources Information Center

McLeod, Sharynne; Baker, Elise; McCormack, Jane; Wren, Yvonne; Roulstone, Sue; Crowe, Kathryn; Masso, Sarah; White, Paul; Howland, Charlotte

2017-01-01

Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and…

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol

PubMed Central

2014-01-01

Background Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. Methods/Design This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. Discussion The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and

School-based cognitive behavioral interventions for anxious youth: study protocol for a randomized controlled trial.

PubMed

Haugland, Bente Storm Mowatt; Raknes, Solfrid; Haaland, Aashild Tellefsen; Wergeland, Gro Janne; Bjaastad, Jon Fauskanger; Baste, Valborg; Himle, Joe; Rapee, Ron; Hoffart, Asle

2017-03-04

Anxiety disorders are prevalent among adolescents and may have long-lasting negative consequences for the individual, the family and society. Cognitive behavioral therapy (CBT) is an effective treatment. However, many anxious youth do not seek treatment. Low-intensity CBT in schools may improve access to evidence-based services. We aim to investigate the efficacy of two CBT youth anxiety programs with different intensities (i.e., number and length of sessions), both group-based and administered as early interventions in a school setting. The objectives of the study are to examine the effects of school-based interventions for youth anxiety and to determine whether a less intensive intervention is non-inferior to a more intensive intervention. The present study is a randomized controlled trial comparing two CBT interventions to a waitlist control group. A total of 18 schools participate and we aim to recruit 323 adolescents (12-16 years). Youth who score above a cutoff on an anxiety symptom scale will be included in the study. School nurses recruit participants and deliver the interventions, with mental health workers as co-therapists and/or supervisors. Primary outcomes are level of anxiety symptoms and anxiety-related functional impairments. Secondary outcomes are level of depressive symptoms, quality of life and general psychosocial functioning. Non-inferiority between the two active interventions will be declared if a difference of 1.4 or less is found on the anxiety symptom measure post-intervention and a difference of 0.8 on the interference scale. Effects will be analyzed by mixed effect models, applying an intention to treat procedure. The present study extends previous research by comparing two programs with different intensity. A brief intervention, if effective, could more easily be subject to large-scale implementation in school health services. ClinicalTrials.gov, NCT02279251 . Registered on 15 October 2014. Retrospectively registered.

The Neurobiology of Intervention and Prevention in Early Adversity.

PubMed

Fisher, Philip A; Beauchamp, Kate G; Roos, Leslie E; Noll, Laura K; Flannery, Jessica; Delker, Brianna C

2016-01-01

Early adverse experiences are well understood to affect development and well-being, placing individuals at risk for negative physical and mental health outcomes. A growing literature documents the effects of adversity on developing neurobiological systems. Fewer studies have examined stress neurobiology to understand how to mitigate the effects of early adversity. This review summarizes the research on three neurobiological systems relevant to interventions for populations experiencing high levels of early adversity: the hypothalamic-adrenal-pituitary axis, the prefrontal cortex regions involved in executive functioning, and the system involved in threat detection and response, particularly the amygdala. Also discussed is the emerging field of epigenetics and related interventions to mitigate early adversity. Further emphasized is the need for intervention research to integrate knowledge about the neurobiological effects of prenatal stressors (e.g., drug use, alcohol exposure) and early adversity. The review concludes with a discussion of the implications of this research topic for clinical psychology practice and public policy.

Benefits of Early Intervention for Special Children.

ERIC Educational Resources Information Center

Bailey, Pamela W.; Trohanis, Pascal L.

The document contains summaries of over 50 publicly available publications which support the case for early intervention for handicapped children and their families. Section 1 contains studies pertaining to the effectiveness of any intervention. This section also describes projects approved by the United States Department of Education's Joint…

An exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds: a protocol paper for Teeth Tales

PubMed Central

Gibbs, Lisa; Waters, Elizabeth; de Silva, Andrea; Riggs, Elisha; Moore, Laurence; Armit, Christine; Johnson, Britt; Morris, Michal; Calache, Hanny; Gussy, Mark; Young, Dana; Tadic, Maryanne; Christian, Bradley; Gondal, Iqbal; Watt, Richard; Pradel, Veronika; Truong, Mandy; Gold, Lisa

2014-01-01

Introduction Inequalities are evident in early childhood caries rates with the socially disadvantaged experiencing greater burden of disease. This study builds on formative qualitative research, conducted in the Moreland/Hume local government areas of Melbourne, Victoria 2006–2009, in response to community concerns for oral health of children from refugee and migrant backgrounds. Development of the community-based intervention described here extends the partnership approach to cogeneration of contemporary evidence with continued and meaningful involvement of investigators, community, cultural and government partners. This trial aims to establish a model for child oral health promotion for culturally diverse communities in Australia. Methods and analysis This is an exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds. Families from an Iraqi, Lebanese or Pakistani background with children aged 1–4 years, residing in metropolitan Melbourne, were invited to participate in the trial by peer educators from their respective communities using snowball and purposive sampling techniques. Target sample size was 600. Moreland, a culturally diverse, inner-urban metropolitan area of Melbourne, was chosen as the intervention site. The intervention comprised peer educator led community oral health education sessions and reorienting of dental health and family services through cultural Competency Organisational Review (CORe). Ethics and dissemination Ethics approval for this trial was granted by the University of Melbourne Human Research Ethics Committee and the Department of Education and Early Childhood Development Research Committee. Study progress and output will be disseminated via periodic newsletters, peer-reviewed research papers, reports, community seminars and at National and International conferences. Trial registration number Australian New Zealand Clinical Trials

The thresholds for statistical and clinical significance – a five-step procedure for evaluation of intervention effects in randomised clinical trials

PubMed Central

2014-01-01

Background Thresholds for statistical significance are insufficiently demonstrated by 95% confidence intervals or P-values when assessing results from randomised clinical trials. First, a P-value only shows the probability of getting a result assuming that the null hypothesis is true and does not reflect the probability of getting a result assuming an alternative hypothesis to the null hypothesis is true. Second, a confidence interval or a P-value showing significance may be caused by multiplicity. Third, statistical significance does not necessarily result in clinical significance. Therefore, assessment of intervention effects in randomised clinical trials deserves more rigour in order to become more valid. Methods Several methodologies for assessing the statistical and clinical significance of intervention effects in randomised clinical trials were considered. Balancing simplicity and comprehensiveness, a simple five-step procedure was developed. Results For a more valid assessment of results from a randomised clinical trial we propose the following five-steps: (1) report the confidence intervals and the exact P-values; (2) report Bayes factor for the primary outcome, being the ratio of the probability that a given trial result is compatible with a ‘null’ effect (corresponding to the P-value) divided by the probability that the trial result is compatible with the intervention effect hypothesised in the sample size calculation; (3) adjust the confidence intervals and the statistical significance threshold if the trial is stopped early or if interim analyses have been conducted; (4) adjust the confidence intervals and the P-values for multiplicity due to number of outcome comparisons; and (5) assess clinical significance of the trial results. Conclusions If the proposed five-step procedure is followed, this may increase the validity of assessments of intervention effects in randomised clinical trials. PMID:24588900

Testing a workplace physical activity intervention: a cluster randomized controlled trial

PubMed Central

2011-01-01

Background Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. Methods A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Results and discussion Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B = -1.79 mm/Hg) and resting heart rate (B = -2.08 beats) and significantly increased body mass index (B = .18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. Conclusions The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. Trial registration Current controlled trials ISRCTN08807396 PMID:21481265

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…

Early Risers. What Works Clearinghouse Intervention Report

ERIC Educational Resources Information Center

What Works Clearinghouse, 2012

2012-01-01

"Early Risers" is a multi-year prevention program for elementary school children demonstrating early aggressive and disruptive behavior. The intervention model includes two child-focused components and two parent/family components. The Child Skills component is designed to teach skills that enhance children's emotional and behavioral…

An exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds: a protocol paper for Teeth Tales.

PubMed

Gibbs, Lisa; Waters, Elizabeth; de Silva, Andrea; Riggs, Elisha; Moore, Laurence; Armit, Christine; Johnson, Britt; Morris, Michal; Calache, Hanny; Gussy, Mark; Young, Dana; Tadic, Maryanne; Christian, Bradley; Gondal, Iqbal; Watt, Richard; Pradel, Veronika; Truong, Mandy; Gold, Lisa

2014-03-12

Inequalities are evident in early childhood caries rates with the socially disadvantaged experiencing greater burden of disease. This study builds on formative qualitative research, conducted in the Moreland/Hume local government areas of Melbourne, Victoria 2006-2009, in response to community concerns for oral health of children from refugee and migrant backgrounds. Development of the community-based intervention described here extends the partnership approach to cogeneration of contemporary evidence with continued and meaningful involvement of investigators, community, cultural and government partners. This trial aims to establish a model for child oral health promotion for culturally diverse communities in Australia. This is an exploratory trial implementing a community-based child oral health promotion intervention for Australian families from refugee and migrant backgrounds. Families from an Iraqi, Lebanese or Pakistani background with children aged 1-4 years, residing in metropolitan Melbourne, were invited to participate in the trial by peer educators from their respective communities using snowball and purposive sampling techniques. Target sample size was 600. Moreland, a culturally diverse, inner-urban metropolitan area of Melbourne, was chosen as the intervention site. The intervention comprised peer educator led community oral health education sessions and reorienting of dental health and family services through cultural Competency Organisational Review (CORe). Ethics approval for this trial was granted by the University of Melbourne Human Research Ethics Committee and the Department of Education and Early Childhood Development Research Committee. Study progress and output will be disseminated via periodic newsletters, peer-reviewed research papers, reports, community seminars and at National and International conferences. Australian New Zealand Clinical Trials Registry (ACTRN12611000532909).

A trial of an iPad™ intervention targeting social communication skills in children with autism.

PubMed

Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen

2016-10-01

This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent-child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad(™) apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains. © The Author(s) 2015.

T42. WHEN SHOULD EARLY INTERVENTION START, AND FOR HOW LONG SHOULD IT LAST?

PubMed Central

Albert, Nikolai; Melau, Marianne; Jensen, Heidi; Hastrup, Lene Halling; Hjorthøj, Carsten; Nordentoft, Merete

2018-01-01

Abstract Background Early intervention in psychosis facilities have often failed to integrate the two main elements of early intervention. While some facilities have focused on early, and have had Duration of Untreated Psychosis (DUP) as their main target, others have focused on the intervention and the treatment provided when patients were diagnosed. As both DUP reduction and specialized early intervention (SEI) has proved to have an effect on the treatment of patients with first-episode psychosis one could hope of a synergetic effect if the two strategies were integrated. In this study, we use data from a randomized clinical trial testing the effect of prolonged early intervention (5 years) compared to standard specialized early intervention (2 years). Overall the study found that both treatment groups remained stable or improved in psychopathology, functioning and cognition and that there was no further beneficial effect of the prolonged the treatment. Participants had a long DUP (median 52 weeks). For this specific sub-study we hypothesized that patients who were treated early in their course of illness would have a beneficial effect of the prolonged treatment compared to those who only received 2 years of specialized treatment. Methods 296 participants with a psychotic diagnosis within the schizophrenia spectrum (ICD 10 – F2x, excluding F21) were included. DUP start was assessed from first psychotic symptom equivalent to 3 or above on a global SAPS item. DUP stop was when patients started antipsychotic treatment or specialized early intervention treatment. To assess if there were a delay within the mental health referral system we used the national register to identify when participants first were diagnosed with a schizophrenia spectrum diagnosis and calculated the time until they started SEI treatment. Finally, we added the DUP and the treatment delay together to assess the time from first psychotic symptom until the start of adequate treatment (both

Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood.

PubMed

Redsell, Sarah A; Edmonds, Barrie; Swift, Judy Anne; Siriwardena, Aloysius Niroshan; Weng, Stephen; Nathan, Dilip; Glazebrook, Cris

2016-01-01

The risk factors for childhood overweight and obesity are known and can be identified antenatally or during infancy, however, the majority of effective interventions are designed for older children. This review identified interventions designed to reduce the risk of overweight/obesity that were delivered antenatally or during the first 2 years of life, with outcomes reported from birth to 7 years of age. Six electronic databases were searched for papers reporting randomised controlled trials of interventions published from January 1990 to September 2013. A total of 35 eligible studies were identified, describing 27 unique trials of which 24 were behavioural and three were non-behavioural. The 24 behavioural trials were categorised by type of intervention: (1) nutritional and/or responsive feeding interventions targeted at parents of infants, which improved feeding practices and had some impact on child weight (n = 12); (2) breastfeeding promotion and lactation support for mothers, which had a positive effect on breastfeeding but not child weight (n = 5); (3) parenting and family lifestyle (n = 4); and (4) maternal health (n = 3) interventions that had some impact on feeding practices but not child weight. The non-behavioural trials comprised interventions manipulating formula milk composition (n = 3). Of these, lower/hydrolysed protein formula milk had a positive effect on weight outcomes. Interventions that aim to improve diet and parental responsiveness to infant cues showed most promise in terms of self-reported behavioural change. Despite the known risk factors, there were very few intervention studies for pregnant women that continue during infancy which should be a priority for future research. © 2015 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

Systematic review of randomised controlled trials of interventions that aim to reduce the risk, either directly or indirectly, of overweight and obesity in infancy and early childhood

PubMed Central

Edmonds, Barrie; Swift, Judy Anne; Siriwardena, Aloysius Niroshan; Weng, Stephen; Nathan, Dilip; Glazebrook, Cris

2016-01-01

Abstract The risk factors for childhood overweight and obesity are known and can be identified antenatally or during infancy, however, the majority of effective interventions are designed for older children. This review identified interventions designed to reduce the risk of overweight/obesity that were delivered antenatally or during the first 2 years of life, with outcomes reported from birth to 7 years of age. Six electronic databases were searched for papers reporting randomised controlled trials of interventions published from January 1990 to September 2013. A total of 35 eligible studies were identified, describing 27 unique trials of which 24 were behavioural and three were non‐behavioural. The 24 behavioural trials were categorised by type of intervention: (1) nutritional and/or responsive feeding interventions targeted at parents of infants, which improved feeding practices and had some impact on child weight (n = 12); (2) breastfeeding promotion and lactation support for mothers, which had a positive effect on breastfeeding but not child weight (n = 5); (3) parenting and family lifestyle (n = 4); and (4) maternal health (n = 3) interventions that had some impact on feeding practices but not child weight. The non‐behavioural trials comprised interventions manipulating formula milk composition (n = 3). Of these, lower/hydrolysed protein formula milk had a positive effect on weight outcomes. Interventions that aim to improve diet and parental responsiveness to infant cues showed most promise in terms of self‐reported behavioural change. Despite the known risk factors, there were very few intervention studies for pregnant women that continue during infancy which should be a priority for future research. PMID:25894857

Video-feedback Intervention to promote Positive Parenting adapted to Autism (VIPP-AUTI): A randomized controlled trial.

PubMed

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

2015-07-01

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 interaction and reducing the child's individual Autism Spectrum Disorder-related symptomatology in five home visits. VIPP-AUTI, as compared with usual care, demonstrated efficacy in reducing parental intrusiveness. Moreover, parents who received VIPP-AUTI showed increased feelings of self-efficacy in child rearing. No significant group differences were found on other aspects of parent-child interaction or on child play behavior. At 3-months follow-up, intervention effects were found on child-initiated joint attention skills, not mediated by intervention effects on parenting. Implementation of VIPP-AUTI in clinical practice is facilitated by the use of a detailed manual and a relatively brief training of interveners. © The Author(s) 2014.

The effect of newborn vitamin A supplementation on infant immune functions: trial design, interventions, and baseline data.

PubMed

Ahmad, Shaikh Meshbahuddin; Raqib, Rubhana; Qadri, Firdausi; Stephensen, Charles B

2014-11-01

In recent years, neonatal vitamin A supplementation is considered as an essential infant-survival intervention but the evidence is not conclusive. This randomized controlled clinical trial was conducted to evaluate the effect of vitamin A on immune competence in early infancy. Results would provide a mechanistic basis for understanding the effect of this intervention on infant survival. Within 2 days of birth, infants born at one maternity clinic located in a poor slum area of Dhaka city were supplemented with either 50,000 IU vitamin A or placebo. Live attenuated oral polio vaccine (OPV) and BCG vaccine were provided after supplementation. Infants also receive diphtheria, pertussis, tetanus (TT), hepatitis B (HBV) and Haemophilus influenzae B vaccines (pentavalent combination) along with OPV at 6, 10 and 14 weeks of age. Infant thymus size, anthropometry, feeding practice and morbidity data were collected at regular interval. Infant blood samples were collected to determine T-cell-receptor excision circle (TREC), total, naïve and memory T cells and mucosal targeting lymphocytes including Treg cells. TT-, HBV-, BCG- and OPV-specific T cell blastogenic, cytokine and plasma cell antibody responses were also measured. In 16 mo enrollment period, 306 newborns, equal number of boys and girls, were enrolled. ~95% completed the 4-month follow-up period. Baseline characteristics are presented here. Anthropometry and immune assays with fresh blood samples were completed immediately while stored samples were analyzed in single batches at the end of the trial. Connecting different aspects of immunological data in early infancy will help elucidate immune competence for protecting infection. Trial registration ClinicalTrials.gov: NCT01583972. Copyright © 2014 Elsevier Inc. All rights reserved.

Promoting Early Presentation of Breast Cancer in Older Women: Implementing an Evidence-Based Intervention in Routine Clinical Practice

PubMed Central

Forbes, Lindsay J. L.; Forster, Alice S.; Dodd, Rachael H.; Tucker, Lorraine; Laming, Rachel; Sellars, Sarah; Patnick, Julietta; Ramirez, Amanda J.

2012-01-01

Background. Women over 70 with breast cancer have poorer one-year survival and present at a more advanced stage than younger women. Promoting early symptomatic presentation in older women may reduce stage cost effectively and is unlikely to lead to overdiagnosis. After examining efficacy in a randomised controlled trial, we piloted a brief health professional-delivered intervention to equip women to present promptly with breast symptoms, as an integral part of the final invited mammogram at age ~70, in the English National Health Service Breast Screening Programme. Methods. We trained mammographers, who then offered the intervention to older women in four breast screening services. We examined breast cancer awareness at baseline and one month in women receiving the intervention, and also in a service where the intervention was not offered. Results. We trained 27 mammographers to deliver the intervention confidently to a high standard. Breast cancer awareness increased 7-fold at one month in women receiving the intervention compared with 2-fold in the comparison service (odds ratio 15.2, 95% confidence interval 10.0 to 23.2). Conclusions. The PEP Intervention can be implemented in routine clinical practice with a potency similar to that achieved in a randomised controlled trial. It has the potential to reduce delay in diagnosis for breast cancer in older women. PMID:23213334

Early Intervention Paraprofessional Standards: Development and Field Validation

ERIC Educational Resources Information Center

Banerjee, Rashida; Chopra, Ritu V.; DiPalma, Geraldine

2017-01-01

Personnel standards are the foundations for how states and nations approve a program, engage in systemic assessment, and provide effective professional development to its early childhood professionals. However, despite the extensive use of paraprofessionals in early intervention/early childhood special education programs, there is a lack of…

Early Intervention, Maternal Development and Children's Play.

ERIC Educational Resources Information Center

Slaughter, Diana T.

The purposes of this longitudinal study of early intervention with 83 black mother-child dyads were (a) to test the thesis that sociocultural transmission influences childhood development in educationally significant ways, and (b) to describe the process through which such transmission can occur. Two social intervention programs were contrasted;…

Reducing disease burden and health inequalities arising from chronic disease among indigenous children: an early childhood caries intervention in Aotearoa/New Zealand

PubMed Central

2013-01-01

Background Maaori are the Indigenous people of New Zealand and do not enjoy the same oral health status as the non-Indigenous majority. To overcome oral health disparities, the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants. The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child. This study seeks to determine whether implementing a kaupapa Maaori (Maaori philosophical viewpoint) in an early childhood caries (ECC) intervention reduces dental disease burden among Maaori children. The intervention consists of four approaches to prevent early childhood caries: dental care provided during pregnancy, fluoride varnish application to the teeth of children, motivational interviewing, and anticipatory guidance. Methods/design The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui. This randomised-control trial will be undertaken utilising the principles of kaupapa Maaori research, which encompasses Maaori leadership, Maaori relationships, Maaori customary practices, etiquette and protocol. Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention. Self-report information will be collected in a baseline questionnaire during pregnancy and when children are aged 24 and 36 months. Clinical oral health data will be collected during standardised examinations at ages 24 and 36 months by calibrated dental professionals. All participants receive the ECC intervention benefits, with the intervention delayed by 24 months for participants who are randomised to the control-delayed arm. Discussion The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa

Different methods to analyze stepped wedge trial designs revealed different aspects of intervention effects.

PubMed

Twisk, J W R; Hoogendijk, E O; Zwijsen, S A; de Boer, M R

2016-04-01

Within epidemiology, a stepped wedge trial design (i.e., a one-way crossover trial in which several arms start the intervention at different time points) is increasingly popular as an alternative to a classical cluster randomized controlled trial. Despite this increasing popularity, there is a huge variation in the methods used to analyze data from a stepped wedge trial design. Four linear mixed models were used to analyze data from a stepped wedge trial design on two example data sets. The four methods were chosen because they have been (frequently) used in practice. Method 1 compares all the intervention measurements with the control measurements. Method 2 treats the intervention variable as a time-independent categorical variable comparing the different arms with each other. In method 3, the intervention variable is a time-dependent categorical variable comparing groups with different number of intervention measurements, whereas in method 4, the changes in the outcome variable between subsequent measurements are analyzed. Regarding the results in the first example data set, methods 1 and 3 showed a strong positive intervention effect, which disappeared after adjusting for time. Method 2 showed an inverse intervention effect, whereas method 4 did not show a significant effect at all. In the second example data set, the results were the opposite. Both methods 2 and 4 showed significant intervention effects, whereas the other two methods did not. For method 4, the intervention effect attenuated after adjustment for time. Different methods to analyze data from a stepped wedge trial design reveal different aspects of a possible intervention effect. The choice of a method partly depends on the type of the intervention and the possible time-dependent effect of the intervention. Furthermore, it is advised to combine the results of the different methods to obtain an interpretable overall result. Copyright © 2016 Elsevier Inc. All rights reserved.

[Parental self-efficacy in family-centered early intervention].

PubMed

Sarimski, Klaus; Hintermair, Manfred; Lang, Markus

2012-01-01

Parental self-efficacy is seen as an important concern in family-centered early intervention. This article reports the data from 125 parents of young children with intellectual disabilities, hearing impairment or visual impairment. The relationship between parental self-efficacy, parental stress and several parent and child variables is analyzed. The results support the relevance of parental self-efficacy for parental coping. Some recommendations for promoting their experience of participation and partnership in early intervention services are discussed.

Four-level evaluation of health promotion intervention for preventing early childhood caries: a randomized controlled trial.

PubMed

Basir, Leila; Rasteh, Bita; Montazeri, Ali; Araban, Marzieh

2017-10-02

Early childhood caries (ECC) is the most common dental disease among children, which can affect children's primary teeth during their teething. This study evaluates an intervention for preventing early childhood caries in a pediatric population in Ahvaz, Iran. The population of this study (IRCT2017070210804N10) consists of 104 women with 12 to 36 months of age without dental caries referred to a health care center in Ahvaz, Iran. The children were randomly assigned to either an experimental or control group in equal numbers. First, the demographic information of participants was collected through a questionnaire containing components of perceived threat, health literacy, and oral health behaviors using a valid and reliable questionnaire. The ECC status of the children was established by a dentist. Control group received "standard well baby care". The experimental group received standard well baby care in addition to educational interventions, including lecture and group discussion. After 6 months, the participant completed the questionnaire for the second time, and the children's teeth were reexamined. Data were analyzed using SPSS version 15 at a significance level of p < 0.05. The mean ages of women and children were 31 ± 6.68 years and 18 ± 7.21 months, respectively. Before the intervention, no significant difference was documented between the groups for the study variables, p > 0.05. However, after the intervention, a significant difference was observed between the perceived threats (41.15 ± 4.46 in the experimental group and 38.26 ± 4.21 in the control group, p = 0.001), health literacy (20.98 ± 2.15 in the experimental group and 19.76 ± 2.70 in the control group, p = 0.01), oral health behaviors (7.75 ± 2.30 in the experimental group and 6.15 ± 2.65 in the control group, p = 0.01), and the incidence of ECC (13% in the experimental group and 35% in the control group, p = 0.001). This intervention had positive effects on

Promoting healthy eating, active play and sustainability consciousness in early childhood curricula, addressing the Ben10™ problem: a randomised control trial.

PubMed

Skouteris, Helen; Edwards, Susan; Rutherford, Leonie; Cutter-MacKenzie, Amy; Huang, Terry; O'Connor, Amanda

2014-06-03

This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of '360 degree marketing' on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children's knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections. This cluster-randomised trial will be conducted with 300, 4 to 5 year-old children attending pre-school. Early childhood educators will develop a curriculum intervention using a pedagogical communication strategy that integrates content knowledge about healthy eating, active play and sustainability consciousness and deliver this to their pre-school class. Children will be interviewed about their knowledge of healthy eating, active play and the sustainability consequences of their food and toy selections. Parents will complete an Eating and Physical Activity Questionnaire rating their children's food preferences, digital media viewing and physical activity habits. All measures will be administered at baseline, the end of the intervention and 6 months post intervention. Informed consent will be obtained from all parents and the pre-school classes will be allocated randomly to the intervention or wait-list control group. This study is the first to utilise an integrated pedagogical communication strategy developed specifically for early childhood educators focusing on children's healthy eating, active play, and sustainability consciousness. The significance of the early childhood period, for young children's learning about healthy eating, active play and sustainability, is now unquestioned. The specific teaching and learning practices used by early

Session 6: Infant nutrition: future research developments in Europe EARNEST, the early nutrition programming project: EARly Nutrition programming - long-term Efficacy and Safety Trials and integrated epidemiological, genetic, animal, consumer and economic research.

PubMed

Fewtrell, M S

2007-08-01

Increasing evidence from lifetime experimental studies in animals and observational and experimental studies in human subjects suggests that pre- and postnatal nutrition programme long-term health. However, key unanswered questions remain on the extent of early-life programming in contemporary European populations, relevant nutritional exposures, critical time periods, mechanisms and the effectiveness of interventions to prevent or reverse programming effects. The EARly Nutrition programming - long-term Efficacy and Safety Trials and integrated epidemiological, genetic, animal, consumer and economic research (EARNEST) consortium brings together a multi-disciplinary team of scientists from European research institutions in an integrated programme of work that includes experimental studies in human subjects, modern prospective observational studies and mechanistic animal work including physiological studies, cell-culture models and molecular techniques. Theme 1 tests early nutritional programming of disease in human subjects, measuring disease markers in childhood and early adulthood in nineteen randomised controlled trials of nutritional interventions in pregnancy and infancy. Theme 2 examines associations between early nutrition and later outcomes in large modern European population-based prospective studies, with detailed measures of diet in pregnancy and early life. Theme 3 uses animal, cellular and molecular techniques to study lifetime effects of early nutrition. Biomedical studies are complemented by studies of the social and economic importance of programming (themes 4 and 5), and themes encouraging integration, communication, training and wealth creation. The project aims to: help formulate policies on the composition and testing of infant foods; improve the nutritional value of infant formulas; identify interventions to prevent and reverse adverse early nutritional programming. In addition, it has the potential to develop new products through industrial

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

PubMed

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

2016-01-01

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. 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. 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. 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, was sustained for the long

Evaluation of Young Children for Early Intervention and Early Childhood Special Education.

ERIC Educational Resources Information Center

Allen, Diana

This technical assistance document provides guidelines for child assessment and eligibility determination for early intervention and early childhood special education programs in Oregon. An overview of the assessment process explains screening, eligibility evaluation, and assessment for the Individual Family Service Plan (IFSP). Legal requirements…

Nutrition intervention for high-risk auto workers: results of the Next Step Trial.

PubMed

Tilley, B C; Glanz, K; Kristal, A R; Hirst, K; Li, S; Vernon, S W; Myers, R

1999-03-01

The Next Step Trial tested interventions encouraging prevention and early detection practices in automotive-industry employees at increased colorectal cancer risk. This article describes results of the nutrition intervention promoting low-fat, high-fiber eating patterns. Twenty-eight worksites (5,042 employees at baseline) were randomized to a 2-year nutrition intervention including classes, mailed self-help materials, and personalized dietary feedback. Control worksites received no intervention. Nutrition outcomes were assessed by mailed food frequency questionnaires (FFQs) Primary nutrition outcomes included percentage energy from fat and fiber density (g/1,000 kcal) at 1 year postrandomization. Secondary outcomes included servings of fruits/vegetables and dietary measures at 2 years postrandomization. Analyses were adjusted for within worksite correlations and baseline covariates. Fifty-eight percent of employees returned FFQs. At 1 year, there were modest but statistically significant intervention effects for fat (-0.9 %en), fiber (+0.5 g/1,000 kcal), and fruits/vegetables (+0.2 servings/day) (all P < 0.007). At 2 years, due to significant positive changes in control worksites, intervention effects were smaller, significant for fiber only. Intervention effects were larger in younger (<50 years), active employees and class attendees. The nutrition intervention produced significant but modest effects on dietary fat and fiber and fruits/vegetables in these high-risk employees. Age and dose effects suggest younger employees may be more responsive to this intervention. Copyright 1999 American Health Foundation and Academic Press.

Peyronie's disease intervention trials: methodological challenges and issues.

PubMed

Müller, Alexander; Mulhall, John P

2009-03-01

Peyronie's Disease (PD) has been studied for more than 260 years since Francois de la Peyronie's description in 1743. Based on the current literature, the prevalence of PD seems 3-9% with an average age of onset in the fifth life decade. Much effort has been spent on developing nonsurgical treatment options to cure or at least prevent disease progression. The recent examination of drug trials for erectile dysfunction has led us to assess PD trial methodology more closely. An Iinternet search on PubMed was performed using MeSH words PD, clinical trials, oral, transdermal, intralesional and shock wave therapy focusing on 26 representing studies published over the last 15 years. Mean Outcome Measures. A comprehensive review of the current literature on nonsurgical treatment options for PD was conducted to address methodological issues and challenges in PD trials highlighting trial design, patient population, and symptom and sign assessment. The majority of the reviewed studies are underpowered and the heterogeneity in the methodological approach and patient assessment between the studies is one of the remarkable findings from our review. Studies should use a uniform means of defining the degree and type of penile deformity and a large enough cohort of patients should be studied for adequate study power. An ideally designed PD intervention trial should comprise: (i) a randomized, placebo-controlled design; (ii) with a PD patient set representative of the general PD population; and (iii) a comprehensive symptom and sign assessment before and at the end of treatment which includes an assessment of at least deformity, pain, and sexual function. A number of challenges exist for the design of PD intervention trials and deciphering the data generated from them. The field would benefit greatly from a consensus statement or guidelines development on the design and conduct of such trials.

Cost of intervention delivery in a lifestyle weight loss trial in type 2 diabetes: results from the Look AHEAD clinical trial

PubMed Central

Wing, R.; Wadden, T. A.; Knowler, W. C.; Lawlor, M.; Evans, M.; Killean, T.; Montez, M.; Espeland, M. A.; Zhang, P.

2017-01-01

Summary Objective The Action for Health in Diabetes (Look AHEAD) trial was a randomized controlled clinical trial to compare the effects of 10 years of intensive lifestyle intervention (ILI) with a control condition of diabetes support and education (DSE) on health outcomes in over 5,000 participants with type 2 diabetes. The ILI had significantly greater weight losses than DSE throughout the trial. The goal of this analysis is to describe the cost of delivering the intervention. Methods The ILI was designed to promote weight loss and increase physical activity. It involved a combination of group plus individual intervention sessions, with decreasing frequency of contact over the 10 years. The intervention incorporated a variety of strategies, including meal replacement products, to improve weight loss outcomes. The costs of intervention delivery were derived from staff surveys of effort and from records of intervention materials from the 16 US academic clinical trial sites. Costs were calculated from the payer perspective and presented in 2012 dollars. Results During the first year, when intervention delivery was most intensive, the annual cost of intervention delivery, averaged (standard deviation) across clinical sites, was $2,864.6 ($513.3) per ILI participant compared with $202.4 ($76.6) per DSE participant. As intervention intensity declined, costs decreased, such that from years 5 to 9 of the trial, the annual cost of intervention was $1,119.8 ($227.7) per ILI participant and $102.9 ($33.0) per DSE participant. Staffing accounted for the majority of costs throughout the trial, with meal replacements and materials to promote adherence accounting for smaller shares. Conclusions The sustained weight losses produced by the Look AHEAD intervention were supported by intervention costs that were within the range of other weight loss programmes. Future work will include an evaluation of the cost‐effectiveness of the ILI and will contain additional follow�

Methods of dietary and nutritional assessment and intervention and other methods in the Multiple Risk Factor Intervention Trial.

PubMed

Dolecek, T A; Stamler, J; Caggiula, A W; Tillotson, J L; Buzzard, I M

1997-01-01

Various dietary assessment instruments were used in the Multiple Risk Factor Intervention Trial (MRFIT), either to assist with the special intervention program or to assess trial outcomes. For the latter purpose, the 24-h recall was the main method and was selected with the understanding that the single recall collected at baseline and at most annual visits--considered by itself--would be useful mainly for assessing groups rather than individuals. Major components of the data collection and analysis system developed for the 24-h recall included central training and certification of nutritionists, a central nutrient coding system, and a food grouping system to assist interventionists in using recall data for counseling. Several additional nutritional assessment methods were used for men in the special intervention group only to assist them in attaining the dietary goals. These goals consisted chiefly of reduced intake of saturated fat and cholesterol and a modest increase in intake of polyunsaturated fat; total fat intake was also decreased, primarily for control of energy intake. Short-term success at attainment of these nutritional goals was evaluated by means of 3-d food records collected before the intervention and after the initial 10-wk intensive intervention period. The MRFIT nutrient goals, which became more vigorous at certain points in the trial, were translated into food patterns. Adherence to these food patterns was also assessed by scoring of 3-d records and by subjective evaluation by nutritionists throughout the trial. Methods of collecting other trial data are also described in this chapter.

The Effectiveness of the BITSEA as a Tool to Early Detect Psychosocial Problems in Toddlers, a Cluster Randomized Trial

PubMed Central

Kruizinga, Ingrid; Jansen, Wilma; van Sprang, Nicolien C.; Carter, Alice S.; Raat, Hein

2015-01-01

Objective Effective early detection tools are needed in child health care to detect psychosocial problems among young children. This study aimed to evaluate the effectiveness of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA), in reducing psychosocial problems at one year follow-up, compared to care as usual. Method Well-child centers in Rotterdam, the Netherlands, were allocated in a cluster randomized controlled trial to the intervention condition (BITSEA—15 centers), or to the control condition (‘care-as-usual’- 16 centers). Parents of 2610 2-year-old children (1,207 intervention; 1,403 control) provided informed consent and completed the baseline and 1-year follow-up questionnaire. Multilevel regression analyses were used to evaluate the effect of condition on psychosocial problems and health related quality of life (i.e. respectively Child Behavior Checklist and Infant-Toddler Quality of Life). The number of (pursuits of) referrals and acceptability of the BITSEA were also evaluated. Results Children in the intervention condition scored more favourably on the CBCL at follow-up than children in the control condition: B = -2.43 (95% confidence interval [95%CI] = -3.53;-1.33 p<0.001). There were no differences between conditions regarding ITQOL. Child health professionals reported referring fewer children in the intervention condition (n = 56, 5.7%), compared to the control condition (n = 95, 7.9%; p<0.05). There was no intervention effect on parents’ reported number of referrals pursued. It took less time to complete (parents) or work with (child health professional) the BITSEA, compared to care as usual. In the control condition, 84.2% of the parents felt (very) well prepared for the well-child visit, compared to 77.9% in the intervention condition (p<0.001). Conclusion The results support the use of the BITSEA as a tool for child health professionals in the early detection of psychosocial problems in 2-year-olds. We recommend future

A systematic review of randomised control trials of sexual health interventions delivered by mobile technologies.

PubMed

Burns, Kara; Keating, Patrick; Free, Caroline

2016-08-12

Sexually transmitted infections (STIs) pose a serious public health problem globally. The rapid spread of mobile technology creates an opportunity to use innovative methods to reduce the burden of STIs. This systematic review identified recent randomised controlled trials that employed mobile technology to improve sexual health outcomes. The following databases were searched for randomised controlled trials of mobile technology based sexual health interventions with any outcome measures and all patient populations: MEDLINE, EMBASE, PsycINFO, Global Health, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, NHS Health Technology Assessment Database, and Web of Science (science and social science citation index) (Jan 1999-July 2014). Interventions designed to increase adherence to HIV medication were not included. Two authors independently extracted data on the following elements: interventions, allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. Trials were assessed for methodological quality using the Cochrane risk of bias tool. We calculated effect estimates using intention to treat analysis. A total of ten randomised trials were identified with nine separate study groups. No trials had a low risk of bias. The trials targeted: 1) promotion of uptake of sexual health services, 2) reduction of risky sexual behaviours and 3) reduction of recall bias in reporting sexual activity. Interventions employed up to five behaviour change techniques. Meta-analysis was not possible due to heterogeneity in trial assessment and reporting. Two trials reported statistically significant improvements in the uptake of sexual health services using SMS reminders compared to controls. One trial increased knowledge. One trial reported promising results in increasing condom use but no trial reported statistically significant increases in condom

[Early Intervention and Cognitive Development: A Longitudinal Study with Psychologically Stressed Mother-Child-Dyad during Early Childhood].

PubMed

Zwönitzer, Annabel; Ziegenhain, Ute; Bovenschen, Ina; Pillhofer, Melanie; Spangler, Gottfried; Gerlach, Jennifer; Gabler, Sandra; Kindler, Heinz; Fegert, Jörg M; Künster, Anne Katrin

2016-01-01

Early intervention programs aiming at developing parents’ relationship and parenting skills and supporting young families have become increasingly established in Germany throughout the last decade. The present longitudinal study analyzed 53 children and their mothers receiving early intervention due to their psychosocially highly challenging life situations and personal circumstances. The children were examined at birth and at an age of twelve months as well as between ages two and four. The results revealed that the child’s cognitive development could be predicted by both maternal sensitivity and mother’s psychosocial stress. However, the amount, type, and intensity of early intervention did not have any effect on the child’s development. In terms of the effectiveness of early interventions the results implicate that interventions seems to be offered in an unspecific manner and does not contribute to an improvement of the child’s developmental status.

Early Childhood Intervention in China

ERIC Educational Resources Information Center

Zheng, Yuzhu; Maude, Susan P.; Brotherson, Mary Jane

2015-01-01

With rapid economic development and increasing awareness of the importance of early childhood intervention (ECI), China is re-examining its social and educational practices for young children with disabilities. This re-examination may have a significant impact on young children with disabilities in China. It may also set an example for other…

Defining Family-Friendly Early Intervention.

ERIC Educational Resources Information Center

Wadsworth, Donna E. Dugger; Wartelle, Noah L.

Prior to the 1986 passage of PL 99-457, an extension of the special services coverage under the Education for All Handicapped Children Act, early intervention programs were primarily interventionist directed and child focused. The new legislation provided incentives for providing programs that were family-centered and family-driven. The goal of…

“Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial

PubMed Central

2013-01-01

Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. Methods/Design One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These

Early intervention and recovery among children with failure to thrive: follow-up at age 8.

PubMed

Black, Maureen M; Dubowitz, Howard; Krishnakumar, Ambika; Starr, Raymond H

2007-07-01

We sought to examine the impact of a randomized, controlled trial of home visiting among infants with failure to thrive on growth, academic/cognitive performance, and home/classroom behavior at age 8. Infants with failure to thrive (N = 130) or adequate growth (N = 119) were recruited from pediatric primary care clinics serving low-income, urban communities. Eligibility criteria included age <25 months, gestational age >36 weeks, birth weight >2500 g, and no significant medical conditions. Evaluation included anthropometries, Bayley scales, maternal anthropometries, demographics, negative affect, IQ, and the Home Observation for Measurement of the Environment scale. Infants with failure to thrive were treated in an interdisciplinary growth and nutrition clinic and randomized into clinical-intervention-plus-home-intervention or clinical-care-only groups. The home-visiting curriculum promoted maternal sensitivity, parent-infant relationships, and child development. Follow-up visits were conducted by evaluators who were unaware of the children's growth or intervention history. At age 8, the evaluation included anthropometries, the Wechsler Intelligence Scale for Children III, and the Wide Range Achievement Test, Revised. Mothers completed the Child Behavior Checklist and teachers completed the Teacher Report Form. Multivariate analyses of variance were used to examine differences in growth, cognitive/academic performance, and home/school behavior, adjusted by maternal education, public assistance, and, when appropriate, infant Bayley score, maternal BMI, height, negative affect, IQ, and Home Observation for Measurement of the Environment scores. Retention was 74% to 78%. Children in the adequate-growth group were significantly taller, heavier, and had better arithmetic scores than the clinical-intervention-only group, with the clinical-intervention-plus-home-intervention group intermediate. There were no group differences in IQ, reading, or mother-reported behavior

77 FR 9947 - Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-21

...] Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... ``Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing... for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and...

[Basics of early intervention in children with autism spectrum disorders].

PubMed

Zalaquett, Daniela F; Schönstedt, Marianne G; Angeli, Milagros; Herrrera, Claudia C; Moyano, Andrea C

2015-01-01

Autism Spectrum Disorders (ASD) are characterized by impairments in communication and social interaction, as well as restricted and repetitive patterns of behavior. They have a prevalence of 0.6% in the general population, although there are no national statistics. Even though their evolution is variable, it has been observed that early intervention is an important factor determining prognosis. The aim of this study is to update concepts regarding the current available evidence on the importance of early intervention. After analyzing the collected information, the importance of early intervention programs for children with ASD is confirmed, as well as the role of pediatricians and other health professionals in the early detection of these disorders. Copyright © 2015. Publicado por Elsevier España, S.L.U.

Fadeout in an Early Mathematics Intervention: Constraining Content or Preexisting Differences?

ERIC Educational Resources Information Center

Bailey, Drew H.; Nguyen, Tutrang; Jenkins, Jade Marcus; Domina, Thurston; Clements, Douglas H.; Sarama, Julie S.

2016-01-01

A robust finding across research on early childhood educational interventions is that the treatment effect diminishes over time, with children not receiving the intervention eventually catching up to children who did. One popular explanation for fadeout of early mathematics interventions is that elementary school teachers may not teach the kind of…

Promotion, Prevention and Early Intervention for Mental Health: National Consultation.

ERIC Educational Resources Information Center

2003

This report provides a description of a national consultation that was undertaken in 2001-2002 to provide feedback on two companion national policy documents: "National Action Plan for Promotion, Prevention and Early Intervention for Mental Health 2000" and "Promotion, Prevention and Early Intervention for Mental Health: A…

Behavioural and skill-based early interventions in children with autism spectrum disorders.

PubMed

Weinmann, Stefan; Schwarzbach, Christoph; Begemann, Matthias; Roll, Stephanie; Vauth, Christoph; Willich, Stefan N; Greiner, Wolfgang

2009-07-29

Autism spectrum disorders (ASD) comprise typical or infantile autism (Kanner syndrome), Asperger's disorder and atypical autism or pervasive developmental disorder - not otherwise specified. The syndrome is characterized by deficits in (1) verbal and nonverbal communication, (2) reciprocal social interaction and (3) repetitive patterns of behaviour, interests and activities. Early behavioural interventions are based on learning theory and behaviour therapy. They take into account specific deficits in perception, emotional reactions, social interaction and communication. In Germany, these comprehensive models are not widely evaluated and implemented. What are the clinical effectiveness and safety of early behavioural or skills-based early interventions in autism compared to other interventions or to treatment as usual?What are specific factors responsible for the effectiveness?What are the cost-effectiveness and cost consequences of different early interventions in autism?Which legal, social and ethical aspects are relevant with regard to the implementation of the respective interventions in persons with autism? Following a systematic review of the literature, controlled studies on early behavioural or skills-based interventions published since 2000 in English or German with children until the age of twelve are included and critically appraised. Studies must have at least ten participants per intervention group. In total, 15 publications based on 14 studies, eight systematic reviews and one health economic study are included. Most studies evaluate early interventions based upon the Lovaas model (Early intensive behavioural treatment (EIBT), Applied behavioural analysis (ABA)). Other evaluate pragmatic interventions or interventions based on other theoretical models like specific parent interventions, responsive education and prelinguistic milieu teaching, joint attention, symbolic play, and picture exchange communication system. Behaviour analytic interventions

Behavioural and skill-based early interventions in children with autism spectrum disorders

PubMed Central

Weinmann, Stefan; Schwarzbach, Christoph; Begemann, Matthias; Roll, Stephanie; Vauth, Christoph; Willich, Stefan N.; Greiner, Wolfgang

2009-01-01

Introduction Autism spectrum disorders (ASD) comprise typical or infantile autism (Kanner syndrome), Asperger’s disorder and atypical autism or pervasive developmental disorder - not otherwise specified. The syndrome is characterized by deficits in (1) verbal and nonverbal communication, (2) reciprocal social interaction and (3) repetitive patterns of behaviour, interests and activities. Early behavioural interventions are based on learning theory and behaviour therapy. They take into account specific deficits in perception, emotional reactions, social interaction and communication. In Germany, these comprehensive models are not widely evaluated and implemented. Research questions What are the clinical effectiveness and safety of early behavioural or skills-based early interventions in autism compared to other interventions or to treatment as usual? What are specific factors responsible for the effectiveness? What are the cost-effectiveness and cost consequences of different early interventions in autism? Which legal, social and ethical aspects are relevant with regard to the implementation of the respective interventions in persons with autism? Methods Following a systematic review of the literature, controlled studies on early behavioural or skills-based interventions published since 2000 in English or German with children until the age of twelve are included and critically appraised. Studies must have at least ten participants per intervention group. Results In total, 15 publications based on 14 studies, eight systematic reviews and one health economic study are included. Most studies evaluate early interventions based upon the Lovaas model (Early intensive behavioural treatment (EIBT), Applied behavioural analysis (ABA)). Other evaluate pragmatic interventions or interventions based on other theoretical models like specific parent interventions, responsive education and prelinguistic milieu teaching, joint attention, symbolic play, and picture exchange

Ethnic variations in pathways into early intervention services for psychosis.

PubMed

Ghali, Sharif; Fisher, Helen L; Joyce, John; Major, Barnaby; Hobbs, Lorna; Soni, Sujata; Chisholm, Brock; Rahaman, Nikola; Papada, Peggy; Lawrence, Jo; Bloy, Sally; Marlowe, Karl; Aitchison, Katherine J; Power, Paddy; Johnson, Sonia

2013-04-01

Ethnic variations have previously been identified in the duration of untreated psychosis (DUP) and pathways into psychiatric services. These have not been examined in the context of early intervention services, which may alter these trajectories. To explore ethnic differences in the nature and duration of pathways into early intervention services. In a naturalistic cohort study, data were collected for 1024 individuals with psychotic disorders accepted for case management by eight London early intervention services. Duration of untreated psychosis was prolonged in the White British group compared with most other ethnic groups. White British individuals were more likely to make contact with their general practitioner and less likely to be seen within emergency medical services. All Black patient groups were more likely than their White British counterparts to experience involvement of criminal justice agencies. Variations continue to exist in how and when individuals from different ethnic groups access early intervention services. These may account for disparities in DUP.

Leber congenital amaurosis/early-onset severe retinal dystrophy: clinical features, molecular genetics and therapeutic interventions.

PubMed

Kumaran, Neruban; Moore, Anthony T; Weleber, Richard G; Michaelides, Michel

2017-09-01

Leber congenital amaurosis (LCA) and early-onset severe retinal dystrophy (EOSRD) are both genetically and phenotypically heterogeneous, and characterised clinically by severe congenital/early infancy visual loss, nystagmus, amaurotic pupils and markedly reduced/absent full-field electroretinograms. The vast genetic heterogeneity of inherited retinal disease has been established over the last 10 - 20 years, with disease-causing variants identified in 25 genes to date associated with LCA/EOSRD, accounting for 70-80% of cases, with thereby more genes yet to be identified. There is now far greater understanding of the structural and functional associations seen in the various LCA/EOSRD genotypes. Subsequent development/characterisation of LCA/EOSRD animal models has shed light on the underlying pathogenesis and allowed the demonstration of successful rescue with gene replacement therapy and pharmacological intervention in multiple models. These advancements have culminated in more than 12 completed, ongoing and anticipated phase I/II and phase III gene therapy and pharmacological human clinical trials. This review describes the clinical and genetic characteristics of LCA/EOSRD and the differential diagnoses to be considered. We discuss in further detail the diagnostic clinical features, pathophysiology, animal models and human treatment studies and trials, in the more common genetic subtypes and/or those closest to intervention. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

[The community-oriented experience of early intervention services in Taipei City].

PubMed

Chu, Feng-Ying

2007-10-01

The purpose of this paper is to emphasize the importance of early intervention. The purpose of early intervention in Taipei City is to help child development, promote parenting skills, and reduce educational and social costs. In order to meet these goals, parenting groups and Taipei City Council have made great efforts to make early intervention work in Taipei City. In April 1995, Taipei City Government started planning and setting up the service network. To date, Taipei City has set up one reporting and referral center?, ?six community resources centers, 22 medical assessment and intervention clinics, 12 child development centers, one early intervention training center, three non-profit foundations and more than 300 inclusion schools, such as kindergartens and day care centers. With parent participation, professional devotion and Taipei City Government's commitment, the number of assisted children has increased from 98 to 2,523 /year. By the end of 2006, Taipei had already funded 25,277 children. We estimate Taipei City early intervention services to have affected at least 75,000 persons, including development-delayed and disabled children, their parents?, ?grandparents and siblings. We found that early intervention services help the children to build up self esteem, grow their potential, learn how to socialize, and receive an education, while the most important aim is to help them to reduce their level of disability or to prevent them from getting worse. At the same time, their families get support and a diverse range of services. An integrated early intervention program should include children, families, and multidisciplinary professionals. The system should therefore be more "family-centered" and "community-oriented" to provide appropriate services to children and families through a positive and aggressive attitude.

Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol.

PubMed

Sgandurra, Giuseppina; Bartalena, Laura; Cioni, Giovanni; Greisen, Gorm; Herskind, Anna; Inguaggiato, Emanuela; Lorentzen, Jakob; Nielsen, Jens Bo; Sicola, Elisa

2014-10-15

Preterm infants are at risk for neurodevelopmental disorders, including motor, cognitive or behavioural problems, which may potentially be modified by early intervention. The EU CareToy Project Consortium (http://www.caretoy.eu) has developed a new modular system for intensive, individualized, home-based and family-centred early intervention, managed remotely by rehabilitation staff. A randomised controlled trial (RCT) has been designed to evaluate the efficacy of CareToy training in a first sample of low-risk preterm infants. The trial, randomised, multi-center, evaluator-blinded, parallel group controlled, is designed according to CONSORT Statement. Eligible subjects are infants born preterm without major complications, aged 3-9 months of corrected age with specific gross-motor abilities defined by Ages & Stages Questionnaire scores. Recruited infants, whose parents will sign a written informed consent for participation, will be randomized in CareToy training and control groups at baseline (T0). CareToy group will perform four weeks of personalized activities with the CareToy system, customized by the rehabilitation staff. The control group will continue standard care. Infant Motor Profile Scale is the primary outcome measure and a total sample size of 40 infants has been established. Bayley-Cognitive subscale, Alberta Infants Motor Scale and Teller Acuity Cards are secondary outcome measures. All measurements will be performed at T0 and at the end of training/control period (T1). For ethical reasons, after this first phase infants enrolled in the control group will perform the CareToy training, while the training group will continue standard care. At the end of open phase (T2) all infants will be assessed as at T1. Further assessment will be performed at 18 months corrected age (T3) to evaluate the long-term effects on neurodevelopmental outcome. Caregivers and rehabilitation staff will not be blinded whereas all the clinical assessments will be performed

Intervention of Behavioural, Cognitive and Sex on Early Childhood's Aggressive Behaviour

ERIC Educational Resources Information Center

Purwati; Japar, Muhammad

2015-01-01

This study aims to find out the effect of behavioural intervention, cognitive intervention, and sex intervention toward the aggressive behaviour of early childhood. The study is conducted at two non-formal institutions of Education on Early Childhood in Magelang. This study obtains the data from two experimental groups consisting of 14 early…

Effects of an 18-week exercise programme started early during breast cancer treatment: a randomised controlled trial.

PubMed

Travier, Noémie; Velthuis, Miranda J; Steins Bisschop, Charlotte N; van den Buijs, Bram; Monninkhof, Evelyn M; Backx, Frank; Los, Maartje; Erdkamp, Frans; Bloemendal, Haiko J; Rodenhuis, Carla; de Roos, Marnix A J; Verhaar, Marlies; ten Bokkel Huinink, Daan; van der Wall, Elsken; Peeters, Petra H M; May, Anne M

2015-06-08

Exercise started shortly after breast cancer diagnosis might prevent or diminish fatigue complaints. The Physical Activity during Cancer Treatment (PACT) study was designed to primarily examine the effects of an 18-week exercise intervention, offered in the daily clinical practice setting and starting within 6 weeks after diagnosis, on preventing an increase in fatigue. This multi-centre controlled trial randomly assigned 204 breast cancer patients to usual care (n = 102) or supervised aerobic and resistance exercise (n = 102). By design, all patients received chemotherapy between baseline and 18 weeks. Fatigue (i.e., primary outcome at 18 weeks), quality of life, anxiety, depression, and physical fitness were measured at 18 and 36 weeks. Intention-to-treat mixed linear model analyses showed that physical fatigue increased significantly less during cancer treatment in the intervention group compared to control (mean between-group differences at 18 weeks: -1.3; 95 % CI -2.5 to -0.1; effect size -0.30). Results for general fatigue were comparable but did not reach statistical significance (-1.0, 95%CI -2.1; 0.1; effect size -0.23). At 18 weeks, submaximal cardiorespiratory fitness and several muscle strength tests (leg extension and flexion) were significantly higher in the intervention group compared to control, whereas peak oxygen uptake did not differ between groups. At 36 weeks these differences were no longer statistically significant. Quality of life outcomes favoured the exercise group but were not significantly different between groups. A supervised 18-week exercise programme offered early in routine care during adjuvant breast cancer treatment showed positive effects on physical fatigue, submaximal cardiorespiratory fitness, and muscle strength. Exercise early during treatment of breast cancer can be recommended. At 36 weeks, these effects were no longer statistically significant. This might have been caused by the control participants' high physical

Skin self-examination education for early detection of melanoma: a randomized controlled trial of Internet, workbook, and in-person interventions.

PubMed

Robinson, June K; Gaber, Rikki; Hultgren, Brittney; Eilers, Steven; Blatt, Hanz; Stapleton, Jerod; Mallett, Kimberly; Turrisi, Rob; Duffecy, Jenna; Begale, Mark; Martini, Mary; Bilimoria, Karl; Wayne, Jeffrey

2014-01-13

Early detection of melanoma improves survival. Since many melanoma patients and their spouses seek the care of a physician after discovering their melanoma, an ongoing study will determine the efficacy of teaching at-risk melanoma patients and their skin check partner how to conduct skin self-examinations (SSEs). Internet-based health behavior interventions have proven efficacious in creating behavior change in patients to better prevent, detect, or cope with their health issues. The efficacy of electronic interactive SSE educational intervention provided on a tablet device has not previously been determined. The electronic interactive educational intervention was created to develop a scalable, effective intervention to enhance performance and accuracy of SSE among those at-risk to develop melanoma. The intervention in the office was conducted using one of the following three methods: (1) in-person through a facilitator, (2) with a paper workbook, or (3) with a tablet device used in the clinical office. Differences related to method of delivery were elucidated by having the melanoma patient and their skin check partner provide a self-report of their confidence in performing SSE and take a knowledge-based test immediately after receiving the intervention. The three interventions used 9 of the 26 behavioral change techniques defined by Abraham and Michie to promote planning of monthly SSE, encourage performing SSE, and reinforce self-efficacy by praising correct responses to knowledge-based decision making and offering helpful suggestions to improve performance. In creating the electronic interactive SSE educational intervention, the educational content was taken directly from both the scripted in-person presentation delivered with Microsoft PowerPoint by a trained facilitator and the paper workbook training arms of the study. Enrollment totaled 500 pairs (melanoma patient and their SSE partner) with randomization of 165 pairs to the in-person, 165 pairs to the

Dietary Soy Supplement on Fibromyalgia Symptoms: A Randomized, Double-Blind, Placebo-Controlled, Early Phase Trial

PubMed Central

Wahner-Roedler, Dietlind L.; Thompson, Jeffrey M.; Luedtke, Connie A.; King, Susan M.; Cha, Stephen S.; Elkin, Peter L.; Bruce, Barbara K.; Townsend, Cynthia O.; Bergeson, Jody R.; Eickhoff, Andrea L.; Loehrer, Laura L.; Sood, Amit; Bauer, Brent A.

2011-01-01

Most patients with fibromyalgia use complementary and alternative medicine (CAM). Properly designed controlled trials are necessary to assess the effectiveness of these practices. This study was a randomized, double-blind, placebo-controlled, early phase trial. Fifty patients seen at a fibromyalgia outpatient treatment program were randomly assigned to a daily soy or placebo (casein) shake. Outcome measures were scores of the Fibromyalgia Impact Questionnaire (FIQ) and the Center for Epidemiologic Studies Depression Scale (CES-D) at baseline and after 6 weeks of intervention. Analysis was with standard statistics based on the null hypothesis, and separation test for early phase CAM comparative trials. Twenty-eight patients completed the study. Use of standard statistics with intent-to-treat analysis showed that total FIQ scores decreased by 14% in the soy group (P = .02) and by 18% in the placebo group (P < .001). The difference in change in scores between the groups was not significant (P = .16). With the same analysis, CES-D scores decreased in the soy group by 16% (P = .004) and in the placebo group by 15% (P = .05). The change in scores was similar in the groups (P = .83). Results of statistical analysis using the separation test and intent-to-treat analysis revealed no benefit of soy compared with placebo. Shakes that contain soy and shakes that contain casein, when combined with a multidisciplinary fibromyalgia treatment program, provide a decrease in fibromyalgia symptoms. Separation between the effects of soy and casein (control) shakes did not favor the intervention. Therefore, large-sample studies using soy for patients with fibromyalgia are probably not indicated. PMID:18990724

Effects of Critical Thinking Intervention for Early Childhood Teacher Candidates

ERIC Educational Resources Information Center

Han, Heejeong Sophia; Brown, E. Todd

2013-01-01

This study is based on an intervention designed to enhance early childhood teacher candidates' critical thinking abilities. The concept, elements, standards, and traits of critical thinking were integrated into the main course contents, and the effects of the intervention were examined. The results indicated that early childhood teacher…

A National Look at Children and Families Entering Early Intervention

ERIC Educational Resources Information Center

Scarborough, Anita A.; Spiker, Donna; Mallik, Sangeeta; Hebbeler, Kathleen M.; Bailey Jr., Donald B.; Simeonsson, Rune J.

2004-01-01

The National Early Intervention Longitudinal Study (NEILS) is the first study of Part C of the Individuals With Disabilities Education Act (IDEA) early intervention system with a nationally representative sample of infants and toddlers with disabilities. This article presents national estimates of characteristics of infants and toddlers and their…

Parent Involvement in Early Intervention: What Role Does Setting Play?

ERIC Educational Resources Information Center

Kellar-Guenther, Yvonne; Rosenberg, Steven A.; Block, Stephen R.; Robinson, Cordelia C.

2014-01-01

This study compared levels of parent involvement in early intervention services for children under three which were delivered in community settings (children's homes and child care programs) and specialized settings (early intervention centers and provider offices) in the USA. Respondents reported the highest levels of parental involvement in the…

Intervention with African American Premature Infants: Four-Month Results of an Early Intervention Program

ERIC Educational Resources Information Center

Teti, Douglas M.; Black, Maureen M.; Viscardi, Rose; Glass, Penny; O'Connell, Melissa A.; Baker, Linda; Cusson, Regina; Reiner Hess, Christine

2009-01-01

This study evaluates the efficacy of an early intervention program targeting African American mothers and their premature, low birth weight infants at 3 to 4 months' corrected age from four neonatal intensive care units, 173 families are recruited (84 intervention, 89 control). The 8-session, 20-week intervention consists of a psychoeducational…

A randomized controlled trial on early physiotherapy intervention versus usual care in acute care unit for elderly: potential benefits in light of dietary intakes.

PubMed

Blanc-Bisson, C; Dechamps, A; Gouspillou, G; Dehail, P; Bourdel-Marchasson, I

2008-01-01

To evaluate effects of early intensive physiotherapy during acute illness on post hospitalization activity daily living autonomy (ADL). Prospective randomized controlled trial of intensive physiotherapy rehabilitation on day 1 to 2 after admission until clinical stability or usual care. acute care geriatric medicine ward. A total of 76 acutely ill patients, acutely bedridden or with reduced mobility but who were autonomous for mobility within the previous 3 months. Patients in palliative care or with limiting mobility pathology were excluded. Mean age was 85.4 (SD 6.6) years. At admission, at clinical stability and one month later: anthropometry, energy and protein intakes, hand grip strength, ADL scores, and baseline inflammatory parameters. An exploratory principal axis analysis was performed on the baseline characteristics and general linear models were used to explore the course of ADL and nutritional variables. A 4-factor solution was found explaining 71.7% of variance with a factor "nutrition", a factor "function" (18.8% of variance) for ADL, handgrip strength, bedridden state, energy and protein intakes, serum albumin and C-reactive protein concentrations; a factor "strength" and a fourth factor . During follow-up, dietary intakes, handgrip strength, and ADL scores improved but no changes occurred for anthropometric variables. Intervention was associated only with an increase in protein intake. Better improvement in ADL was found in intervention group when model was adjusted on "function" factor items. Physical intervention programs should be proposed according to nutritional intakes with the aim of preventing illness induced disability.

Cancer survivors' uptake and adherence in diet and exercise intervention trials: an integrative data analysis.

PubMed

Adams, Rebecca N; Mosher, Catherine E; Blair, Cindy K; Snyder, Denise C; Sloane, Richard; Demark-Wahnefried, Wendy

2015-01-01

The health benefits of diet and exercise interventions for cancer survivors are well documented. However, little is known regarding demographic and medical predictors of survivors' willingness to participate in diet and exercise intervention trials, study enrollment, intervention adherence, and study completion. To assist in interpreting the generalizability of trial findings and to improve the design of future trials, this study examined predictors of these process measures. An integrative data analysis was performed on data from 3 of the largest home-based diet and exercise intervention trials for cancer survivors (n = 23,841). Demographic and medical factors (ie, sex, race, age, time since diagnosis, and cancer type) were examined as predictors of willingness to participate, study enrollment, intervention adherence, and study completion in the pooled sample. A 99% confidence interval was used to determine statistical significance. Across trials, 11.1% of contacted survivors were willing to participate, and 5.7% were eligible and enrolled. Among enrollees, 53.4% demonstrated ≥75% adherence to the intervention, and 91.1% completed the study. Race (Caucasian vs others), age, time since diagnosis, and cancer type predicted survivors' willingness to participate (P < .01). All examined predictors were associated with the likelihood of study enrollment (P < .01). No significant predictors of intervention adherence or study completion were found among study enrollees (P ≥ .01). Cancer survivors' demographic and medical characteristics predicted their interest and participation in diet and exercise intervention trials. These findings have implications for the generalizability of results and can help to guide procedures used in future trials to enhance patient representation. © 2014 American Cancer Society.

Thrombolysis in the age of Primary Percutaneous Coronary Intervention: Mini-Review and Meta-analysis of Early PCI.

PubMed

Al Shammeri, O; Garcia, LA

2013-01-01

Primary Percutaneous Coronary Intervention (PCI) is the treatment of choice for ST-segment Elevation Myocardial Infarction (STEMI) if performed within 90 minutes from first medical contact. However, primary PCI is only available for less than 25% of patients with STEMI. Early PCI or Pharmaco-invasive strategy has evolved from facilitated PCI but with more delayed timing from thrombolysis to PCI. Assess the safety and effectiveness of Early PCI. We reviewed the data of the available therapy options for patients with STEMI. Then we performed a meta-analysis for all randomized controlled trials of early PCI versus standard therapy. Five studies fulfilled our inclusion criteria. Our meta-analysis showed improved cardiovascular events with early PCI compared to standard therapy (odd ratio of 0.54; 95% Confidence interval 0.47-0.7, p<0.001). There were no significant bleeding complications when doing early PCI 4 to 24 hours after successful thrombolysis. Early PCI should be done to all STEMI patients within 24 hours after successful thrombolysis.

Comparison of Percentage of Syllables Stuttered With Parent-Reported Severity Ratings as a Primary Outcome Measure in Clinical Trials of Early Stuttering Treatment.

PubMed

Onslow, Mark; Jones, Mark; O'Brian, Sue; Packman, Ann; Menzies, Ross; Lowe, Robyn; Arnott, Simone; Bridgman, Kate; de Sonneville, Caroline; Franken, Marie-Christine

2018-04-17

This report investigates whether parent-reported stuttering severity ratings (SRs) provide similar estimates of effect size as percentage of syllables stuttered (%SS) for randomized trials of early stuttering treatment with preschool children. Data sets from 3 randomized controlled trials of an early stuttering intervention were selected for analyses. Analyses included median changes and 95% confidence intervals per treatment group, Bland-Altman plots, analysis of covariance, and Spearman rho correlations. Both SRs and %SS showed large effect sizes from pretreatment to follow-up, although correlations between the 2 measures were moderate at best. Absolute agreement between the 2 measures improved as percentage reduction of stuttering frequency and severity increased, probably due to innate measurement limitations for participants with low baseline severity. Analysis of covariance for the 3 trials showed consistent results. There is no statistical reason to favor %SS over parent-reported stuttering SRs as primary outcomes for clinical trials of early stuttering treatment. However, there are logistical reasons to favor parent-reported stuttering SRs. We conclude that parent-reported rating of the child's typical stuttering severity for the week or month prior to each assessment is a justifiable alternative to %SS as a primary outcome measure in clinical trials of early stuttering treatment.

Randomized controlled trials of simulation-based interventions in Emergency Medicine: a methodological review.

PubMed

Chauvin, Anthony; Truchot, Jennifer; Bafeta, Aida; Pateron, Dominique; Plaisance, Patrick; Yordanov, Youri

2018-04-01

The number of trials assessing Simulation-Based Medical Education (SBME) interventions has rapidly expanded. Many studies show that potential flaws in design, conduct and reporting of randomized controlled trials (RCTs) can bias their results. We conducted a methodological review of RCTs assessing a SBME in Emergency Medicine (EM) and examined their methodological characteristics. We searched MEDLINE via PubMed for RCT that assessed a simulation intervention in EM, published in 6 general and internal medicine and in the top 10 EM journals. The Cochrane Collaboration risk of Bias tool was used to assess risk of bias, intervention reporting was evaluated based on the "template for intervention description and replication" checklist, and methodological quality was evaluated by the Medical Education Research Study Quality Instrument. Reports selection and data extraction was done by 2 independents researchers. From 1394 RCTs screened, 68 trials assessed a SBME intervention. They represent one quarter of our sample. Cardiopulmonary resuscitation (CPR) is the most frequent topic (81%). Random sequence generation and allocation concealment were performed correctly in 66 and 49% of trials. Blinding of participants and assessors was performed correctly in 19 and 68%. Risk of attrition bias was low in three-quarters of the studies (n = 51). Risk of selective reporting bias was unclear in nearly all studies. The mean MERQSI score was of 13.4/18.4% of the reports provided a description allowing the intervention replication. Trials assessing simulation represent one quarter of RCTs in EM. Their quality remains unclear, and reproducing the interventions appears challenging due to reporting issues.

Early Intervention Practices in China: Present Situation and Future Directions

ERIC Educational Resources Information Center

Hu, Xiaoyi; Yang, Xijie

2013-01-01

Early intervention services to young children with developmental delays in China have experienced significant growth since 1978, the beginning of the period of Reform and Opening. This article described the present situation of early intervention practices in mainland China, framed around the key components and guiding principles of Guralnick's…

Brief oral health promotion intervention among parents of young children to reduce early childhood dental decay

PubMed Central

2013-01-01

Background Severe untreated dental decay affects a child’s growth, body weight, quality of life as well as cognitive development, and the effects extend beyond the child to the family, the community and the health care system. Early health behavioural factors, including dietary practices and eating patterns, can play a major role in the initiation and development of oral diseases, particularly dental caries. The parent/caregiver, usually the mother, has a critical role in the adoption of protective health care behaviours and parental feeding practices strongly influence children’s eating behaviours. This study will test if an early oral health promotion intervention through the use of brief motivational interviewing (MI) and anticipatory guidance (AG) approaches can reduce the incidence of early childhood dental decay and obesity. Methods The study will be a randomised controlled study with parents and their new-born child/ren who are seen at 6–12 weeks of age by a child/community health nurse. Consenting parents will complete a questionnaire on oral health knowledge, behaviours, self-efficacy, oral health fatalism, parenting stress, prenatal and peri-natal health and socio-demographic factors at study commencement and at 12 and 36 months. Each child–parent pair will be allocated to an intervention or a standard care group, using a computer-generated random blocks. The standard group will be managed through the standard early oral health screening program; “lift the lip”. The intervention group will be provided with tailored oral health counselling by oral health consultants trained in MI and AG. Participating children will be examined at 24, and 36 months for the occurrence of dental decay and have their height and weight recorded. Dietary information obtained from a food frequency chart will be used to determine food and dietary patterns. Data analysis will use intention to treat and per protocol analysis and will use tests of independent

Antenatal care trial interventions: a systematic scoping review and taxonomy development of care models.

PubMed

Symon, Andrew; Pringle, Jan; Downe, Soo; Hundley, Vanora; Lee, Elaine; Lynn, Fiona; McFadden, Alison; McNeill, Jenny; Renfrew, Mary J; Ross-Davie, Mary; van Teijlingen, Edwin; Whitford, Heather; Alderdice, Fiona

2017-01-06

Antenatal care models vary widely around the world, reflecting local contexts, drivers and resources. Randomised controlled trials (RCTs) have tested the impact of multi-component antenatal care interventions on service delivery and outcomes in many countries since the 1980s. Some have applied entirely new schemes, while others have modified existing care delivery approaches. Systematic reviews (SRs) indicate that some specific antenatal interventions are more effective than others; however the causal mechanisms leading to better outcomes are poorly understood, limiting implementation and future research. As a first step in identifying what might be making the difference we conducted a scoping review of interventions tested in RCTs in order to establish a taxonomy of antenatal care models. A protocol-driven systematic search was undertaken of databases for RCTs and SRs reporting antenatal care interventions. Results were unrestricted by time or locality, but limited to English language. Key characteristics of both experimental and control interventions in the included trials were mapped using SPIO (Study design; Population; Intervention; Outcomes) criteria and the intervention and principal outcome measures were described. Commonalities and differences between the components that were being tested in each study were identified by consensus, resulting in a comprehensive description of emergent models for antenatal care interventions. Of 13,050 articles retrieved, we identified 153 eligible articles including 130 RCTs in 34 countries. The interventions tested in these trials varied from the number of visits to the location of care provision, and from the content of care to the professional/lay group providing that care. In most studies neither intervention nor control arm was well described. Our analysis of the identified trials of antenatal care interventions produced the following taxonomy: Universal provision model (for all women irrespective of health state or

The challenges of control groups, placebos and blinding in clinical trials of dietary interventions.

PubMed

Staudacher, Heidi M; Irving, Peter M; Lomer, Miranda C E; Whelan, Kevin

2017-08-01

High-quality placebo-controlled evidence for food, nutrient or dietary advice interventions is vital for verifying the role of diet in optimising health or for the management of disease. This could be argued to be especially important where the benefits of dietary intervention are coupled with potential risks such as compromising nutrient intake, particularly in the case of exclusion diets. The objective of the present paper is to explore the challenges associated with clinical trials in dietary research, review the types of controls used and present the advantages and disadvantages of each, including issues regarding placebos and blinding. Placebo-controlled trials in nutrient interventions are relatively straightforward, as in general placebos can be easily produced. However, the challenges associated with conducting placebo-controlled food interventions and dietary advice interventions are protean, and this has led to a paucity of placebo-controlled food and dietary advice trials compared with drug trials. This review appraises the types of controls used in dietary intervention trials and provides recommendations and nine essential criteria for the design and development of sham diets for use in studies evaluating the effect of dietary advice, along with practical guidance regarding their evaluation. The rationale for these criteria predominantly relate to avoiding altering the outcome of interest in those delivered the sham intervention in these types of studies, while not compromising blinding.

Preterm birth-associated cost of early intervention services: an analysis by gestational age.

PubMed

Clements, Karen M; Barfield, Wanda D; Ayadi, M Femi; Wilber, Nancy

2007-04-01

Characterizing the cost of preterm birth is important in assessing the impact of increasing prematurity rates and evaluating the cost-effectiveness of therapies to prevent preterm delivery. To assess early intervention costs that are associated with preterm births, we estimated the program cost of early intervention services for children who were born in Massachusetts, by gestational age at birth. Using the Pregnancy to Early Life Longitudinal Data Set, birth certificates for infants who were born in Massachusetts between July 1999 and June 2000 were linked to early intervention claims through 2003. We determined total program costs, in 2003 dollars, of early intervention and mean cost per surviving infant by gestational age. Costs by plurality, eligibility criteria, provider discipline, and annual costs for children's first 3 years also were examined. Overall, 14,033 of 76,901 surviving infants received early intervention services. Program costs totaled almost $66 million, with mean cost per surviving infant of $857. Mean cost per infant was highest for children who were 24 to 31 weeks' gestational age ($5393) and higher for infants who were 32 to 36 weeks' gestational age ($1578) compared with those who were born at term ($725). Cost per surviving infant generally decreased with increasing gestational age. Among children in early intervention, mean cost per child was higher for preterm infants than for term infants. At each gestational age, mean cost per surviving infant was higher for multiples than for singletons, and annual early intervention costs were higher for toddlers than for infants. Compared with their term counterparts, preterm infants incurred higher early intervention costs. This information along with data on birth trends will inform budget forecasting for early intervention programs. Costs that are associated with early childhood developmental services must be included when considering the long-term costs of prematurity.

A Randomized Clinical Trial of the Effects of Parent Mentors on Early Childhood Obesity: Study Design and Baseline Data

PubMed Central

Foster, Byron A.; Aquino, Christian; Gil, Mario; Flores, Glenn; Hale, Daniel

2015-01-01

Background Few effective community-based interventions exist for early childhood obesity. Parent mentors have been successful as an intervention for other conditions, but have not been used for childhood obesity. We designed an intervention for early childhood obesity using parent mentors and a positive outlier approach to assess potential efficacy, feasibility, and acceptability. Methods This trial enrolled obese (≥95th BMI percentile for age and gender) 2-5-year-old children in a Head Start program and their parents, with allocation to either parent mentors trained in positively deviant behaviors regarding childhood obesity, or community health workers delivering health education on obesity-related behaviors. The primary outcome is body mass index z-score change at the six-month follow-up assessment. Secondary outcomes include feeding behaviors and practices, health-related quality of life, dietary intake, and participation levels. Results We enrolled three parent mentors and 60 parent-child dyads. The population is 100% Hispanic; 44% of parents speak Spanish as their primary language and 45% were not high-school graduates. Children had a reported median vegetable and fruit intake of 0.3 and 1.1 cups per day, respectively, at baseline, and a median daily screen time of three hours. There was no intergroup difference in quality-of-life scores at baseline. Retention has been high, at 90% at three months. Conclusions In this randomized trial of the effects of parent mentors on early childhood obesity, parent-child dyads from an underserved, Hispanic population were successfully enrolled through a partnership with a Head Start organization, with a high retention rate. PMID:26343746

Applying metabolomics to cardiometabolic intervention studies and trials: past experiences and a roadmap for the future.

PubMed

Rankin, Naomi J; Preiss, David; Welsh, Paul; Sattar, Naveed

2016-10-01

Metabolomics and lipidomics are emerging methods for detailed phenotyping of small molecules in samples. It is hoped that such data will: (i) enhance baseline prediction of patient response to pharmacotherapies (beneficial or adverse); (ii) reveal changes in metabolites shortly after initiation of therapy that may predict patient response, including adverse effects, before routine biomarkers are altered; and( iii) give new insights into mechanisms of drug action, particularly where the results of a trial of a new agent were unexpected, and thus help future drug development. In these ways, metabolomics could enhance research findings from intervention studies. This narrative review provides an overview of metabolomics and lipidomics in early clinical intervention studies for investigation of mechanisms of drug action and prediction of drug response (both desired and undesired). We highlight early examples from drug intervention studies associated with cardiometabolic disease. Despite the strengths of such studies, particularly the use of state-of-the-art technologies and advanced statistical methods, currently published studies in the metabolomics arena are largely underpowered and should be considered as hypothesis-generating. In order for metabolomics to meaningfully improve stratified medicine approaches to patient treatment, there is a need for higher quality studies, with better exploitation of biobanks from randomized clinical trials i.e. with large sample size, adjudicated outcomes, standardized procedures, validation cohorts, comparison witth routine biochemistry and both active and control/placebo arms. On the basis of this review, and based on our research experience using clinically established biomarkers, we propose steps to more speedily advance this area of research towards potential clinical impact. © The Author 2016; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

PubMed

Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Attrition in trials evaluating complex interventions for schizophrenia: Systematic review and meta-analysis.

PubMed

Szymczynska, P; Walsh, S; Greenberg, L; Priebe, S

2017-07-01

Essential criteria for the methodological quality and validity of randomized controlled trials are the drop-out rates from both the experimental intervention and the study as a whole. This systematic review and meta-analysis assessed these drop-out rates in non-pharmacological schizophrenia trials. A systematic literature search was used to identify relevant trials with ≥100 sample size and to extract the drop-out data. The rates of drop-out from the experimental intervention and study were calculated with meta-analysis of proportions. Meta-regression was applied to explore the association between the study and sample characteristics and the drop-out rates. 43 RCTs were found, with drop-out from intervention ranging from 0% to 63% and study drop-out ranging from 4% to 71%. Meta-analyses of proportions showed an overall drop-out rate of 14% (95% CI: 13-15%) at the experimental intervention level and 20% (95% CI: 17-24%) at the study level. Meta-regression showed that the active intervention drop-out rates were predicted by the number of intervention sessions. In non-pharmacological schizophrenia trials, drop-out rates of less than 20% can be achieved for both the study and the experimental intervention. A high heterogeneity of drop-out rates across studies shows that even lower rates are achievable. Copyright © 2017 Elsevier Ltd. All rights reserved.

Improving Early Palliative Care with a Scalable, Stepped Peer Navigator and Social Work Intervention: A Single-Arm Clinical Trial.

PubMed

Bekelman, David B; Johnson-Koenke, Rachel; Bowles, Daniel W; Fischer, Stacy M

2018-02-20

Patients with cancer could benefit from early primary (i.e., basic) palliative care. Scalable models of care delivery are needed. Examine the feasibility of a stepped peer navigator and social work intervention developed to improve palliative care outcomes. Single-arm prospective clinical trial. The peer navigator educated patients to advocate for pain and symptom management with their healthcare providers, motivated patients to pursue advance care planning, and discussed the role of hospice. The social worker saw patients with persistent psychosocial distress. Patients with advanced cancer at a VA Medical Center not currently in palliative care or hospice whose oncologist would not be surprised if the patient died in the subsequent year. Participation and retention rates, patient-reported symptoms and quality of life, advance directive documentation, patient satisfaction survey, and semistructured interviews. The participation rate was 38% (17/45), and 35% (7/17) completed final survey measures. Patients had stage IV (81%) and primarily genitourinary (47%) and lung (24%) malignancies. Median Eastern Cooperative Oncology Group performance status was 0. Patient-reported surveys indicated low distress (mean scores: Functional Assessment of Cancer Therapy-General, 75.3 [standard deviation {SD} 17.6]; Edmonton Symptom Assessment Scale symptom scores ranged from 1.6 to 3.8; Patient Health Questionnaire-9, 5.7 [SD 5.2]; and Generalized Anxiety Disorder-7, 2.8 [SD 4.1]). Of those who had not completed advance directives at baseline (n = 11, 65%), five completed them by the end of study (5/11, 45%). Patients who completed satisfaction surveys (n = 7) and interviews (n = 4) provided mixed reviews of the intervention. At a single site, a stepped peer navigator and social work palliative care study had several challenges to feasibility, including low patient-reported distress and loss to follow-up.

Implementing a complex rehabilitation intervention in a stroke trial: a qualitative process evaluation of AVERT.

PubMed

Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie

2016-05-10

The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phase III stroke rehabilitation trial (AVERT). A descriptive qualitative approach was used. We purposively sampled 53 allied health and nursing staff from 19 acute stroke units in Australia, New Zealand and Scotland. Semi-structured interviews were conducted by phone, voice-internet, or face to face. Digitally recorded interviews were transcribed and analysed by two researchers using rigorous thematic analysis. Our analysis uncovered ten important themes that provide insight into the challenges of implementing complex new rehabilitation practices within complex care settings, plus factors and strategies that assisted implementation. Themes were grouped into three main categories: staff experience of implementing the trial intervention, barriers to implementation, and overcoming the barriers. Participation in the trial was challenging but had personal rewards and improved teamwork at some sites. Over the years that the trial ran some staff perceived a change in usual care. Barriers to trial implementation at some sites included poor teamwork, inadequate staffing, various organisational barriers, staff attitudes and beliefs, and patient-related barriers. Participants described successful implementation strategies that were built on interdisciplinary teamwork, education and strong leadership to 'get staff on board', and developing different ways of working. The AVERT stroke rehabilitation trial required commitment to deliver an intervention that needed strong collaboration between nurses and

Does early intervention improve outcomes in physiotherapy management of lumbar radicular syndrome? A mixed-methods study protocol

PubMed Central

Walters, Stephen J; Baxter, Susan

2017-01-01

Introduction Lumbar radicular syndrome (LRS) can be a painful and debilitating condition. The optimum management strategies and their timing remain elusive despite extensive research. Surgery provides good short-term outcomes but has concomitant risks and costs. Physiotherapy is commonly practised for patients with LRS but its effects remain equivocal and there is a lack of consensus on the type, duration and timing of physiotherapy intervention. There is a lack of high-quality evidence into new and innovative management strategies and the timings of those strategies for LRS. This pilot trial is an essential preliminary to a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of early physiotherapy intervention for patients with LRS. The study will test the protocol, the intervention, the use of outcome measures and the ability to set-up and run the trial to enable refinement of a future definitive RCT. Methods and analysis This is a mixed-methods study encompassing an external pilot RCT with integrated qualitative interviews with patients, clinicians and other key stakeholders. 80 patients will be recruited from primary care and randomised, after consent into 1 of 2 groups. Both groups will receive individually tailored, goal orientated physiotherapy. The usual care group will begin their physiotherapy 6 weeks after randomisation and the intervention group at 2 weeks after randomisation. Outcome measures will primarily be feasibility parameters including the ability to recruit and retain patients and to deliver the intervention. Data will be collected at baseline, and 6, 12 and 26 weeks following randomisation. Ethics and dissemination The study has received favourable ethical review from the East of Scotland Research Ethics Service (EoSRES) on the 20 August 2015 (15/ES/0130). Recruitment began on the 1 March 2016 and is expected to close in January 2017. Data collection is anticipated to be complete in July 2017

Randomized Trial of a Social Networking Intervention for Cancer-Related Distress.

PubMed

Owen, Jason E; O'Carroll Bantum, Erin; Pagano, Ian S; Stanton, Annette

2017-10-01

Web and mobile technologies appear to hold promise for delivering evidence-informed and evidence-based intervention to cancer survivors and others living with trauma and other psychological concerns. Health-space.net was developed as a comprehensive online social networking and coping skills training program for cancer survivors living with distress. The purpose of this study was to evaluate the effects of a 12-week social networking intervention on distress, depression, anxiety, vigor, and fatigue in cancer survivors reporting high levels of cancer-related distress. We recruited 347 participants from a local cancer registry and internet, and all were randomized to either a 12-week waiting list control group or to immediate access to the intervention. Intervention participants received secure access to the study website, which provided extensive social networking capabilities and coping skills training exercises facilitated by a professional facilitator. Across time, the prevalence of clinically significant depression symptoms declined from 67 to 34 % in both conditions. The health-space.net intervention had greater declines in fatigue than the waitlist control group, but the intervention did not improve outcomes for depression, trauma-related anxiety symptoms, or overall mood disturbance. For those with more severe levels of anxiety at baseline, greater engagement with the intervention was associated with higher levels of symptom reduction over time. The intervention resulted in small but significant effects on fatigue but not other primary or secondary outcomes. Results suggest that this social networking intervention may be most effective for those who have distress that is not associated with high levels of anxiety symptoms or very poor overall psychological functioning. The trial was registered with the ClinicalTrials.gov database ( ClinicalTrials.gov #NCT01976949).

A Single-Session, Web-Based Parenting Intervention to Prevent Adolescent Depression and Anxiety Disorders: Randomized Controlled Trial

PubMed Central

Cardamone-Breen, Mairead C; Jorm, Anthony F; Lawrence, Katherine A; Rapee, Ronald M; Mackinnon, Andrew J

2018-01-01

Background Depression and anxiety disorders are significant contributors to burden of disease in young people, highlighting the need to focus preventive efforts early in life. Despite substantial evidence for the role of parents in the prevention of adolescent depression and anxiety disorders, there remains a need for translation of this evidence into preventive parenting interventions. To address this gap, we developed a single-session, Web-based, tailored psychoeducation intervention that aims to improve parenting practices known to influence the development of adolescent depression and anxiety disorders. Objective The aim of this study was to evaluate the short-term effects of the intervention on parenting risk and protective factors and symptoms of depression and anxiety in adolescent participants. Methods We conducted a single-blind, parallel group, superiority randomized controlled trial comparing the intervention with a 3-month waitlist control. The intervention is fully automated and consists of two components: (1) completion of an online self-assessment of current parenting practices against evidence-based parenting recommendations for the prevention of adolescent depression and anxiety disorders and (2) an individually tailored feedback report highlighting each parent’s strengths and areas for improvement based on responses to the self-assessment. A community sample of 349 parents, together with 327 adolescents (aged 12-15 years), were randomized to either the intervention or waitlist control condition. Parents and adolescents completed online self-reported assessments of parenting and adolescent symptoms of depression and anxiety at baseline, 1-month (parent-report of parenting only), and 3-month follow-up. Results Compared with controls, intervention group parents showed significantly greater improvement in parenting risk and protective factors from baseline to 1-month and 3-month follow-up (F2,331.22=16.36, P<.001), with a small to medium effect size

SheppHeartCABG trial—comprehensive early rehabilitation after coronary artery bypass grafting: a protocol for a randomised clinical trial

PubMed Central

Moons, Philip; Hansen, Niels Viggo; La Cour, Søren; Olsen, Peter Skov; Gluud, Christian; Winkel, Per; Lindschou, Jane; Thygesen, Lau Caspar; Egerod, Ingrid; Berg, Selina Kikkenborg

2017-01-01

Introduction Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial. Methods/analysis SheppHeartCABG is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, employing 1:1 central randomisation to rehabilitation plus usual care versus usual care alone. On the basis of a sample size calculation, 326 patients undergoing coronary artery bypass grafting will be included from two clinical sites. All patients receive usual care and patients allocated to the experimental intervention follow 4 weeks rehabilitation consisting of an exercise programme, psycho-educative consultations and a compact mindfulness programme. The primary outcome is physical function measured by the 6-min walk test. The secondary outcomes are mental health and physical activity measured by the Medical Outcome Study Short Form (SF-12), anxiety and depression measured by the Hospital Anxiety and Depression Scale questionnaire, physical, emotional and global scores by the HeartQoL questionnaire, sleep measured by the Pittsburgh Sleep Quality Index, pain measured by the Örebro Musculoskeletal Screening Questionnaire and muscle endurance measured by the sit-to-stand test. A number of explorative analyses will also be conducted. Ethics and dissemination SheppHeartCABG is approved by the regional ethics committee (no. H-4-2014-109) and the Danish Data Protection Agency (no. 30-1309) and is performed in accordance with good clinical practice and the Declaration of Helsinki in its latest form. Positive, neutral and

Early versus Deferred Treatment for Smoldering Multiple Myeloma: A Meta-Analysis of Randomized, Controlled Trials

PubMed Central

Tompkins, Van S.; Gao, Lu; Wu, Xiaosong; Tao, Yi; Hu, Xiaojing; Hou, Jun; Han, Ying; Xu, Hongwei; Zhan, Fenghuang; Shi, Jumei

2014-01-01

Purpose Whether patients with smoldering multiple myeloma (SMM) needed to receive early interventional treatment remains controversial. Herein, we conducted a meta-analysis comparing the efficacy and safety of early treatment over deferred treatment for patients with SMM. Methods MEDLINE and Cochrane Library were searched to May 2014 for randomized controlled trials (RCTs) that assessed the effect of early treatment over deferred treatment. Primary outcome measure was mortality, and secondary outcome measures were progression, response rate, and adverse events. Results Overall, 5 trials including 449 patients were identified. There was a markedly reduced risk of disease progression with early treatment (Odds Ratio [OR] = 0.13, 95% confidence interval [CI] = 0.07 to 0.24). There were no significant differences in mortality and response rate (OR = 0.85, 95% CI = 0.45 to 1.60, and OR = 0.63, 95% CI = 0.32 to 1.23, respectively). More patients in the early treatment arm experienced gastrointestinal toxicities (OR = 10.02, 95%CI = 4.32 to 23.23), constipation (OR = 8.58, 95%CI = 3.20 to 23.00) and fatigue or asthenia (OR = 2.72, 95%CI = 1.30 to 5.67). No significant differences were seen with the development of acute leukemia (OR = 2.80, 95%CI = 0.42 to 18.81), hematologic cancer (OR = 2.07, 95%CI = 0.43 to 10.01), second primary tumors (OR = 3.45, 95%CI = 0.81 to 14.68), nor vertebral compression (OR = 0.18, 95%CI = 0.02 to 1.59). Conclusions Early treatment delayed disease progression but increased the risk of gastrointestinal toxicities, constipation and fatigue or asthenia. The differences on vertebral compression, acute leukemia, hematological cancer and second primary tumors were not statistically significant. Based on the current evidence, early treatment didn’t significantly affect mortality and response rate. However, further much larger trials were needed to provide more evidence

Early intervention in South Africa: moving beyond hearing screening.

PubMed

Storbeck, Claudine; Pittman, Paula

2008-01-01

Since little information is available on the outcome of early hearing intervention programs in South Africa, this article examines data on infants and families registered with a family-centred, home-based intervention program (HI HOPES) over a 12-month period in order to track the effectiveness of the holistic unbiased support to families of infants and toddlers with a hearing-loss. The aim of HI HOPES, which is based on the SKI-HI model of early intervention in the USA, is to ensure that families are enabled to make informed choices for their unique infant. Data were gathered on 32 infants ages birth to three years and their families using both qualitative and quantitative measures which included analysis of demographic data, quarterly language assessments, and parent satisfaction surveys. The report on the pilot year of this early intervention program shows that, though the sample is small, there is significant improvement in infant receptive and expressive language for infants identified before seven months of age, as well as a high level of satisfaction from families who have received services.

Early Childhood Special Education and Early Intervention Personnel Preparation Standards of the Division for Early Childhood: Field Validation

ERIC Educational Resources Information Center

Cochran, Deborah C.; Gallagher, Peggy A.; Stayton, Vicki D.; Dinnebeil, Laurie A.; Lifter, Karin; Chandler, Lynette K.; Christensen, Kimberly A.

2012-01-01

Results of the field validation survey of the revised initial and new advanced Council for Exceptional Children (CEC) Division for Early Childhood (DEC) early childhood special education (ECSE)/early intervention (EI) personnel standards are presented. Personnel standards are used as part of educational accountability systems and in teacher…

Implementing and evaluating early intervention for children with autism: Where are the gaps and what should we do?

PubMed

Vivanti, Giacomo; Kasari, Connie; Green, Jonathan; Mandell, David; Maye, Melissa; Hudry, Kristelle

2018-01-01

Despite recent advances, the evidence base supporting early intervention for young children with autism spectrum disorder (ASD) remains relatively sparse. The International Society for Autism Research (INSAR) recently sponsored a Special Interest Group (SIG) on Implementing and Evaluating Community-Based Early Intervention. Across three meetings, in 2015, 2016, and 2017, conveners of this SIG engaged >200 members to identify knowledge gaps and research priorities for moving the field forward. Here, we summarize the perspectives that emerged from group discussion at the SIG meetings as represented by scholars working actively in the field. Despite encouraging progress, critical gaps and research priorities were identified across all the stages of intervention development and testing from conceptualization to community implementation. Key issues include the need for (a) formal theories to guide early intervention development, evaluation, and implementation; and alignment of intervention goals with scientific knowledge and societal changes that have occurred in the decades since interventions were originally developed; (b) increased focus on feasibility of treatment procedures and alignment with stakeholder values during pilot evaluations; (c) use of research designs that allow for comparisons of different interventions and formats, analyses of active ingredients of treatment, and identification of moderators and mediators of outcome; (d) use of community-partnered participatory research to guide adaptation of intervention models to community settings; (e) inclusion of constructs related to implementation processes and outcomes in treatment trials and; (f) an iterative approach to the progression of knowledge from intervention development to implementation. Autism Res 2018, 11: 16-23. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. In this article, we summarize the themes discussed at the INSAR Special Interest Group (SIG) on Implementing

Parent-mediated intervention versus no intervention for infants at high risk of autism: a parallel, single-blind, randomised trial

PubMed Central

Green, Jonathan; Charman, Tony; Pickles, Andrew; Wan, Ming W; Elsabbagh, Mayada; Slonims, Vicky; Taylor, Carol; McNally, Janet; Booth, Rhonda; Gliga, Teodora; Jones, Emily J H; Harrop, Clare; Bedford, Rachael; Johnson, Mark H

2015-01-01

Summary Background Risk markers for later autism identified in the first year of life present plausible intervention targets during early development. We aimed to assess the effect of a parent-mediated intervention for infants at high risk of autism on these markers. Methods We did a two-site, two-arm assessor-blinded randomised controlled trial of families with an infant at familial high risk of autism aged 7–10 months, testing the adapted Video Interaction to Promote Positive Parenting (iBASIS-VIPP) versus no intervention. Families were randomly assigned to intervention or no intervention groups using a permuted block approach stratified by centre. Assessors, but not families or therapists, were masked to group assignment. The primary outcome was infant attentiveness to parent. Regression analysis was done on an intention-to-treat basis. This trial is registered with ISCRTN Registry, number ISRCTN87373263. Findings We randomly assigned 54 families between April 11, 2011, and Dec 4, 2012 (28 to intervention, 26 to no intervention). Although CIs sometimes include the null, point estimates suggest that the intervention increased the primary outcome of infant attentiveness to parent (effect size 0·29, 95% CI −0·26 to 0·86, thus including possibilities ranging from a small negative treatment effect to a strongly positive treatment effect). For secondary outcomes, the intervention reduced autism-risk behaviours (0·50, CI −0·15 to 1·08), increased parental non-directiveness (0·81, 0·28 to 1·52), improved attention disengagement (0·48, −0·01 to 1·02), and improved parent-rated infant adaptive function (χ2[2] 15·39, p=0·0005). There was a possibility of nil or negative effect in language and responsivity to vowel change (P1: ES–0·62, CI −2·42 to 0·31; P2: −0·29, −1·55 to 0·71). Interpretation With the exception of the response to vowel change, our study showed positive estimates across a wide range of behavioural and brain function

A multicenter, randomized controlled trial comparing the identification rate of stigmata of recent hemorrhage and rebleeding rate between early and elective colonoscopy in outpatient-onset acute lower gastrointestinal bleeding: study protocol for a randomized controlled trial.

PubMed

Niikura, Ryota; Nagata, Naoyoshi; Yamada, Atsuo; Doyama, Hisashi; Shiratori, Yasutoshi; Nishida, Tsutomu; Kiyotoki, Shu; Yada, Tomoyuki; Fujita, Tomoki; Sumiyoshi, Tetsuya; Hasatani, Kenkei; Mikami, Tatsuya; Honda, Tetsuro; Mabe, Katsuhiro; Hara, Kazuo; Yamamoto, Katsumi; Takeda, Mariko; Takata, Munenori; Tanaka, Mototsugu; Shinozaki, Tomohiro; Fujishiro, Mitsuhiro; Koike, Kazuhiko

2018-04-03

The clinical benefit of early colonoscopy within 24 h of arrival in patients with severe acute lower gastrointestinal bleeding (ALGIB) remains controversial. This trial will compare early colonoscopy (performed within 24 h) versus elective colonoscopy (performed between 24 and 96 h) to examine the identification rate of stigmata of recent hemorrhage (SRH) in ALGIB patients. We hypothesize that, compared with elective colonoscopy, early colonoscopy increases the identification of SRH and subsequently improves clinical outcomes. This trial is an investigator-initiated, multicenter, randomized, open-label, parallel-group trial examining the superiority of early colonoscopy over elective colonoscopy (standard therapy) in ALGIB patients. The primary outcome measure is the identification of SRH. Secondary outcomes include 30-day rebleeding, success of endoscopic treatment, need for additional endoscopic examination, need for interventional radiology, need for surgery, need for transfusion during hospitalization, length of stay, 30-day thrombotic events, 30-day mortality, preparation-related adverse events, and colonoscopy-related adverse events. The sample size will enable detection of a 9% SRH rate in elective colonoscopy patients and a SRH rate of ≥ 26% in early colonoscopy patients with a risk of type I error of 5% and a power of 80%. This trial will provide high-quality data on the benefits and risks of early colonoscopy in ALGIB patients. UMIN-CTR Identifier, UMIN000021129 . Registered on 21 February 2016; ClinicalTrials.gov Identifier, NCT03098173 . Registered on 24 March 2017.

Smartphone application for multi-phasic interventional trials in psychiatry: Technical design of a smart server.

PubMed

Zhang, Melvyn W B; Ho, Roger C M

2017-01-01

Smartphones and their accompanying applications are currently widely utilized in various healthcare interventions. Prior to the deployment of these tools for healthcare intervention, typically, proof of concept feasibility studies, as well as randomized trials are conducted to determine that these tools are efficacious prior to their actual implementation. In the field of psychiatry, most of the current interventions seek to compare smartphone based intervention against conventional care. There remains a paucity of research evaluating different forms of interventions using a single smartphone application. In the field of nutrition, there has been recent pioneering research demonstrating how a multi-phasic randomized controlled trial could be conducted using a single smartphone application. Despite the innovativeness of the previous smartphone conceptualization, there remains a paucity of technical information underlying the conceptualization that would support a multi-phasic interventional trial. It is thus the aim of the current technical note to share insights into an innovative server design that would enable the delivery of multi-phasic trials.

Interventions to reduce sedentary behaviour in 0–5-year-olds: a systematic review and meta-analysis of randomised controlled trials

PubMed Central

Downing, Katherine L; Hnatiuk, Jill A; Hinkley, Trina; Salmon, Jo; Hesketh, Kylie D

2018-01-01

Aim or objective To evaluate the effectiveness of behavioural interventions that report sedentary behaviour outcomes during early childhood. Design Systematic review and meta-analysis. Data sources Academic Search Complete, CINAHL Complete, Global Health, MEDLINE Complete, PsycINFO, SPORTDiscus with Full Text and EMBASE electronic databases were searched in March 2016. Eligibility criteria for selecting studies Inclusion criteria were: (1) published in a peer-reviewed English language journal; (2) sedentary behaviour outcomes reported; (3) randomised controlled trial (RCT) study design; and (4) participants were children with a mean age of ≤5.9 years and not yet attending primary/elementary school at postintervention. Results 31 studies were included in the systematic review and 17 studies in the meta-analysis. The overall mean difference in screen time outcomes between groups was −17.12 (95% CI −28.82 to −5.42) min/day with a significant overall intervention effect (Z=2.87, p=0.004). The overall mean difference in sedentary time between groups was −18.91 (95% CI −33.31 to −4.51) min/day with a significant overall intervention effect (Z=2.57, p=0.01). Subgroup analyses suggest that for screen time, interventions of ≥6 months duration and those conducted in a community-based setting are most effective. For sedentary time, interventions targeting physical activity (and reporting changes in sedentary time) are more effective than those directly targeting sedentary time. Summary/conclusions Despite heterogeneity in study methods and results, overall interventions to reduce sedentary behaviour in early childhood show significant reductions, suggesting that this may be an opportune time to intervene. Trial registration number CRD42015017090. PMID:29449219

Teacher-Conducted Trial-Based Functional Analyses as the Basis for Intervention

ERIC Educational Resources Information Center

Bloom, Sarah E.; Lambert, Joseph M.; Dayton, Elizabeth; Samaha, Andrew L.

2013-01-01

Previous studies have focused on whether a trial-based functional analysis (FA) yields the same outcomes as more traditional FAs, and whether interventions based on trial-based FAs can reduce socially maintained problem behavior. We included a full range of behavior functions and taught 3 teachers to conduct a trial-based FA with 3 boys with…

Development of Children at Risk for Adverse Outcomes Participating in Early Intervention in Developing Countries: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Wallander, Jan L.; Bann, Carla M.; Biasini, Fred J.; Goudar, Shivaprasad S.; Pasha, Omrana; Chomba, Elwyn; McClure, Elizabeth; Carlo, Waldemar A.

2014-01-01

Background: Previous research has indicated positive effects of early developmental intervention (EDI) on the development of children in developing countries. Few studies, however, have examined longitudinally when differential treatment effects may be observed and whether differential outcomes are associated with exposure to different risk…

Reducing disease burden and health inequalities arising from chronic disease among indigenous children: an early childhood caries intervention in Aotearoa/New Zealand.

PubMed

Broughton, John R; Maipi, Joyce Te H; Person, Marie; Thomson, W Murray; Morgaine, Kate C; Tiakiwai, Sarah-Jane; Kilgour, Jonathan; Berryman, Kay; Lawrence, Herenia P; Jamieson, Lisa M

2013-12-13

Maaori are the Indigenous people of New Zealand and do not enjoy the same oral health status as the non-Indigenous majority. To overcome oral health disparities, the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants. The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child. This study seeks to determine whether implementing a kaupapa Maaori (Maaori philosophical viewpoint) in an early childhood caries (ECC) intervention reduces dental disease burden among Maaori children. The intervention consists of four approaches to prevent early childhood caries: dental care provided during pregnancy, fluoride varnish application to the teeth of children, motivational interviewing, and anticipatory guidance. The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui.This randomised-control trial will be undertaken utilising the principles of kaupapa Maaori research, which encompasses Maaori leadership, Maaori relationships, Maaori customary practices, etiquette and protocol. Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention. Self-report information will be collected in a baseline questionnaire during pregnancy and when children are aged 24 and 36 months. Clinical oral health data will be collected during standardised examinations at ages 24 and 36 months by calibrated dental professionals. All participants receive the ECC intervention benefits, with the intervention delayed by 24 months for participants who are randomised to the control-delayed arm. The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research

Physical activity intervention for elderly patients with reduced physical performance after acute coronary syndrome (HULK study): rationale and design of a randomized clinical trial.

PubMed

Tonet, Elisabetta; Maietti, Elisa; Chiaranda, Giorgio; Vitali, Francesco; Serenelli, Matteo; Bugani, Giulia; Mazzoni, Gianni; Ruggiero, Rossella; Myers, Jonathan; Villani, Giovanni Quinto; Corvi, Ursula; Pasanisi, Giovanni; Biscaglia, Simone; Pavasini, Rita; Lucchi, Giulia Ricci; Sella, Gianluigi; Ferrari, Roberto; Volpato, Stefano; Campo, Gianluca; Grazzi, Giovanni

2018-05-21

Reduced physical performance and impaired mobility are common in elderly patients after acute coronary syndrome (ACS) and they represent independent risk factors for disability, morbidity, hospital readmission and mortality. Regular physical exercise represents a means for improving functional capacity. Nevertheless, its clinical benefit has been less investigated in elderly patients in the early phase after ACS. The HULK trial aims to investigate the clinical benefit of an early, tailored low-cost physical activity intervention in comparison to standard of care in elderly ACS patients with reduced physical performance. HULK is an investigator-initiated, prospective multicenter randomized controlled trial (NCT03021044). After successful management of the ACS acute phase and uneventful first 1 month, elderly (≥70 years) patients showing reduced physical performance are randomized (1:1 ratio) to either standard of care or physical activity intervention. Reduced physical performance is defined as a short physical performance battery (SPPB) score of 4-9. The early, tailored, low-cost physical intervention includes 4 sessions of physical activity with a supervisor and an home-based program of physical exercise. The chosen primary endpoint is the 6-month SPPB value. Secondary endpoints briefly include quality of life, on-treatment platelet reactivity, some laboratory data and clinical adverse events. To demonstrate an increase of at least one SPPB point in the experimental arm, a sample size of 226 patients is needed. The HULK study will test the hypothesis that an early, tailored low-cost physical activity intervention improves physical performance, quality of life, frailty status and outcome in elderly ACS patients with reduced physical performance. Clinicaltrials.gov, identifier NCT03021044 , first posted January, 13th 2017.

Early versus late surgical intervention or medical management for infective endocarditis: a systematic review and meta-analysis.

PubMed

Anantha Narayanan, Mahesh; Mahfood Haddad, Toufik; Kalil, Andre C; Kanmanthareddy, Arun; Suri, Rakesh M; Mansour, George; Destache, Christopher J; Baskaran, Janani; Mooss, Aryan N; Wichman, Tammy; Morrow, Lee; Vivekanandan, Renuga

2016-06-15

Infective endocarditis is associated with high morbidity and mortality and optimal timing for surgical intervention is unclear. We performed a systematic review and meta-analysis to compare early surgical intervention with conservative therapy in patients with infective endocarditis. PubMed, Cochrane, EMBASE, CINAHL and Google-scholar databases were searched from January 1960 to April 2015. Randomised controlled trials, retrospective cohorts and prospective observational studies comparing outcomes between early surgery at 20 days or less and conservative management for infective endocarditis were analysed. A total of 21 studies were included. OR of all-cause mortality for early surgery was 0.61 (95% CI 0.50 to 0.74, p<0.001) in unmatched groups and 0.41 (95% CI 0.31 to 0.54, p<0.001) in the propensity-matched groups (matched for baseline variables). For patients who had surgical intervention at 7 days or less, OR of all-cause mortality was 0.61 (95% CI 0.39 to 0.96, p=0.034) and in those who had surgical intervention within 8-20 days, the OR of mortality was 0.64 (95% CI 0.48 to 0.86, p=0.003) compared with conservative management. In propensity-matched groups, the OR of mortality in patients with surgical intervention at 7 days or less was 0.30 (95% CI 0.16 to 0.54, p<0.001) and in the subgroup of patients who underwent surgery between 8 and 20 days was 0.51 (95% CI 0.35 to 0.72, p<0.001). There was no significant difference in in-hospital mortality, embolisation, heart failure and recurrence of endocarditis between the overall unmatched cohorts. The results of our meta-analysis suggest that early surgical intervention is associated with significantly lower risk of mortality in patients with infective endocarditis. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Entitled to What? Public Policy and the Responsibilities of Early Intervention.

ERIC Educational Resources Information Center

Brown, Wesley; Conroy, Maureen

1999-01-01

Examines early-intervention entitlements currently extended by all states. Perspectives from the legislative process, federal and state implementation, judicial interpretation, and professional views are included. Distinctions among the key provisions for differing early intervention service systems are presented, legal cases are reviewed, and…

"How Early Is Early?" or "How Late Is Late?": Thinking through Some Issues in Early Intervention

ERIC Educational Resources Information Center

Mercieca, Daniela; Mercieca, Duncan P.

2014-01-01

Early intervention comes in-between the lives of children, families and teachers. This article uses part of a report written by an educational psychologist about a little girl to question the nature of intervention through Rancière's writings. As children and parents are seen as put into the position of inadequacy, they require such…

The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) framework: protocol to determine a core outcome set for efficacy and effectiveness trials of alcohol screening and brief intervention.

PubMed

Shorter, G W; Heather, N; Bray, Jeremy W; Giles, E L; Holloway, A; Barbosa, C; Berman, A H; O'Donnell, A J; Clarke, M; Stockdale, K J; Newbury-Birch, D

2017-12-22

The evidence base to assess the efficacy and effectiveness of alcohol brief interventions (ABI) is weakened by variation in the outcomes measured and by inconsistent reporting. The 'Outcome Reporting in Brief Intervention Trials: Alcohol' (ORBITAL) project aims to develop a core outcome set (COS) and reporting guidance for its use in future trials of ABI in a range of settings. An international Special Interest Group was convened through INEBRIA (International Network on Brief Interventions for Alcohol and Other Drugs) to inform the development of a COS for trials of ABI. ORBITAL will incorporate a systematic review to map outcomes used in efficacy and effectiveness trials of ABI and their measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This will support a multi-round Delphi study to prioritise outcomes. Delphi panellists will be drawn from a range of settings and stakeholder groups, and the Delphi study will also be used to determine if a single COS is relevant for all settings. A consensus meeting with key stakeholder representation will determine the final COS and associated guidance for its use in trials of ABI. ORBITAL will develop a COS for alcohol screening and brief intervention trials, with outcomes stratified into domains and guidance on outcome measurement instruments. The standardisation of ABI outcomes and their measurement will support the ongoing development of ABI studies and a systematic synthesis of emerging research findings. We will track the extent to which the COS delivers on this promise through an exploration of the use of the guidance in the decade following COS publication.

Early Ventricular Tachycardia or Fibrillation in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention and Impact on Mortality and Stent Thrombosis (from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction Trial).

PubMed

Kosmidou, Ioanna; Embacher, Monica; McAndrew, Thomas; Dizon, José M; Mehran, Roxana; Ben-Yehuda, Ori; Mintz, Gary S; Stone, Gregg W

2017-11-15

The prevalence and impact of early ventricular arrhythmias (ventricular tachycardia [VT]/ventricular fibrillation [VF]) occurring before mechanical revascularization for acute ST segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention are poorly understood. We sought to investigate the association between early VT/VF and long-term clinical outcomes using data from the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial. Among 3,602 patients with STEMI, 108 patients (3.0%) had early VT/VF. Baseline clinical characteristics were similar in patients with versus without early VT/VF. Patients with early VT/VF had shorter symptom-to-balloon times and lower left ventricular ejection fraction and underwent more frequent thrombectomy compared with patients without early VT/VF. Adjusted 3-year rates of all-cause death (15.7% vs 6.5%; adjusted hazard ratio 2.62, 95% confidence interval 1.48 to 4.61, p <0.001) and stent thrombosis (13.7% vs 5.7%; adjusted hazard ratio 2.74, 95% confidence interval 1.52 to 4.93, p <0.001) were significantly higher in patients with early VT/VF compared with patients without early VT/VF. In conclusion, in the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction trial, VT/VF occurring before coronary angiography and revascularization in patients with STEMI was strongly associated with increased 3-year rates of death and stent thrombosis. Further investigation into the mechanisms underlying the increased risk of early stent thrombosis in patients with early VT/VF is required. Copyright © 2017 Elsevier Inc. All rights reserved.

Early Intensive Leg Training to Enhance Walking in Children With Perinatal Stroke: Protocol for a Randomized Controlled Trial.

PubMed

Hurd, Caitlin; Livingstone, Donna; Brunton, Kelly; Teves, Michelle; Zewdie, Ephrem; Smith, Allison; Ciechanski, Patrick; Gorassini, Monica A; Kirton, Adam; Watt, Man-Joe; Andersen, John; Yager, Jerome; Yang, Jaynie F

2017-08-01

Development of motor pathways is modulated by activity in these pathways, when they are maturing (ie, critical period). Perinatal stroke injures motor pathways, including the corticospinal tracts, reducing their activity and impairing motor function. Current intervention for the lower limb emphasizes passive approaches (stretching, braces, botulinum toxin injections). The study hypothesis was that intensive, early, child-initiated activity during the critical period will enhance connectivity of motor pathways to the legs and improve motor function. The study objective was to determine whether early intervention with intensive activity is better than standard care, intervention delivered during the proposed critical period is better than after, and the outcomes are different when the intervention is delivered by a physical therapist in an institution vs. a parent at home. A prospective, delay-group, single-blind, randomized controlled trial (RCT) and a parallel, cohort study of children living beyond commuting distance and receiving an intervention delivered by their parent. The RCT intervention was provided in university laboratories, and parent training was provided in the childs home. Children 8 months to 3 years old with MRI-confirmed perinatal ischemic stroke and early signs of hemiparesis. Intensive, play-based leg activity with weights for the affected leg and foot, 1 hour/day, 4 days/week for 12 weeks. The primary outcome was the Gross Motor Function Measure-66 score. Secondary outcomes were motion analysis of walking, full-day step counts, motor evoked potentials from transcranial magnetic stimulation, and patellar tendon reflexes. Inter-individual heterogeneity in the severity of the stroke and behavioral differences are substantial but measurable. Differences in intervention delivery and assessment scoring are minimized by standardization and training. The intervention, contrary to current practice, could change physical therapy interventions for children

Interventions to improve patient understanding of cancer clinical trial participation: a systematic review.

PubMed

Kao, C Y; Aranda, S; Krishnasamy, M; Hamilton, B

2017-03-01

Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio-visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process. © 2016 John Wiley & Sons Ltd.

A randomized controlled trial comparing Circle of Security Intervention and treatment as usual as interventions to increase attachment security in infants of mentally ill mothers: Study Protocol.

PubMed

Ramsauer, Brigitte; Lotzin, Annett; Mühlhan, Christine; Romer, Georg; Nolte, Tobias; Fonagy, Peter; Powell, Bert

2014-01-30

Psychopathology in women after childbirth represents a significant risk factor for parenting and infant mental health. Regarding child development, these infants are at increased risk for developing unfavorable attachment strategies to their mothers and for subsequent behavioral, emotional and cognitive impairments throughout childhood. To date, the specific efficacy of an early attachment-based parenting group intervention under standard clinical outpatient conditions, and the moderators and mediators that promote attachment security in infants of mentally ill mothers, have been poorly evaluated. This randomized controlled clinical trial tests whether promoting attachment security in infancy with the Circle of Security (COS) Intervention will result in a higher rate of securely attached children compared to treatment as usual (TAU). Furthermore, we will determine whether the distributions of securely attached children are moderated or mediated by variations in maternal sensitivity, mentalizing, attachment representations, and psychopathology obtained at baseline and at follow-up. We plan to recruit 80 mother-infant dyads when infants are aged 4-9 months with 40 dyads being randomized to each treatment arm. Infants and mothers will be reassessed when the children are 16-18 months of age. Methodological aspects of the study are systematic recruitment and randomization, explicit inclusion and exclusion criteria, research assessors and coders blinded to treatment allocation, advanced statistical analysis, manualized treatment protocols and assessments of treatment adherence and integrity. The aim of this clinical trial is to determine whether there are specific effects of an attachment-based intervention that promotes attachment security in infants. Additionally, we anticipate being able to utilize data on maternal and child outcome measures to obtain preliminary indications about potential moderators of the intervention and inform hypotheses about which intervention

A Community-Based Early Intervention Program for Toddlers with Autism Spectrum Disorders

ERIC Educational Resources Information Center

Rollins, Pamela Rosenthal; Campbell, Michelle; Hoffman, Renee Thibodeau; Self, Kayli

2016-01-01

This study examined Pathways Early Autism Intervention, a community-based, parent-mediated, intensive behavioral and developmental intervention program for children with autism spectrum disorders that could be used as a model for state-funded early intervention programs. A single-subject, multiple-baseline, across-participants design was used.…

Partnership Patterns: Addressing Emotional Needs in Early Intervention

ERIC Educational Resources Information Center

Brotherson, Mary Jane; Summers, Jean Ann; Naig, Lisa A.; Kyzar, Kathleen; Friend, Anna; Epley, Pamela; Gotto, George S., IV; Turnbull, Ann P.

2010-01-01

Home visiting in early intervention is the primary model for delivering services and building partnerships with children and families. Using interviews with early interventionists and family members, this study investigated the extent to which families' and professionals' emotional needs were met during home visits and what factors contributed to…

Early Detection and Intervention of ASD: A European Overview

PubMed Central

Narzisi, Antonio; García-Primo, Patricia; Kawa, Rafal

2017-01-01

Over the last several years there has been an increasing focus on early detection of Autism Spectrum Disorder (ASD), not only from the scientific field but also from professional associations and public health systems all across Europe. Not surprisingly, in order to offer better services and quality of life for both children with ASD and their families, different screening procedures and tools have been developed for early assessment and intervention. However, current evidence is needed for healthcare providers and policy makers to be able to implement specific measures and increase autism awareness in European communities. The general aim of this review is to address the latest and most relevant issues related to early detection and treatments. The specific objectives are (1) analyse the impact, describing advantages and drawbacks, of screening procedures based on standardized tests, surveillance programmes, or other observational measures; and (2) provide a European framework of early intervention programmes and practices and what has been learnt from implementing them in public or private settings. This analysis is then discussed and best practices are suggested to help professionals, health systems and policy makers to improve their local procedures or to develop new proposals for early detection and intervention programmes. PMID:29194420

A multilevel intervention to increase physical activity and improve healthy eating and physical literacy among young children (ages 3-5) attending early childcare centres: the Healthy Start-Départ Santé cluster randomised controlled trial study protocol.

PubMed

Bélanger, Mathieu; Humbert, Louise; Vatanparast, Hassan; Ward, Stéphanie; Muhajarine, Nazeem; Chow, Amanda Froehlich; Engler-Stringer, Rachel; Donovan, Denise; Carrier, Natalie; Leis, Anne

2016-04-12

Childhood obesity is a growing concern for public health. Given a majority of children in many countries spend approximately 30 h per week in early childcare centers, this environment represents a promising setting for implementing strategies to foster healthy behaviours for preventing and controlling childhood obesity. Healthy Start-Départ Santé was designed to promote physical activity, physical literacy, and healthy eating among preschoolers. The objectives of this study are to assess the effectiveness of the Healthy Start-Départ Santé intervention in improving physical activity levels, physical literacy, and healthy eating among preschoolers attending early childcare centers. This study follows a cluster randomized controlled trial design in which the childcare centers are randomly assigned to receive the intervention or serve as usual care controls. The Healthy Start-Départ Santé intervention is comprised of interlinked components aiming to enable families and educators to integrate physical activity and healthy eating in the daily lives of young children by influencing factors at the intrapersonal, interpersonal, organizational, community, physical environment and policy levels. The intervention period, spanning 6-8 months, is preceded and followed by data collections. Participants are recruited from 61 childcare centers in two Canadian provinces, New Brunswick and Saskatchewan. Centers eligible for this study have to prepare and provide meals for lunch and have at least 20 children between the ages of 3 and 5. Centers are excluded if they have previously received a physical activity or nutrition promoting intervention. Eligible centers are stratified by province, geographical location (urban or rural) and language (English or French), then recruited and randomized using a one to one protocol for each stratum. Data collection is ongoing. The primary study outcomes are assessed using accelerometers (physical activity levels), the Test of Gross Motor

Four-Year Cost-effectiveness of Cognitive Behavior Therapy for Preventing First-episode Psychosis: The Dutch Early Detection Intervention Evaluation (EDIE-NL) Trial.

PubMed

Ising, Helga K; Lokkerbol, Joran; Rietdijk, Judith; Dragt, Sara; Klaassen, Rianne M C; Kraan, Tamar; Boonstra, Nynke; Nieman, Dorien H; van den Berg, David P G; Linszen, Don H; Wunderink, Lex; Veling, Wim; Smit, Filip; van der Gaag, Mark

2017-03-01

This study aims to evaluate the long-term cost-effectiveness of add-on cognitive behavior therapy (CBT) for the prevention of psychosis for individuals at ultrahigh risk (UHR) of psychosis. The Dutch Early Detection and Intervention randomized controlled trial was used, comparing routine care (RC; n = 101) with routine care plus CBT for UHR (here called CBTuhr; n = 95). A cost-effectiveness analysis was conducted with treatment response (defined as proportion of averted transitions to psychosis) as an outcome and a cost-utility analysis with quality-adjusted life years (QALYs) gained as a secondary outcome. The proportion of averted transitions to psychosis was significantly higher in the CBTuhr condition (with a risk difference of 0.122; b = 1.324, SEb = 0.017, z = 7.99, P < 0.001). CBTuhr showed an 83% probability of being more effective and less costly than RC by -US$ 5777 (savings) per participant. In addition, over the 4-year follow-up period, cumulative QALY health gains were marginally (but not significantly) higher in CBTuhr than for RC (2.63 vs. 2.46) and the CBTuhr intervention had a 75% probability of being the superior treatment (more QALY gains at lower costs) and a 92% probability of being cost-effective compared with RC at the Dutch threshold value (US$ 24 560; €20 000 per QALY). Add-on preventive CBTuhr had a high likelihood (83%) of resulting in more averted transitions to psychosis and lower costs as compared with RC. In addition, the intervention had a high likelihood (75%) of resulting in more QALY gains and lower costs as compared to RC. © The Author 2016. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com

Assessing Early Intervention Provider Needs: Insights from One State

ERIC Educational Resources Information Center

Spence, Christine M.; Connor, Susan M.; Burke, Ted; Cheema, Jehanzeb R.; Ostrosky, Michaelene M.

2018-01-01

A statewide needs assessment was conducted with early interventionists to gather information on perceived professional development (PD) needs. Across 3 years, 4,455 early interventionists responded to an online survey. Data were analyzed for reported needs on PD topics in seven broad areas related to early intervention processes and content.…

Speech outcome in young children born with unilateral cleft lip and palate treated with one- or two-stage palatal repair and the impact of early intervention.

PubMed

Raud Westberg, Liisi; Höglund Santamarta, Lena; Karlsson, Jenny; Nyberg, Jill; Neovius, Erik; Lohmander, Anette

2017-10-25

The aim of this study was to describe speech at 1, 1;6 and 3 years of age in children born with unilateral cleft lip and palate (UCLP) and relate the findings to operation method and amount of early intervention received. A prospective trial of children born with UCLP operated with a one-stage (OS) palatal repair at 12 months or a two-stage repair (TS) with soft palate closure at 3-4 months and hard palate closure at 12 months was undertaken (Scandcleft). At 1 and 1;6 years the place and manner of articulation and number of different consonants produced in babbling were reported in 33 children. At three years of age percentage consonants correct adjusted for age (PCC-A) and cleft speech errors were assessed in 26 of the 33 children. Early intervention was not provided as part of the trial but according to the clinical routine and was extracted from patient records. At age 3, the mean PCC-A was 68% and 46% of the children produced articulation errors with no significant difference between the two groups. At one year there was a significantly higher occurrence of oral stops and anterior place consonants in the TS group. There were significant correlations between the consonant production between one and three years of age, but not with amount of early intervention received. The TS method was beneficial for consonant production at age 1, but not shown at 1;6 or 3 years. Behaviourally based early intervention still needs to be evaluated.

Ursodeoxycholic acid versus placebo, and early term delivery versus expectant management, in women with intrahepatic cholestasis of pregnancy: semifactorial randomised clinical trial

PubMed Central

Chappell, Lucy C; Gurung, Vinita; Seed, Paul T; Chambers, Jenny; Williamson, Catherine

2012-01-01

Objectives To test whether ursodeoxycholic acid reduces pruritus in women with intrahepatic cholestasis of pregnancy, whether early term delivery does not increase the incidence of caesarean section, and the feasibility of recruiting women with intrahepatic cholestasis of pregnancy to trials of these interventions. Design First phase of a semifactorial randomised controlled trial. Setting Nine consultant led maternity units, United Kingdom. Participants 125 women with intrahepatic cholestasis of pregnancy (pruritus and raised levels of serum bile acids) or pruritus and raised alanine transaminase levels (>100 IU/L) recruited after 24 weeks’ gestation and followed until delivery. 56 women were randomised to ursodeoxycholic acid, 55 to placebo, 30 to early term delivery, and 32 to expectant management. Interventions Ursodeoxycholic acid 500 mg twice daily or placebo increased as necessary for symptomatic or biochemical improvement until delivery; early term delivery (induction or delivery started between 37+0 and 37+6) or expectant management (spontaneous labour awaited until 40 weeks’ gestation or caesarean section undertaken by normal obstetric guidelines, usually after 39 weeks’ gestation). Main outcome measures The primary outcome for ursodeoxycholic acid was maternal itch (arithmetic mean of measures (100 mm visual analogue scale) of worst itch in past 24 hours) and for the timing of delivery was caesarean section. Secondary outcomes were other maternal and perinatal outcomes and recruitment rates. Results Ursodeoxycholic acid reduced itching by −16 mm (95% confidence interval −27 mm to −6 mm), less than the 30 mm difference prespecified by clinicians and women as clinically meaningful. 32% (14/44) of women randomised to ursodeoxycholic acid experienced a reduction in worst itching by at least 30 mm compared with 16% (6/37) randomised to placebo. The difference of 16% (95% confidence interval −3 to 34); this would represent a number needed to treat

Defining Parent Education in Early Intervention.

ERIC Educational Resources Information Center

Dinnebeil, Laurie A.

1999-01-01

This response to Mahoney et al. (EC 623 392) offers a definition of parent education and discusses the importance of identifying intended outcomes and providing effective educational opportunities. Two models of parent education in early intervention are described: Parents Interacting with Infants and the Individualized Support Project. Some…

Children's parasympathetic reactivity to specific emotions moderates response to intervention for early-onset aggression.

PubMed

Gatzke-Kopp, Lisa M; Greenberg, Mark; Bierman, Karen

2015-01-01

Following theories that individual differences in respiratory sinus arrhythmia (RSA) denote differential sensitivity to environmental influences, this study examines whether differences in RSA reactivity to specific emotional challenges predict differential response to intervention. We present data from a randomized clinical trial of a targeted intervention for early onset aggression. In collaboration with a high-risk urban school district, 207 kindergarten children (73% African American, 66% male), identified by their teachers as having high levels of aggressive and disruptive behavior, were recruited. All children received a universal social-emotional curriculum. One hundred children were randomly assigned to an additional intervention consisting of weekly peer-based social skills training. Complete RSA data were available for 139 of the children. Teacher-reported externalizing symptoms and emotion regulation in 1st grade (post intervention) were examined controlling for baseline levels. First-grade peer nominations of aggressive behavior, controlling for baseline nominations, were also examined as outcomes. No effect of resting RSA was found. However, greater reactivity to anger was associated with higher externalizing symptoms and lower emotion regulation skills in 1st grade relative to low reactive children. Lower reactivity to fear was associated with greater improvement over time, an effect that was enhanced in the targeted intervention condition. Results suggest that measures of affective reactivity may provide insight into children's capacity to benefit from different types of interventions.

Evaluation of early efficacy endpoints for proof-of-concept trials.

PubMed