Sample records for random assignment design

  1. Preference option randomized design (PORD) for comparative effectiveness research: Statistical power for testing comparative effect, preference effect, selection effect, intent-to-treat effect, and overall effect.

    PubMed

    Heo, Moonseong; Meissner, Paul; Litwin, Alain H; Arnsten, Julia H; McKee, M Diane; Karasz, Alison; McKinley, Paula; Rehm, Colin D; Chambers, Earle C; Yeh, Ming-Chin; Wylie-Rosett, Judith

    2017-01-01

    Comparative effectiveness research trials in real-world settings may require participants to choose between preferred intervention options. A randomized clinical trial with parallel experimental and control arms is straightforward and regarded as a gold standard design, but by design it forces and anticipates the participants to comply with a randomly assigned intervention regardless of their preference. Therefore, the randomized clinical trial may impose impractical limitations when planning comparative effectiveness research trials. To accommodate participants' preference if they are expressed, and to maintain randomization, we propose an alternative design that allows participants' preference after randomization, which we call a "preference option randomized design (PORD)". In contrast to other preference designs, which ask whether or not participants consent to the assigned intervention after randomization, the crucial feature of preference option randomized design is its unique informed consent process before randomization. Specifically, the preference option randomized design consent process informs participants that they can opt out and switch to the other intervention only if after randomization they actively express the desire to do so. Participants who do not independently express explicit alternate preference or assent to the randomly assigned intervention are considered to not have an alternate preference. In sum, preference option randomized design intends to maximize retention, minimize possibility of forced assignment for any participants, and to maintain randomization by allowing participants with no or equal preference to represent random assignments. This design scheme enables to define five effects that are interconnected with each other through common design parameters-comparative, preference, selection, intent-to-treat, and overall/as-treated-to collectively guide decision making between interventions. Statistical power functions for testing all these effects are derived, and simulations verified the validity of the power functions under normal and binomial distributions.

  2. Introductory Statistics Students' Conceptual Understanding of Study Design and Conclusions

    NASA Astrophysics Data System (ADS)

    Fry, Elizabeth Brondos

    Recommended learning goals for students in introductory statistics courses include the ability to recognize and explain the key role of randomness in designing studies and in drawing conclusions from those studies involving generalizations to a population or causal claims (GAISE College Report ASA Revision Committee, 2016). The purpose of this study was to explore introductory statistics students' understanding of the distinct roles that random sampling and random assignment play in study design and the conclusions that can be made from each. A study design unit lasting two and a half weeks was designed and implemented in four sections of an undergraduate introductory statistics course based on modeling and simulation. The research question that this study attempted to answer is: How does introductory statistics students' conceptual understanding of study design and conclusions (in particular, unbiased estimation and establishing causation) change after participating in a learning intervention designed to promote conceptual change in these areas? In order to answer this research question, a forced-choice assessment called the Inferences from Design Assessment (IDEA) was developed as a pretest and posttest, along with two open-ended assignments, a group quiz and a lab assignment. Quantitative analysis of IDEA results and qualitative analysis of the group quiz and lab assignment revealed that overall, students' mastery of study design concepts significantly increased after the unit, and the great majority of students successfully made the appropriate connections between random sampling and generalization, and between random assignment and causal claims. However, a small, but noticeable portion of students continued to demonstrate misunderstandings, such as confusion between random sampling and random assignment.

  3. True and Quasi-Experimental Designs. ERIC/AE Digest.

    ERIC Educational Resources Information Center

    Gribbons, Barry; Herman, Joan

    Among the different types of experimental design are two general categories: true experimental designs and quasi- experimental designs. True experimental designs include more than one purposively created group, common measured outcomes, and random assignment. Quasi-experimental designs are commonly used when random assignment is not practical or…

  4. Reference Values of Within-District Intraclass Correlations of Academic Achievement by District Characteristics: Results from a Meta-Analysis of District-Specific Values

    ERIC Educational Resources Information Center

    Hedberg, E. C.; Hedges, Larry V.

    2014-01-01

    Randomized experiments are often considered the strongest designs to study the impact of educational interventions. Perhaps the most prevalent class of designs used in large scale education experiments is the cluster randomized design in which entire schools are assigned to treatments. In cluster randomized trials (CRTs) that assign schools to…

  5. Alternatives to the Randomized Controlled Trial

    PubMed Central

    West, Stephen G.; Duan, Naihua; Pequegnat, Willo; Gaist, Paul; Des Jarlais, Don C.; Holtgrave, David; Szapocznik, José; Fishbein, Martin; Rapkin, Bruce; Clatts, Michael; Mullen, Patricia Dolan

    2008-01-01

    Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented. PMID:18556609

  6. The Implications of "Contamination" for Experimental Design in Education

    ERIC Educational Resources Information Center

    Rhoads, Christopher H.

    2011-01-01

    Experimental designs that randomly assign entire clusters of individuals (e.g., schools and classrooms) to treatments are frequently advocated as a way of guarding against contamination of the estimated average causal effect of treatment. However, in the absence of contamination, experimental designs that randomly assign intact clusters to…

  7. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

    PubMed

    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  8. Evaluation of a School-Based Teen Obesity Prevention Minimal Intervention

    ERIC Educational Resources Information Center

    Abood, Doris A.; Black, David R.; Coster, Daniel C.

    2008-01-01

    Objective: A school-based nutrition education minimal intervention (MI) was evaluated. Design: The design was experimental, with random assignment at the school level. Setting: Seven schools were randomly assigned as experimental, and 7 as delayed-treatment. Participants: The experimental group included 551 teens, and the delayed treatment group…

  9. Preference in Random Assignment: Implications for the Interpretation of Randomized Trials

    PubMed Central

    Gold, Paul B.; Hargreaves, William A.; Aronson, Elliot; Bickman, Leonard; Barreira, Paul J.; Jones, Danson R.; Rodican, Charles F.; Fisher, William H.

    2009-01-01

    Random assignment to a preferred experimental condition can increase service engagement and enhance outcomes, while assignment to a less-preferred condition can discourage service receipt and limit outcome attainment. We examined randomized trials for one prominent psychiatric rehabilitation intervention, supported employment, to gauge how often assignment preference might have complicated the interpretation of findings. Condition descriptions, and greater early attrition from services-as-usual comparison conditions, suggest that many study enrollees favored assignment to new rapid-job-placement supported employment, but no study took this possibility into account. Reviews of trials in other service fields are needed to determine whether this design problem is widespread. PMID:19434489

  10. A Bayesian Nonparametric Causal Model for Regression Discontinuity Designs

    ERIC Educational Resources Information Center

    Karabatsos, George; Walker, Stephen G.

    2013-01-01

    The regression discontinuity (RD) design (Thistlewaite & Campbell, 1960; Cook, 2008) provides a framework to identify and estimate causal effects from a non-randomized design. Each subject of a RD design is assigned to the treatment (versus assignment to a non-treatment) whenever her/his observed value of the assignment variable equals or…

  11. Randomizing Roaches: Exploring the "Bugs" of Randomization in Experimental Design

    ERIC Educational Resources Information Center

    Wagler, Amy; Wagler, Ron

    2014-01-01

    Understanding the roles of random selection and random assignment in experimental design is a central learning objective in most introductory statistics courses. This article describes an activity, appropriate for a high school or introductory statistics course, designed to teach the concepts, values and pitfalls of random selection and assignment…

  12. The direct assignment option as a modular design component: an example for the setting of two predefined subgroups.

    PubMed

    An, Ming-Wen; Lu, Xin; Sargent, Daniel J; Mandrekar, Sumithra J

    2015-01-01

    A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed. Here, we illustrate the modularity of the direct assignment option by applying it to the setting of two predefined subgroups and testing for separate subgroup main effects. We power the 2-subgroup direct assignment option design with 1 IA (DAD-1) to test for separate subgroup main effects, with assessment of power to detect an interaction in a post-hoc test. Simulations assessed the statistical properties of this design compared to the 2-subgroup balanced randomized design with 1 IA, BRD-1. Different response rates for treatment/control in subgroup 1 (0.4/0.2) and in subgroup 2 (0.1/0.2, 0.4/0.2) were considered. The 2-subgroup DAD-1 preserves power and type I error rate compared to the 2-subgroup BRD-1, while exhibiting reasonable power in a post-hoc test for interaction. The direct assignment option is a flexible design component that can be incorporated into broader design frameworks, while maintaining desirable statistical properties, clinical appeal, and logistical simplicity.

  13. Exploring the statistical and clinical impact of two interim analyses on the Phase II design with option for direct assignment.

    PubMed

    An, Ming-Wen; Mandrekar, Sumithra J; Edelman, Martin J; Sargent, Daniel J

    2014-07-01

    The primary goal of Phase II clinical trials is to understand better a treatment's safety and efficacy to inform a Phase III go/no-go decision. Many Phase II designs have been proposed, incorporating randomization, interim analyses, adaptation, and patient selection. The Phase II design with an option for direct assignment (i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis (IA) at 50% accrual) was recently proposed [An et al., 2012]. We discuss this design in the context of existing designs, and extend it from a single-IA to a two-IA design. We compared the statistical properties and clinical relevance of the direct assignment design with two IA (DAD-2) versus a balanced randomized design with two IA (BRD-2) and a direct assignment design with one IA (DAD-1), over a range of response rate ratios (2.0-3.0). The DAD-2 has minimal loss in power (<2.2%) and minimal increase in T1ER (<1.6%) compared to a BRD-2. As many as 80% more patients were treated with experimental vs. control in the DAD-2 than with the BRD-2 (experimental vs. control ratio: 1.8 vs. 1.0), and as many as 64% more in the DAD-2 than with the DAD-1 (1.8 vs. 1.1). We illustrate the DAD-2 using a case study in lung cancer. In the spectrum of Phase II designs, the direct assignment design, especially with two IA, provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Random Assignment within Schools: Lessons Learned from the Teach for America Experiment

    ERIC Educational Resources Information Center

    Glazerman, Steven

    2012-01-01

    Randomized trials are a common way to provide rigorous evidence on the impacts of education programs. This article discusses the trade-offs associated with study designs that involve random assignment of students within schools and describes the experience from one such study of Teach for America (TFA). The TFA experiment faced challenges with…

  15. Intraclass Correlation Values for Planning Group-Randomized Trials in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2007-01-01

    Experiments that assign intact groups to treatment conditions are increasingly common in social research. In educational research, the groups assigned are often schools. The design of group-randomized experiments requires knowledge of the intraclass correlation structure to compute statistical power and sample sizes required to achieve adequate…

  16. Random Assignment: Practical Considerations from Field Experiments.

    ERIC Educational Resources Information Center

    Dunford, Franklyn W.

    1990-01-01

    Seven qualitative issues associated with randomization that have the potential to weaken or destroy otherwise sound experimental designs are reviewed and illustrated via actual field experiments. Issue areas include ethics and legality, liability risks, manipulation of randomized outcomes, hidden bias, design intrusiveness, case flow, and…

  17. Effects of an Early Numeracy Intervention on Struggling Kindergarteners' Mathematics Performance

    ERIC Educational Resources Information Center

    Bryant, Brian R.; Bryant, Diane Pedrotty; Roberts, Greg; Fall, Anna-Maria

    2016-01-01

    The purpose of this study was to investigate the effects of an early numeracy intervention delivered by kindergarten teachers to students identified as having mathematics difficulties. A multigroup growth-modeling-with-random-assignment-to-intervention-condition design was employed. Thirty-two teachers were randomly assigned to the treatment or…

  18. Design approaches to experimental mediation☆

    PubMed Central

    Pirlott, Angela G.; MacKinnon, David P.

    2016-01-01

    Identifying causal mechanisms has become a cornerstone of experimental social psychology, and editors in top social psychology journals champion the use of mediation methods, particularly innovative ones when possible (e.g. Halberstadt, 2010, Smith, 2012). Commonly, studies in experimental social psychology randomly assign participants to levels of the independent variable and measure the mediating and dependent variables, and the mediator is assumed to causally affect the dependent variable. However, participants are not randomly assigned to levels of the mediating variable(s), i.e., the relationship between the mediating and dependent variables is correlational. Although researchers likely know that correlational studies pose a risk of confounding, this problem seems forgotten when thinking about experimental designs randomly assigning participants to levels of the independent variable and measuring the mediator (i.e., “measurement-of-mediation” designs). Experimentally manipulating the mediator provides an approach to solving these problems, yet these methods contain their own set of challenges (e.g., Bullock, Green, & Ha, 2010). We describe types of experimental manipulations targeting the mediator (manipulations demonstrating a causal effect of the mediator on the dependent variable and manipulations targeting the strength of the causal effect of the mediator) and types of experimental designs (double randomization, concurrent double randomization, and parallel), provide published examples of the designs, and discuss the strengths and challenges of each design. Therefore, the goals of this paper include providing a practical guide to manipulation-of-mediator designs in light of their challenges and encouraging researchers to use more rigorous approaches to mediation because manipulation-of-mediator designs strengthen the ability to infer causality of the mediating variable on the dependent variable. PMID:27570259

  19. Design approaches to experimental mediation.

    PubMed

    Pirlott, Angela G; MacKinnon, David P

    2016-09-01

    Identifying causal mechanisms has become a cornerstone of experimental social psychology, and editors in top social psychology journals champion the use of mediation methods, particularly innovative ones when possible (e.g. Halberstadt, 2010, Smith, 2012). Commonly, studies in experimental social psychology randomly assign participants to levels of the independent variable and measure the mediating and dependent variables, and the mediator is assumed to causally affect the dependent variable. However, participants are not randomly assigned to levels of the mediating variable(s), i.e., the relationship between the mediating and dependent variables is correlational. Although researchers likely know that correlational studies pose a risk of confounding, this problem seems forgotten when thinking about experimental designs randomly assigning participants to levels of the independent variable and measuring the mediator (i.e., "measurement-of-mediation" designs). Experimentally manipulating the mediator provides an approach to solving these problems, yet these methods contain their own set of challenges (e.g., Bullock, Green, & Ha, 2010). We describe types of experimental manipulations targeting the mediator (manipulations demonstrating a causal effect of the mediator on the dependent variable and manipulations targeting the strength of the causal effect of the mediator) and types of experimental designs (double randomization, concurrent double randomization, and parallel), provide published examples of the designs, and discuss the strengths and challenges of each design. Therefore, the goals of this paper include providing a practical guide to manipulation-of-mediator designs in light of their challenges and encouraging researchers to use more rigorous approaches to mediation because manipulation-of-mediator designs strengthen the ability to infer causality of the mediating variable on the dependent variable.

  20. Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

    ERIC Educational Resources Information Center

    Lohr, Sharon L.; Zhu, Xiaoshu

    2017-01-01

    Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

  1. 77 FR 5850 - Notice of Random Assignment Study To Evaluate Workforce Investment Act Adult and Dislocated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-06

    ...: One commenter was concerned about 50 percent of the participants being placed in a control group. The... impact methodology for the evaluation. The design of the study was described as follows: The evaluation... eligible for intensive services would be randomly assigned to one of three groups. The three research...

  2. Best (but oft-forgotten) practices: designing, analyzing, and reporting cluster randomized controlled trials.

    PubMed

    Brown, Andrew W; Li, Peng; Bohan Brown, Michelle M; Kaiser, Kathryn A; Keith, Scott W; Oakes, J Michael; Allison, David B

    2015-08-01

    Cluster randomized controlled trials (cRCTs; also known as group randomized trials and community-randomized trials) are multilevel experiments in which units that are randomly assigned to experimental conditions are sets of grouped individuals, whereas outcomes are recorded at the individual level. In human cRCTs, clusters that are randomly assigned are typically families, classrooms, schools, worksites, or counties. With growing interest in community-based, public health, and policy interventions to reduce obesity or improve nutrition, the use of cRCTs has increased. Errors in the design, analysis, and interpretation of cRCTs are unfortunately all too common. This situation seems to stem in part from investigator confusion about how the unit of randomization affects causal inferences and the statistical procedures required for the valid estimation and testing of effects. In this article, we provide a brief introduction and overview of the importance of cRCTs and highlight and explain important considerations for the design, analysis, and reporting of cRCTs by using published examples. © 2015 American Society for Nutrition.

  3. No Randomization? No Problem: Experimental Control and Random Assignment in Single Case Research

    ERIC Educational Resources Information Center

    Ledford, Jennifer R.

    2018-01-01

    Randomization of large number of participants to different treatment groups is often not a feasible or preferable way to answer questions of immediate interest to professional practice. Single case designs (SCDs) are a class of research designs that are experimental in nature but require only a few participants, all of whom receive the…

  4. Packet Randomized Experiments for Eliminating Classes of Confounders

    PubMed Central

    Pavela, Greg; Wiener, Howard; Fontaine, Kevin R.; Fields, David A.; Voss, Jameson D.; Allison, David B.

    2014-01-01

    Background Although randomization is considered essential for causal inference, it is often not possible to randomize in nutrition and obesity research. To address this, we develop a framework for an experimental design—packet randomized experiments (PREs), which improves causal inferences when randomization on a single treatment variable is not possible. This situation arises when subjects are randomly assigned to a condition (such as a new roommate) which varies in one characteristic of interest (such as weight), but also varies across many others. There has been no general discussion of this experimental design, including its strengths, limitations, and statistical properties. As such, researchers are left to develop and apply PREs on an ad hoc basis, limiting its potential to improve causal inferences among nutrition and obesity researchers. Methods We introduce PREs as an intermediary design between randomized controlled trials and observational studies. We review previous research that used the PRE design and describe its application in obesity-related research, including random roommate assignments, heterochronic parabiosis, and the quasi-random assignment of subjects to geographic areas. We then provide a statistical framework to control for potential packet-level confounders not accounted for by randomization. Results PREs have successfully been used to improve causal estimates of the effect of roommates, altitude, and breastfeeding on weight outcomes. When certain assumptions are met, PREs can asymptotically control for packet-level characteristics. This has the potential to statistically estimate the effect of a single treatment even when randomization to a single treatment did not occur. Conclusions Applying PREs to obesity-related research will improve decisions about clinical, public health, and policy actions insofar as it offers researchers new insight into cause and effect relationships among variables. PMID:25444088

  5. Social and Clinical Effects of a Leisure Program on Adults with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Garcia-Villamisar, Domingo; Dattilo, John

    2011-01-01

    Using a pre-test, post-test experimental design, effects of a 1-year group leisure program were examined on 31 participants (20 male and 11 female), ages 27-38 (M = 32.05 at start of program), with an autism spectrum disorder (ASD) diagnosis randomly assigned to the experimental condition and a group of 20 adults with ASD randomly assigned to the…

  6. Data-Division-Specific Robustness and Power of Randomization Tests for ABAB Designs

    ERIC Educational Resources Information Center

    Manolov, Rumen; Solanas, Antonio; Bulte, Isis; Onghena, Patrick

    2010-01-01

    This study deals with the statistical properties of a randomization test applied to an ABAB design in cases where the desirable random assignment of the points of change in phase is not possible. To obtain information about each possible data division, the authors carried out a conditional Monte Carlo simulation with 100,000 samples for each…

  7. A Comparison of Single Sample and Bootstrap Methods to Assess Mediation in Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Pituch, Keenan A.; Stapleton, Laura M.; Kang, Joo Youn

    2006-01-01

    A Monte Carlo study examined the statistical performance of single sample and bootstrap methods that can be used to test and form confidence interval estimates of indirect effects in two cluster randomized experimental designs. The designs were similar in that they featured random assignment of clusters to one of two treatment conditions and…

  8. The experimental design of the Missouri Ozark Forest Ecosystem Project

    Treesearch

    Steven L. Sheriff; Shuoqiong He

    1997-01-01

    The Missouri Ozark Forest Ecosystem Project (MOFEP) is an experiment that examines the effects of three forest management practices on the forest community. MOFEP is designed as a randomized complete block design using nine sites divided into three blocks. Treatments of uneven-aged, even-aged, and no-harvest management were randomly assigned to sites within each block...

  9. Strategies for Improving Power in School-Randomized Studies of Professional Development

    ERIC Educational Resources Information Center

    Kelcey, Ben; Phelps, Geoffrey

    2013-01-01

    Objectives: Group-randomized designs are well suited for studies of professional development because they can accommodate programs that are delivered to intact groups (e.g., schools), the collaborative nature of professional development, and extant teacher/school assignments. Though group designs may be theoretically favorable, prior evidence has…

  10. Optimal Design in Three-Level Block Randomized Designs with Two Levels of Nesting: An ANOVA Framework with Random Effects

    ERIC Educational Resources Information Center

    Konstantopoulos, Spyros

    2013-01-01

    Large-scale experiments that involve nested structures may assign treatment conditions either to subgroups such as classrooms or to individuals such as students within subgroups. Key aspects of the design of such experiments include knowledge of the variance structure in higher levels and the sample sizes necessary to reach sufficient power to…

  11. A Scenario-Based Parametric Analysis of Stable Marriage Approaches to the Army Officer Assignment Problem

    DTIC Science & Technology

    2017-03-23

    solutions obtained through their proposed method to comparative instances of a generalized assignment problem with either ordinal cost components or... method flag: Designates the method by which the changed/ new assignment problem instance is solved. methodFlag = 0:SMAWarmstart Returns a matching...of randomized perturbations. We examine the contrasts between these methods in the context of assigning Army Officers among a set of identified

  12. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial.

    PubMed

    McCarren, Madeline; Twedt, Elaine L; Mansuri, Faizmohamed M; Nelson, Philip R; Peek, Brian T

    2014-01-01

    Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to "favor" a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design. Agreeable providers were randomized to "favor" either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate. All four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the "favor hydrochlorothiazide" group, there was 99% adherence to that strategy. In the "favor chlorthalidone" group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25-50 mg/day) and 100% for chlorthalidone (12.5-25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change in non-research clinicians. Waiver of patient consent can broaden the representation of patients, providers, and settings.

  13. A Semantic Differential Evaluation of Attitudinal Outcomes of Introductory Physical Science.

    ERIC Educational Resources Information Center

    Hecht, Alfred Roland

    This study was designed to assess the attitudinal outcomes of Introductory Physical Science (IPS) curriculum materials used in schools. Random samples of 240 students receiving IPS instruction and 240 non-science students were assigned to separate Solomon four-group designs with non-equivalent control groups. Random samples of 60 traditional…

  14. The statistical pitfalls of the partially randomized preference design in non-blinded trials of psychological interventions.

    PubMed

    Gemmell, Isla; Dunn, Graham

    2011-03-01

    In a partially randomized preference trial (PRPT) patients with no treatment preference are allocated to groups at random, but those who express a preference receive the treatment of their choice. It has been suggested that the design can improve the external and internal validity of trials. We used computer simulation to illustrate the impact that an unmeasured confounder could have on the results and conclusions drawn from a PRPT. We generated 4000 observations ("patients") that reflected the distribution of the Beck Depression Index (DBI) in trials of depression. Half were randomly assigned to a randomized controlled trial (RCT) design and half were assigned to a PRPT design. In the RCT, "patients" were evenly split between treatment and control groups; whereas in the preference arm, to reflect patient choice, 87.5% of patients were allocated to the experimental treatment and 12.5% to the control. Unadjusted analyses of the PRPT data consistently overestimated the treatment effect and its standard error. This lead to Type I errors when the true treatment effect was small and Type II errors when the confounder effect was large. The PRPT design is not recommended as a method of establishing an unbiased estimate of treatment effect due to the potential influence of unmeasured confounders. Copyright © 2011 John Wiley & Sons, Ltd.

  15. Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy.

    PubMed

    Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L

    2009-10-01

    Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.

  16. An Assessment of Health Behavior Peer Effects in Peking University Dormitories: A Randomized Cluster-Assignment Design for Interference

    PubMed Central

    Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J.

    2013-01-01

    Background Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Methods Study design: Cross-sectional in-dormitory survey. Study population: Current students from Peking University Health Science Center from April to June, 2009. Measurement: Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Results Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Conclusion Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers. PMID:24040377

  17. Sample Selection in Randomized Experiments: A New Method Using Propensity Score Stratified Sampling

    ERIC Educational Resources Information Center

    Tipton, Elizabeth; Hedges, Larry; Vaden-Kiernan, Michael; Borman, Geoffrey; Sullivan, Kate; Caverly, Sarah

    2014-01-01

    Randomized experiments are often seen as the "gold standard" for causal research. Despite the fact that experiments use random assignment to treatment conditions, units are seldom selected into the experiment using probability sampling. Very little research on experimental design has focused on how to make generalizations to well-defined…

  18. Estimating the Standard Error of the Impact Estimator in Individually Randomized Trials with Clustering

    ERIC Educational Resources Information Center

    Weiss, Michael J.; Lockwood, J. R.; McCaffrey, Daniel F.

    2016-01-01

    In the "individually randomized group treatment" (IRGT) experimental design, individuals are first randomly assigned to a treatment arm or a control arm, but then within each arm, are grouped together (e.g., within classrooms/schools, through shared case managers, in group therapy sessions, through shared doctors, etc.) to receive…

  19. Urn models for response-adaptive randomized designs: a simulation study based on a non-adaptive randomized trial.

    PubMed

    Ghiglietti, Andrea; Scarale, Maria Giovanna; Miceli, Rosalba; Ieva, Francesca; Mariani, Luigi; Gavazzi, Cecilia; Paganoni, Anna Maria; Edefonti, Valeria

    2018-03-22

    Recently, response-adaptive designs have been proposed in randomized clinical trials to achieve ethical and/or cost advantages by using sequential accrual information collected during the trial to dynamically update the probabilities of treatment assignments. In this context, urn models-where the probability to assign patients to treatments is interpreted as the proportion of balls of different colors available in a virtual urn-have been used as response-adaptive randomization rules. We propose the use of Randomly Reinforced Urn (RRU) models in a simulation study based on a published randomized clinical trial on the efficacy of home enteral nutrition in cancer patients after major gastrointestinal surgery. We compare results with the RRU design with those previously published with the non-adaptive approach. We also provide a code written with the R software to implement the RRU design in practice. In detail, we simulate 10,000 trials based on the RRU model in three set-ups of different total sample sizes. We report information on the number of patients allocated to the inferior treatment and on the empirical power of the t-test for the treatment coefficient in the ANOVA model. We carry out a sensitivity analysis to assess the effect of different urn compositions. For each sample size, in approximately 75% of the simulation runs, the number of patients allocated to the inferior treatment by the RRU design is lower, as compared to the non-adaptive design. The empirical power of the t-test for the treatment effect is similar in the two designs.

  20. An assessment of health behavior peer effects in Peking University dormitories: a randomized cluster-assignment design for interference.

    PubMed

    Yuan, Changzheng; Lv, Jun; VanderWeele, Tyler J

    2013-01-01

    Relatively little is known about the peer influence in health behaviors within university dormitory rooms. Moreover, in China, the problem of unhealthy behaviors among university students has not yet been sufficiently recognized. We thus investigated health behavior peer influence in Peking University dormitories utilizing a randomized cluster-assignment design. Cross-sectional in-dormitory survey. Current students from Peking University Health Science Center from April to June, 2009. Self-reported questionnaire on health behaviors: physical activity (including bicycling), dietary intake and tobacco use. Use of bicycle, moderate-intensity exercise, frequency of sweet food and soybean milk intake, frequency of roasted/baked/toasted food intake were behaviors significantly or marginally significantly affected by peer influence. Health behavior peer effects exist within dormitory rooms among university students. This could provide guidance on room assignment, or inform intervention programs. Examining these may demand attention from university administrators and policy makers.

  1. Optimizing the Scientific Yield from a Randomized Controlled Trial (RCT): Evaluating Two Behavioral Interventions and Assessment Reactivity with a Single Trial

    PubMed Central

    Carey, Michael P.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.; Vanable, Peter A.; Carey, Kate B.

    2013-01-01

    Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. PMID:23816489

  2. Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Jennings, Patricia A.; Frank, Jennifer L.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

    2013-01-01

    Cultivating Awareness and Resilience in Education (CARE for Teachers) is a mindfulness-based professional development program designed to reduce stress and improve teachers' performance and classroom learning environments. A randomized controlled trial examined program efficacy and acceptability among a sample of 50 teachers randomly assigned to…

  3. The Effects of Team-Based Learning on Social Studies Knowledge Acquisition in High School

    ERIC Educational Resources Information Center

    Wanzek, Jeanne; Vaughn, Sharon; Kent, Shawn C.; Swanson, Elizabeth A.; Roberts, Greg; Haynes, Martha; Fall, Anna-Mária; Stillman-Spisak, Stephanie J.; Solis, Michael

    2014-01-01

    This randomized control trial examined the efficacy of team-based learning implemented within 11th-grade social studies classes. A randomized blocked design was implemented with 26 classes randomly assigned to treatment or comparison. In the treatment classes teachers implemented team-based learning practices to support students in engaging in…

  4. Estimates of Intraclass Correlation for Variables Related to Behavioral HIV/STD Prevention in a Predominantly African American and Hispanic Sample of Young Women

    ERIC Educational Resources Information Center

    Pals, Sherri L.; Beaty, Brenda L.; Posner, Samuel F.; Bull, Sheana S.

    2009-01-01

    Studies designed to evaluate HIV and STD prevention interventions often involve random assignment of groups such as neighborhoods or communities to study conditions (e.g., to intervention or control). Investigators who design group-randomized trials (GRTs) must take the expected intraclass correlation coefficient (ICC) into account in sample size…

  5. Sequential Multiple Assignment Randomized Trial (SMART) with Adaptive Randomization for Quality Improvement in Depression Treatment Program

    PubMed Central

    Chakraborty, Bibhas; Davidson, Karina W.

    2015-01-01

    Summary Implementation study is an important tool for deploying state-of-the-art treatments from clinical efficacy studies into a treatment program, with the dual goals of learning about effectiveness of the treatments and improving the quality of care for patients enrolled into the program. In this article, we deal with the design of a treatment program of dynamic treatment regimens (DTRs) for patients with depression post acute coronary syndrome. We introduce a novel adaptive randomization scheme for a sequential multiple assignment randomized trial of DTRs. Our approach adapts the randomization probabilities to favor treatment sequences having comparatively superior Q-functions used in Q-learning. The proposed approach addresses three main concerns of an implementation study: it allows incorporation of historical data or opinions, it includes randomization for learning purposes, and it aims to improve care via adaptation throughout the program. We demonstrate how to apply our method to design a depression treatment program using data from a previous study. By simulation, we illustrate that the inputs from historical data are important for the program performance measured by the expected outcomes of the enrollees, but also show that the adaptive randomization scheme is able to compensate poorly specified historical inputs by improving patient outcomes within a reasonable horizon. The simulation results also confirm that the proposed design allows efficient learning of the treatments by alleviating the curse of dimensionality. PMID:25354029

  6. The Role of Perpetrator Motivation in Two Crime Scenarios

    ERIC Educational Resources Information Center

    Sizemore, O. J.

    2013-01-01

    Undergraduate volunteers (n = 134) were randomly assigned in a 2 x 2 design that manipulated type of crime (rape vs. robbery) and perpetrator motivation (anger vs. desire). After reading one of the crime scenarios, participants responded to a series of attitude items regarding responsibility for the crime, assigned blame to agents mentioned in the…

  7. Emotional Design in Multimedia Learning

    ERIC Educational Resources Information Center

    Um, Eunjoon; Plass, Jan L.; Hayward, Elizabeth O.; Homer, Bruce D.

    2012-01-01

    Can multimedia learning environments be designed to foster positive emotions that will improve learning and related affective outcomes? College students (N = 118) were randomly assigned to 4 conditions created by 2 factors related to learners' emotion: "external mood induction" (positive vs. neutral emotions) and "emotional design induction"…

  8. Designing Studies That Would Address the Multilayered Nature of Health Care

    PubMed Central

    Pennell, Michael; Rhoda, Dale; Hade, Erinn M.; Paskett, Electra D.

    2010-01-01

    We review design and analytic methods available for multilevel interventions in cancer research with particular attention to study design, sample size requirements, and potential to provide statistical evidence for causal inference. The most appropriate methods will depend on the stage of development of the research and whether randomization is possible. Early on, fractional factorial designs may be used to screen intervention components, particularly when randomization of individuals is possible. Quasi-experimental designs, including time-series and multiple baseline designs, can be useful once the intervention is designed because they require few sites and can provide the preliminary evidence to plan efficacy studies. In efficacy and effectiveness studies, group-randomized trials are preferred when randomization is possible and regression discontinuity designs are preferred otherwise if assignment based on a quantitative score is possible. Quasi-experimental designs may be used, especially when combined with recent developments in analytic methods to reduce bias in effect estimates. PMID:20386057

  9. A Randomized Controlled Trial of Two Syntactic Treatment Procedures with Cantonese-Speaking, School-Age Children with Language Disorders

    ERIC Educational Resources Information Center

    To, Carol K. S.; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y. H

    2015-01-01

    Purpose: In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Method: Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment…

  10. 76 FR 51056 - Notice of Random Assignment Study To Evaluate the YouthBuild Program; Request for Comment

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-17

    ... assigned to the control group can re-apply to the YouthBuild program. The Department is soliciting comments... ``utilize appropriate methodology and research designs, including the use of control groups chosen by.... Accordingly, ETA is conducting a multisite control group evaluation to provide rigorous estimates [[Page 51058...

  11. Effects of Higher and Lower Level Writing-To-Learn Assignments on Higher and Lower Level Examination Questions

    ERIC Educational Resources Information Center

    Nevid, Jeffrey S.; Ambrose, Michael A.; Pyun, Yea Seul

    2017-01-01

    Our study examined whether brief writing-to-learn assignments linked to lower and higher levels in Bloom's taxonomy affected performance differentially on examination performance in assessing these skill levels. Using a quasi-random design, 91 undergraduate students in an introductory psychology class completed eight lower level and eight higher…

  12. Investigating a Tier 1 Intervention Focused on Proportional Reasoning: A Follow-Up Study

    ERIC Educational Resources Information Center

    Jitendra, Asha K.; Harwell, Michael R.; Karl, Stacy R.; Simonson, Gregory R.; Slater, Susan C.

    2017-01-01

    This randomized controlled study investigated the efficacy of a Tier 1 intervention--schema-based instruction--designed to help students with and without mathematics difficulties (MD) develop proportional reasoning. Twenty seventh-grade teachers/classrooms were randomly assigned to a treatment condition (schema-based instruction) or control…

  13. Efficiency of a Care Coordination Model: A Randomized Study with Stroke Patients

    ERIC Educational Resources Information Center

    Claiborne, Nancy

    2006-01-01

    Objectives: This study investigated the efficiency of a social work care coordination model for stroke patients. Care coordination addresses patient care and treatment resources across the health care system to reduce risk, improve clinical outcomes, and maximize efficiency. Method: A randomly assigned, pre-post experimental design measured…

  14. Estimating the Impact of the PROMISE Scholarship Using Propensity Score Weighted Frontier Fuzzy Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Shobo, Yetty; Wong, Jen D.; Bell, Angie

    2014-01-01

    Regression discontinuity (RD), an "as good as randomized," research design is increasingly prominent in education research in recent years; the design gets eligible quasi-experimental designs as close as possible to experimental designs by using a stated threshold on a continuous baseline variable to assign individuals to a…

  15. Optimal Design for Two-Level Random Assignment and Regression Discontinuity Studies

    ERIC Educational Resources Information Center

    Rhoads, Christopher H.; Dye, Charles

    2016-01-01

    An important concern when planning research studies is to obtain maximum precision of an estimate of a treatment effect given a budget constraint. When research designs have a "multilevel" or "hierarchical" structure changes in sample size at different levels of the design will impact precision differently. Furthermore, there…

  16. Clinical Trials

    MedlinePlus

    ... pill that has no medicine in it. Most times participants do not know which they are receiving. Other clinical trials involve a crossover design, where participants are randomly assigned to take a ...

  17. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial.

    PubMed

    Carey, Michael P; Senn, Theresa E; Coury-Doniger, Patricia; Urban, Marguerite A; Vanable, Peter A; Carey, Kate B

    2013-09-01

    Randomized controlled trials (RCTs) remain the gold standard for evaluating intervention efficacy but are often costly. To optimize their scientific yield, RCTs can be designed to investigate multiple research questions. This paper describes an RCT that used a modified Solomon four-group design to simultaneously evaluate two, theoretically-guided, health promotion interventions as well as assessment reactivity. Recruited participants (N = 1010; 56% male; 69% African American) were randomly assigned to one of four conditions formed by crossing two intervention conditions (i.e., general health promotion vs. sexual risk reduction intervention) with two assessment conditions (i.e., general health vs. sexual health survey). After completing their assigned baseline assessment, participants received the assigned intervention, and returned for follow-ups at 3, 6, 9, and 12 months. In this report, we summarize baseline data, which show high levels of sexual risk behavior; alcohol, marijuana, and tobacco use; and fast food consumption. Sexual risk behaviors and substance use were correlated. Participants reported high satisfaction with both interventions but ratings for the sexual risk reduction intervention were higher. Planned follow-up sessions, and subsequent analyses, will assess changes in health behaviors including sexual risk behaviors. This study design demonstrates one way to optimize the scientific yield of an RCT. © 2013 Elsevier Inc. All rights reserved.

  18. Randomized controlled trials in evidence-based mental health care: getting the right answer to the right question.

    PubMed

    Essock, Susan M; Drake, Robert E; Frank, Richard G; McGuire, Thomas G

    2003-01-01

    The purpose of clinical research is to answer this question: Would a new treatment, when added to the existing range of treatment options available in practice, help patients? Randomized controlled trials (RCTs)--in particular, double-blind RCTs--have important methodological advantages over observational studies for addressing this question. These advantages, however, come at a price. RCTs compare treatments using a particular allocation rule for assigning patients to treatments (random assignment) that does not mimic real-world practice. "Favorable" results from an RCT indicating that a new treatment is superior to existing treatments are neither necessary nor sufficient for establishing a "yes" answer to the question posed above. Modeled on an experimental design, RCTs are expensive in time and money and must compare simple differences in treatments. Findings have a high internal validity but may not address the needs of the field, particularly where treatment is complex and rapidly evolving. Design of clinical research needs to take account of the way treatments are allocated in actual practice and include flexible designs to answer important questions most effectively.

  19. The "Healthy Teen Girls Project": Comparison of Health Education and STD Risk Reduction Intervention for Incarcerated Adolescent Females

    ERIC Educational Resources Information Center

    Robertson, Angela R.; St. Lawrence, Janet; Morse, David T.; Baird-Thomas, Connie; Liew, Hui; Gresham, Kathleen

    2011-01-01

    Adolescent girls incarcerated in a state reformatory (N = 246) were recruited and assigned to an 18-session health education program or a time-equivalent HIV prevention program. Cohorts were assigned to conditions using a randomized block design separated by a washout period to reduce contamination. Post intervention, girls in the HIV risk…

  20. The Impact of Anonymous and Assigned Use of Student Response Systems on Student Achievement

    ERIC Educational Resources Information Center

    Poole, Dawn

    2012-01-01

    This study examined the impact of two approaches to use of student response systems (SRSs) on achievement in a study designed to better understand effective use of the devices. One condition was anonymous use of SRSs, in which graduate students selected a random clicker when entering the classroom. The second condition assigned devices to students…

  1. Promoting Social Skill Development in Children with Pervasive Developmental Disorders: A Feasibility and Efficacy Study

    ERIC Educational Resources Information Center

    Koenig, Kathleen; White, Susan Williams; Pachler, Maryellen; Lau, Monika; Lewis, Moira; Klin, Ami; Scahill, Lawrence

    2010-01-01

    A randomized controlled design was employed to evaluate a social skills intervention for children with pervasive developmental disorders. Aims included evaluating the acceptability of the program and gathering preliminary evidence on efficacy. Forty-four children, ages 8-11 years, were randomly assigned to treatment or wait list. Treatment…

  2. Randomized Trial of Drug Abuse Treatment-Linkage Strategies

    ERIC Educational Resources Information Center

    Sorenson, James L.; Masson, Carmen L.; Delucchi, Kevin; Sporer, Karl; Barnett, Paul G.; Mitsuishi, Fumi; Lin, Christine; Song, Yong; Chen, TeChieh; Hall, Sharon M.

    2005-01-01

    A clinical trial contrasted 2 interventions designed to link opioid-dependent hospital patients to drug abuse treatment. The 126 out-of-treatment participants were randomly assigned to (a) case management, (b) voucher for free methadone maintenance treatment (MMT), (c) case management plus voucher, or (d) usual care. Services were provided for 6…

  3. Personalized Mailed Feedback for College Drinking Prevention: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Larimer, Mary E.; Lee, Christine M.; Kilmer, Jason R.; Fabiano, Patricia M.; Stark, Christopher B.; Geisner, Irene M.; Mallett, Kimberly A.; Lostutter, Ty W.; Cronce, Jessica M.; Feeney, Maggie; Neighbors, Clayton

    2007-01-01

    The current study was designed to evaluate the efficacy of a mailed feedback and tips intervention as a universal prevention strategy for college drinking. Participants (N = 1,488) were randomly assigned to feedback or assessment-only control conditions. Results indicated that the mailed feedback intervention had a preventive effect on drinking…

  4. Intraclass Correlations and Covariate Outcome Correlations for Planning Two-and Three-Level Cluster-Randomized Experiments in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, E. C.

    2013-01-01

    Background: Cluster-randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

  5. 78 FR 54653 - Proposed Data Collections Submitted for Public Comment and Recommendations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-05

    ... materials on opinions about CRC screening tests. Each respondent will be randomly assigned to one of three... treatment group that receives a ``No Excuses'' educational flyer designed to dispel many common reasons for... randomly selected from the KN KnowledgePanel[supreg]. A pre-test of study procedures will be conducted...

  6. Intraclass Correlations and Covariate Outcome Correlations for Planning 2 and 3 Level Cluster Randomized Experiments in Education

    ERIC Educational Resources Information Center

    Hedges, Larry V.; Hedberg, Eric C.

    2013-01-01

    Background: Cluster randomized experiments that assign intact groups such as schools or school districts to treatment conditions are increasingly common in educational research. Such experiments are inherently multilevel designs whose sensitivity (statistical power and precision of estimates) depends on the variance decomposition across levels.…

  7. The Effect of Patient Choice of Intervention on Health Outcomes

    PubMed Central

    Clark, Noreen M.; Janz, Nancy K.; Dodge, Julia A.; Mosca, Lori; Lin, Xihong; Long, Qi; Little, Roderick J; Wheeler, John R.C.; Keteyian, Steven; Liang, Jersey

    2008-01-01

    Background Patient preference may influence intervention effects, but has not been extensively studied. Randomized controlled design (N=1075) assessed outcomes when women (60 years +) were given a choice of two formats of a program to enhance heart disease management. Methods Randomization to "no choice" or "choice" study arms. Further randomization of "no choice” to: 1) Group intervention program format, 2) Self-Directed program format, 3) Control Group. "Choice" arm selected their preferred program format. Baseline, four, twelve, and eighteen month follow-up data collected. Two analyses: health outcomes for choice compared to being randomized; and preference effect on treatment efficacy. Results Women who chose a format compared to being assigned a format had better psychosocial functioning at four months (p=0.02) and tended toward better physical functioning at twelve months (p=0.07). At eighteen months women who chose versus being assigned a format had more symptoms measured as: number (p=0.004), frequency (p=0.006) and bother (p=0.004). At four months women who preferred the Group format had better psychosocial functioning when assigned the Group format than when they were assigned the Self Directed format (p=0.03). At eighteen months women preferring a Group format had more symptoms: number (p=0.001), frequency (p=0.001), bother (p=0.001) when assigned the Group format than when assigned the Self Directed format. Conclusions Choice and preference for the Group format each enhanced psychosocial and physical functioning up to one year. Despite the preference for Group format, over the longer term (eighteen months) cardiac symptoms were fewer when assigned the Self-Directed format. PMID:18515187

  8. Lung Cancer: Glossary

    MedlinePlus

    ... effects of radiation therapy Randomized Clinical Trial: Trial design in which participants are assigned by chance to ... effect caused by treatment. Small Cell Lung Cancer: One of the two main categories of lung cancer; ...

  9. Rigorously Assessing Whether the Data Backs the Back School

    PubMed Central

    Vinh, David T.; Johnson, Craig W.; Phelps, Cynthia L.

    2003-01-01

    A rigorous between-subjects methodology employing independent random samples and having broad clinical applicability was designed and implemented to evaluate the effectiveness of back safety and patient transfer training interventions for both hospital nurses and nursing assistants. Effects upon self-efficacy, cognitive, and affective measures are assessed for each of three back safety procedures. The design solves the problem of obtaining randomly assigned independent controls where all experimental subjects must participate in the training interventions. PMID:14728544

  10. Non-manipulation quantitative designs.

    PubMed

    Rumrill, Phillip D

    2004-01-01

    The article describes non-manipulation quantitative designs of two types, correlational and causal comparative studies. Both of these designs are characterized by the absence of random assignment of research participants to conditions or groups and non-manipulation of the independent variable. Without random selection or manipulation of the independent variable, no attempt is made to draw causal inferences regarding relationships between independent and dependent variables. Nonetheless, non-manipulation studies play an important role in rehabilitation research, as described in this article. Examples from the contemporary rehabilitation literature are included. Copyright 2004 IOS Press

  11. Sexual Harassment Prevention Initiatives: Quantitative and Qualitative Approaches

    DTIC Science & Technology

    2010-10-28

    design , and the time series with nonequivalent control group design . The experimental research approach will randomly assign participants...Leedy & Ormrod, 2005). According to Fife- Schaw (2006) there are three quasi-experimental designs : the nonequivalent control group design , the time...that have controlled and isolated variables. A specific quantitative approach available to the researcher is the use of surveys. Surveys, in

  12. A Cognitive Strategy Instruction to Improve Math Calculation for Children with ADHD and LD: A Randomized Controlled Study

    ERIC Educational Resources Information Center

    Iseman, Jackie S.; Naglieri, Jack A.

    2011-01-01

    The authors examined the effectiveness of cognitive strategy instruction based on PASS (Planning, Attention, Simultaneous, Successive) given by special education teachers to students with ADHD randomly assigned by classroom. Students in the experimental group were exposed to a brief cognitive strategy instruction for 10 days, which was designed to…

  13. A Cardiovascular Risk Reduction Program for American Indians with Metabolic Syndrome: The Balance Study

    ERIC Educational Resources Information Center

    Lee, Elisa T.; Jobe, Jared B.; Yeh, Jeunliang; Ali, Tauqeer; Rhoades, Everett R.; Knehans, Allen W.; Willis, Diane J.; Johnson, Melanie R.; Zhang, Ying; Poolaw, Bryce; Rogers, Billy

    2012-01-01

    The Balance Study is a randomized controlled trial designed to reduce cardiovascular disease (CVD) risk in 200 American Indian (AI) participants with metabolic syndrome who reside in southwestern Oklahoma. Major risk factors targeted include weight, diet, and physical activity. Participants are assigned randomly to one of two groups, a guided or a…

  14. Comparison of Collaboration and Performance in Groups of Learners Assembled Randomly or Based on Learners' Topic Preferences

    ERIC Educational Resources Information Center

    Cela, Karina L.; Sicilia, Miguel Ángel; Sánchez, Salvador

    2015-01-01

    Teachers and instructional designers frequently incorporate collaborative learning approaches into their e-learning environments. A key factor of collaborative learning that may affect learner outcomes is whether the collaborative groups are assigned project topics randomly or based on a shared interest in the topic. This is a particularly…

  15. Outcomes of an HIV Prevention Peer Group Intervention for Rural Adults in Malawi

    ERIC Educational Resources Information Center

    Kaponda, Chrissie P. N.; Norr, Kathleen F.; Crittenden, Kathleen S.; Norr, James L.; McCreary, Linda L.; Kachingwe, Sitingawawo I.; Mbeba, Mary M.; Jere, Diana L. N.; Dancy, Barbara L.

    2011-01-01

    This study used a quasi-experimental design to evaluate a six-session peer group intervention for HIV prevention among rural adults in Malawi. Two rural districts were randomly assigned to intervention and control conditions. Independent random samples of community adults compared the districts at baseline and at 6 and 18 months postintervention.…

  16. The Role of Exposure Condition in the Effectiveness of Explicit Correction

    ERIC Educational Resources Information Center

    Yilmaz, Yucel

    2016-01-01

    This article reports on a study that investigated the effects of two feedback exposure conditions on the acquisition of two Turkish morphemes. The study followed a randomized experimental design with an immediate and a delayed posttest. Forty-two Chinese-speaking learners of Turkish were randomly assigned to one of three groups: receivers,…

  17. Testing the Efficacy of a Kindergarten Mathematics Intervention by Small Group Size

    ERIC Educational Resources Information Center

    Clarke, Ben; Doabler, Christian T.; Kosty, Derek; Kurtz Nelson, Evangeline; Smolkowski, Keith; Fien, Hank; Turtura, Jessica

    2017-01-01

    This study used a randomized controlled trial design to investigate the ROOTS curriculum, a 50-lesson kindergarten mathematics intervention. Ten ROOTS-eligible students per classroom (n = 60) were randomly assigned to one of three conditions: a ROOTS five-student group, a ROOTS two-student group, and a no-treatment control group. Two primary…

  18. Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship – Quasi-Experimental Designs

    PubMed Central

    Schweizer, Marin L.; Braun, Barbara I.; Milstone, Aaron M.

    2016-01-01

    Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt non-randomized interventions. Quasi-experimental studies can be categorized into three major types: interrupted time series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. PMID:27267457

  19. An Instructional Design for Accelerating Children's Concept Learning. Technical Report No. 321.

    ERIC Educational Resources Information Center

    McMurray, Nancy E.; And Others

    An instructional design based on task analysis procedures was used to develop two experimental lessons to accelerate attainment of a subject-matter concept by fourth grade students. A variation of the Solomon Four-Group design was employed to determine the effects of the pretest. Performance of 118 randomly assigned subjects on a measure assessing…

  20. 40 CFR 798.6200 - Motor activity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    .... The choice of species should take into consideration such factors as the comparative metabolism of the... randomly assigned to test and control groups. Each test or control group must be designed to contain a... designs, calculations can be made according to Dixon and Massey (1957) under paragraph (f)(1) of this...

  1. 40 CFR 798.6200 - Motor activity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    .... The choice of species should take into consideration such factors as the comparative metabolism of the... randomly assigned to test and control groups. Each test or control group must be designed to contain a... designs, calculations can be made according to Dixon and Massey (1957) under paragraph (f)(1) of this...

  2. 40 CFR 798.6200 - Motor activity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    .... The choice of species should take into consideration such factors as the comparative metabolism of the... randomly assigned to test and control groups. Each test or control group must be designed to contain a... designs, calculations can be made according to Dixon and Massey (1957) under paragraph (f)(1) of this...

  3. 40 CFR 798.6200 - Motor activity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    .... The choice of species should take into consideration such factors as the comparative metabolism of the... randomly assigned to test and control groups. Each test or control group must be designed to contain a... designs, calculations can be made according to Dixon and Massey (1957) under paragraph (f)(1) of this...

  4. 40 CFR 798.6200 - Motor activity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    .... The choice of species should take into consideration such factors as the comparative metabolism of the... randomly assigned to test and control groups. Each test or control group must be designed to contain a... designs, calculations can be made according to Dixon and Massey (1957) under paragraph (f)(1) of this...

  5. Optimal Design for Regression Discontinuity Studies with Clustering

    ERIC Educational Resources Information Center

    Rhoads, Christopher; Dye, Charles

    2014-01-01

    Recent years have seen an increased interest in quantitative educational research studies that use random assignment (RA) to evaluate the causal impacts of educational interventions (Angrist, 2004). The multi-level structure of the public education system in the United States often leads to experimental designs where naturally occurring clusters…

  6. A comparative study of restricted randomization procedures for multiarm trials with equal or unequal treatment allocation ratios.

    PubMed

    Ryeznik, Yevgen; Sverdlov, Oleksandr

    2018-06-04

    Randomization designs for multiarm clinical trials are increasingly used in practice, especially in phase II dose-ranging studies. Many new methods have been proposed in the literature; however, there is lack of systematic, head-to-head comparison of the competing designs. In this paper, we systematically investigate statistical properties of various restricted randomization procedures for multiarm trials with fixed and possibly unequal allocation ratios. The design operating characteristics include measures of allocation balance, randomness of treatment assignments, variations in the allocation ratio, and statistical characteristics such as type I error rate and power. The results from the current paper should help clinical investigators select an appropriate randomization procedure for their clinical trial. We also provide a web-based R shiny application that can be used to reproduce all results in this paper and run simulations under additional user-defined experimental scenarios. Copyright © 2018 John Wiley & Sons, Ltd.

  7. Extensions of Existing Methods for Use with a New Class of Experimental Designs Useful when There Is Treatment Effect Contamination

    ERIC Educational Resources Information Center

    Rhoads, Christopher

    2011-01-01

    Researchers planning a randomized field trial to evaluate the effectiveness of an educational intervention often face the following dilemma. They plan to recruit schools to participate in their study. The question is, "Should the researchers randomly assign individuals (either students or teachers, depending on the intervention) within schools to…

  8. Longitudinal Evaluation of a Scale-up Model for Teaching Mathematics with Trajectories and Technologies: Persistence of Effects in the Third Year

    ERIC Educational Resources Information Center

    Clements, Douglas H.; Sarama, Julie; Wolfe, Christopher B.; Spitler, Mary Elaine

    2013-01-01

    Using a cluster randomized trial design, we evaluated the persistence of effects of a research-based model for scaling up educational interventions. The model was implemented in 42 schools in two city districts serving low-resource communities, randomly assigned to three conditions. In pre-kindergarten, the two experimental interventions were…

  9. Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

    ERIC Educational Resources Information Center

    Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

    2014-01-01

    This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

  10. The Impact of Curriculum-Based Professional Development on Science Instruction: Results from a Cluster-Randomized Trial

    ERIC Educational Resources Information Center

    Taylor, Joseph; Kowalski, Susan; Getty, Stephen; Wilson, Christopher; Carlson, Janet

    2011-01-01

    This research is part of a larger, IES-funded study titled: "Measuring the Efficacy and Student Achievement of Research-based Instructional Materials in High School Multidisciplinary Science" (Award # R305K060142). The larger study seeks to use a cluster-randomized trial design, with schools as the unit of assignment, to make causal…

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

    ERIC Educational Resources Information Center

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

    2011-01-01

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

  12. A Randomized Controlled Trial of a Parent Training and Emotion Socialization Program for Families of Hyperactive Preschool-Aged Children

    ERIC Educational Resources Information Center

    Herbert, Sharonne D.; Harvey, Elizabeth A.; Roberts, Jasmin L.; Wichowski, Kayla; Lugo-Candelas, Claudia I.

    2013-01-01

    The present study evaluated the effectiveness of a parent training and emotion socialization program designed specifically for hyperactive preschoolers. Participants were 31 preschool-aged children whose parents were randomly assigned to a parent training (PT) or waitlist (WL) control group. PT parents took part in a 14-week parenting program that…

  13. Effects of Animation on Naming and Identification across Two Graphic Symbol Sets Representing Verbs and Prepositions

    ERIC Educational Resources Information Center

    Schlosser, Ralf W.; Koul, Rajinder; Shane, Howard; Sorce, James; Brock, Kristofer; Harmon, Ashley; Moerlein, Dorothy; Hearn, Emilia

    2014-01-01

    Purpose: The effects of animation on naming and identification of graphic symbols for verbs and prepositions were studied in 2 graphic symbol sets in preschoolers. Method: Using a 2 × 2 × 2 × 3 completely randomized block design, preschoolers across three age groups were randomly assigned to combinations of symbol set (Autism Language Program…

  14. The Effects of Scenario Planning on Participant Reports of Resilience

    ERIC Educational Resources Information Center

    Chermack, Thomas J.; Coons, Laura M.; O'barr, Gregory; Khatami, Shiva

    2017-01-01

    Purpose: The purpose of this research is to examine the effects of scenario planning on participant ratings of resilience. Design/methodology/approach: The research design is a quasi experimental pretest/posttest with treatment and control groups. Random selection or assignment was not achieved. Findings: Results show a significant difference in…

  15. Designing Guidance for Interpreting Dynamic Visualizations: Generating versus Reading Explanations

    ERIC Educational Resources Information Center

    Ryoo, Kihyun; Linn, Marcia C.

    2014-01-01

    We compared designs of guidance to support students while interacting with dynamic visualizations of complex scientific phenomena in inquiry instruction. Three hundred thirty-two 7th-grade students were randomly assigned to either a reading or a generating condition and completed a web-based inquiry unit focusing on energy concepts in…

  16. Are Written Instructions Enough? Efficacy of Male Condom Packaging Leaflets among College Students

    ERIC Educational Resources Information Center

    Lindemann, Dana F.; Harbke, Colin R.

    2013-01-01

    Objective: To evaluate whether or not written condom use instructions successfully inform correct condom use skills. Design: Between-subjects, two-group design. Setting: Public university located in rural Midwestern region of the United States. Method: Participants were randomly assigned to either a control condition (read physical exercise…

  17. Effect of Training in Math Metacognitive Strategy on Fractional Achievement of Nigerian Schoolchildren

    ERIC Educational Resources Information Center

    Onu, V. C.; Eskay, M.; Igbo, J. N.; Obiyo, N.; Agbo, O.

    2012-01-01

    This study examined the effect of training in math metacognition on fractional mathematics among primary school pupils, with a quasi-experimental design, specifically a post-test only control group design. Two intact classes were randomly selected and assigned to treatment and control conditions. Sixty primary six pupils constituted the sample…

  18. The Power of the Test for Treatment Effects in Three-Level Block Randomized Designs

    ERIC Educational Resources Information Center

    Konstantopoulos, Spyros

    2008-01-01

    Experiments that involve nested structures may assign treatment conditions either to subgroups (such as classrooms) or individuals within subgroups (such as students). The design of such experiments requires knowledge of the intraclass correlation structure to compute the sample sizes necessary to achieve adequate power to detect the treatment…

  19. Can Coloring Mandalas Reduce Anxiety? A Replication Study

    ERIC Educational Resources Information Center

    van der Vennet, Renee; Serice, Susan

    2012-01-01

    This experimental study replicated Curry and Kasser's (2005) research that tested whether coloring a mandala would reduce anxiety. After inducing an anxious mood via a writing activity, participants were randomly assigned to three groups that colored either on a mandala design, on a plaid design, or on a blank paper. Anxiety level was measured…

  20. A More Powerful Test in Three-Level Cluster Randomized Designs

    ERIC Educational Resources Information Center

    Konstantopoulos, Spyros

    2011-01-01

    Field experiments that involve nested structures frequently assign treatment conditions to entire groups (such as schools). A key aspect of the design of such experiments includes knowledge of the clustering effects that are often expressed via intraclass correlation. This study provides methods for constructing a more powerful test for the…

  1. Multimedia Use in Higher Education in the UAE: A Cognitive Load Theory Perspective

    ERIC Educational Resources Information Center

    Moussa-Inaty, Jase; Atallah, Fida

    2012-01-01

    The study investigates the use of different multimedia instructional design formats on learning. Undergraduate students from the College of Education at a public university in the United Arab Emirates were randomly assigned to groups corresponding to six instructional design formats, namely; Listen Only, Read Only, Read+ Listen, Listen + Graphics,…

  2. Hypothesis testing in clinical trials.

    PubMed

    Green, S B

    2000-08-01

    In designing and analyzing any clinical trial, two issues related to patient heterogeneity must be considered: (1) the effect of chance and (2) the effect of bias. These issues are addressed by enrolling adequate numbers of patients in the study and using randomization for treatment assignment. An "intention-to-treat" analysis of outcome data includes all individuals randomized and counted in the group to which they are randomized. There is an increased risk of spurious results with a greater number of subgroup analyses, particularly when these analyses are data derived. Factorial designs are sometimes appropriate and can lead to efficiencies by addressing more than one comparison of interventions in a single trial.

  3. Design, conduct, and analyses of Breast International Group (BIG) 1-98: a randomized, double-blind, phase-III study comparing letrozole and tamoxifen as adjuvant endocrine therapy for postmenopausal women with receptor-positive, early breast cancer.

    PubMed

    Giobbie-Hurder, Anita; Price, Karen N; Gelber, Richard D

    2009-06-01

    Aromatase inhibitors provide superior disease control when compared with tamoxifen as adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer. To present the design, history, and analytic challenges of the Breast International Group (BIG) 1-98 trial: an international, multicenter, randomized, double-blind, phase-III study comparing the aromatase inhibitor letrozole with tamoxifen in this clinical setting. From 1998-2003, BIG 1-98 enrolled 8028 women to receive monotherapy with either tamoxifen or letrozole for 5 years, or sequential therapy of 2 years of one agent followed by 3 years of the other. Randomization to one of four treatment groups permitted two complementary analyses to be conducted several years apart. The first, reported in 2005, provided a head-to-head comparison of letrozole versus tamoxifen. Statistical power was increased by an enriched design, which included patients who were assigned sequential treatments until the time of the treatment switch. The second, reported in late 2008, used a conditional landmark approach to test the hypothesis that switching endocrine agents at approximately 2 years from randomization for patients who are disease-free is superior to continuing with the original agent. The 2005 analysis showed the superiority of letrozole compared with tamoxifen. The patients who were assigned tamoxifen alone were unblinded and offered the opportunity to switch to letrozole. Results from other trials increased the clinical relevance about whether or not to start treatment with letrozole or tamoxifen, and analysis plans were expanded to evaluate sequential versus single-agent strategies from randomization. Due to the unblinding of patients assigned tamoxifen alone, analysis of updated data will require ascertainment of the influence of selective crossover from tamoxifen to letrozole. BIG 1-98 is an example of an enriched design, involving complementary analyses addressing different questions several years apart, and subject to evolving analytic plans influenced by new data that emerge over time.

  4. Short-Term-Effectiveness of a Relationship Education Program for Distressed Military Couples, in the Context of Foreign Assignments for the German Armed Forces. Preliminary Findings From a Randomized Controlled Study.

    PubMed

    Kröger, Christoph; Kliem, Sören; Zimmermann, Peter; Kowalski, Jens

    2018-04-01

    This study examines the short-term effectiveness of a relationship education program designed for military couples. Distressed couples were randomly placed in either a wait-list control group or an intervention group. We conducted training sessions before a 3-month foreign assignment, and refresher courses approximately 6-week post-assignment. We analyzed the dyadic data of 32 couples, using hierarchical linear modeling in a two-level model. Reduction in unresolved conflicts was found in the intervention group, with large pre-post effects for both partners. Relationship satisfaction scores were improved, with moderate-to-large effects only for soldiers, rather than their partners. Post-follow-up effect sizes suggested further improvement in the intervention group. Future research should examine the long-term effectiveness of this treatment. © 2017 American Association for Marriage and Family Therapy.

  5. Learning Historical Thinking with Oral History Interviews: A Cluster Randomized Controlled Intervention Study of Oral History Interviews in History Lessons

    ERIC Educational Resources Information Center

    Bertram, Christiane; Wagner, Wolfgang; Trautwein, Ulrich

    2017-01-01

    The present study examined the effectiveness of the oral history approach with respect to students' historical competence. A total of 35 ninth-grade classes (N = 900) in Germany were randomly assigned to one of four conditions--live, video, text, or a (nontreated) control group--in a pretest, posttest, and follow-up design. Comparing the three…

  6. Muscle Strength Enhancement Following Home-Based Virtual Cycling Training in Ambulatory Children with Cerebral Palsy

    ERIC Educational Resources Information Center

    Chen, Chia-Ling; Hong, Wei-Hsien; Cheng, Hsin-Yi Kathy; Liaw, Mei-Yun; Chung, Chia-Ying; Chen, Chung-Yao

    2012-01-01

    This study is the first well-designed randomized controlled trial to assess the effects of a novel home-based virtual cycling training (hVCT) program for improving muscle strength in children with spastic cerebral palsy (CP). Twenty-eight ambulatory children with spastic CP aged 6-12 years were randomly assigned to an hVCT group (n = 13) or a…

  7. Evaluation of a Treatment Approach Combining Nicotine Gum with Self-Guided Behavioral Treatments for Smoking Relapse Prevention.

    ERIC Educational Resources Information Center

    Killen, Joel D.; And Others

    1990-01-01

    Randomly assigned 1,218 smokers to cells in 4 (nicotine gum delivered ad lib, fixed regimen nicotine gum, placebo gum, no gum) x 3 (self-selected relapse prevention modules, randomly administered modules, no modules) design. Subjects receiving nicotine gum were more likely to be abstinent at 2- and 6-month followups. Fixed regimen accounted for…

  8. Partially Nested Randomized Controlled Trials in Education Research: A Guide to Design and Analysis. NCER 2014-2000

    ERIC Educational Resources Information Center

    Lohr, Sharon; Schochet, Peter Z.; Sanders, Elizabeth

    2014-01-01

    Suppose an education researcher wants to test the impact of a high school drop-out prevention intervention in which at-risk students attend classes to receive intensive summer school instruction. The district will allow the researcher to randomly assign students to the treatment classes or to the control group. Half of the students (the treatment…

  9. Effects of a Randomized Couple-Based Intervention on Quality of Life of Breast Cancer Patients and Their Partners

    ERIC Educational Resources Information Center

    Kayser, Karen; Feldman, Barry N.; Borstelmann, Nancy A.; Daniels, Ann A.

    2010-01-01

    The purpose of this study was to determine the effectiveness of a couple-based intervention on the quality of life (QOL) of early-stage breast cancer patients and their partners. A randomized controlled design was used to assign couples to either the hospital standard social work services (SSWS) or a couple-based intervention, the Partners in…

  10. Using Bayesian Adaptive Trial Designs for Comparative Effectiveness Research: A Virtual Trial Execution.

    PubMed

    Luce, Bryan R; Connor, Jason T; Broglio, Kristine R; Mullins, C Daniel; Ishak, K Jack; Saunders, Elijah; Davis, Barry R

    2016-09-20

    Bayesian and adaptive clinical trial designs offer the potential for more efficient processes that result in lower sample sizes and shorter trial durations than traditional designs. To explore the use and potential benefits of Bayesian adaptive clinical trial designs in comparative effectiveness research. Virtual execution of ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as if it had been done according to a Bayesian adaptive trial design. Comparative effectiveness trial of antihypertensive medications. Patient data sampled from the more than 42 000 patients enrolled in ALLHAT with publicly available data. Number of patients randomly assigned between groups, trial duration, observed numbers of events, and overall trial results and conclusions. The Bayesian adaptive approach and original design yielded similar overall trial conclusions. The Bayesian adaptive trial randomly assigned more patients to the better-performing group and would probably have ended slightly earlier. This virtual trial execution required limited resampling of ALLHAT patients for inclusion in RE-ADAPT (REsearch in ADAptive methods for Pragmatic Trials). Involvement of a data monitoring committee and other trial logistics were not considered. In a comparative effectiveness research trial, Bayesian adaptive trial designs are a feasible approach and potentially generate earlier results and allocate more patients to better-performing groups. National Heart, Lung, and Blood Institute.

  11. An Exploratory Study of Universal Design for Teaching Chemistry to Students with and without Disabilities

    ERIC Educational Resources Information Center

    King-Sears, Margaret E.; Johnson, Todd M.; Berkeley, Sheri; Weiss, Margaret P.; Peters-Burton, Erin E.; Evmenova, Anya S.; Menditto, Anna; Hursh, Jennifer C.

    2015-01-01

    In this exploratory study, students in four co-taught high school chemistry classes were randomly assigned to a Universal Design for Learning (UDL) treatment or a comparison condition. Each co-teaching team taught one comparison and treatment class. UDL principles were operationalized for treatment: (a) a self-management strategy (using a…

  12. The Effect of Choosing versus Receiving Feedback on College Students' Performance

    ERIC Educational Resources Information Center

    Cutumisu, Maria; Schwartz, Daniel L.

    2016-01-01

    This study examines the effect of choosing versus receiving feedback on the learning performance of n = 98 post-secondary students from California on a digital poster design task. The study employs a yoked experimental design where college students are randomly assigned to play a choice-based assessment game, Posterlet, in one of two conditions,…

  13. Effect of Ethnochemistry Practices on Secondary School Students' Attitude towards Chemistry

    ERIC Educational Resources Information Center

    Singh, Indra Sen; Chibuye, Bitwell

    2016-01-01

    The main purpose of the study was to find out the effect of ethnochemistry practices on secondary school students' attitude towards Chemistry. The design of the study was pre-test post-test control group quasiexperimental design. Two grade 11 intact classes were assigned into experimental and control groups randomly. The total sample size…

  14. Teaching in Cyberspace: Online versus Traditional Instruction Using a Waiting-List Experimental Design

    ERIC Educational Resources Information Center

    Poirier, Christopher R.; Feldman, Robert S.

    2004-01-01

    To test the effectiveness of an online introductory psychology course, we randomly assigned students to a large, traditional course or to an online course from a population of students who indicated that either course type was acceptable using a "waiting list" experimental design. Students in the online course performed better on exams and equally…

  15. Evaluation of a Decision-Making Curriculum for Teaching Adolescents with Disabilities to Resist Negative Peer Pressure

    ERIC Educational Resources Information Center

    Khemka, Ishita; Hickson, Linda; Mallory, Sarah B.

    2016-01-01

    This study was designed to assess the impact of a decision-making curriculum (PEER-DM) on the social peer relationship knowledge and self-protective decision-making skills of adolescents with disabilities in hypothetical situations involving negative peer pressure. A randomized design was used to assign students with disabilities from…

  16. Treatment of Obsessive Compulsive Disorder in Young Children: An Intervention Model and Case Series

    ERIC Educational Resources Information Center

    Ginsburg, Golda S.; Burstein, Marcy; Becker, Kimberly D.; Drake, Kelly L.

    2011-01-01

    This article presents an intervention model for young children with obsessive-compulsive disorder (OCD). The intervention, designed to reduce compulsive behavior and improve parenting practices, was tested using a multiple baseline design with 7 children (M = 6 years old; 57% female) in which participants were randomly assigned to 1, 2, or 3 weeks…

  17. Evaluation of safe performance secondary school driver education curriculum demonstration project

    DOT National Transportation Integrated Search

    1983-06-01

    The primary objective of this Project was to determine the crash reduction potential of a quality, competency-based driver training program known as the Safe Performance Curriculum (SPC). The experimental design called for the random assignment of 18...

  18. A brief randomized controlled intervention targeting parents improves grades during middle school.

    PubMed

    Destin, Mesmin; Svoboda, Ryan C

    2017-04-01

    Despite a growing number of brief, psychosocial interventions that improve academic achievement, little research investigates how to leverage parents during such efforts. We designed and tested a randomized controlled intervention targeting parents to influence important discussions about the future and responses to academic difficulty experienced by their adolescent during eighth grade in the United States. We recruited experienced parents to convey the main messages of the intervention in a parent panel format. As expected, current parents who were randomly assigned to observe the parent panel subsequently planned to talk with their adolescents sooner about future opportunities and to respond more positively to experiences of academic difficulty than parents who were randomly assigned to a control group. The intervention also led to a significant increase in student grades, which was mediated by parents' responses to academic difficulty. We suggest an increase in experimental research that utilizes parents to influence student achievement. Copyright © 2017 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  19. Determining the Effects That the Order of Abstraction and Type of Reflection Have on Content Knowledge When Teaching Experientially: An Exploratory Experiment

    ERIC Educational Resources Information Center

    Baker, Marshall A.; Brown, Nicholas R.; Blackburn, J. Joey; Robinson, J. Shane

    2014-01-01

    The purpose of this experimental study was to determine the effects of order of abstraction and type of reflection on student knowledge acquisition. Students were assigned randomly to one of four treatment combinations in the completely randomized 2 x 2 design which included either abstraction prior to or directly after an experience, and either…

  20. Some practical problems in implementing randomization.

    PubMed

    Downs, Matt; Tucker, Kathryn; Christ-Schmidt, Heidi; Wittes, Janet

    2010-06-01

    While often theoretically simple, implementing randomization to treatment in a masked, but confirmable, fashion can prove difficult in practice. At least three categories of problems occur in randomization: (1) bad judgment in the choice of method, (2) design and programming errors in implementing the method, and (3) human error during the conduct of the trial. This article focuses on these latter two types of errors, dealing operationally with what can go wrong after trial designers have selected the allocation method. We offer several case studies and corresponding recommendations for lessening the frequency of problems in allocating treatment or for mitigating the consequences of errors. Recommendations include: (1) reviewing the randomization schedule before starting a trial, (2) being especially cautious of systems that use on-demand random number generators, (3) drafting unambiguous randomization specifications, (4) performing thorough testing before entering a randomization system into production, (5) maintaining a dataset that captures the values investigators used to randomize participants, thereby allowing the process of treatment allocation to be reproduced and verified, (6) resisting the urge to correct errors that occur in individual treatment assignments, (7) preventing inadvertent unmasking to treatment assignments in kit allocations, and (8) checking a sample of study drug kits to allow detection of errors in drug packaging and labeling. Although we performed a literature search of documented randomization errors, the examples that we provide and the resultant recommendations are based largely on our own experience in industry-sponsored clinical trials. We do not know how representative our experience is or how common errors of the type we have seen occur. Our experience underscores the importance of verifying the integrity of the treatment allocation process before and during a trial. Clinical Trials 2010; 7: 235-245. http://ctj.sagepub.com.

  1. Statistical Power and Optimum Sample Allocation Ratio for Treatment and Control Having Unequal Costs Per Unit of Randomization

    ERIC Educational Resources Information Center

    Liu, Xiaofeng

    2003-01-01

    This article considers optimal sample allocation between the treatment and control condition in multilevel designs when the costs per sampling unit vary due to treatment assignment. Optimal unequal allocation may reduce the cost from that of a balanced design without sacrificing any power. The optimum sample allocation ratio depends only on the…

  2. Impact of Norm Perceptions and Guilt on Audience Response to Anti-Smoking Norm PSAs: The Case of Korean Male Smokers

    ERIC Educational Resources Information Center

    Lee, Hyegyu; Paek, Hye-Jin

    2013-01-01

    Objective: To examine how norm appeals and guilt influence smokers' behavioural intention. Design: Quasi-experimental design. Setting: South Korea. Method: Two hundred and fifty-five male smokers were randomly assigned to descriptive, injunctive, or subjective anti-smoking norm messages. After they viewed the norm messages, their norm perceptions,…

  3. The Influence of Education and Experience Upon Contextual and Task Performance in Warehouse Operations

    DTIC Science & Technology

    2016-09-01

    leadership. Subjects were randomly assigned to one of four groups to conduct a mixed- design experiment; the design included a 2 x 2 factorial component...The experimental design should have resulted in baseline groups that were representative of the target population; therefore, one would expect...1983; Sheridan, 2015). “SRK provides a language in which to talk about types of behavior as a basis for system design . It provides a basis on which

  4. An Empirical Comparison of Methods for Equating with Randomly Equivalent Groups of 50 to 400 Test Takers. Research Report. ETS RR-10-05

    ERIC Educational Resources Information Center

    Livingston, Samuel A.; Kim, Sooyeon

    2010-01-01

    A series of resampling studies investigated the accuracy of equating by four different methods in a random groups equating design with samples of 400, 200, 100, and 50 test takers taking each form. Six pairs of forms were constructed. Each pair was constructed by assigning items from an existing test taken by 9,000 or more test takers. The…

  5. 76 FR 17654 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    ... OMB Review; Comment Request Title: Evaluation of Adolescent Pregnancy Prevention Approaches-- First... as part of the Evaluation of Adolescent Pregnancy Prevention Approaches (PPA). PPA is a random assignment evaluation designed to result in rigorous evidence on effective ways to reduce teen pregnancy. The...

  6. Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it.

    PubMed

    Pandis, Nikolaos; Polychronopoulou, Argy; Eliades, Theodore

    2011-12-01

    Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

  7. Exploring the impact of positive and negative emotions on cooperative behaviour in a Prisoner’s Dilemma Game

    PubMed Central

    Thompson, Sam

    2013-01-01

    Objective. To explore the influences of discrete positive and negative emotions on cooperation in the context of a social dilemma game. Design. Two controlled studies were undertaken. In Study 1, 69 participants were randomly assigned to an essay emotion manipulation task designed to induce either guilt, joy or no strong emotion. In Study 2, 95 participants were randomly assigned to one of the same three tasks, and the impact of emotional condition on cooperation was explored using a repeated Prisoner’s Dilemma Game. Results. Study 1 established that the manipulation task was successful in inducing the specified emotions. The analysis from Study 2 revealed no significant main effects for emotions, in contrast to previous research. However, there was a significant effect for participants’ pre-existing tendency to cooperate (social value orientation; SVO). Conclusion. Methodological explanations for the result are explored, including the possible impact of trial-and-error strategies, different cooperation games and endogenous vs exogenous emotions. PMID:24432196

  8. Use of personalized Dynamic Treatment Regimes (DTRs) and Sequential Multiple Assignment Randomized Trials (SMARTs) in mental health studies

    PubMed Central

    Liu, Ying; ZENG, Donglin; WANG, Yuanjia

    2014-01-01

    Summary Dynamic treatment regimens (DTRs) are sequential decision rules tailored at each point where a clinical decision is made based on each patient’s time-varying characteristics and intermediate outcomes observed at earlier points in time. The complexity, patient heterogeneity, and chronicity of mental disorders call for learning optimal DTRs to dynamically adapt treatment to an individual’s response over time. The Sequential Multiple Assignment Randomized Trial (SMARTs) design allows for estimating causal effects of DTRs. Modern statistical tools have been developed to optimize DTRs based on personalized variables and intermediate outcomes using rich data collected from SMARTs; these statistical methods can also be used to recommend tailoring variables for designing future SMART studies. This paper introduces DTRs and SMARTs using two examples in mental health studies, discusses two machine learning methods for estimating optimal DTR from SMARTs data, and demonstrates the performance of the statistical methods using simulated data. PMID:25642116

  9. Exploring the impact of positive and negative emotions on cooperative behaviour in a Prisoner's Dilemma Game.

    PubMed

    Kjell, Oscar N E; Thompson, Sam

    2013-12-19

    Objective. To explore the influences of discrete positive and negative emotions on cooperation in the context of a social dilemma game. Design. Two controlled studies were undertaken. In Study 1, 69 participants were randomly assigned to an essay emotion manipulation task designed to induce either guilt, joy or no strong emotion. In Study 2, 95 participants were randomly assigned to one of the same three tasks, and the impact of emotional condition on cooperation was explored using a repeated Prisoner's Dilemma Game. Results. Study 1 established that the manipulation task was successful in inducing the specified emotions. The analysis from Study 2 revealed no significant main effects for emotions, in contrast to previous research. However, there was a significant effect for participants' pre-existing tendency to cooperate (social value orientation; SVO). Conclusion. Methodological explanations for the result are explored, including the possible impact of trial-and-error strategies, different cooperation games and endogenous vs exogenous emotions.

  10. Principles for designing randomized preventive trials in mental health: an emerging developmental epidemiology paradigm.

    PubMed

    Brown, C H; Liao, J

    1999-10-01

    An emerging population-based paradigm is now being used to guide the design of preventive trials used to test developmental models. We discuss elements of the designs of several ongoing randomized preventive trials involving reduction of risk for children of divorce, for children who exhibit behavioral or learning problems, and for children whose parents are being treated for depression. To test developmental models using this paradigm, we introduce three classes of design issues: design for prerandomization, design for intervention, and design for postintervention. For each of these areas, we present quantitative results from power calculations. Both scientific and cost implications of these power calculations are discussed in terms of variation among subjects on preintervention measures, unit of intervention, assignment, balancing, number of pretest and posttest measures, and the examination of moderation effects.

  11. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

    PubMed Central

    Carey, Michael P.; Senn, Theresa E.; Walsh, Jennifer L.; Coury-Doniger, Patricia; Urban, Marguerite A.; Fortune, Thierry; Vanable, Peter A.; Carey, Kate B.

    2014-01-01

    We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

  12. Can Nonexperimental Estimates Replicate Estimates Based on Random Assignment in Evaluations of School Choice? A Within-Study Comparison

    ERIC Educational Resources Information Center

    Bifulco, Robert

    2012-01-01

    The ability of nonexperimental estimators to match impact estimates derived from random assignment is examined using data from the evaluation of two interdistrict magnet schools. As in previous within-study comparisons, nonexperimental estimates differ from estimates based on random assignment when nonexperimental estimators are implemented…

  13. 76 FR 43729 - Notice of Random Assignment Study To Evaluate Workforce Investment Act Adult and Dislocated...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-21

    ... DEPARTMENT OF LABOR Employment and Training Administration Notice of Random Assignment Study To... interest to use a random assignment impact methodology for the study. In the local workforce investment... study during a 12-18 month period. The Department is soliciting comments concerning the Department's...

  14. Revisiting the Quality of Reporting Randomized Controlled Trials in Nursing Literature.

    PubMed

    Adams, Yenupini Joyce; Kamp, Kendra; Liu, Cheng Ching; Stommel, Manfred; Thana, Kanjana; Broome, Marion E; Smith, Barbara

    2018-03-01

    To examine and update the literature on the quality of randomized controlled trials (RCTs) as reported in top nursing journals, based on manuscripts' adherence to the CONsolidated Standards of Reporting Trials (CONSORT) guidelines. Descriptive review of adherence of RCT manuscript to CONSORT guidelines. Top 40 International Scientific Indexing (ISI) ranked nursing journals that published 20 or more RCTs between 2010 and 2014, were included in the study. Selected articles were randomly assigned to four reviewers who assessed the quality of the articles using the CONSORT checklist. Data were analyzed using descriptive and inferential statistics. A total of 119 articles were included in the review. The mean CONSORT score significantly differed by journal but did not differ based on year of publication. The least consistently reported items included random allocation, who randomly assigned participants and whether those administering the interventions were blinded to group assignment. Although progress has been made, there is still room for improvement in the quality of RCT reporting in nursing journals. Special attention must be paid to how adequately studies adhere to the CONSORT prior to publication in nursing journals. Evidence from (RCTs) are thought to provide the best evidence for evaluating the impact of treatments and interventions by the U.S. Preventive Services Task Force. Since the evidence may be used for the development of clinical practice guidelines, it is critical that RCTs be designed, conducted, and reported appropriately and precisely. © 2017 Sigma Theta Tau International.

  15. A Comparison of Two Teaching Methodologies for a Course in Basic Reference. Final Report.

    ERIC Educational Resources Information Center

    Gothberg, Helen M.

    The purpose of the investigation was to develop and test an audio-tutorial program for a course in Basic Reference. The design of the investigation was a posttest-only-control group design with 63 students randomly assigned to either an audio-tutorial or a lecture group. Data were collected and analyzed using a t-test for two groups and four…

  16. Differential Impact of Unguided versus Guided Use of a Multimedia Introduction to Equine Obstetrics in Veterinary Education

    ERIC Educational Resources Information Center

    Govaere Jan, L. J.; de Kruif, Aart; Valcke, Martin

    2012-01-01

    In view of supporting the study of the complex domain of equine obstetrics, a Foal"in"Mare multimedia package with 3D designs has been developed. The present study centers on questions as to the most optimal implementation of the multimedia package in veterinary education. In a pretest-posttest cross-over design, students were randomly assigned to…

  17. Evaluation of Child Health Matters: A Web-Based Tutorial to Enhance School Nurses' Communications with Families about Weight-Related Health

    ERIC Educational Resources Information Center

    Steele, Ric G.; Wu, Yelena P.; Cushing, Christopher C.; Jensen, Chad D.

    2013-01-01

    The goal of the current study was to assess the efficacy and acceptability of a web-based tutorial (Child Health Matters, CHM) designed to improve school nurses' communications with families about pediatric weight-related health issues. Using a randomized wait-list control design, a nationally representative sample of school nurses was assigned to…

  18. Responding to Misinformation about Climate Change

    ERIC Educational Resources Information Center

    Lawrence, Eva K.; Estow, Sarah

    2017-01-01

    This study examined responses to climate change misinformation and messages designed to counter misinformation. Participants (N = 406) first responded to a social media post denying the existence of global warming and then were randomly assigned to read one of three responses to the original post (correction, collaboration, control). Participants…

  19. 78 FR 24423 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-25

    ... an experimental research design. Program applicants who are eligible for CSPED services will be randomly assigned to either a program group that is offered program services or a control group that is not...) conducting focus groups with program participants to elicit participation experiences; (3) administering a...

  20. 75 FR 24934 - Submission for OMB Review; Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-06

    ... student archived data (e.g., state mandated standardized test scores); follow-up surveys for students... experimental design that utilizes the random assignment. LIC is an English Language Arts (ELA)-based character education curriculum that is expected to have positive impacts on student academic performance, attendance...

  1. 75 FR 9189 - Notice of Proposed Information Collection Requests

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-01

    ... mandated standardized test scores); follow-up surveys for students; teacher and parent rating/observation on various student aspects (e.g., student social skills); baseline and follow-up surveys for teachers... Character (LIC) program. This study is based on an experimental design that utilizes the random assignment...

  2. A minimal-contact intervention for cardiac inpatients: long-term effects on smoking cessation.

    PubMed

    Bolman, Catherine; de Vries, Hein; van Breukelen, Gerard

    2002-08-01

    This study examined the 1-year effects of a minimal-contact smoking cessation intervention for cardiac inpatients. The multicenter study included cardiac inpatients who had smoked prior to hospitalization. A pretest-posttest quasi-experimental design was used. Patients' experimental condition depended on the hospital they were assigned to. The design was partially randomized: 4 of the 11 hospitals selected the experimental condition themselves (2 experimental, 2 control), while the remaining 7 hospitals were randomly assigned. The experimental group consisted of patients of 5 hospitals (N = 388). Patients of 6 other hospitals served as the control group (N = 401). The intervention included stop-smoking advice by the cardiologist, brief counseling by the nurse, the provision of self-help materials, and aftercare by the cardiologist. Logistic regression analyses controlling for baseline differences and covariates did not show significant intervention effects on point prevalence and continuous abstinence. The study also showed that the outcomes were not significantly related to the way hospitals were assigned to the experimental condition. While short-term effects were found, the minimal-contact intervention did not result in significant effects after 12 months, at least if patients lost to follow-up were treated as posttest smokers. Efforts should be made to improve the intervention, especially the aftercare.

  3. SMS text pre-notification and delivery of reminder e-mails to increase response rates to postal questionnaires in the SUSPEND trial: a factorial design, randomised controlled trial.

    PubMed

    Starr, Kathryn; McPherson, Gladys; Forrest, Mark; Cotton, Seonaidh C

    2015-07-08

    Patient-reported outcomes are vital in informing randomised controlled trials (RCTs) and health-care interventions and policies from the patient's perspective. However, participant non-response may introduce bias and can affect the generalisability of the trial. This study evaluates two interventions aimed at increasing response rates to postal questionnaires within a large, UK-wide RCT: pre-notification via short messenger service (SMS) text prior to sending the initial mailing of trial questionnaires versus no pre-notification; for non-responders to the initial mailing of the questionnaires, an e-mail reminder (containing a hyperlink to complete the questionnaire online) versus a postal reminder. This study is a 2 × 2 partial factorial design RCT nested within an RCT of medical expulsive therapy for ureteric stone disease. Participants who supplied a mobile telephone number were randomly assigned to receive an SMS text pre-notification of questionnaire delivery or no pre-notification. Those who supplied an e-mail address were randomly assigned to receive a questionnaire reminder by e-mail or post. Participants could be randomly assigned to the pre-notification comparison or the reminder comparison or both. The primary outcome measure was response rate at each questionnaire time point. Four hundred eighteen participants were randomly assigned to the SMS pre-notification comparison (80% were male, and the mean age was 41 years with a standard deviation (SD) of 11.1). The intervention had no effect on response rate at either questionnaire time point. In subgroup analyses, SMS pre-notification increased response rates in women but only at the first questionnaire time point. One hundred nineteen participants were randomly assigned to the reminder comparison (80% were male, and the mean age was 42 years with an SD of 12.1). There was no difference in response rate in those who received an e-mail reminder compared with those who received a postal reminder. SMS text pre-notification of questionnaire delivery and email delivery of questionnaire reminders did not improve response rates. There was some evidence to suggest that SMS text pre-notification may be effective in women, and further studies to investigate this may be warranted. E-mail reminders for participants to return their postal questionnaire could be advantageous given that response rates were similar following either type of reminder and the low cost of delivering an e-mail compared with a postal reminder. This is a substudy of the SUSPEND trial (ISCTRN69423238) (18 Nov. 2010).

  4. Effect of rumen-undegradable protein supplementation and fresh forage composition on nitrogen utilization of dairy ewes.

    PubMed

    Mikolayunas, C; Thomas, D L; Armentano, L E; Berger, Y M

    2011-01-01

    Previous trials with dairy ewes fed stored feeds indicate a positive effect of rumen-undegradable protein (RUP) supplementation on milk yield. However, dairy sheep production in the United States is primarily based on grazing mixed grass-legume pastures, which contain a high proportion of rumen-degradable protein. Two trials were conducted to evaluate the effects of high-RUP protein supplementation and fresh forage composition on milk yield and N utilization of lactating dairy ewes fed in confinement or on pasture. In a cut-and-carry trial, 16 multiparous dairy ewes in mid-lactation were randomly assigned to 8 pens of 2 ewes each. Pens were randomly assigned 1 of 2 protein supplementation treatments, receiving either 0.0 or 0.3 kg of a high-RUP protein supplement (Soy Pass, LignoTech USA Inc., Rothschild, WI) per day. Within supplementation treatment, pens were randomly assigned to 1 of 4 forage treatments, which were applied in a 4×4 Latin square design for 10-d periods. Forage treatments included the following percentages of orchardgrass:alfalfa dry matter: 25:75, 50:50, 75:25, and 100:0. No interactions were observed between supplement and forage treatments. Supplementation with a high-RUP source tended to increase milk yield by 9%. Milk yield, milk protein yield, milk urea N, and urinary urea N excretion increased linearly with increased percentage of alfalfa. Milk N efficiency was greatest on the 100% orchardgrass diet. In a grazing trial, 12 multiparous dairy ewes in mid lactation were randomly assigned to 3 groups of 4 ewes each. Within group, 2 ewes were randomly assigned to receive either 0.0 or 0.3 kg of a high-RUP protein supplement (SoyPlus, West Central Cooperative, Ralston, IA) per day. Grazing treatments were arranged in a 3×3 Latin square design and applied to groups for 10-d periods. Ewes grazed paddocks that contained the following percentages of surface area of pure stands of orchardgrass:alfalfa: 50:50, 75:25, and 100:0. No interactions were found between supplement and forage treatments. Milk yield, milk protein yield, and milk urea N increased linearly with increased percentage of alfalfa in the paddock. In conclusion, supplementing with high-RUP protein tended to increase milk yield and increasing the proportion of alfalfa in the diet increased dry matter intake, milk yield, and protein yield of lactating dairy ewes fed or grazing fresh forage. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  5. Using Multisensory Phonics to Foster Reading Skills of Adolescent Delinquents

    ERIC Educational Resources Information Center

    Warnick, Kristan; Caldarella, Paul

    2016-01-01

    This study examined the effectiveness of a multisensory phonics-based reading remediation program for adolescent delinquents classified as poor readers living at a residential treatment center. We used a pretest--posttest control group design with random assignment. The treatment group participated in a 30-hr multisensory phonics reading…

  6. Effects of a Multifocused Prevention Program on Preschool Children's Competencies and Behavior Problems

    ERIC Educational Resources Information Center

    Stefan, Catrinel A.; Miclea, Mircea

    2013-01-01

    This study was designed to assess the effectiveness of a multifocused (child-, teacher- and parent-focused) prevention program for Romanian preschoolers, targeting social--emotional competence development, as well as reduction of behavior problems. Fourteen classrooms were randomly assigned to the intervention and control conditions. Subsequent…

  7. Leader Positivity and Follower Creativity: An Experimental Analysis

    ERIC Educational Resources Information Center

    Avey, James B.; Richmond, F. Lynn; Nixon, Don R.

    2012-01-01

    Using an experimental research design, 191 working adults were randomly assigned to two experimental conditions in order to test a theoretical model linking leader and follower positive psychological capital (PsyCap). Multiple methods were used to gather information from the participants. We found when leader PsyCap was manipulated experimentally,…

  8. Experimental Evaluation of the Effects of a Research-Based Preschool Mathematics Curriculum

    ERIC Educational Resources Information Center

    Clements, Douglas H.; Sarama, Julie

    2008-01-01

    A randomized-trials design was used to evaluate the effectiveness of a preschool mathematics program based on a comprehensive model of research-based curricula development. Thirty-six preschool classrooms were assigned to experimental (Building Blocks), comparison (a different preschool mathematics curriculum), or control conditions. Children were…

  9. An Intervention to Improve Motivation for Homework

    ERIC Educational Resources Information Center

    Akioka, Elisabeth; Gilmore, Linda

    2013-01-01

    A repeated measures design, with randomly assigned intervention and control groups and multiple sources of information on each participant, was used to examine whether changing the method of delivery of a school's homework program in order to better meet the students' needs for autonomy, relatedness and competence would lead to more positive…

  10. Interrupted Time Series Analysis: A Research Technique for Evaluating Social Programs for the Elderly

    ERIC Educational Resources Information Center

    Calsyn, Robert J.; And Others

    1977-01-01

    After arguing that treatment programs for the elderly need to be evaluated with better research designs, the authors illustrate how interrupted time series analysis can be used to evaluate programs for the elderly when random assignment to experimental and control groups is not possible. (Author)

  11. Does Early Reading Failure Decrease Children's Reading Motivation?

    ERIC Educational Resources Information Center

    Morgan, Paul L.; Fuchs, Douglas; Compton, Donald L.; Cordray, David S.; Fuchs, Lynn S.

    2008-01-01

    The authors used a pretest-posttest control group design with random assignment to evaluate whether early reading failure decreases children's motivation to practice reading. First, they investigated whether 60 first-grade children would report substantially different levels of interest in reading as a function of their relative success or failure…

  12. Performance, Cognitive Load, and Behaviour of Technology-Assisted English Listening Learning: From CALL to MALL

    ERIC Educational Resources Information Center

    Chang, Chi-Cheng; Warden, Clyde A.; Liang, Chaoyun; Chou, Pao-Nan

    2018-01-01

    This study examines differences in English listening comprehension, cognitive load, and learning behaviour between outdoor ubiquitous learning and indoor computer-assisted learning. An experimental design, employing a pretest-posttest control group is employed. Randomly assigned foreign language university majors joined either the experimental…

  13. The Effects of Concealing Academic Achievement Information on Adolescents' Self-Concept

    ERIC Educational Resources Information Center

    Zhang, Baoshan; Wang, Mo; Li, Juan; Yu, Guoliang; Bi, Yan-Ling

    2011-01-01

    Using an experimental design, the effect of concealing academic achievement information on adolescents' self-concept was examined in the current study. Specifically, adolescents with low academic achievement and adolescents with average to high academic achievement (N = 129) were randomly assigned to different interview contexts wherein…

  14. Validation of a Supplemental Reading Intervention for First-Grade Children

    ERIC Educational Resources Information Center

    Case, Lisa Pericola; Speece, Deborah L.; Silverman, Rebecca; Ritchey, Kristen D.; Schatschneider, Christopher; Cooper, David H.; Montanaro, Elizabeth; Jacobs, Dawn

    2010-01-01

    This experimental study was designed to validate a short-term supplemental reading intervention for at-risk first-grade children. Although substantial research on long-term supplemental reading interventions exists, less is known about short-term interventions. Thirty first-grade children were randomly assigned to intervention or control…

  15. Maternal Attachment Behaviors with Adopted and Birth Infants.

    ERIC Educational Resources Information Center

    Chan, Marilyn M.

    This study investigated: (1) effects of teaching mothers the unique behavioral cues of their adopted infants and (2) potential differences between the mothering practices of adoptive and birth mothers. A pretest, posttest experimental prospective design was used with random assignment of mother-infant dyads. Mother-adopted infant dyads were…

  16. How Do Hired Workers Fare under Consumer-Directed Personal Care?

    ERIC Educational Resources Information Center

    Dale, Stacy; Brown, Randall; Phillips, Barbara; Carlson, Barbara Lepidus

    2005-01-01

    Purpose: This study describes the experiences of workers hired under consumer direction. Design and Methods: Medicaid beneficiaries who volunteered for the Cash and Counseling demonstration were randomly assigned to the treatment group, which could participate in the consumer-directed program, or the control group, which was referred to agency…

  17. 77 FR 69812 - Agency Information Collection Activities; Comment Request; DC Choice Evaluation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-21

    ... oversubscribed. The study will include the administration of annual academic assessments and surveys of students... randomized control trial comparing outcomes of eligible applicants (students and their parents) assigned by lottery to receive or not receive a scholarship. This design is consistent with the requirement for a...

  18. Supervisor Attachment, Supervisory Working Alliance, and Affect in Social Work Field Instruction

    ERIC Educational Resources Information Center

    Bennett, Susanne; Mohr, Jonathan; Deal, Kathleen Holtz; Hwang, Jeongha

    2013-01-01

    Objective: This study focused on interrelationships among supervisor attachment, supervisory working alliance, and supervision-related affect, plus the moderating effect of a field instructor training. Method: The researchers employed a pretest-posttest follow-up design of 100 randomly assigned field instructors and 64 students in two…

  19. Mastery, Maladaptive Learning Behaviour, and Academic Achievement: An Intervention Approach

    ERIC Educational Resources Information Center

    Ranellucci, John; Hall, Nathan; Muis, Krista; Lajoie, Susanne; Robinson, Kristy

    2017-01-01

    The effects of three interventions designed to boost academic achievement among mastery-oriented students were evaluated on interest-based studying, social desirability, and perceived goal difficulty. Undergraduate students (N = 177) completed relevant self-report measures at the beginning and the end of the semester and were randomly assigned to…

  20. Systematic Changes in Families Following Prevention Trials

    ERIC Educational Resources Information Center

    Patterson, Gerald R.; DeGarmo, David; Forgatch, Marion S.

    2004-01-01

    A selective prevention design was applied to 238 recently separated families. Of these, 153 mothers randomly assigned to the experimental (E) group participated in 14 group sessions focused on Parent Management Treatment (PMT). Prior analyses showed that, over time, the group of families in the untreated group deteriorated in both parenting…

  1. Improving Reading Comprehension and Social Studies Knowledge in Middle School

    ERIC Educational Resources Information Center

    Vaughn, Sharon; Swanson, Elizabeth A.; Roberts, Greg; Wanzek, Jeanne; Stillman-Spisak, Stephanie J.; Solis, Michael; Simmons, Deborah

    2013-01-01

    This study aimed to determine the efficacy of a content acquisition and reading comprehension treatment implemented by eighth-grade social studies teachers. Using a within-teacher design, the eighth-grade teachers' social studies classes were randomly assigned to treatment or comparison conditions. Teachers (n = 5) taught the same instructional…

  2. A school-based intervention for diabetes risk reduction

    USDA-ARS?s Scientific Manuscript database

    We examined the effects of a multicomponent, school-based program, addressing risk factors for diabetes among children whose race, or ethnic group and socioeconomic status placed them at high risk for obesity and type 2 diabetes. Using a cluster design, we randomly assigned 42 schools to either a mu...

  3. Being "SMART" About Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency.

    PubMed

    August, Gerald J; Piehler, Timothy F; Bloomquist, Michael L

    2016-01-01

    The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Toward this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. The SMART feasibility pilot study includes a sample of 100 youth (13-17 years of age) identified by law enforcement as early stage offenders and referred for precourt juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems.

  4. Influence of study goals on study design and execution.

    PubMed

    Kirklin, J W; Blackstone, E H; Naftel, D C; Turner, M E

    1997-12-01

    From the viewpoint of a clinician who makes recommendations to patients about choosing from the multiple possible management schemes, quantitative information derived from statistical analyses of observational studies is useful. Although random assignment of therapy is optimal, appropriately performed studies in which therapy has been nonrandomly "assigned" are considered acceptable, albeit occasionally with limitations in inferences. The analyses are considered most useful when they generate multivariable equations suitable for predicting time-related outcomes in individual patients. Graphic presentations improve communication with patients and facilitate truly informed consent.

  5. Power Calculations for Moderators in Multi-Site Cluster Randomized Trials

    ERIC Educational Resources Information Center

    Spybrook, Jessaca; Kelcey, Ben; Dong, Nianbo

    2016-01-01

    Cluster randomized trials (CRTs), or studies in which intact groups of individuals are randomly assigned to a condition, are becoming more common in evaluation studies of educational programs. A specific type of CRT in which clusters are randomly assigned to treatment within blocks or sites, known as multisite cluster randomized trials (MSCRTs),…

  6. Effects of an Online Learning Community on Active and Reflective Learners' Learning Performance and Attitudes in a Face-to-Face Undergraduate Course

    ERIC Educational Resources Information Center

    Zhan, Zehui; Xu, Fuyin; Ye, Huiwen

    2011-01-01

    The purpose of this study was to examine the effects of an Online Learning Community (OLC) on active and reflective learners' learning performance and attitude in a face-to-face undergraduate digital design course. 814 freshmen in an introductory digital design course were randomly assigned to one of two treatments: one offered students an OLC,…

  7. Replicated Findings of an Evaluation of a Brief Intervention Designed to Prevent High-Risk Drinking among First-Year College Students: Implications for Social Norming Theory

    ERIC Educational Resources Information Center

    Stamper, Georgia Ann; Smith, Bradley H.; Gant, Rick; Bogle, Kristin E.

    2004-01-01

    College students were randomly assigned to receive either (a) standard alcohol programming (SAP) or (b) SAP plus an intervention designed to change perceptions of alcohol norms (PAN). Effects of the intervention delivered during one class period (i.e., 55 minutes) were assessed using pre- and post-intervention surveys about personal alcohol use…

  8. The Effects of a Simulation Game on Learning of Geographic Information at the Fifth Grade Level. Final Report.

    ERIC Educational Resources Information Center

    Keach, Everett T., Jr.; Pierfy, David A.

    The research in this report was conducted to assess the cognitive impact of a simulation game designed to teach selected geographic data about wind and ocean currents to fifth graders. A two-group, post-test research design was used. A random procedure was used to assign 185 students to two treatment groups. The sample was divided by sex, ranked…

  9. The Impact of Staff Training on the Knowledge of Support Staff in Relation to Bereavement and People with an Intellectual Disability

    ERIC Educational Resources Information Center

    Watters, Laura; McKenzie, Karen; Wright, Rachel

    2012-01-01

    This study aimed to investigate whether a 1-day training course improved support staff knowledge about bereavement and grief in people with a learning disability. A questionnaire based, mixed design was used. Forty-eight participants were randomly assigned to one of two equal groups. A staggered design allowed for group 2 to act both as a control…

  10. Roads to Success: Estimated Impacts of an Education and Career Planning Program during Middle School. Final Report

    ERIC Educational Resources Information Center

    Chaplin, Duncan; Bleeker, Martha; Booker, Kevin

    2010-01-01

    Roads to Success (RTS) is a school and career planning program designed to be implemented for 45 minutes per week in grades 7 through 12. Researchers at Mathematica Policy Research used a random assignment design to estimate the impacts of receiving RTS in grades 7 and 8. More than half of the students in these schools were eligible for free or…

  11. Pain sensitivity and torque used during measurement predicts change in range of motion at the knee.

    PubMed

    Bishop, Mark D; George, Steven Z

    2017-01-01

    To determine the extent to which changes in knee range of motion (ROM) after a stretching program are related to sensory factors at the time of testing and the amount of force used during the measurement of ROM, rather than changes in soft-tissue properties. Randomized, single-blind design. Participants were randomly assigned to a control or stretching group. Research laboratory. Forty-four healthy volunteers (22.8±2.8 years of age; 23 men). The stretching group undertook static stretching twice a day for 8 weeks. The control group continued with routine activity, but was discouraged from starting a flexibility program. ROM and tissue extensibility was assessed using a Biodex3 dynamometer, and ratings of thermal pain were collected at baseline and at 4 and 8 weeks by an examiner blinded to group assignment. Multilevel modeling was used to examine predictors of ROM across time. The stretching group showed a 6% increase, and the control group had a 2% increase, in ROM over the 8-week program. However, when fixed and random effects were tested in a complete model, the group assignment was not significant. End-point torque during ROM testing ( p =0.021) and the ratings in response to thermal testing ( p <0.001) were significant, however. ROM measured in a testing session was not predicted by assignment to a stretching program. Rather, ROM was predicted by the ratings of thermal stimuli and the peak torque used to apply the stretch.

  12. The effect of role assignment in high fidelity patient simulation on nursing students: An experimental research study.

    PubMed

    Weiler, Dustin T; Gibson, Andrea L; Saleem, Jason J

    2018-04-01

    Previous studies have evaluated the effectiveness of high fidelity patient simulators (HFPS) on nursing training; however, a gap exists on the effects of role assignment on critical thinking, self-efficacy, and situation awareness skills in team-based simulation scenarios. This study aims to determine if role assignment and the involvement level related to the roles yields significant effects and differences in critical thinking, situation awareness and self-efficacy scores in team-based high-fidelity simulation scenarios. A single factorial design with five levels and random assignment was utilized. A public university-sponsored simulation center in the United States of America. A convenience sample of 69 junior-level baccalaureate nursing students was recruited for participation. Participants were randomly assigned one of five possible roles and completed pre-simulation critical thinking and self-efficacy assessments prior to the simulation beginning. Playing within their assigned roles, participants experienced post-partum hemorrhaging scenario using an HFPS. After completing the simulation, participants completed a situation awareness assessment and a post-simulation critical thinking and self-efficacy assessment. Role assignment was found to have a statistically significant effect on critical thinking skills and a statistically significant difference in various areas of self-efficacy was also noted. However, no statistical significance in situation awareness abilities was found. Results support the notion that certain roles required the participant to be more involved with the simulation scenario, which may have yielded higher critical thinking and self-efficacy scores than roles that required a lesser level of involvement. Copyright © 2018 Elsevier Ltd. All rights reserved.

  13. An Investigation of Factors Influencing Learning in the Mentally Retarded, and Their Use in the Design of Instructional Materials; Effects of a Set for Delayed Response on Recall by MR's. Interim Report.

    ERIC Educational Resources Information Center

    Seitz, Sue; Morris, Dan

    In a study on short term memory, 32 educable mentally retarded subjects (mean IQ 62.68, mean mental age 103.78 months) were randomly assigned to each of the four experimental conditions. An automated machine presented the stimuli (32 three-letter words) and the interference items (a list of random numbers read aloud between stimuli presentations).…

  14. A Probabilistic Design Method Applied to Smart Composite Structures

    NASA Technical Reports Server (NTRS)

    Shiao, Michael C.; Chamis, Christos C.

    1995-01-01

    A probabilistic design method is described and demonstrated using a smart composite wing. Probabilistic structural design incorporates naturally occurring uncertainties including those in constituent (fiber/matrix) material properties, fabrication variables, structure geometry and control-related parameters. Probabilistic sensitivity factors are computed to identify those parameters that have a great influence on a specific structural reliability. Two performance criteria are used to demonstrate this design methodology. The first criterion requires that the actuated angle at the wing tip be bounded by upper and lower limits at a specified reliability. The second criterion requires that the probability of ply damage due to random impact load be smaller than an assigned value. When the relationship between reliability improvement and the sensitivity factors is assessed, the results show that a reduction in the scatter of the random variable with the largest sensitivity factor (absolute value) provides the lowest failure probability. An increase in the mean of the random variable with a negative sensitivity factor will reduce the failure probability. Therefore, the design can be improved by controlling or selecting distribution parameters associated with random variables. This can be implemented during the manufacturing process to obtain maximum benefit with minimum alterations.

  15. German adjuvant intergroup node-positive study: a phase III trial to compare oral ibandronate versus observation in patients with high-risk early breast cancer.

    PubMed

    von Minckwitz, Gunter; Möbus, Volker; Schneeweiss, Andreas; Huober, Jens; Thomssen, Christoph; Untch, Michael; Jackisch, Christian; Diel, Ingo J; Elling, Dirk; Conrad, Bettina; Kreienberg, Rolf; Müller, Volkmar; Lück, Hans-Joachim; Bauerfeind, Ingo; Clemens, Michael; Schmidt, Marcus; Noeding, Stefanie; Forstbauer, Helmut; Barinoff, Jana; Belau, Antje; Nekljudova, Valentina; Harbeck, Nadia; Loibl, Sibylle

    2013-10-01

    Bisphosphonates prevent skeletal-related events in patients with metastatic breast cancer. Their effect in early breast cancer is controversial. Ibandronate is an orally and intravenously available amino-bisphosphonate with a favorable toxicity profile. It therefore qualifies as potential agent for adjuvant use. The GAIN (German Adjuvant Intergroup Node-Positive) study was an open-label, randomized, controlled phase III trial with a 2 × 2 factorial design. Patients with node-positive early breast cancer were randomly assigned 1:1 to two different dose-dense chemotherapy regimens and 2:1 to ibandronate 50 mg per day orally for 2 years or observation. In all, 2,640 patients and 728 events were estimated to be required to demonstrate an increase in disease-free survival (DFS) by ibandronate from 75% to 79.5% by using a two-sided α = .05 and 1-β of 80%. We report here the efficacy analysis for ibandronate, which was released by the independent data monitoring committee because the futility boundary was not crossed after 50% of the required DFS events were observed. Between June 2004 and August 2008, 2,015 patients were randomly assigned to ibandronate and 1,008 to observation. Patients randomly assigned to ibandronate showed no superior DFS or overall survival (OS) compared with patients randomly assigned to observation (DFS: hazard ratio, 0.945; 95% CI, 0.768 to 1.161; P = .589; OS: HR, 1.040; 95% CI, 0.763 to 1.419; P = .803). DFS was numerically longer if ibandronate was used in patients younger than 40 years or older than 60 years compared with patients age 40 to 59 years (test for interaction P = .093). Adjuvant treatment with oral ibandronate did not improve outcome of patients with high-risk early breast cancer who received dose-dense chemotherapy.

  16. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol

    PubMed Central

    2011-01-01

    Background Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. Methods/design This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. Discussion We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. Trial Registration http://www.clinicaltrials.gov NCT00302718 PMID:21967830

  17. Randomized controlled dissemination study of community-to-clinic navigation to promote CRC screening: Study design and implications.

    PubMed

    Larkey, Linda; Szalacha, Laura; Herman, Patricia; Gonzalez, Julie; Menon, Usha

    2017-02-01

    Regular screening facilitates early diagnosis of colorectal cancer (CRC) and reduction of CRC morbidity and mortality. Screening rates for minorities and low-income populations remain suboptimal. Provider referral for CRC screening is one of the strongest predictors of adherence, but referrals are unlikely among those who have no clinic home (common among poor and minority populations). This group randomized controlled study will test the effectiveness of an evidence based tailored messaging intervention in a community-to-clinic navigation context compared to no navigation. Multicultural, underinsured individuals from community sites will be randomized (by site) to receive CRC screening education only, or education plus navigation. In Phase I, those randomized to education plus navigation will be guided to make a clinic appointment to receive a provider referral for CRC screening. Patients attending clinic appointments will continue to receive navigation until screened (Phase II) regardless of initial arm assignment. We hypothesize that those receiving education plus navigation will be more likely to attend clinic appointments (H1) and show higher rates of screening (H2) compared to those receiving education only. Phase I group assignment will be used as a control variable in analysis of screening follow-through in Phase II. Costs per screening achieved will be evaluated for each condition and the RE-AIM framework will be used to examine dissemination results. The novelty of our study design is the translational dissemination model that will allow us to assess the real-world application of an efficacious intervention previously tested in a randomized controlled trial. Copyright © 2016. Published by Elsevier Inc.

  18. The Loci Mnemonic Technique in Learning and Memory.

    ERIC Educational Resources Information Center

    Montague, William E.; Carter, John

    This study investigated the facilitative effects of the loci system using mental imagery for acquisition and recall within a retroactive inhibition (RI) paradigm. Fifty-five college undergraduates were randomly assigned to five treatment conditions. Four groups formed cells in a 2x2 factorial design which included (1) an RI factor (AB-AD vs.…

  19. Impact of Thematic Approach on Communication Skill in Preschool

    ERIC Educational Resources Information Center

    Ashokan, Varun; Venugopal, Kalpana

    2016-01-01

    The study investigated the effects of thematic approach on communication skills for preschool children. The study was a quasi experimental non-equivalent pretest-post-test control group design whereby 5-6 year old preschool children (n = 49) were randomly assigned to an experimental and a control group. The experimental group students were exposed…

  20. Increasing Positive Perceptions of Counseling: The Importance of Repeated Exposures

    ERIC Educational Resources Information Center

    Kaplan, Scott A.; Vogel, David L.; Gentile, Douglas A.; Wade, Nathaniel G.

    2012-01-01

    This study assesses the effectiveness of repeated exposures to a video intervention based on the Elaboration Likelihood Model. The video was designed to increase help-seeking attitudes and perceptions of peer norms and to decrease the stigma associated with seeking counseling. Participants were 290 undergraduates who were randomly assigned to a…

  1. Validity of a Checklist for the Design, Content, and Instructional Qualities of Children's Books

    ERIC Educational Resources Information Center

    Çer, Erkan; Sahin, Ertugrul

    2016-01-01

    The purpose of this study was to develop a checklist whose validity has been tested in assessing children's books. Participants consisted of university students who had taken a course in children's literature. They were selected through convenience sampling and randomly assigned into experimental and control groups. Participants in the…

  2. On the Impact of Formative Assessment on Student Motivation, Achievement, and Conceptual Change

    ERIC Educational Resources Information Center

    Yin, Yue; Shavelson, Richard J.; Ayala, Carlos C.; Ruiz-Primo, Maria Araceli; Brandon, Paul R.; Furtak, Erin Marie; Tomita, Miki K.; Young, Donald B.

    2008-01-01

    Formative assessment was hypothesized to have a beneficial impact on students' science achievement and conceptual change, either directly or indirectly by enhancing motivation. We designed and embedded formatives assessments within an inquiry science unit. Twelve middle-school science teachers with their students were randomly assigned either to…

  3. Power Analysis for Models of Change in Cluster Randomized Designs

    ERIC Educational Resources Information Center

    Li, Wei; Konstantopoulos, Spyros

    2017-01-01

    Field experiments in education frequently assign entire groups such as schools to treatment or control conditions. These experiments incorporate sometimes a longitudinal component where for example students are followed over time to assess differences in the average rate of linear change, or rate of acceleration. In this study, we provide methods…

  4. School Nurse Online Emergency Preparedness Training: An Analysis of Knowledge, Skills, and Confidence

    ERIC Educational Resources Information Center

    Elgie, Robert; Sapien, Robert; Fullerton, Lynne; Moore, Brian

    2010-01-01

    The objective of this study was to evaluate the effectiveness of a computer-assisted emergency preparedness course for school nurses. Participants from a convenience sample (52) of school nurses from New Mexico were randomly assigned to intervention or control groups in an experimental after-only posttest design. Intervention group participants…

  5. The Influence of Small Class Size, Duration, Intensity, and Heterogeneity on Head Start Fade

    ERIC Educational Resources Information Center

    Huss, Christopher D.

    2010-01-01

    The researcher conducted a nonexperimental study to investigate and analyze the influence of reduced class sizes, intensity (all day and every day), duration (five years), and heterogeneity (random class assignment) on the Head Start Fade effect. The researcher employed retrospective data analysis using a longitudinal explanatory design on data…

  6. Leveraging Volunteers: An Experimental Evaluation of a Tutoring Program for Struggling Readers

    ERIC Educational Resources Information Center

    Jacob, Robin; Armstrong, Catherine; Bowden, A. Brooks; Pan, Yilin

    2016-01-01

    This study evaluates the impacts and costs of the Reading Partners program, which uses community volunteers to provide one-on-one tutoring to struggling readers in under-resourced elementary schools. The evaluation uses an experimental design. Students were randomly assigned within 19 different Reading Partners sites to a program or control…

  7. Death Anxiety and Cancer-Related Stigma: A Terror Management Analysis

    ERIC Educational Resources Information Center

    Mosher, Catherine E.; Danoff-Burg, Sharon

    2007-01-01

    In a study designed to examine correlates of cancer-related stigma, 405 college students were assigned randomly to listen to an audiotaped interview in which the target's cancer type and smoking status were manipulated. In the lung cancer conditions, target gender also was manipulated. Social distance and emotional responses differed according to…

  8. Searching for Buried Treasure: Uncovering Discovery in Discovery-Based Learning

    ERIC Educational Resources Information Center

    Chase, Kiera; Abrahamson, Dor

    2018-01-01

    Forty 4th and 9th grade students participated individually in tutorial interviews centered on a problem-solving activity designed for learning basic algebra mechanics through diagrammatic modeling of an engaging narrative about a buccaneering giant burying and unearthing her treasure on a desert island. Participants were randomly assigned to…

  9. Emotional Intelligence, Personality, and Task-Induced Stress

    ERIC Educational Resources Information Center

    Matthews, Gerald; Emo, Amanda K.; Funke, Gregory; Zeidner, Moshe; Roberts, Richard D.; Costa, Paul T.; Schulze, Ralf

    2006-01-01

    Emotional intelligence (EI) may predict stress responses and coping strategies in a variety of applied settings. This study compares EI and the personality factors of the Five Factor Model (FFM) as predictors of task-induced stress responses. Participants (N = 200) were randomly assigned to 1 of 4 task conditions, 3 of which were designed to be…

  10. Effects of Situated Learning on Students' Knowledge Acquisition: An Individual Differences Perspective

    ERIC Educational Resources Information Center

    Zheng, Robert

    2010-01-01

    This study focuses on the effects of situated learning on students' knowledge acquisition by investigating the influence of individual differences in such learning. Seventy-nine graduates were recruited from an educational department and were assigned to situated learning and traditional learning based on a randomized block design. Results…

  11. Mindful Music Listening Instruction Increases Listening Sensitivity and Enjoyment

    ERIC Educational Resources Information Center

    Anderson, William Todd

    2016-01-01

    The purpose of this study was to examine the effect of mindful listening instruction on music listening sensitivity and music listening enjoyment. A pretest--posttest control group design was used. Participants, fourth-grade students (N = 42) from an elementary school in a large city in the Northeastern United States, were randomly assigned to two…

  12. Efficacy of an Electronic Editing Strategy with College Students with Intellectual and Developmental Disabilities

    ERIC Educational Resources Information Center

    Woods-Groves, Suzanne; Hua, Youjia; Ford, Jeremy W.; Neil, Katelyn M.

    2017-01-01

    In this study we investigated an editing strategy to develop effective proofreading skills (i.e., mechanics and substantive revisions) within electronic texts through an experimental pre- and posttest group design with random assignment. Fifteen college students with intellectual and developmental disabilities participated in this investigation.…

  13. Educational Research with Real-World Data: Reducing Selection Bias with Propensity Scores

    ERIC Educational Resources Information Center

    Adelson, Jill L.

    2013-01-01

    Often it is infeasible or unethical to use random assignment in educational settings to study important constructs and questions. Hence, educational research often uses observational data, such as large-scale secondary data sets and state and school district data, and quasi-experimental designs. One method of reducing selection bias in estimations…

  14. Some Effects of Training Preservice Teachers in Science Teaching Strategy Analysis.

    ERIC Educational Resources Information Center

    Yeany, Russell, Jr.

    This study was designed to assess the effectiveness of three treatments for encouraging and training prospective elementary science teachers in the use of inductive/indirect strategies in science teaching. Subjects were randomly assigned to one of four treatment groups: (1) Strategy Analysis Level - subjects were trained in science teaching…

  15. Power Analysis for Cross Level Mediation in CRTs

    ERIC Educational Resources Information Center

    Kelcey, Ben

    2014-01-01

    A common design in education research for interventions operating at a group or cluster level is a cluster randomized trial (CRT) (Bloom, 2005). In CRTs, intact clusters (e.g., schools) are assigned to treatment conditions rather than individuals (e.g., students) and are frequently an effective way to study interventions because they permit…

  16. Assessing the Impact of a School-Based Group Approach with Adolescent Males

    ERIC Educational Resources Information Center

    Liddell, T. Michael; Kurpius, Sharon Robinson

    2014-01-01

    This study assessed the impact of a school-based group intervention, "The Council for Boys and Young Men," specifically designed for adolescent males. The participants who attended an alternative school in a metropolitan area were randomly assigned to the intervention or to waitlist control groups. Measures assessed self-esteem, future…

  17. Advancing Scientific Reasoning in Upper Elementary Classrooms: Direct Instruction versus Task Structuring

    ERIC Educational Resources Information Center

    Lazonder, Ard W.; Wiskerke-Drost, Sjanou

    2015-01-01

    Several studies found that direct instruction and task structuring can effectively promote children's ability to design unconfounded experiments. The present study examined whether the impact of these interventions extends to other scientific reasoning skills by comparing the inquiry activities of 55 fifth-graders randomly assigned to one of…

  18. Results and Implications of a Problem-Solving Treatment Program for Obesity.

    ERIC Educational Resources Information Center

    Mahoney, B. K.; And Others

    Data are from a large scale experimental study which was designed to evaluate a multimethod problem solving approach to obesity. Obese adult volunteers (N=90) were randomly assigned to three groups: maximal treatment, minimal treatment, and no treatment control. In the two treatment groups, subjects were exposed to bibliographic material and…

  19. Engaging Struggling Adolescent Readers to Improve Reading Skills

    ERIC Educational Resources Information Center

    Kim, James S.; Hemphill, Lowry; Troyer, Margaret; Thomson, Jenny M.; Jones, Stephanie M.; LaRusso, Maria D.; Donovan, Suzanne

    2017-01-01

    This study examined the efficacy of a supplemental, multicomponent adolescent reading intervention for middle school students who scored below proficient on a state literacy assessment. Using a within-school experimental design, the authors randomly assigned 483 students in grades 6-8 to a business-as-usual control condition or to the Strategic…

  20. Observing and Deterring Social Cheating on College Exams

    ERIC Educational Resources Information Center

    Fendler, Richard J.; Yates, Michael C.; Godbey, Johnathan M.

    2018-01-01

    This research introduces a unique multiple choice exam design to observe and measure the degree to which students copy answers from their peers. Using data collected from the exam, an empirical experiment is conducted to determine whether random seat assignment deters cheating relative to a control group of students allowed to choose their seats.…

  1. AUDITORY DISCRIMINATION TRAINING IN THE DEVELOPMENT OF WORD ANALYSIS SKILLS.

    ERIC Educational Resources Information Center

    COLEMAN, JAMES C.; MCNEIL, JOHN D.

    THE HYPOTHESIS THAT CHILDREN WHO ARE TAUGHT TO HEAR AND DESIGNATE SEPARATE SOUNDS IN SPOKEN WORDS WILL ACHIEVE GREATER SUCCESS IN LEARNING TO ANALYZE PRINTED WORDS WAS TESTED. THE SUBJECTS WERE 90 KINDERGARTEN CHILDREN, PREDOMINATELY MEXICAN-AMERICANS AND NEGROES. CHILDREN WERE RANDOMLY ASSIGNED TO ONE OF THREE TREATMENTS, EACH OF 3-WEEKS DURATION…

  2. Parenting after Divorce: Evaluation of Preventive Programs for Divorcing Families.

    ERIC Educational Resources Information Center

    Warren, Nancy J.; And Others

    Preventive educational programs are potentially useful in reducing the effects of divorce on children and families. Parenting After Divorce is an ongoing study designed to evaluate preventive programs. Divorcing families with children aged 7-12 are identified from court records and contacted to participate. Families are randomly assigned to one of…

  3. Studying the Effectiveness of an Online Language Learning Platform in China

    ERIC Educational Resources Information Center

    Baker, Ryan; Wang, Feng; Ma, Zhenjun; Ma, Wei; Zheng, Shiyue

    2018-01-01

    In this paper we evaluate the effectiveness of an adaptive online learning platform, designed to support Chinese students in learning the English language. The adaptive platform is studied in three studies, where the experimental platform is compared to an alternate, non-adaptive platform, with random assignment to conditions (the adaptive…

  4. Applications of random forest feature selection for fine-scale genetic population assignment.

    PubMed

    Sylvester, Emma V A; Bentzen, Paul; Bradbury, Ian R; Clément, Marie; Pearce, Jon; Horne, John; Beiko, Robert G

    2018-02-01

    Genetic population assignment used to inform wildlife management and conservation efforts requires panels of highly informative genetic markers and sensitive assignment tests. We explored the utility of machine-learning algorithms (random forest, regularized random forest and guided regularized random forest) compared with F ST ranking for selection of single nucleotide polymorphisms (SNP) for fine-scale population assignment. We applied these methods to an unpublished SNP data set for Atlantic salmon ( Salmo salar ) and a published SNP data set for Alaskan Chinook salmon ( Oncorhynchus tshawytscha ). In each species, we identified the minimum panel size required to obtain a self-assignment accuracy of at least 90% using each method to create panels of 50-700 markers Panels of SNPs identified using random forest-based methods performed up to 7.8 and 11.2 percentage points better than F ST -selected panels of similar size for the Atlantic salmon and Chinook salmon data, respectively. Self-assignment accuracy ≥90% was obtained with panels of 670 and 384 SNPs for each data set, respectively, a level of accuracy never reached for these species using F ST -selected panels. Our results demonstrate a role for machine-learning approaches in marker selection across large genomic data sets to improve assignment for management and conservation of exploited populations.

  5. Rehabilitation R and D Progress Reports, 1991

    DTIC Science & Technology

    1991-01-01

    FES) is a challeng- work of our group , we are addressing the problem ing problem. A crucial difficulty is controlling the of designing a functional FES... control data. Background infor- research to design and evaluate interventions which mation will be obtained on the visual, sensory, help to reduce the...the senior was randomly Larger scale research is planned to investigate assigned to either a control or service group . the incidence of minor accidents

  6. Short-Term Impact of a Teen Pregnancy-Prevention Intervention Implemented in Group Homes.

    PubMed

    Oman, Roy F; Vesely, Sara K; Green, Jennifer; Fluhr, Janene; Williams, Jean

    2016-11-01

    Youth living in group home settings are at significantly greater risk for sexual risk behaviors; however, there are no sexual health programs designed specifically for these youth. The study's purpose was to assess the effectiveness of a teen pregnancy-prevention program for youth living in group home foster care settings and other out-of-home placements. The study design was a cluster randomized controlled trial involving youth (N = 1,037) recruited from 44 residential group homes located in California, Maryland, and Oklahoma. Within each state, youth (mean age = 16.2 years; 82% male; 37% Hispanic, 20% African-American, 20% white, and 17% multiracial) in half the group homes were randomly assigned to the intervention group (n = 40 clusters) and the other half were randomly assigned to a control group that offered "usual care" (n = 40 clusters). The intervention (i.e., Power Through Choices [PTC]) was a 10-session, age-appropriate, and medically accurate sexual health education program. Compared to the control group, youth in the PTC intervention showed significantly greater improvements (p < .05) from preintervention to postintervention in all three knowledge areas, one of two attitude areas, all three self-efficacy areas, and two of three behavioral intention areas. This is the first published randomized controlled trial of a teen pregnancy-prevention program designed for youth living in foster care settings and other out-of-home placements. The numerous significant improvements in short-term outcomes are encouraging and provide preliminary evidence that the PTC program is an effective pregnancy-prevention program. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

  7. Statistical power for the comparative regression discontinuity design with a nonequivalent comparison group.

    PubMed

    Tang, Yang; Cook, Thomas D; Kisbu-Sakarya, Yasemin

    2018-03-01

    In the "sharp" regression discontinuity design (RD), all units scoring on one side of a designated score on an assignment variable receive treatment, whereas those scoring on the other side become controls. Thus the continuous assignment variable and binary treatment indicator are measured on the same scale. Because each must be in the impact model, the resulting multi-collinearity reduces the efficiency of the RD design. However, untreated comparison data can be added along the assignment variable, and a comparative regression discontinuity design (CRD) is then created. When the untreated data come from a non-equivalent comparison group, we call this CRD-CG. Assuming linear functional forms, we show that power in CRD-CG is (a) greater than in basic RD; (b) less sensitive to the location of the cutoff and the distribution of the assignment variable; and that (c) fewer treated units are needed in the basic RD component within the CRD-CG so that savings can result from having fewer treated cases. The theory we develop is used to make numerical predictions about the efficiency of basic RD and CRD-CG relative to each other and to a randomized control trial. Data from the National Head Start Impact study are used to test these predictions. The obtained estimates are closer to the predicted parameters for CRD-CG than for basic RD and are generally quite close to the parameter predictions, supporting the emerging argument that CRD should be the design of choice in many applications for which basic RD is now used. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

  8. Group Matching: Is This a Research Technique to Be Avoided?

    ERIC Educational Resources Information Center

    Ross, Donald C.; Klein, Donald F.

    1988-01-01

    The variance of the sample difference and the power of the "F" test for mean differences were studied under group matching on covariates and also under random assignment. Results shed light on systematic assignment procedures advocated to provide more precise estimates of treatment effects than simple random assignment. (TJH)

  9. Social stories: mechanisms of effectiveness in increasing game play skills in children diagnosed with autism spectrum disorder using a pretest posttest repeated measures randomized control group design.

    PubMed

    Quirmbach, Linda M; Lincoln, Alan J; Feinberg-Gizzo, Monica J; Ingersoll, Brooke R; Andrews, Siri M

    2009-02-01

    An increasing body of literature has indicated that social stories are an effective way to teach individuals diagnosed with autism appropriate social behavior. This study compared two formats of a social story targeting the improvement of social skills during game play using a pretest posttest repeated measures randomized control group design. A total of 45 children diagnosed with Autism Spectrum Disorder (ASD) ages 7-14 were randomly assigned to standard, directive, or control story conditions. Results demonstrated that the standard and directive story formats were equally as effective in eliciting, generalizing and maintaining the targeted social skills in participants who had prior game play experience and Verbal Comprehension Index (VCI) scores from the WISC-IV intelligence test in the borderline range or above.

  10. Being “SMART” about Adolescent Conduct Problems Prevention: Executing a SMART Pilot Study in a Juvenile Diversion Agency

    PubMed Central

    August, Gerald J.; Piehler, Timothy F.; Bloomquist, Michael L.

    2014-01-01

    OBJECTIVE The development of adaptive treatment strategies (ATS) represents the next step in innovating conduct problems prevention programs within a juvenile diversion context. Towards this goal, we present the theoretical rationale, associated methods, and anticipated challenges for a feasibility pilot study in preparation for implementing a full-scale SMART (i.e., sequential, multiple assignment, randomized trial) for conduct problems prevention. The role of a SMART design in constructing ATS is presented. METHOD The SMART feasibility pilot study includes a sample of 100 youth (13–17 years of age) identified by law enforcement as early stage offenders and referred for pre-court juvenile diversion programming. Prior data on the sample population detail a high level of ethnic diversity and approximately equal representations of both genders. Within the SMART, youth and their families are first randomly assigned to one of two different brief-type evidence-based prevention programs, featuring parent-focused behavioral management or youth-focused strengths-building components. Youth who do not respond sufficiently to brief first-stage programming will be randomly assigned a second time to either an extended parent- or youth-focused second-stage programming. Measures of proximal intervention response and measures of potential candidate tailoring variables for developing ATS within this sample are detailed. RESULTS Results of the described pilot study will include information regarding feasibility and acceptability of the SMART design. This information will be used to refine a subsequent full-scale SMART. CONCLUSIONS The use of a SMART to develop ATS for prevention will increase the efficiency and effectiveness of prevention programing for youth with developing conduct problems. PMID:25256135

  11. A randomized controlled design reveals barriers to citizenship for low-income immigrants.

    PubMed

    Hainmueller, Jens; Lawrence, Duncan; Gest, Justin; Hotard, Michael; Koslowski, Rey; Laitin, David D

    2018-01-30

    Citizenship endows legal protections and is associated with economic and social gains for immigrants and their communities. In the United States, however, naturalization rates are relatively low. Yet we lack reliable knowledge as to what constrains immigrants from applying. Drawing on data from a public/private naturalization program in New York, this research provides a randomized controlled study of policy interventions that address these constraints. The study tested two programmatic interventions among low-income immigrants who are eligible for citizenship. The first randomly assigned a voucher that covers the naturalization application fee among immigrants who otherwise would have to pay the full cost of the fee. The second randomly assigned a set of behavioral nudges, similar to outreach efforts used by service providers, among immigrants whose incomes were low enough to qualify them for a federal waiver that eliminates the application fee. Offering the fee voucher increased naturalization application rates by about 41%, suggesting that application fees act as a barrier for low-income immigrants who want to become US citizens. The nudges to encourage the very poor to apply had no discernible effect, indicating the presence of nonfinancial barriers to naturalization. Copyright © 2018 the Author(s). Published by PNAS.

  12. A randomized controlled design reveals barriers to citizenship for low-income immigrants

    PubMed Central

    Hainmueller, Jens; Gest, Justin; Hotard, Michael; Koslowski, Rey; Laitin, David D.

    2018-01-01

    Citizenship endows legal protections and is associated with economic and social gains for immigrants and their communities. In the United States, however, naturalization rates are relatively low. Yet we lack reliable knowledge as to what constrains immigrants from applying. Drawing on data from a public/private naturalization program in New York, this research provides a randomized controlled study of policy interventions that address these constraints. The study tested two programmatic interventions among low-income immigrants who are eligible for citizenship. The first randomly assigned a voucher that covers the naturalization application fee among immigrants who otherwise would have to pay the full cost of the fee. The second randomly assigned a set of behavioral nudges, similar to outreach efforts used by service providers, among immigrants whose incomes were low enough to qualify them for a federal waiver that eliminates the application fee. Offering the fee voucher increased naturalization application rates by about 41%, suggesting that application fees act as a barrier for low-income immigrants who want to become US citizens. The nudges to encourage the very poor to apply had no discernible effect, indicating the presence of nonfinancial barriers to naturalization. PMID:29339470

  13. A random walk rule for phase I clinical trials.

    PubMed

    Durham, S D; Flournoy, N; Rosenberger, W F

    1997-06-01

    We describe a family of random walk rules for the sequential allocation of dose levels to patients in a dose-response study, or phase I clinical trial. Patients are sequentially assigned the next higher, same, or next lower dose level according to some probability distribution, which may be determined by ethical considerations as well as the patient's response. It is shown that one can choose these probabilities in order to center dose level assignments unimodally around any target quantile of interest. Estimation of the quantile is discussed; the maximum likelihood estimator and its variance are derived under a two-parameter logistic distribution, and the maximum likelihood estimator is compared with other nonparametric estimators. Random walk rules have clear advantages: they are simple to implement, and finite and asymptotic distribution theory is completely worked out. For a specific random walk rule, we compute finite and asymptotic properties and give examples of its use in planning studies. Having the finite distribution theory available and tractable obviates the need for elaborate simulation studies to analyze the properties of the design. The small sample properties of our rule, as determined by exact theory, compare favorably to those of the continual reassessment method, determined by simulation.

  14. A TAD better for myeloma therapy?

    PubMed

    Giralt, Sergio

    2010-02-11

    In this issue of Blood, Lokhorst and colleagues report on the results of HOVON-50, a phase 3 randomized trial designed to evaluate the effects of thalidomide during induction treatment and as maintenance in patients with multiple myeloma. There were 556 patients randomly assigned either to 3 cycles of VAD or to TAD. All patients were to receive high-dose melphalan with autologous stem cell support followed by maintenance with interferon for the VAD arm or thalidomide for the TAD arm.(1) This study together with other randomized and nonrandomized trials establish a definitive role for thalidomide as induction therapy in conjunction with dexamethasone, anthracyclines, and alkylating agents.

  15. Acceptability of randomization to levonorgestrel versus copper intrauterine device among women requesting IUD insertion for contraception

    PubMed Central

    Achilles, Sharon L.; Chen, Beatrice A.; Lee, Jessica K.; Gariepy, Aileen M.; Creinin, Mitchell D.

    2015-01-01

    Objective Assess feasibility of randomizing women to intrauterine device (IUD) type. Study Design Women enrolling in a 2-month study who desired an IUD for contraception were randomized 1:1 to receive a levonorgestrel 52mg IUD (LNG-IUD) or copper T380A (Cu-IUD), understanding they could switch IUD type at the end of the study. Results Randomization to IUD type was acceptable to 54/55 (98%) women who screened. All 32 enrolled participants completed follow-up. Two women exchanged their IUD (Cu-IUD to LNG-IUD) and 2 requested removal (1 LNG-IUD, 1 Cu-IUD). Overall, 88% continued their assigned IUD. Conclusions Randomization to IUD type is feasible and few women change their IUD. PMID:26297203

  16. Are parent-reported outcomes for self-directed or telephone-assisted behavioral family intervention enhanced if parents are observed?

    PubMed

    Morawska, Alina; Sanders, Matthew R

    2007-05-01

    The study examined the effects of conducting observations as part of a broader assessment of families participating in behavior family intervention (BFI). It was designed to investigate whether the observations improve intervention outcomes. Families were randomly assigned to different levels of BFI or a waitlist control condition and subsequently randomly assigned to either observation or no-observation conditions. This study demonstrated significant intervention and observation effects. Mothers in more intensive BFI reported more improvement in their child's behavior and their own parenting. Observed mothers reported lower intensity of child behavior problems and more effective parenting styles. There was also a trend for less anger among mothers who were observed and evidence of an observation-intervention interaction for parental anger, with observed mothers in more intensive intervention reporting less anger compared to those not observed. Implications for clinical and research intervention contexts are discussed.

  17. Family Caregiver Training Program (FCTP): A Randomized Controlled Trial.

    PubMed

    DiZazzo-Miller, Rosanne; Winston, Kristin; Winkler, Sandra L; Donovan, Mary L

    The purpose of this study was to examine the effectiveness of the Family Caregiver Training Program (FCTP) for caregivers of people with dementia. A random assignment control group research design with a 3-mo follow-up was implemented. Thirty-six family caregivers of people with dementia demonstrated an increase in activity of daily living (ADL) knowledge (p < .001) and maintenance of that knowledge 3 mo posttest. Caregiver confidence, regardless of group assignment, improved; however, it was not maintained. Burden, depression, and occupational performance and satisfaction remained unchanged for the intervention group; however, physical health as it pertained to quality of life improved 3 mo posttest (p < .001). Findings demonstrate that the FCTP can effectively provide knowledge to family caregivers on how to assist people with dementia with ADLs. Even when standard care was provided, there was limited information on ADLs that family caregivers faced daily. Copyright © 2017 by the American Occupational Therapy Association, Inc.

  18. Examining the Preparatory Effects of Problem Generation and Solution Generation on Learning from Instruction

    ERIC Educational Resources Information Center

    Kapur, Manu

    2018-01-01

    The goal of this paper is to isolate the preparatory effects of problem-generation from solution generation in problem-posing contexts, and their underlying mechanisms on learning from instruction. Using a randomized-controlled design, students were assigned to one of two conditions: (a) problem-posing with solution generation, where they…

  19. Effect of incremental flaxseed supplementation of an herbage diet on methane output and ruminal fermentation in continuous culture

    USDA-ARS?s Scientific Manuscript database

    A 4-unit dual-flow continuous culture fermentor system was used to assess the effect of increasing flax supplementation of an herbage-based diet on nutrient digestibility, bacterial N synthesis and methane output. Treatments were randomly assigned to fermentors in a 4 x 4 Latin square design with 7 ...

  20. Caring for Others: Internet Video-Conferencing Group Intervention for Family Caregivers of Older Adults with Neurodegenerative Disease

    ERIC Educational Resources Information Center

    Marziali, Elsa; Donahue, Peter

    2006-01-01

    Purpose: The aim of this pilot feasibility study was to evaluate the effects of an innovative, Internet-based psychosocial intervention for family caregivers of older adults with neurodegenerative disease. Design and Methods: After receiving signed informed consent from each participant, we randomly assigned 66 caregivers to an Internet-based…

  1. Text Density and Learner-Control as Design Variables with CBI and Print Media.

    ERIC Educational Resources Information Center

    Ross, Steven M.; And Others

    This study investigated the effects of computer and print text density on learning, and the nature and effects of learner preference for different density levels in both print and computer presentation modes. Subjects were 48 undergraduate teacher education majors, who were assigned at random to six treatment groups in which a statistics lesson…

  2. Testing the Recognition and Perception of Errors in Context

    ERIC Educational Resources Information Center

    Brandenburg, Laura C.

    2015-01-01

    This study tests the recognition of errors in context and whether the presence of errors affects the reader's perception of the writer's ethos. In an experimental, posttest only design, participants were randomly assigned a memo to read in an online survey: one version with errors and one version without. Of the six intentional errors in version…

  3. Empathetic Responses and Attitudes about Older Adults: How Experience with the Aging Game Measures up

    ERIC Educational Resources Information Center

    Henry, Beverly W.; Ozier, Amy D.; Johnson, Amy

    2011-01-01

    This study aimed to assess the impact of pre-professional education on students' knowledge and attitudes about aging, including the option of a simulated learning activity. Using a mixed design, groups of nursing and nutrition students (n = 127) were randomly assigned to experience the Aging Game. Pre- and posttest observations included measures…

  4. A Study of Reliability of Marking and Absolute Grading in Secondary Schools

    ERIC Educational Resources Information Center

    Abdul Gafoor, K.; Jisha, P.

    2014-01-01

    Using a non-experimental comparative group design in a sample consisting of 100 English teachers randomly selected from 30 secondary schools of a district of Kerala and assigning fifty teachers to groups for marking and grading, this study compares inter and intra-individual reliability in marking and absolute grading. Studying (1) the in marking…

  5. The Hard but Necessary Task of Gathering Order-One Effect Size Indices in Meta-Analysis

    ERIC Educational Resources Information Center

    Ortego, Carmen; Botella, Juan

    2010-01-01

    Meta-analysis of studies with two groups and two measurement occasions must employ order-one effect size indices to represent study outcomes. Especially with non-random assignment, non-equivalent control group designs, a statistical analysis restricted to post-treatment scores can lead to severely biased conclusions. The 109 primary studies…

  6. Effects of a Supplemental Intervention Focused in Equivalency Concepts for Students with Varying Abilities

    ERIC Educational Resources Information Center

    Hunt, Jessica H.

    2014-01-01

    The purpose of this study was to examine the effects of a Tier 2 supplemental intervention focused on rational number equivalency concepts and applications on the mathematics performance of third-grade students with and without mathematics difficulties. The researcher used a pretest-posttest control group design and random assignment of 19…

  7. The Incremental Validity of the MMPI-2: When Does Therapist Access Not Enhance Treatment Outcome?

    ERIC Educational Resources Information Center

    Lima, Elizabeth N.; Stanley, Sheila; Kaboski, Beth; Reitzel, Lorraine R.; Richey, Anthony; Castro, Yezzennya; Williams, Foluso M.; Tannenbaum, Kendra R.; Stellrecht, Nadia E.; Jakobsons, Lara J.; Wingate, LaRicka R.; Joiner, Thomas E.

    2005-01-01

    The present study examined whether therapist access to the Minnesota Multiphasic Personality Inventory (MMPI-2) predicted favorable treatment outcome, above and beyond other assessment measures. A manipulated assessment design was used, in which patients were randomly assigned either to a group in which therapists had access to their MMPI-2 data…

  8. Effects of Risperidone on Cognitive-Motor Performance and Motor Movements in Chronically Medicated Children

    ERIC Educational Resources Information Center

    Aman, Michael G.; Hollway, Jill A.; Leone, Sarah; Masty, Jessica; Lindsay, Ronald; Nash, Patricia; Arnold, L. Eugene

    2009-01-01

    This study was designed to explore the placebo-controlled effects of risperidone on cognitive-motor processes, dyskinetic movements, and behavior in children receiving maintenance risperidone therapy. Sixteen children aged 4-14 years with disruptive behavior were randomly assigned to drug order in a crossover study of risperidone and placebo for 2…

  9. An Experimental Study Comparing English-Only and Transitional Bilingual Education on Spanish-Speaking Preschoolers' Early Literacy Development

    ERIC Educational Resources Information Center

    Duran, Lillian K.; Roseth, Cary J.; Hoffman, Patricia

    2010-01-01

    A longitudinal, experimental-control design was used to test the hypothesis that native language instruction enhances English language learner's (ELL's) native language and literacy development without significant cost to English development. In this study, 31 Spanish-speaking preschoolers (aged 38-48 months) were randomly assigned to two Head…

  10. The Impact of Concept Mapping on EFL Learners' Critical Thinking Ability

    ERIC Educational Resources Information Center

    Khodadady, Ebrahim; Ghanizadeh, Afsaneh

    2011-01-01

    The present study investigated the influence of concept mapping as a post-reading strategy on EFL learners' critical thinking ability. The study utilized a pretest-posttest control and experimental group design. To do so, thirty six EFL learners at upper intermediate and advanced levels were randomly assigned to experimental (n=18) and control…

  11. Teaching Efficacy in the Classroom: Skill Based Training for Teachers' Empowerment

    ERIC Educational Resources Information Center

    Karimzadeh, Mansoureh; Salehi, Hadi; Embi, Mohamed Amin; Nasiri, Mehdi; Shojaee, Mohammad

    2014-01-01

    This study aims to use an experimental research design to enhance teaching efficacy by social-emotional skills training in teachers. The statistical sample comprised of 68 elementary teachers (grades 4 and 5) with at least 10 years teaching experience and a bachelor's degree who were randomly assigned into control (18 female, 16 male) and…

  12. Consultation-Based Academic Interventions for Children with ADHD: Effects on Reading and Mathematics Achievement

    ERIC Educational Resources Information Center

    DuPaul, George J.; Jitendra, Asha K.; Volpe, Robert J.; Tresco, Katy E.; Lutz, J. Gary; Vile Junod, Rosemary E.; Cleary, Kristi S.; Flammer, Lizette M.; Mannella, Mark C.

    2006-01-01

    The purpose of this investigation was to evaluate the relative efficacy of two consultation-based models for designing academic interventions to enhance the educational functioning of children with attention-deficit/hyperactivity disorder (ADHD). Children (N = 167) meeting DSM-IV criteria for ADHD were randomly assigned to one of two consultation…

  13. An Experiment in the Evaluation of Instruction at the Junior College.

    ERIC Educational Resources Information Center

    Partridge, Patrick V.

    This study was designed to determine the effectiveness of textbook and lecture methods of instruction on student achievement during 10 days of an introductory psychology course. The 48 subjects were randomly assigned to four treatment groups. The same examination was given as pretest and as post-test. The test was concerned with recall of factual…

  14. Covert Modeling vs. Behavior Rehearsal in the Training and Generalization of Assertive Behaviors: A Crossover Design.

    ERIC Educational Resources Information Center

    Zielinski, Joseph J.; Williams, Leslie J.

    1979-01-01

    Twenty-four underassertive adults were randomly assigned to two treatment orders that included covert modeling and behavior rehearsal. No measurable difference in treatments was found, but participants preferred and had greater expectations of behavior rehearsal. Skill generalization to untrained situations occurred on 8 of 11 behavioral measures.…

  15. Proportional Reasoning Word Problem Performance for Middle School Students with High-Incidence Disabilities (HID)

    ERIC Educational Resources Information Center

    Brawand, Anne Eichorn

    2013-01-01

    Schema-based instruction (SBI) was used to examine the solving of proportional reasoning word problems for middle school students with high-incidence disabilities (HID). Seventh- and eighth-grade students with HID participated in the study. Students were randomly assigned to one of three groups. A multiple-baseline-across-groups design was…

  16. Early Implementation Experiences of the 2010 Teacher Incentive Fund Grantees. NCEE Study Snapshot. NCEE 2014-4021

    ERIC Educational Resources Information Center

    National Center for Education Evaluation and Regional Assistance, 2014

    2014-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  17. Interactivity of Question Prompts and Feedback on Secondary Students' Science Knowledge Acquisition and Cognitive Load

    ERIC Educational Resources Information Center

    Huang, Kun; Chen, Ching-Huei; Wu, Wen-Shiuan; Chen, Wei-Yu

    2015-01-01

    This study investigated how question prompts and feedback influenced knowledge acquisition and cognitive load when learning Newtonian mechanics within a web-based multimedia module. Participants were one hundred eighteen 9th grade students who were randomly assigned to one of four experimental conditions, forming a 2 x 2 factorial design with the…

  18. Moving Teachers: Implementation of Transfer Incentives in Seven Districts. Executive Summary. NCEE 2012-4052

    ERIC Educational Resources Information Center

    Glazerman, Steven; Protik, Ali; Teh, Bing-ru; Bruch, Julie; Seftor, Neil

    2012-01-01

    This report describes the implementation and intermediate impacts of an intervention designed to provide incentives for a school district's highest-performing teachers to work in its lowest-achieving schools. The report is part of a larger study in which random assignment was used to form two equivalent groups of classrooms organized into teacher…

  19. Comparing Two Versions of Professional Development for Teachers Using Formative Assessment in Networked Mathematics Classrooms

    ERIC Educational Resources Information Center

    Yin, Yue; Olson, Judith; Olson, Melfried; Solvin, Hannah; Brandon, Paul R.

    2015-01-01

    This study compared two versions of professional development (PD) designed for teachers using formative assessment (FA) in mathematics classrooms that were networked with Texas Instruments Navigator (NAV) technology. Thirty-two middle school mathematics teachers were randomly assigned to one of the two groups: FA-then-NAV group and FA-and-NAV…

  20. An Analysis of 1-Year Impacts of Youth Transition Demonstration Projects

    ERIC Educational Resources Information Center

    Fraker, Thomas M.; Luecking, Richard G.; Mamun, Arif A.; Martinez, John M.; Reed, Deborah S.; Wittenburg, David C.

    2016-01-01

    This article examines the impacts of the Youth Transition Demonstration, an initiative of the Social Security Administration (SSA) to improve employment outcomes for youth with disabilities. Based on a random assignment design, the analysis uses data from a 1-year follow-up survey and SSA administrative records for 5,203 youth in six research…

  1. Outcomes of the Smoker's Health Project: A Pragmatic Comparative Effectiveness Trial of Tobacco-Dependence Interventions Based on Self-Determination Theory

    ERIC Educational Resources Information Center

    Williams, Geoffrey C.; Niemiec, Christopher P.; Patrick, Heather; Ryan, Richard M.; Deci, Edward L.

    2016-01-01

    A pragmatic comparative effectiveness trial examined whether extending the duration of a cost-effective, intensive tobacco-dependence intervention designed to support autonomy will facilitate long-term tobacco abstinence. Participants were randomly assigned to one of three tobacco-dependence interventions based on self-determination theory,…

  2. Interaction between a tannin-containing legume and endophyte-infected tall fescue seed on lambs’ feeding behavior and physiology

    USDA-ARS?s Scientific Manuscript database

    It was hypothesized that a tannin-rich legume like sainfoin reduces the negative postingestive effects of ergot alkaloids in tall fescue. Thirty-two 3-month-old lambs were individually penned and randomly assigned to a 2X2 factorial experimental design with two legume species (1-sainfoin [SF; tannin...

  3. Laughing Our Way to a Stronger Democracy: Political Comedy's Potential to Equalize Political Interest in Community College Students

    ERIC Educational Resources Information Center

    Lawrason, Lisa

    2017-01-01

    What effect does political comedy have on political interest? Through an experimental design, changes in political interest are measured through a pre and posttest, comparing groups randomly assigned to watch "The Daily Show," "NBC Nightly News," "Entertainment Tonight" and a no-exposure group. Models indicate…

  4. Effects of Redundancy and Modality on the Situational Interest of Adult Learners in Multimedia Learning

    ERIC Educational Resources Information Center

    Dousay, Tonia A.

    2016-01-01

    This study investigated the effects of two design principles as prescribed by the cognitive theory of multimedia learning on the situational interest of adult learners in a multimedia-based continuing education training program. One hundred and two adult learners employed by an emergency medical service were randomly assigned to one of three…

  5. Comparison of the Effects of Computer-Based Practice and Conceptual Understanding Interventions on Mathematics Fact Retention and Generalization

    ERIC Educational Resources Information Center

    Kanive, Rebecca; Nelson, Peter M.; Burns, Matthew K.; Ysseldyke, James

    2014-01-01

    The authors' purpose was to determine the effects of computer-based practice and conceptual interventions on computational fluency and word-problem solving of fourth- and fifth-grade students with mathematics difficulties. A randomized pretest-posttest control group design found that students assigned to the computer-based practice intervention…

  6. Early Numeracy Intervention Program for First-Grade Students with Mathematics Difficulties

    ERIC Educational Resources Information Center

    Bryant, Diane Pedrotty; Bryant, Brian R.; Roberts, Greg; Vaughn, Sharon; Pfannenstiel, Kathleen Hughes; Porterfield, Jennifer; Gersten, Russell

    2011-01-01

    The purpose of this study was to determine the effects of an early numeracy preventative Tier 2 intervention on the mathematics performance of first-grade students with mathematics difficulties. Researchers used a pretest-posttest control group design with randomized assignment of 139 students to the Tier 2 treatment condition and 65 students to…

  7. The Impact of Cooperative Learning on Tertiary EFL Learners' Motivation

    ERIC Educational Resources Information Center

    Ning, Huiping; Hornby, Garry

    2014-01-01

    This study was aimed at investigating the impact of cooperative learning on the motivation of tertiary English learners. Participants were from two randomly assigned classes at a university in the north of China. A pre-test-post-test control group design was employed to compare the impact of the cooperative learning approach with that of…

  8. Technology Instructional Package Mediated Instruction and Senior Secondary School Students' Academic Performance in Biology Concepts

    ERIC Educational Resources Information Center

    Yaki, Akawo Angwal; Babagana, Mohammed

    2016-01-01

    The paper examined the effects of a Technological Instructional Package (TIP) on secondary school students' performance in biology. The study adopted a pre-test, post-test experimental control group design. The sample size of the study was 80 students from Minna metropolis, Niger state, Nigeria; the samples were randomly assigned into treatment…

  9. An Investigation of Strategic Writing Instruction for Post-Secondary Students with Developmental Disabilities

    ERIC Educational Resources Information Center

    Woods-Groves, Suzanne; Hua, Youjia; Therrien, William J.; Kaldenberg, Erica R.; Lucas, Kristin G.; Hendrickson, Jo M.; McAninch, Melissa J.

    2014-01-01

    This investigation explored the use of strategic instruction to improve the essay-test taking skills of young adults who were enrolled in a campus-based, post-secondary education program for individuals with developmental disabilities. A random assignment to treatment or control groups and a pre- and posttest design was used. The participants…

  10. An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies

    ERIC Educational Resources Information Center

    Austin, Peter C.

    2011-01-01

    The propensity score is the probability of treatment assignment conditional on observed baseline characteristics. The propensity score allows one to design and analyze an observational (nonrandomized) study so that it mimics some of the particular characteristics of a randomized controlled trial. In particular, the propensity score is a balancing…

  11. The Effect of Hypertext Annotation Presentation Formats on Perceived Cognitive Load and Learner Control

    ERIC Educational Resources Information Center

    Yao, Yuanming; Gill, Michele

    2009-01-01

    The impact of hypertext presentation formats on learner control and cognitive load was examined in this study using Campbell and Stanley's (1963) Posttest Only Control Group design. One hundred eighty-six undergraduate students were randomly assigned to read a web-based text with no annotations, online glossary annotations, embedded annotations,…

  12. A Wilderness Adventure Program as an Alternative for Juvenile Probationers: An Evaluation.

    ERIC Educational Resources Information Center

    Winterdyk, John Albert

    A true experimental design with 60 male probationers, ages 13-16, was used to evaluate the viability of an Ontario-based 21-day wilderness adventure program as an alternative for adjudicated juveniles placed on probation. Participants were randomly assigned to a control group and an experimental group. The experimental group was subdivided into 3…

  13. Affective Learning Outcomes in Workplace Training: A Test of Synchronous vs. Asynchronous Online Learning Environments

    ERIC Educational Resources Information Center

    Cleveland-Innes, Martha; Ally, Mohamed

    2004-01-01

    Research employing an experimental design pilot-tested two delivery platforms, WebCT™ and vClass™, for the generation of affective learning outcomes in the workplace. Using a sample of volunteer participants in the help-desk industry, participants were randomly assigned to one of the two types of delivery software. Thirty-eight subjects…

  14. Learning Auditory Discrimination with Computer-Assisted Instruction: A Comparison of Two Different Performance Objectives.

    ERIC Educational Resources Information Center

    Steinhaus, Kurt A.

    A 12-week study of two groups of 14 college freshmen music majors was conducted to determine which group demonstrated greater achievement in learning auditory discrimination using computer-assisted instruction (CAI). The method employed was a pre-/post-test experimental design using subjects randomly assigned to a control group or an experimental…

  15. Effect of vitamin E on the immune system of ewes during late pregnancy and lactation

    USDA-ARS?s Scientific Manuscript database

    The present experiment was designed to determine the effects of a regimen of repeated, intramuscular (i.m.) injections of vitamin E (VE) on innate and humoral components of the immune response of pregnant and lactating ewes. Pregnant ewes were randomly assigned to two treatments consisting of i.m. i...

  16. A Deposit Contract Method to Deliver Abstinence Reinforcement for Cigarette Smoking

    ERIC Educational Resources Information Center

    Dallery, Jesse; Meredith, Steven; Glenn, Irene M.

    2008-01-01

    Eight smokers were randomly assigned to a deposit contract ($50.00) or to a no-deposit group. Using a reversal design, participants could recoup their deposit (deposit group) or earn vouchers (no-deposit group) for smoking reductions and abstinence (breath carbon monoxide [CO] less than or equal to 4 parts per million) during treatment phases.…

  17. Effects of Tutorial Interventions in Mathematics and Attention for Low-Performing Preschool Children

    ERIC Educational Resources Information Center

    Barnes, Marcia A.; Klein, Alice; Swank, Paul; Starkey, Prentice; McCandliss, Bruce; Flynn, Kylie; Zucker, Tricia; Huang, Chun-Wei; Fall, Anna-Mária; Roberts, Greg

    2016-01-01

    Two intervention approaches designed to address the multifaceted academic and cognitive difficulties of low-income children who enter pre-K with very low math knowledge were tested in a randomized experiment. Blocking on classroom, children who met screening criteria were assigned to a Math + Attention condition in which the Pre-Kindergarten…

  18. Evaluating the Impact of a Brief Artistic Intervention on Cardiovascular Recovery from Acute Stress

    ERIC Educational Resources Information Center

    Keogh, Katharina; Creaven, Ann-Marie

    2017-01-01

    In this study we tested whether drawing and coloring influence cardiovascular recovery and perceived stress following exposure to a stressor. In a mixed experimental design, participants (N = 62) completed an acute stress task before being randomly assigned to one of three brief activities: free-form drawing (full creative control), coloring…

  19. Media Literacy Interventions: What Makes Them Boom or Boomerang?

    ERIC Educational Resources Information Center

    Byrne, Sahara

    2009-01-01

    This study advances research on media literacy by comparing the effectiveness of two versions of a media literacy intervention over time. Participants (156 children in 4th or 5th grade) were randomly assigned to one of two treatment groups or a control group. Both treatment groups were exposed to an instructional intervention designed to reduce…

  20. Child and Parenting Outcomes after 1 Year of Educare

    ERIC Educational Resources Information Center

    Yazejian, Noreen; Bryant, Donna M.; Hans, Sydney; Horm, Diane; St. Clair, Lisa; File, Nancy; Burchinal, Margaret

    2017-01-01

    Educare is a birth to age 5 early education program designed to reduce the achievement gap between children from low-income families and their more economically advantaged peers through high-quality center-based programming and strong school-family partnerships. This study randomly assigned 239 children (< 19 months) from low-income families to…

  1. Changing Network Support for Drinking: Network Support Project 2-Year Follow-up

    ERIC Educational Resources Information Center

    Litt, Mark D.; Kadden, Ronald M.; Kabela-Cormier, Elise; Petry, Nancy M.

    2009-01-01

    The Network Support Project was designed to determine whether a treatment could lead patients to change their social network from one that supports drinking to one that supports sobriety. This study reports 2-year posttreatment outcomes. Alcohol-dependent men and women (N = 210) were randomly assigned to 1 of 3 outpatient treatment conditions:…

  2. Enhancing Learning from Different Visualizations by Self-Explanation Prompts

    ERIC Educational Resources Information Center

    Lin, Lijia; Atkinson, Robert K.

    2013-01-01

    The purpose of the two experiments was to investigate the potential effects of different types of visualizations and self-explanation prompts on learning human cardiovascular system in a multimedia environment. In Experiments 1 and 2, 70 and 44 college students were randomly assigned to one of the four conditions in a 2 × 2 factorial design with…

  3. Attitudes toward People with Disabilities Caused by Illness or Injury: Beyond Physical Impairment

    ERIC Educational Resources Information Center

    Shiloh, Shoshana; Heruti, Irit; Berkovitz, Tamar

    2011-01-01

    This study examined differences in attitudes toward and reactions to individuals with comparable disabilities caused by injury or illness. Participants were students and healthcare professionals randomly assigned to read one of eight vignettes constructed in a between-subjects, full-factorial design: 2 (illness/injury)x2 (male/female)x2…

  4. Celebration Intoxication: An Evaluation of 21St Birthday Alcohol Consumption

    ERIC Educational Resources Information Center

    Neighbors, Clayton; Spieker, Casey J.; Oster-Aaland, Laura; Lewis, Melissa A.; Bergstrom, Rochelle L.

    2005-01-01

    The authors designed this study to evaluate the prevalence and magnitude of heavy drinking among college students in celebrating their 21st birthdays and the impact of a birthday card suggesting moderation. The authors randomly assigned subjects to receive or not receive the card approximately 1 week prior to their birthday. Approximately 1 week…

  5. The Effect of Using Computer Edutainment on Developing 2nd Primary Graders' Writing Skills

    ERIC Educational Resources Information Center

    Mohammed Abdel Raheem, Azza Ashraf

    2011-01-01

    The present study attempted to examine the effect of using computer edutainment on developing 2nd graders' writing skills. The study comprised thirty-second year primary stage enrolled in Bani Hamad primary governmental school, Minia governorate. The study adopted the quasi-experimental design. Thirty participants were randomly assigned to one…

  6. Impact of dietary starch concentration formulated with two types corn silage on the performance of dairy cows

    USDA-ARS?s Scientific Manuscript database

    This study explored the effect of feeding different starch concentrations and conventional or brown midrib corn silage on the performance of lactating dairy cows. Forty-eight Holstein cows were assigned to 1 of 4 diets using a randomized complete block design with a 2-wk covariate period followed by...

  7. The Longitudinal Impact of Cognitive Speed of Processing Training on Driving Mobility

    ERIC Educational Resources Information Center

    Edwards, Jerri D.; Myers, Charlsie; Ross, Lesley A.; Roenker, Daniel L.; Cissell, Gayla M.; McLaughlin, Alexis M.; Ball, Karlene K.

    2009-01-01

    Purpose: To examine how cognitive speed of processing training affects driving mobility across a 3-year period among older drivers. Design and Methods: Older drivers with poor Useful Field of View (UFOV) test performance (indicating greater risk for subsequent at-fault crashes and mobility declines) were randomly assigned to either a speed of…

  8. Fostering First Graders' Fluency with Basic Subtraction and Larger Addition Combinations via Computer-Assisted Instruction

    ERIC Educational Resources Information Center

    Baroody, Arthur J.; Purpura, David J.; Eiland, Michael D.; Reid, Erin E.

    2014-01-01

    Achieving fluency with basic subtraction and add-with-8 or -9 combinations is difficult for primary grade children. A 9-month training experiment entailed evaluating the efficacy of software designed to promote such fluency via guided learning of reasoning strategies. Seventy-five eligible first graders were randomly assigned to one of three…

  9. Effects of Field Instructor Training on Student Competencies and the Supervisory Alliance

    ERIC Educational Resources Information Center

    Deal, Kathleen Holtz; Bennett, Susanne; Mohr, Jonathan; Hwang, Jeongha

    2011-01-01

    Objectives: This study of a field instructor (FI) training model, offered at two universities, focused on the relationship between student competencies, the supervisory alliance, and students' attachment styles. Method: The study used a pretest-posttest follow-up design of 100 randomly assigned FIs (training group = 48; control group = 52) and 64…

  10. Enhancing Learning from Dynamic and Static Visualizations by Means of Cueing

    ERIC Educational Resources Information Center

    Kuhl, Tim; Scheiter, Katharina; Gerjets, Peter

    2012-01-01

    The current study investigated whether learning from dynamic and two presentation formats for static visualizations can be enhanced by means of cueing. One hundred and fifty university students were randomly assigned to six conditions, resulting from a 2x3-design, with cueing (with/without) and type of visualization (dynamic, static-sequential,…

  11. Effects of energy deficit, dietary protein, and feeding on intracellular regulators of skeletal muscle proteolysis

    USDA-ARS?s Scientific Manuscript database

    This study examined ubiquitin-mediated proteolysis and associated gene expression in normal-23 weight adults consuming varying levels of dietary protein during short-term energy deficit. 24 Using a randomized-bock design, 32 men and 7 women were assigned to diets providing protein 25 at 0.8 (RDA), 1...

  12. Flipping the Classroom: Embedding Self-Regulated Learning Prompts in Videos

    ERIC Educational Resources Information Center

    Moos, Daniel C.; Bonde, Caitlin

    2016-01-01

    This study examined the effectiveness of embedding self-regulated learning (SRL) prompts in a video designed for the flipped class model. The sample included 32 undergraduate participants who were randomly assigned to one of two conditions: control (video) or experimental (video + SRL prompts). Prior knowledge was measured with a pre-test, SRL was…

  13. Reading Comprehension Strategy Instruction and Attribution Retraining for Secondary Students with Learning and Other Mild Disabilities

    ERIC Educational Resources Information Center

    Berkeley, Sheri; Mastropieri, Margo A.; Scruggs, Thomas E.

    2011-01-01

    A pre-post experimental design with 6-week delayed posttest was implemented to investigate the effects of reading comprehension strategy (RCS) instruction with and without attribution retraining (AR) on reading outcomes for seventh, eighth, and ninth graders with learning and other mild disabilities. Students were randomly assigned to one of three…

  14. Effect of feeding warm-season annuals with orchardgrass on ruminal fermentation and methane output in continuous culture

    USDA-ARS?s Scientific Manuscript database

    A 4-unit, dual-flow continuous culture fermentor system was used to assess nutrient digestibility, volatile fatty acids (VFA) production, bacterial protein synthesis and CH4 output of warm-season summer annual grasses. Treatments were randomly assigned to fermentors in a 4 × 4 Latin square design us...

  15. The Promise of Multimedia Stories for Kindergarten Children at Risk

    ERIC Educational Resources Information Center

    Verhallen, Maria J. A. J.; Bus, Adriana G.; de Jong, Maria T.

    2006-01-01

    This research focuses on the ability of book-based animated stories, when well designed and produced, to have positive effects on young viewers' narrative comprehension and language skills. Sixty 5-year-olds, learning Dutch as a 2nd language, were randomly assigned to 4 experimental and 2 control conditions. The children profited to some extent…

  16. Mood Effects of Alcohol and Expectancies during the Menstrual Cycle.

    ERIC Educational Resources Information Center

    Adesso, Vincent J.; Freitag, Wendy J.

    This research attempted to develop a profile of women's moods across the menstrual cycle and to determine alcohol's effects upon those moods. The Profile of Mood States was used to measure mood in 96 female college students who were heavy drinkers. Subjects were randomly assigned to the cells of the balanced placebo design with equal numbers in…

  17. Single-Case Experimental Designs in Educational Research: A Methodology for Causal Analyses in Teaching and Learning

    ERIC Educational Resources Information Center

    Plavnick, Joshua B.; Ferreri, Summer J.

    2013-01-01

    Current legislation requires educational practices be informed by science. The effort to establish educational practices supported by science has, to date, emphasized experiments with large numbers of participants who are randomly assigned to an intervention or control condition. A potential limitation of such an emphasis at the expense of other…

  18. Measuring Foundation School Effectiveness Using English Administrative Data, Survey Data and a Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Allen, Rebecca

    2013-01-01

    Apparently sophisticated school performance measures have been used to claim that giving schools autonomy from local government control improves pupil exam performance. This paper explores the extent to which inferring causality between autonomy and pupil achievement is reasonable given that pupils are not randomly assigned to schools and schools…

  19. Interventions to Reduce Distress in Adult Victims of Rape and Sexual Violence: A Systematic Review

    ERIC Educational Resources Information Center

    Regehr, Cheryl; Alaggia, Ramona; Dennis, Jane; Pitts, Annabel; Saini, Michael

    2013-01-01

    Objectives: This article presents a systematic evaluation of the effectiveness of interventions aimed at reducing distress in adult victims of rape and sexual violence. Method: Studies were eligible for the review if the assignment of study participants to experimental or control groups was by random allocation or parallel cohort design. Results:…

  20. Treatment Assignment Guesses by Study Participants in a Double-Blind Dose Escalation Clinical Trial of Saw Palmetto

    PubMed Central

    Moore, Page; Kusek, John; Barry, Michael

    2014-01-01

    Abstract Objectives: This report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM). Design: Participants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. Settings: The study was conducted at 11 clinical centers in North America. Participants: Study participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). Outcome measures: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment. Results: For participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto. Conclusions: Blinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto. PMID:23383975

  1. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design.

    PubMed

    Rush, A John; Fava, Maurizio; Wisniewski, Stephen R; Lavori, Philip W; Trivedi, Madhukar H; Sackeim, Harold A; Thase, Michael E; Nierenberg, Andrew A; Quitkin, Frederic M; Kashner, T Michael; Kupfer, David J; Rosenbaum, Jerrold F; Alpert, Jonathan; Stewart, Jonathan W; McGrath, Patrick J; Biggs, Melanie M; Shores-Wilson, Kathy; Lebowitz, Barry D; Ritz, Louise; Niederehe, George

    2004-02-01

    STAR*D is a multisite, prospective, randomized, multistep clinical trial of outpatients with nonpsychotic major depressive disorder. The study compares various treatment options for those who do not attain a satisfactory response with citalopram, a selective serotonin reuptake inhibitor antidepressant. The study enrolls 4000 adults (ages 18-75) from both primary and specialty care practices who have not had either a prior inadequate response or clear-cut intolerance to a robust trial of protocol treatments during the current major depressive episode. After receiving citalopram (level 1), participants without sufficient symptomatic benefit are eligible for randomization to level 2 treatments, which entail four switch options (sertraline, bupropion, venlafaxine, cognitive therapy) and three citalopram augment options (bupropion, buspirone, cognitive therapy). Those who receive cognitive therapy (switch or augment options) at level 2 without sufficient improvement are eligible for randomization to one of two level 2A switch options (venlafaxine or bupropion). Level 2 and 2A participants are eligible for random assignment to two switch options (mirtazapine or nortriptyline) and to two augment options (lithium or thyroid hormone) added to the primary antidepressant (citalopram, bupropion, sertraline, or venlafaxine) (level 3). Those without sufficient improvement at level 3 are eligible for level 4 random assignment to one of two switch options (tranylcypromine or the combination of mirtazapine and venlafaxine). The primary outcome is the clinician-rated, 17-item Hamilton Rating Scale for Depression, administered at entry and exit from each treatment level through telephone interviews by assessors masked to treatment assignments. Secondary outcomes include self-reported depressive symptoms, physical and mental function, side-effect burden, client satisfaction, and health care utilization and cost. Participants with an adequate symptomatic response may enter the 12-month naturalistic follow-up phase with brief monthly and more complete quarterly assessments.

  2. HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.

    PubMed

    Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

    2015-12-15

    Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). Outpatient HIV clinics. Treatment-experienced patients with HIV infection and viral resistance. Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Unblinded study design, and the study may not be applicable to resource-poor settings. Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

  3. Pre-discharge stress echocardiography and exercise ECG for risk stratification after uncomplicated acute myocardial infarction: results of the COSTAMI-II (cost of strategies after myocardial infarction) trial

    PubMed Central

    Desideri, A; Fioretti, P M; Cortigiani, L; Trocino, G; Astarita, C; Gregori, D; Bax, J; Velasco, J; Celegon, L; Bigi, R; Pirelli, S; Picano, E

    2005-01-01

    Objective: To compare in a prospective, randomised, multicentre trial the relative merits of pre-discharge exercise ECG and early pharmacological stress echocardiography concerning risk stratification and costs of treating patients with uncomplicated acute myocardial infarction. Design: 262 patients from six participating centres with a recent uncomplicated myocardial infarction were randomly assigned to early (day 3–5) pharmacological stress echocardiography (n  =  132) or conventional pre-discharge (day 7–9) maximum symptom limited exercise ECG (n  =  130). Results: No complication occurred during either stress echocardiography or exercise ECG. At one year follow up there were 26 events (1 death, 5 non-fatal reinfarctions, 20 patients with unstable angina requiring hospitalisation) in patients randomly assigned to early stress echocardiography and 18 events (2 reinfarctions, 16 unstable angina requiring hospitalisation) in the group randomly assigned to exercise ECG (not significant). The negative predictive value was 92% for stress echocardiography and 88% for exercise ECG (not significant). Total costs of the two strategies were similar (not significant). Conclusion: Early pharmacological stress echocardiography and conventional pre-discharge symptom limited exercise ECG have similar clinical outcome and costs after uncomplicated infarction. Early pharmacological stress echocardiography should be considered a valid alternative even for patients with interpretable baseline ECG who can exercise. PMID:15657220

  4. Design, rationale, and baseline characteristics of a cluster randomized controlled trial of pay for performance for hypertension treatment: study protocol.

    PubMed

    Petersen, Laura A; Urech, Tracy; Simpson, Kate; Pietz, Kenneth; Hysong, Sylvia J; Profit, Jochen; Conrad, Douglas; Dudley, R Adams; Lutschg, Meghan Z; Petzel, Robert; Woodard, Lechauncy D

    2011-10-03

    Despite compelling evidence of the benefits of treatment and well-accepted guidelines for treatment, hypertension is controlled in less than one-half of United States citizens. This randomized controlled trial tests whether explicit financial incentives promote the translation of guideline-recommended care for hypertension into clinical practice and improve blood pressure (BP) control in the primary care setting. Using constrained randomization, we assigned 12 Veterans Affairs hospital outpatient clinics to four study arms: physician-level incentive; group-level incentive; combination of physician and group incentives; and no incentives (control). All participants at the hospital (cluster) were assigned to the same study arm. We enrolled 83 full-time primary care physicians and 42 non-physician personnel. The intervention consisted of an educational session about guideline-recommended care for hypertension, five audit and feedback reports, and five disbursements of incentive payments. Incentive payments rewarded participants for chart-documented use of guideline-recommended antihypertensive medications, BP control, and appropriate responses to uncontrolled BP during a prior four-month performance period over the 20-month intervention. To identify potential unintended consequences of the incentives, the study team interviewed study participants, as well as non-participant primary care personnel and leadership at study sites. Chart reviews included data collection on quality measures not related to hypertension. To evaluate the persistence of the effect of the incentives, the study design includes a washout period. We briefly describe the rationale for the interventions being studied, as well as the major design choices. Rigorous research designs such as the one described here are necessary to determine whether performance-based payment arrangements such as financial incentives result in meaningful quality improvements. http://www.clinicaltrials.govNCT00302718.

  5. Summer School Effects in a Randomized Field Trial

    ERIC Educational Resources Information Center

    Zvoch, Keith; Stevens, Joseph J.

    2013-01-01

    This field-based randomized trial examined the effect of assignment to and participation in summer school for two moderately at-risk samples of struggling readers. Application of multiple regression models to difference scores capturing the change in summer reading fluency revealed that kindergarten students randomly assigned to summer school…

  6. Implications of clinical trial design on sample size requirements.

    PubMed

    Leon, Andrew C

    2008-07-01

    The primary goal in designing a randomized controlled clinical trial (RCT) is to minimize bias in the estimate of treatment effect. Randomized group assignment, double-blinded assessments, and control or comparison groups reduce the risk of bias. The design must also provide sufficient statistical power to detect a clinically meaningful treatment effect and maintain a nominal level of type I error. An attempt to integrate neurocognitive science into an RCT poses additional challenges. Two particularly relevant aspects of such a design often receive insufficient attention in an RCT. Multiple outcomes inflate type I error, and an unreliable assessment process introduces bias and reduces statistical power. Here we describe how both unreliability and multiple outcomes can increase the study costs and duration and reduce the feasibility of the study. The objective of this article is to consider strategies that overcome the problems of unreliability and multiplicity.

  7. A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation.

    PubMed

    Lifson, Alan R; Workneh, Sale; Hailemichael, Abera; MacLehose, Richard F; Horvath, Keith J; Hilk, Rose; Fabian, Lindsey; Sites, Anne; Shenie, Tibebe

    2018-06-01

    Although HIV therapy is delivered to millions globally, treatment default (especially soon after entering care) remains a challenge. Community health workers (CHWs) can provide many services for people with HIV, including in rural and resource-limited settings. We designed and implemented a 32 site community randomized trial throughout southern Ethiopia to assess an intervention using CHWs to improve retention in HIV care. Sixteen district hospital and 16 local health center HIV clinics were randomized 1:1 to be intervention or control sites. From each site, we enrolled adults newly entering HIV care. Participants at intervention sites were assigned a CHW who provided: HIV and health education; counseling and social support; and facilitated communication with HIV clinics. All participants are followed through three years with annual health surveys, plus HIV clinic record abstraction including clinic visit dates. CHWs record operational data about their client contacts. 1799 HIV patients meeting inclusion criteria were enrolled and randomized: 59% were female, median age = 32 years, median CD4 + count = 263 cells/mm 3 , and 41% were WHO Stage III or IV. A major enrollment challenge was fewer new HIV patients initiating care at participating sites due to shortage of HIV test kits. At intervention sites, 71 CHWs were hired, trained and assigned to clients. In meeting with clients, CHWs needed to accommodate to various challenges, including HIV stigma, distance, and clients lacking cell phones. This randomized community HIV trial using CHWs in a resource-limited setting was successfully launched, but required flexibility to adapt to unforeseen challenges.

  8. The Role of Access to Head Start and Quality Ratings for Spanish-Speaking Dual Language Learners’ (DLLs) Participation in Early Childhood Education

    PubMed Central

    2014-01-01

    Data from the Head Start Impact Study (N = 4,442) were used to test for differences between Spanish-speaking Dual Language Learners (DLLs) and monolingual English-speaking children in: (1) Head Start attendance rates when randomly assigned admission; and (2) quality ratings of other early childhood education (ECE) programs attended when not randomly assigned admission to Head Start. Logistic regressions showed that Spanish-speaking DLL children randomly assigned a spot in Head Start were more likely than monolingual-English learners to attend. Further, Spanish-speaking DLLs not randomly assigned a spot in Head Start were more likely to attend higher-quality ECE centers than non-DLL children. Policy implications are discussed, suggesting that, if given access, Spanish-speaking DLL families will take advantage of quality ECE programs. PMID:25018585

  9. Research Methods in Healthcare Epidemiology and Antimicrobial Stewardship-Quasi-Experimental Designs.

    PubMed

    Schweizer, Marin L; Braun, Barbara I; Milstone, Aaron M

    2016-10-01

    Quasi-experimental studies evaluate the association between an intervention and an outcome using experiments in which the intervention is not randomly assigned. Quasi-experimental studies are often used to evaluate rapid responses to outbreaks or other patient safety problems requiring prompt, nonrandomized interventions. Quasi-experimental studies can be categorized into 3 major types: interrupted time-series designs, designs with control groups, and designs without control groups. This methods paper highlights key considerations for quasi-experimental studies in healthcare epidemiology and antimicrobial stewardship, including study design and analytic approaches to avoid selection bias and other common pitfalls of quasi-experimental studies. Infect Control Hosp Epidemiol 2016;1-6.

  10. Short communication: effect of oilseed supplementation of an herbage diet on ruminal fermentation in continuous culture

    USDA-ARS?s Scientific Manuscript database

    A four-unit continuous culture fermentor system was used to evaluate the effects of oilseed supplementation of an herbage-based diet on ruminal fermentation. Treatments were randomly assigned to fermentors in a 4 x 4 Latin square design with 7 d for diet adaptation and 3 d for data and sample collec...

  11. The Transitory Phase to the Attainment of Self-Regulatory Skill in Mathematical Problem Solving

    ERIC Educational Resources Information Center

    Lazakidou, G.; Paraskeva, F.; Retalis, S.

    2007-01-01

    Three phases of development of self-regulatory skill in the domain of mathematical problem solving were designed to examine students' behaviour and the effects on their problem solving ability. Forty-eight Grade 4 students (10 year olds) participated in this pilot study. The students were randomly assigned to one of three groups, each representing…

  12. Thermal equilibrium of Nellore cattle in tropical conditions: an investigation of circadian pattern

    USDA-ARS?s Scientific Manuscript database

    The aim of this work was to evaluate the diurnal patterns of physiological responses and the thermal regulation of adult Nellore bulls. Six 30-mo-old Nellore bulls (669 ± 65 kg BW) were randomly assigned to four 6-h periods in a Latin Square design such that measurements of each animal cover a 24-h ...

  13. Effect of Low-Carbohydrate Claims on Consumer Perceptions about Food Products' Healthfulness and Helpfulness for Weight Management

    ERIC Educational Resources Information Center

    Labiner-Wolfe, Judith; Lin, Chung-Tung Jordan; Verrill, Linda

    2010-01-01

    Objective: Evaluate effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management. Design: Experiment in which participants were randomly assigned 1 of 12 front-of-package claim conditions on bread or a frozen dinner. Seven of the 12 conditions also included Nutrition Facts (NF)…

  14. Enhancing Building, Conversation, and Learning through Caregiver-Child Interactions in a Children's Museum

    ERIC Educational Resources Information Center

    Benjamin, Nora; Haden, Catherine A.; Wilkerson, Erin

    2010-01-01

    The authors adapted an experimental design to examine effects of instruction prior to entry into a children's museum exhibit on caregiver-child interactions and children's learning. One hundred twenty-one children (mean age = 6.6 years) and their caregivers were randomly assigned to 1 of 5 conditions that varied according to what, if any,…

  15. The Effects of Handwriting Instruction on Reading for Students in Grades 1 and 2

    ERIC Educational Resources Information Center

    Stroik, Linda R.

    2016-01-01

    The purpose of this quantitative quasi-experimental group comparison study using a repeated measures comparison group design with random assignment of subjects to groups was to investigate the effects of handwriting instruction on reading progress for learners in grade 1 and grade 2. At three points in time, the number of words each student read…

  16. The Effects of a Flipped Classroom Model of Instruction on Students' Performance and Attitudes towards Chemistry

    ERIC Educational Resources Information Center

    Olakanmi, Eunice Eyitayo

    2017-01-01

    This study establishes the effects of a flipped classroom model of instruction on academic performance and attitudes of 66 first-year secondary school students towards chemistry. A pre-test and post-test experimental design was employed to assign students randomly into either the experimental or control group. In order to assess the suitability of…

  17. Web-Based Tutoring of the Structure Strategy with or without Elaborated Feedback or Choice for Fifth- and Seventh-Grade Readers

    ERIC Educational Resources Information Center

    Meyer, Bonnie J. F.; Wijekumar, Kay; Middlemiss, Wendy; Higley, Kelli; Lei, Pui-Wa; Meier, Catherine; Spielvogel, James

    2010-01-01

    This study investigated the effects of different versions of Web-based instruction focused on text structure on fifth- and seventh-grade students' reading comprehension. Stratified random assignment was employed in a two-factor experiment embedded within a pretest and multiple posttests design (immediate and four-month delayed posttests). The two…

  18. The Anger Management Project: A Group Intervention for Anger in People with Physical and Multiple Disabilities

    ERIC Educational Resources Information Center

    Hagiliassis, Nick; Gulbenkoglu, Hrepsime; Di Marco, Mark; Young, Suzanne; Hudson, Alan

    2005-01-01

    Background: This paper describes the evaluation of a group program designed specifically to meet the anger management needs of a group of individuals with various levels of intellectual disability and/or complex communication needs. Method: Twenty-nine individuals were randomly assigned to an intervention group or a waiting-list comparison group.…

  19. Assessing the Effectiveness of a 3-D Instructional Game on Improving Mathematics Achievement and Motivation of Middle School Students

    ERIC Educational Resources Information Center

    Bai, Haiyan; Pan, Wei; Hirumi, Astusi; Kebritchi, Mansureh

    2012-01-01

    This research study assessed the effectiveness of a three-dimensional mathematics game, DimensionM, through a pretest-posttest control group quasi-experimental design. Participants consisted of 437 eighth graders. The classrooms were randomly assigned either to the treatment group that utilized DimensionM as a supplement to regular classroom…

  20. Effects of long versus short duration transportation on body composition on Brahman x Hereford calves

    USDA-ARS?s Scientific Manuscript database

    This study was designed to determine the effects of transport duration on body composition of Brahman x Hereford calves. Calves (8.5±0.4 mo of age) from Overton, TX, were blocked by sex (n=18 steers; n=14 heifers), BW, and temperament score and were randomly assigned to a transportation treatment of...

  1. Multiple-Component Remediation for Developmental Reading Disabilities: IQ, Socioeconomic Status, and Race as Factors in Remedial Outcome

    ERIC Educational Resources Information Center

    Morris, Robin D.; Lovett, Maureen W.; Wolf, Maryanne; Sevcik, Rose A.; Steinbach, Karen A.; Frijters, Jan C.; Shapiro, Marla B.

    2012-01-01

    Results from a controlled evaluation of remedial reading interventions are reported: 279 young disabled readers were randomly assigned to a program according to a 2 x 2 x 2 factorial design (IQ, socioeconomic status [SES], and race). The effectiveness of two multiple-component intervention programs for children with reading disabilities (PHAB +…

  2. Daughters and Mothers Exercising Together (DAMET): Effects of Home- and University-Based Interventions on Physical Activity Behavior and Family Relations

    ERIC Educational Resources Information Center

    Ransdell, Lynda B.; Eastep, Eric; Taylor, Alison; Oakland, Darcie; Schmidt, Jenny; Moyer-Mileur, Laurie; Shultz, Barry

    2003-01-01

    This study compared two interventions in terms of impact on physical activity participation and mother-daughter relations. Previously sedentary mothers and daughters (N = 34) were randomly assigned to a 12-week university-or home-based physical activity group. Program activities were designed using focus group information, aspects of the social…

  3. Impact Evaluation of the U.S. Department of Education's Student Mentoring Program. Final Report. NCEE 2009-4047

    ERIC Educational Resources Information Center

    Bernstein, Lawrence; Rappaport, Catherine Dun; Olsho, Lauren; Hunt, Dana; Levin, Marjorie

    2009-01-01

    This report summarizes the findings from a national evaluation of mentoring programs funded under the U.S. Department of Education's Student Mentoring Program. The impact evaluation used an experimental design in which students were randomly assigned to a treatment or control group. Thirty-two purposively selected School Mentoring Programs and…

  4. THE EFFECT OF WORD ASSOCIATIONS ON THE RECOGNITION OF FLASHED WORDS.

    ERIC Educational Resources Information Center

    SAMUELS, S. JAY

    THE HYPOTHESIS THAT WHEN ASSOCIATED PAIRS OF WORDS ARE PRESENTED, SPEED OF RECOGNITION WILL BE FASTER THAN WHEN NONASSOCIATED WORD PAIRS ARE PRESENTED OR WHEN A TARGET WORD IS PRESENTED BY ITSELF WAS TESTED. TWENTY UNIVERSITY STUDENTS, INITIALLY SCREENED FOR VISION, WERE ASSIGNED RANDOMLY TO ROWS OF A 5 X 5 REPEATED-MEASURES LATIN SQUARE DESIGN.…

  5. Do Students Using Electronic Books Display Different Reading Comprehension and Motivation Levels than Students Using Traditional Print Books?

    ERIC Educational Resources Information Center

    Wells, Casey L.

    2012-01-01

    The effect of electronic books on the reading comprehension of middle and high school students was examined using an experimental posttest-only control-group design. A convenience sample of 140 randomly assigned middle and high school English students at an independent school in eastern North Carolina participated. Half of the students used…

  6. Effects of D-a-tocopherol and dietary energy on growth and health of preruminant dairy calves

    USDA-ARS?s Scientific Manuscript database

    To observe the effects of supplemental dietary d-a-tocopherol in relation to dietary energy on growth and immune status in dairy calves, 32 newborn Holstein bull calves were assigned to 1 of 4 treatments for 5 weeks in a 2x2 factorial randomized complete block, split-plot design. Calves received mod...

  7. Effects of d-a-Tocopherol and Dietary Energy on Growth and Health of Pre-ruminant Dairy Calves

    USDA-ARS?s Scientific Manuscript database

    To observe the effects of supplemental dietary d-a-tocopherol in relation to dietary energy on growth and immune status in dairy calves, 32 newborn Holstein bull calves were assigned to 1 of 4 treatments for 5 wks in a 2x2 factorial randomized complete block, split-plot design. Calves received moder...

  8. Comparing the Effectiveness of On-Line versus In-Person Caregiver Education and Training for Behavioral Regulation in Families of Children with FASD

    ERIC Educational Resources Information Center

    Kable, Julie A.; Coles, Claire D.; Strickland, Dorothy; Taddeo, Elles

    2012-01-01

    Different formats for delivering parent education designed to improve the functioning of children with FASD were evaluated. Participants were randomly assigned to a treatment condition: (1) Community Standard/Informational Packet, (2) Group Workshops, and (3) Internet Training. Overall satisfaction was high for all formats but the Workshop group…

  9. Technology and Teaching: Searching under Cups for Clues about Memory--An Online Demonstration

    ERIC Educational Resources Information Center

    Kahan, Todd A.; Mathis, Katherine M.

    2007-01-01

    An online demonstration, designed to enhance comprehension of Sternberg's (1966) short-term memory scanning task, involved rapidly searching under virtual cups for a ball. We randomly assigned students to 1 of 3 groups, all of whom read the same textbook description of Sternberg's work: A demonstration group used 3 search methods to look for balls…

  10. Identity Entrepreneurship and the Consequences of Identity Failure: The Dynamics of Leadership in the BBC Prison Study

    ERIC Educational Resources Information Center

    Haslam, S. Alexander; Reicher, Stephen

    2007-01-01

    The BBC Prison Study was an experimental case study in which participants were randomly assigned to groups as prisoners or guards. This paper examines the impact of interventions designed to increase prisoners' sense of shared social identity on processes of leadership. It presents psychometric, behavioral, and observational data which support the…

  11. Effects of Four Instructional Sequences on Application and Transfer. IDD&E Working Paper No. 12

    ERIC Educational Resources Information Center

    Chao, Chun-I; And Others

    Using the Component Display Theory as an analyzing tool, this study compared the effects of expository and discovery methods of instruction on two learning outcomes, application and transfer. One hundred ninth grade students in each of four earth science classes were randomly assigned to five groups--four experimental groups designed to test four…

  12. An Investigation of the Effects of a Graphic Organizer in an Online Serious Game on Learning Outcomes and Attitudinal Perceptions

    ERIC Educational Resources Information Center

    Cheon, Jongpil; Chung, Sungwon; Song, Jaeki; Kim, Yongjin

    2015-01-01

    A serious game, which is designed for learning purposes rather than recreational purposes, has been applied for digital game-based Learning. This study investigated the effects of graphic organizers in a serious game, "The Transistor", on learning outcomes and attitudinal perceptions. A total of 99 participants were randomly assigned to…

  13. Interactive Book Reading: Promoting Emergent Literacy Skills in Preschool Children through a Parent Training Program

    ERIC Educational Resources Information Center

    Woods, Latasha S.

    2017-01-01

    This pilot study examined the effects of the Interactive Book Reading at Home (IBR; Wasik, 2009) parent training program on the emergent literacy skills of preschool children and parent beliefs about reading. A quasi-experimental, pretest and posttest design was utilized. Twenty parent-child dyads were randomly assigned to a control or treatment…

  14. Elaborative Talk during and after an Event: Conversational Style Influences Children's Memory Reports

    ERIC Educational Resources Information Center

    Hedrick, Amy M.; Haden, Catherine A.; Ornstein, Peter A.

    2009-01-01

    An experimental design was utilized to examine the effects of elaborative talk during and/or after an event on children's event memory reports. Sixty preschoolers were assigned randomly to one of four conditions that varied according to a researcher's use of high- or low- elaborative during- and/or post-event talk about a camping event. In a…

  15. Academic Incentives for Students Can Increase Participation in and Effectiveness of a Physical Activity Program

    ERIC Educational Resources Information Center

    DeVahl, Julie; King, Richard; Williamson, Jon W.

    2005-01-01

    The authors sought to determine whether a greater academic incentive would improve the effectiveness and student adherence to a 12-week voluntary exercise program designed to decrease students' percentage of body fat. They randomly assigned 210 students to 1 of 2 groups with different academic reward structures. The group with the greater reward…

  16. Teacher and Student Thoughts on Effectiveness of Cooperative Learning in Geography Teaching

    ERIC Educational Resources Information Center

    Kus, Metin; Filiz, Erkan; Altun, Sertel

    2014-01-01

    The aim of this study was to determine teachers' and students?' opinions on the effectiveness of cooperative learning. This study was conducted in Istanbul Lycee and it had a qualitative research design. The participant of the study assigned randomly among ninth grade students who were studying in Istanbul Lycee in the year of 2012 to 2013. Among…

  17. Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. NCEE 2014-4019

    ERIC Educational Resources Information Center

    Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

    2014-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  18. Evaluation of the Teacher Incentive Fund: Implementation and Impacts of Pay-for-Performance after Two Years. NCEE 2015-4020

    ERIC Educational Resources Information Center

    Chiang, Hanley; Wellington, Alison; Hallgren, Kristin; Speroni, Cecilia; Herrmann, Mariesa; Glazerman, Steven; Constantine, Jill

    2015-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  19. Effect of Self Regulated Learning Approach on Junior Secondary School Students' Achievement in Basic Science

    ERIC Educational Resources Information Center

    Nwafor, Chika E.; Obodo, Abigail Chikaodinaka; Okafor, Gabriel

    2015-01-01

    This study explored the effect of self-regulated learning approach on junior secondary school students' achievement in basic science. Quasi-experimental design was used for the study.Two co-educational schools were drawn for the study through simple random sampling technique. One school was assigned to the treatment group while the other was…

  20. The Effects of an Independent Laboratory Investigation on the Critical Thinking Ability and Scientific Attitude of Students in a General Microbiology Class.

    ERIC Educational Resources Information Center

    Norton, Sylvia; And Others

    To demonstrate that properly designed laboratory instruction does provide affective and higher order learning benefits, an experiment was carried out in two replications. The subjects were 80 students enrolled in General Microbiology at Wallace Community College, Alabama. Students were randomly assigned to experimental and control groups. The…

  1. Exercise training for depressed older adults with Alzheimer's disease.

    PubMed

    Williams, C L; Tappen, R M

    2008-01-01

    The purpose of this study was to compare the effects of 16 weeks of a comprehensive exercise routine to supervised walking and social conversation on depression in nursing home residents with Alzheimer's disease (AD). This study was a three-group, repeated-measures design with random assignment to treatment group. Forty-five nursing home residents with moderate to severe AD were randomly assigned to a 16-week programme of comprehensive exercise, supervised walking or social conversation. Raters were blinded to treatment group assignment. Major outcome variables were depression measured by the Cornell Scale for Depression in Dementia, mood measured by the Dementia Mood Assessment Scale and the Alzheimer's Mood Scale, and affect measured by the Observed Affect Scale. Depression was reduced in all three groups with some evidence of superior benefit from exercise. Depression is a common problem with serious and costly consequences for nursing home residents with AD. Exercise as a behavioural approach to treatment of depression in nursing home residents with severe AD evidenced a clear benefit to participants in this study. More research is needed to clarify the relative benefits of different types of exercise in conjunction with or without pharmacological intervention.

  2. Effectiveness of Placebo Therapy for Maintaining Masking in a Clinical Trial of Vergence/Accommodative Therapy

    PubMed Central

    Kulp, Marjean; Mitchell, G. Lynn; Borsting, Eric; Scheiman, Mitchell; Cotter, Susan; Rouse, Michael; Tamkins, Susanna; Mohney, Brian G.; Toole, Andrew; Reuter, Kathleen

    2009-01-01

    Purpose To evaluate the effectiveness of the Convergence Insufficiency Treatment Trial (CITT) placebo therapy program in maintaining masking of patients randomized to the office-based treatment arms, determine whether demographic variables affect masking, and determine whether perception of assigned treatment group was associated with treatment outcome or adherence to treatment. Methods Patients (n = 221, ages, 9–17 years) were randomized to one of four treatment groups, two of which were office-based and masked to treatment (n = 114). The placebo therapy program was designed to appear to be real vergence/accommodative therapy, without stimulating vergence, accommodation, or fine saccades (beyond levels of daily visual activities). After treatment, patients in the office-based groups were asked whether they thought they had received real or placebo therapy and how confident they were in their answers. Results Ninety-three percent of patients assigned to real therapy and 85% assigned to placebo therapy thought they were in the real therapy group (P = 0.17). No significant differences were found between the two groups in adherence to the therapy (P ≥ 0.22 for all comparisons). The percentage of patients who thought they were assigned to real therapy did not differ by age, sex, race, or ethnicity (P > 0.30 for all comparisons). No association was found between patients' perception of group assignment and symptoms or signs at outcome (P ≥ 0.38 for all comparisons). Conclusions The CITT placebo therapy program was effective in maintaining patient masking in this study and therefore may have potential for use in future clinical trials using vergence/accommodative therapy. Masking was not affected by demographic variables. Perception of group assignment was not related to symptoms or signs at outcome (ClinicalTrials.gov number, NCT00338611). PMID:19151384

  3. Housing First improves subjective quality of life among homeless adults with mental illness: 12-month findings from a randomized controlled trial in Vancouver, British Columbia.

    PubMed

    Patterson, Michelle; Moniruzzaman, Akm; Palepu, Anita; Zabkiewicz, Denise; Frankish, Charles J; Krausz, Michael; Somers, Julian M

    2013-08-01

    This study used an experimental design to examine longitudinal changes in subjective quality of life (QoL) among homeless adults with mental illness after assignment to different types of supported housing or to treatment as usual (TAU, no housing or supports through the study). We hypothesized that subjective QoL would improve over time among participants assigned to supported housing as compared to TAU, regardless of the type of supported housing received or participants' level of need. Participants (n = 497) were stratified by level of need ("high" or "moderate") and randomly assigned to Housing First (HF) in scattered-site apartments, HF in a congregate setting (high needs only), or TAU. Linear mixed-effects regression was used to model the association between study arm and self-reported QoL at baseline and at 6 and 12 months post-baseline by need level. Based on the adjusted overall score on the QoL measure, participants randomized to HF reported significantly greater overall QoL as compared to TAU, regardless of need level or type of supported housing at both 6 and 12 months post-baseline. Scores on the safety and living situation subscales were significantly greater for both high and moderate need participants assigned to supported housing regardless of type at both 6 and 12 months post-baseline as compared to TAU. Despite multiple health and social challenges faced by homeless individuals with mental illness, HF in both scattered-site and congregate models results in significantly greater perceived QoL as compared to individuals who do not receive HF even after a relatively short period of time.

  4. A randomized controlled trial of contingency management for psycho-stimulant use in community mental health outpatients with co-occurring serious mental illness

    PubMed Central

    McDonell, Michael G.; Srebnik, Debra; Angelo, Frank; McPherson, Sterling; Lowe, Jessica M.; Sugar, Andrea; Short, Robert A.; Roll, John M.; Ries, Richard K.

    2014-01-01

    Objective The primary objective of this study was to determine if contingency management was associated with increased stimulant drug abstinence in community mental health outpatients with serious mental illness and stimulant dependence. Secondary objectives were to determine if contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV-risk behavior, and inpatient service utilization. Method A randomized controlled design compared outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomized to three months of contingency management for stimulant abstinence plus treatment-as-usual or treatment-as-usual with reinforcement for study participation only. Urine drug tests, self-report, clinician-report, and service utilization outcomes were assessed during three-month treatment and three-month follow-up periods. Results While participants in the contingency management condition were less likely to complete the treatment period (n=38; 42%) than those assigned to the control condition (n=55; 65%), X2(1)=9.8, p=0.02; those assigned to the contingency management condition were 2.4 (CI=1.9-3.0) times more likely to submit a stimulant-negative urine test during treatment. Participants assigned to contingency management experienced significantly lower levels of alcohol use, injection drug use, psychiatric symptoms, and were five times less likely than those assigned to the control condition to be admitted for psychiatric hospitalization, X2(1)=5.4, p=0.02. Contingency management participants reported significantly fewer days of stimulant drug use, relative to controls during the three-month follow-up. Conclusions When added to treatment-as-usual, contingency management is associated with large reductions in stimulant, injection drug, and alcohol use. Reductions in psychiatric symptoms and hospitalizations were important secondary benefits. PMID:23138961

  5. Randomized trial of the effect of drug presentation on asthma outcomes: the American Lung Association Asthma Clinical Research Centers.

    PubMed

    Wise, Robert A; Bartlett, Susan J; Brown, Ellen D; Castro, Mario; Cohen, Rubin; Holbrook, Janet T; Irvin, Charles G; Rand, Cynthia S; Sockrider, Marianna M; Sugar, Elizabeth A

    2009-09-01

    Information that enhances expectations about drug effectiveness improves the response to placebos for pain. Although asthma symptoms often improve with placebo, it is not known whether the response to placebo or active treatment can be augmented by increasing expectation of benefit. The study objective was to determine whether response to placebo or a leukotriene antagonist (montelukast) can be augmented by messages that increase expectation of benefit. A randomized 20-center controlled trial enrolled 601 asthmatic patients with poor symptom control who were assigned to one of 5 study groups. Participants were randomly assigned to one of 4 treatment groups in a factorial design (ie, placebo with enhanced messages, placebo with neutral messages, montelukast with enhanced messages, or montelukast with neutral messages) or to usual care. Assignment to study drug was double masked, assignment to message content was single masked, and usual care was not masked. The enhanced message aimed to increase expectation of benefit from the drug. The primary outcome was mean change in daily peak flow over 4 weeks. Secondary outcomes included lung function and asthma symptom control. Peak flow and other lung function measures were not improved in participants assigned to the enhanced message groups versus the neutral messages groups for either montelukast or placebo; no differences were noted between the neutral placebo and usual care groups. Placebo-treated participants had improved asthma control with the enhanced message but not montelukast-treated participants; the neutral placebo group did have improved asthma control compared with the usual care group after adjusting for baseline difference. Headaches were more common in participants provided messages that mentioned headache as a montelukast side effect. Optimistic drug presentation augments the placebo effect for patient-reported outcomes (asthma control) but not lung function. However, the effect of montelukast was not enhanced by optimistic messages regarding treatment effectiveness.

  6. A Controlled Evaluation of Family Behavior Therapy in Concurrent Child Neglect and Drug Abuse

    PubMed Central

    Donohue, Brad; Azrin, Nathan H.; Bradshaw, Kelsey; Van Hasselt, Vincent B.; Cross, Chad L.; Urgelles, Jessica; Romero, Valerie; Hill, Heather H.; Allen, Daniel N.

    2015-01-01

    Objective Approximately 50% of Child Protective Service (CPS) referrals abuse drugs; yet, existing treatment studies in this population have been limited to case examinations. Therefore, a family-based behavioral therapy was evaluated in mothers referred from CPS for child neglect and drug abuse utilizing a controlled experimental design. Method 72 mothers evidencing drug abuse or dependence and child neglect were randomly assigned to Family Behavior Therapy (FBT) or Treatment as Usual (TAU). Participants were assessed at baseline, 6- month-, and 10-month post-randomization. Results As hypothesized, intent-to-treat repeated measures analyses revealed mothers referred for child neglect not due to their children being exposed to illicit drugs demonstrated better outcomes in child maltreatment potential from baseline to 6- and 10-month post-randomization assessments when assigned to FBT, as compared with TAU mothers and FBT mothers who were referred due to child drug exposure. Similar results occurred for hard drug use from baseline to 6- and 10-month post-randomization. However, TAU mothers referred due to child drug exposure were also found to decrease their hard drug use more than TAU mothers of non-drug exposed children and FBT mothers of drug exposed children at 6- and 10-month post-randomization. Although effect sizes for mothers assigned to FBT were slightly larger for marijuana use than TAU (medium vs. large), these differences were not statistically significant. Specific to secondary outcomes, mothers in FBT, relative to TAU, increased time employed from baseline to 6- and 10-month post-randomization. Mothers in FBT, compared to TAU, also decreased HIV risk from baseline to 6-month post-randomization. There were no differences in outcome between FBT and TAU for number of days children were in CPS custody and alcohol intoxication, although FBT mothers demonstrated marginal decreases (p = .058) in incarceration from baseline to 6-month post-randomization relative to TAU mothers. Conclusion Family-based behavioral treatment programs offer promise in mothers who have been reported to CPS for concurrent substance abuse and child neglect of their children. However, continued intervention development in this population is very much needed. PMID:24841866

  7. Design of a factorial experiment with randomization restrictions to assess medical device performance on vascular tissue.

    PubMed

    Diestelkamp, Wiebke S; Krane, Carissa M; Pinnell, Margaret F

    2011-05-20

    Energy-based surgical scalpels are designed to efficiently transect and seal blood vessels using thermal energy to promote protein denaturation and coagulation. Assessment and design improvement of ultrasonic scalpel performance relies on both in vivo and ex vivo testing. The objective of this work was to design and implement a robust, experimental test matrix with randomization restrictions and predictive statistical power, which allowed for identification of those experimental variables that may affect the quality of the seal obtained ex vivo. The design of the experiment included three factors: temperature (two levels); the type of solution used to perfuse the artery during transection (three types); and artery type (two types) resulting in a total of twelve possible treatment combinations. Burst pressures of porcine carotid and renal arteries sealed ex vivo were assigned as the response variable. The experimental test matrix was designed and carried out as a split-plot experiment in order to assess the contributions of several variables and their interactions while accounting for randomization restrictions present in the experimental setup. The statistical software package SAS was utilized and PROC MIXED was used to account for the randomization restrictions in the split-plot design. The combination of temperature, solution, and vessel type had a statistically significant impact on seal quality. The design and implementation of a split-plot experimental test-matrix provided a mechanism for addressing the existing technical randomization restrictions of ex vivo ultrasonic scalpel performance testing, while preserving the ability to examine the potential effects of independent factors or variables. This method for generating the experimental design and the statistical analyses of the resulting data are adaptable to a wide variety of experimental problems involving large-scale tissue-based studies of medical or experimental device efficacy and performance.

  8. Effectiveness of interactive discussion group in suicide risk assessment among general nurses in Taiwan: a randomized controlled trial.

    PubMed

    Wu, Chia-Yi; Lin, Yi-Yin; Yeh, Mei Chang; Huang, Lian-Hua; Chen, Shaw-Ji; Liao, Shih-Cheng; Lee, Ming-Been

    2014-11-01

    The evidence of suicide prevention training for nurses is scarce. Strategies to enhance general nurses' ability in suicide risk assessment are critical to develop effective training programs in general medical settings. This study was aimed to examine the effectiveness of an interactive discussion group in a suicide prevention training program for general nurses. In this randomized study with two groups of pre-post study design, the sample was recruited from the Medical, Surgical, and Emergency/Intensive Care Sectors of a 2000-bed general hospital via stratified randomization. Among the 111 nurses, 57 participants randomly assigned to the control group received a two-hour baseline suicide gatekeeper lecture, and 54 participants assigning to the experimental group received an additional five-hour group discussion about suicide risk assessment skills. Using a case vignette, the nurses discussed and assessed suicide risk factors specified in a 10-item Chinese SAD PERSONS Scale during a group discussion intervention. The findings revealed that the nurses achieved significant and consistent improvements of risk identification and assessment after the intervention without influencing their mental health status for assessing suicide risks. The result suggested an effective approach of interactive group discussion for facilitating critical thinking and learning suicide risk assessment skills among general nurses. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. An Evaluation of a Behaviorally Based Social Skills Group for Individuals Diagnosed with Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Leaf, Justin B.; Leaf, Jeremy A.; Milne, Christine; Taubman, Mitchell; Oppenheim-Leaf, Misty; Torres, Norma; Townley-Cochran, Donna; Leaf, Ronald; McEachin, John; Yoder, Paul

    2017-01-01

    In this study we evaluated a social skills group which employed a progressive applied behavior analysis model for individuals diagnosed with autism spectrum disorder. A randomized control trial was utilized; eight participants were randomly assigned to a treatment group and seven participants were randomly assigned to a waitlist control group. The…

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

    ERIC Educational Resources Information Center

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

    2009-01-01

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

  11. ARTS: automated randomization of multiple traits for study design.

    PubMed

    Maienschein-Cline, Mark; Lei, Zhengdeng; Gardeux, Vincent; Abbasi, Taimur; Machado, Roberto F; Gordeuk, Victor; Desai, Ankit A; Saraf, Santosh; Bahroos, Neil; Lussier, Yves

    2014-06-01

    Collecting data from large studies on high-throughput platforms, such as microarray or next-generation sequencing, typically requires processing samples in batches. There are often systematic but unpredictable biases from batch-to-batch, so proper randomization of biologically relevant traits across batches is crucial for distinguishing true biological differences from experimental artifacts. When a large number of traits are biologically relevant, as is common for clinical studies of patients with varying sex, age, genotype and medical background, proper randomization can be extremely difficult to prepare by hand, especially because traits may affect biological inferences, such as differential expression, in a combinatorial manner. Here we present ARTS (automated randomization of multiple traits for study design), which aids researchers in study design by automatically optimizing batch assignment for any number of samples, any number of traits and any batch size. ARTS is implemented in Perl and is available at github.com/mmaiensc/ARTS. ARTS is also available in the Galaxy Tool Shed, and can be used at the Galaxy installation hosted by the UIC Center for Research Informatics (CRI) at galaxy.cri.uic.edu. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  12. ADAPTIVE MATCHING IN RANDOMIZED TRIALS AND OBSERVATIONAL STUDIES

    PubMed Central

    van der Laan, Mark J.; Balzer, Laura B.; Petersen, Maya L.

    2014-01-01

    SUMMARY In many randomized and observational studies the allocation of treatment among a sample of n independent and identically distributed units is a function of the covariates of all sampled units. As a result, the treatment labels among the units are possibly dependent, complicating estimation and posing challenges for statistical inference. For example, cluster randomized trials frequently sample communities from some target population, construct matched pairs of communities from those included in the sample based on some metric of similarity in baseline community characteristics, and then randomly allocate a treatment and a control intervention within each matched pair. In this case, the observed data can neither be represented as the realization of n independent random variables, nor, contrary to current practice, as the realization of n/2 independent random variables (treating the matched pair as the independent sampling unit). In this paper we study estimation of the average causal effect of a treatment under experimental designs in which treatment allocation potentially depends on the pre-intervention covariates of all units included in the sample. We define efficient targeted minimum loss based estimators for this general design, present a theorem that establishes the desired asymptotic normality of these estimators and allows for asymptotically valid statistical inference, and discuss implementation of these estimators. We further investigate the relative asymptotic efficiency of this design compared with a design in which unit-specific treatment assignment depends only on the units’ covariates. Our findings have practical implications for the optimal design and analysis of pair matched cluster randomized trials, as well as for observational studies in which treatment decisions may depend on characteristics of the entire sample. PMID:25097298

  13. Preventing Depression in Later Life: Translation From Concept to Experimental Design and Implementation

    PubMed Central

    Sriwattanakomen, Roy; Ford, Angela F.; Thomas, Stephen B.; Miller, Mark D.; Stack, Jacqueline A.; Morse, Jennifer Q.; Kasckow, John; Brown, Charlotte; Reynolds, Charles F.

    2009-01-01

    Objective The authors detail the public health need for depression prevention research and the decisions made in designing an experiment testing problem solving therapy as “indicated” preventive intervention for high-risk older adults with subsyndromal depression. Special attention is given to the recruitment of African Americans because of well-documented inequalities in mental health services and depression treatment outcomes between races. Methods A total of 306 subjects (half white, half African American) with scores of 16 or higher on the Center for Epidemiological Studies of Depression Scale, but with no history of major depressive disorder in the past 12 months, are being recruited and randomly assigned to either problem solving therapy-primary care or to a dietary education control condition. Time to, and rate of, incident episodes of major depressive disorder are to be modeled using survival analysis. Level of depressive symptoms will be analyzed via a mixed models approach. Results Twenty-two subjects have been recruited into the study, and to date eight have completed the randomly assigned intervention and postintervention assessment. Four of 22 have exited after developing major depressive episodes. None have complained about study procedures or demands. Implementation in a variety of community settings is going well. Conclusion The data collected to date support the feasibility of translating from epidemiology to RCT design and implementation of empirical depression prevention research in later life. PMID:18515690

  14. Teacher-Child Interaction Training: A Pilot Study With Random Assignment.

    PubMed

    Fernandez, Melanie A; Adelstein, Jonathan S; Miller, Samantha P; Areizaga, Margaret J; Gold, Dylann C; Sanchez, Amanda L; Rothschild, Sara A; Hirsch, Emily; Gudiño, Omar G

    2015-07-01

    Teacher-Child Interaction Training (TCIT), adapted from Parent-Child Interaction Therapy (PCIT), is a classroom-based program designed to provide teachers with behavior management skills that foster positive teacher-student relationships and to improve student behavior by creating a more constructive classroom environment. The purpose of this pilot study was to evaluate TCIT in more classrooms than previously reported in the literature, with older children than previously reported, using random assignment of classrooms to TCIT or to a no-TCIT control condition and conducting all but two sessions within the classroom to enhance feasibility. Participants included 11 kindergarten and first grade classroom teachers and their 118 students from three urban, public schools in Manhattan, with five classrooms randomly assigned to receive TCIT and six to the no-TCIT control condition. Observations of teacher skill acquisition were conducted before, during, and after TCIT for all 11 teachers, and teacher reports of student behavior were obtained at these same time points. Teacher satisfaction with TCIT was assessed following training. Results suggested that after receiving TCIT, teachers increased rates of positive attention to students' appropriate behavior, decreased rates of negative attention to misbehavior, reported significantly less distress related to student disruptive behavior, and reported high satisfaction with the training program. Our study supports the growing evidence-base suggesting that TCIT is a promising approach for training teachers in positive behavior management strategies and for improving student disruptive behavior in the classroom. Copyright © 2015. Published by Elsevier Ltd.

  15. 77 FR 3284 - Comment Request for Information Collection for the H-1B Technical Skills Training (H-1B) and the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-23

    ... participants at the time they are randomly assigned to a treatment or control group, ensure that random... assignment of participants into treatment and control groups. A Web- based PTS will execute the random... grantee sites and the services available to control group members. This qualitative information will...

  16. Effect of supplementing orchardgrass herbage with a total mixed ration or flaxseed fermentation profile and bacterial protein synthesis in continuous culture

    USDA-ARS?s Scientific Manuscript database

    A 4-unit dual-flow continuous culture fermentor system was used to evaluate the effects of herbage, a total mixed ration (TMR) and flaxseed on nutrient digestibility and microbial N synthesis. Treatments were randomly assigned to fermentors in a 4 x 4 Latin square design. Each fermentor was fed a to...

  17. Contributions of Platform Motion to Simulator Training Effectiveness: Study II--Aerobatics. Interim Report for Period March 1976-November 1977.

    ERIC Educational Resources Information Center

    Martin, Elizabeth L.; Waag, Wayne L.

    A transfer-of-training design was used to evaluate the contributions of simulator training with synergistic six-degrees-of-freedom platform motion to aerobatic skills acquisition in the novice pilot. Thirty-six undergraduate pilot trainees were randomly assigned to one of three treatment groups: motion, no-motion, and control. Those in the control…

  18. The Effects of Quality Books for Children and the Metacognitive Strategy on Students' Self-Esteem Levels

    ERIC Educational Resources Information Center

    Cer, Erkan; Sahin, Ertugrul

    2017-01-01

    Using a quasi-experimental design with pre-test and post-test control groups, 93 eighth grade students were randomly assigned either to the experimental or to the control group and responded to the Rosenberg Self-Esteem Scale two weeks before and after the intervention. While the students in the experimental group were instructed in quality books…

  19. Use of Portfolio Assessment Technique in Teaching Map Sketching and Location in Secondary School Geography in Jos, Nigeria

    ERIC Educational Resources Information Center

    Ugodulunwa, Christiana; Wakjissa, Sayita

    2015-01-01

    This study investigated the use of portfolio assessment technique in teaching map sketching and location in geography in Jos, Nigeria. It adopted a quasi-experimental design. Two schools were selected using a table of random numbers from a population of 51 schools in Jos South and assigned to each of experimental and control group. The…

  20. Effects of a Computer-Based Early Reading Program on the Early Reading and Oral Language Skills of At-Risk Preschool Children

    ERIC Educational Resources Information Center

    Huffstetter, Mary; King, James R.; Onwuegbuzie, Anthony J.; Schneider, Jenifer J.; Powell-Smith, Kelly A.

    2010-01-01

    This study examined the effects of a computer-based early reading program (Headsprout Early Reading) on the oral language and early reading skills of at-risk preschool children. In a pretest-posttest control group design, 62 children were randomly assigned to receive supplemental instruction with Headsprout Early Reading (experimental group) or…

  1. The Benefits of College Athletic Success: An Application of the Propensity Score Design with Instrumental Variables. NBER Working Paper No. 18196

    ERIC Educational Resources Information Center

    Anderson, Michael L.

    2012-01-01

    Spending on big-time college athletics is often justified on the grounds that athletic success attracts students and raises donations. Testing this claim has proven difficult because success is not randomly assigned. We exploit data on bookmaker spreads to estimate the probability of winning each game for college football teams. We then condition…

  2. Impacts of Abstinence Education on Teen Sexual Activity, Risk of Pregnancy, and Risk of Sexually Transmitted Diseases

    ERIC Educational Resources Information Center

    Trenholm, Christopher; Devaney, Barbara; Fortson, Kenneth; Clark, Melissa; Bridgespan, Lisa Quay; Wheeler, Justin

    2008-01-01

    This paper examines the impacts of four abstinence-only education programs on adolescent sexual activity and risks of pregnancy and sexually transmitted diseases (STDs). Based on an experimental design, the impact analysis uses survey data collected in 2005 and early 2006 from more than 2,000 teens who had been randomly assigned to either a…

  3. The Influence of Family Structure on Sexual Activity in a Randomized Effectiveness Trial for Minority Youth

    ERIC Educational Resources Information Center

    Sherr, Michael E.; Crow, Janet; Stamey, James; Jones, Johnny; Dyer, Preston

    2012-01-01

    This study examined the influence of family structure on the outcomes of a sex education program in Miami, Florida. Using an experimental design, data collection occurred at pretest, 3-month, and 6-month follow-up with a sample of teenagers from high schools with a large majority of minority youth, assigned into treatment (n = 549) and control (n…

  4. Comparison of Four Teacher Training Procedures in Achieving Teacher and Pupil "Translation" Behaviors in Secondary School Social Studies.

    ERIC Educational Resources Information Center

    Millett, Gregg B.

    A study was designed to determine whether different training procedures could change specific behaviors of 39 intern teachers and their pupils in secondary school social studies classes. Interns were randomly assigned to four training groups each of which received typescripts from the 1953 McCarthy investigations which were to be used the next day…

  5. The Effects of Follow-up and Peer Interaction on Quality of Performance and Completion of Online Professional Development

    ERIC Educational Resources Information Center

    Green, Marybeth; Cifuentes, Lauren

    2011-01-01

    This study examined the effects of the inclusion of online follow-up and online peer interaction with a face-to face workshop on quality of support plan and completion of a support plan by Texas school librarians. The study used a posttest-only control group experimental design with randomly assigned self-selected participants. Three online…

  6. Implementation and Impacts of Pay-for-Performance: The 2010 Teacher Incentive Fund (TIF) Grantees after Two Years. NCEE Study Snapshot. NCEE 2015-4022

    ERIC Educational Resources Information Center

    National Center for Education Evaluation and Regional Assistance, 2015

    2015-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  7. Exploring the Effects of Integrating Self-Explanation into a Multi-User Game on the Acquisition of Scientific Concepts

    ERIC Educational Resources Information Center

    Hsu, Chung-Yuan; Tsai, Chin-Chung; Wang, Hung-Yuan

    2016-01-01

    The purpose of this study was to examine the impacts of embedding collaboration into a game with a self-explanation design for supporting the acquisition of light and shadow concepts. The participants were 184 fourth graders who were randomly assigned to three conditions: a solitary mode of the game with self-explanation, a collaborative mode with…

  8. Peer Group Norms and Accountability Moderate the Effect of School Norms on Children's Intergroup Attitudes

    ERIC Educational Resources Information Center

    McGuire, Luke; Rutland, Adam; Nesdale, Drew

    2015-01-01

    The present study examined the interactive effects of school norms, peer norms, and accountability on children's intergroup attitudes. Participants (n = 229) aged 5-11 years, in a between-subjects design, were randomly assigned to a peer group with an inclusion or exclusion norm, learned their school either had an inclusion norm or not, and were…

  9. What Makes a Matrix so Effective? An Empirical Test of the Relative Benefits of Signaling, Extraction, and Localization

    ERIC Educational Resources Information Center

    Kauffman, Douglas F.; Kiewra, Kenneth A.

    2010-01-01

    What type of display helps students learn the most and why? This study investigated how displays differing in terms of signaling, extraction, and localization impact learning. In Experiment 1, 72 students were assigned randomly to one cell of a 4 x 2 design. Students studied a standard text, a text with key ideas extracted, an outline that…

  10. The Effects of Class Size in Online College Courses: Experimental Evidence. CEPA Working Paper No. 15-14

    ERIC Educational Resources Information Center

    Bettinger, Eric; Doss, Christopher; Loeb, Susanna; Taylor, Eric

    2015-01-01

    Class size is a first-order consideration in the study of education production and education costs. How larger or smaller classes affect student outcomes is especially relevant to the growth and design of online classes. We study a field experiment in which college students were quasi-randomly assigned to either a large or a small class. All…

  11. Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years: Executive Summary. NCEE 2018-4005

    ERIC Educational Resources Information Center

    Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

    2017-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  12. Evaluation of the Teacher Incentive Fund: Final Report on Implementation and Impacts of Pay-for-Performance across Four Years. NCEE 2018-4004

    ERIC Educational Resources Information Center

    Chiang, Hanley; Speroni, Cecilia; Herrmann, Mariesa; Hallgren, Kristin; Burkander, Paul; Wellington, Alison

    2017-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  13. Evaluation of the Teacher Incentive Fund: Implementation and Early Impacts of Pay-for-Performance after One Year. Executive Summary. NCEE 2014-4020

    ERIC Educational Resources Information Center

    Max, Jeffrey; Constantine, Jill; Wellington, Alison; Hallgren, Kristin; Glazerman, Steven; Chiang, Hanley; Speroni, Cecilia

    2014-01-01

    The Teacher Incentive Fund (TIF) provides grants to support performance-based compensation systems for teachers and principals in high-need schools. The study measures the impact of pay-for-performance bonuses as part of a comprehensive compensation system within a large, multisite random assignment study design. The treatment schools were to…

  14. Peer-Mentored Preparedness (PM-Prep): A New Disaster Preparedness Program for Adults Living Independently in the Community

    ERIC Educational Resources Information Center

    Eisenman, David Paul; Bazzano, Alicia; Koniak-Griffin, Deborah; Tseng, Chi-hong; Lewis, Mary-Ann; Lamb, Kerry; Lehrer, Danise

    2014-01-01

    The authors studied a health promotion program called PM-Prep (Peer-Mentored Prep), which was designed to improve disaster preparedness among adults living independently in the community. PM-Prep consists of four 2-hour classes co-taught by a health educator and peer-mentors. Adults were randomly assigned to an experimental arm or a wait-list…

  15. The Employment Retention and Advancement Project: How Effective Are Different Approaches Aiming to Increase Employment Retention and Advancement? Final Impacts for Twelve Models. Executive Summary

    ERIC Educational Resources Information Center

    Hendra, Richard; Dillman, Keri-Nicole; Hamilton, Gayle; Lundquist, Erika; Martinson, Karin; Wavelet, Melissa

    2010-01-01

    This report summarizes the final impact results for the national Employment Retention and Advancement (ERA) project. This project tested, using a random assignment design, the effectiveness of numerous programs intended to promote steady work and career advancement. All the programs targeted current and former welfare recipients and other low-wage…

  16. Persuasive Effects of Linguistic Agency Assignments and Point of View in Narrative Health Messages About Colon Cancer.

    PubMed

    Chen, Meng; McGlone, Matthew S; Bell, Robert A

    2015-08-01

    The authors explored the effects of linguistic agency and point of view on narrative force. Participants (N = 499) were randomly assigned to read one version of an article about colon cancer, defined by a 2 (disease agency: cancer, human) × 2 (temporal agency: death, human) × 2 (point of view: first person, third person) between-subjects design. Disease agency language assigned agency to cancer (e.g., "Cancer developed in me") or to humans (e.g., "I developed cancer"). Temporal agency language described death as approaching humans (e.g., "as death closes in on patients) or as being approached by humans (e.g., "as patients close in on death"). The narrative was presented from the first-person singular or third-person plural viewpoint. Participants then completed a questionnaire measuring threat perceptions, efficacy, transportation, and other study variables. Language assigning agency to humans rather than to cancer elevated susceptibility beliefs. Death-approach language led to greater fear than human-approach language without impacting efficacy perceptions. Human-approach language was rated more persuasive than death-approach language, but only in first-person point-of-view narratives. Transportation and identification were positively associated with ratings of threat severity and susceptibility, fear, efficacy, behavioral intentions, and message persuasiveness. Implications for message design are discussed.

  17. Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial.

    PubMed

    Gulluoglu, Bahadir M; Guler, Sertac Ata; Ugurlu, M Umit; Culha, Gulcan

    2013-01-01

    To assess the impact of prophylactic antibiotics on the prevention of surgical site infection (SSI) and the cost-effectiveness of this prophylaxis for breast cancer surgery in overweight or obese women. SSI is higher than expected after breast surgery. Obesity was found to be one of the risk factors. The trial was designed as a phase IV randomized, controlled, parallel-group efficacy trial. It was conducted at a tertiary university hospital. Overweight or obese women with clinically early-stage breast cancer who had been assigned to undergo surgery were eligible. Patients were randomly allocated to either a prophylaxis or a control group by using a computer-generated list. The prophylaxis group received 1 g ampicillin-sulbactam intravenously at anesthesia. The control group received no intervention. Patients and observers were blinded to the assignments. The primary outcome was the comparison of SSI incidences of the 2 groups. Patients were monitored for 30 days. A total of 369 patients were included in final analysis, out of which 187 were allocated for prophylaxis and 182 were randomly assigned to the control group. Analysis was done according to the intention-to-treat principle. Prophylaxis significantly reduced the SSI rate (4.8%) in the prophylaxis group when compared with that in the control group [13.7%; relative risk (RR) 0.35; 95% CI: 0.17-0.73]. No adverse reaction was observed. The mean SSI-related cost (20.26 USD) was found to be significantly higher in the control group when compared with that (8.48 USD) in the prophylaxis group. Antibiotic prophylaxis significantly decreased SSI incidence after elective surgery and was shown to be cost-effective in obese breast cancer patients. ClinicalTrials.gov Identifier: NCT00356148.

  18. Bacteria as bullies: effects of linguistic agency assignment in health message.

    PubMed

    Bell, Robert A; McGlone, Matthew S; Dragojevic, Marko

    2014-01-01

    When describing health threats, communicators can assign agency to the threat (e.g., "Hepatitis C has infected 4 million Americans") or to humans (e.g., "Four million Americans have contracted hepatitis C"). In an online experiment, the authors explored how assignment of agency affects perceptions of susceptibility and severity of a health threat, response efficacy, self-efficacy, fear arousal, and intentions to adopt health-protective recommendations. Participants were 719 individuals recruited through Mechanical Turk ( www.mturk.com ), a crowdsource labor market run by Amazon ( www.amazon.com ). The participants were assigned randomly to read 1 of 8 flyers defined by a 2×4 (Agency Assignment×Topic) factorial design. Each flyer examined 1 health threat (E. coli, necrotizing fasciitis, salmonella, or Carbapenem-resistant Klebsiella pneumoniae) and was written in language that emphasized bacterial or human agency. Perceived susceptibility and severity were highest when bacterial agency language was used. Response efficacy, self-efficacy, and fear arousal were not significantly affected by agency assignment. Participants reported stronger intentions to adopt recommendations when bacteria agency language was used, but this effect did not reach conventional standards of significance (p < .051). The authors concluded that health communicators can increase target audiences' perceptions of susceptibility and severity by assigning agency to the threat in question when devising health messages.

  19. "Fair Play": A Videogame Designed to Address Implicit Race Bias Through Active Perspective Taking.

    PubMed

    Gutierrez, Belinda; Kaatz, Anna; Chu, Sarah; Ramirez, Dennis; Samson-Samuel, Clem; Carnes, Molly

    2014-12-01

    Having diverse faculty in academic health centers will help diversify the healthcare workforce and reduce health disparities. Implicit race bias is one factor that contributes to the underrepresentation of Black faculty. We designed the videogame "Fair Play" in which players assume the role of a Black graduate student named Jamal Davis. As Jamal, players experience subtle race bias while completing "quests" to obtain a science degree. We hypothesized that participants randomly assigned to play the game would have greater empathy for Jamal and lower implicit race bias than participants randomized to read narrative text describing Jamal's experience. University of Wisconsin-Madison graduate students were recruited via e-mail and randomly assigned to play "Fair Play" or read narrative text through an online link. Upon completion, participants took an Implicit Association Test to measure implicit bias and answered survey questions assessing empathy toward Jamal and awareness of bias. As hypothesized, gameplayers showed the least implicit bias but only when they also showed high empathy for Jamal (P=0.013). Gameplayers did not show greater empathy than text readers, and women in the text condition reported the greatest empathy for Jamal (P=0.008). However, high empathy only predicted lower levels of implicit bias among those who actively took Jamal's perspective through gameplay (P=0.014). A videogame in which players experience subtle race bias as a Black graduate student has the potential to reduce implicit bias, possibly because of a game's ability to foster empathy through active perspective taking.

  20. Web-Based Cognitive Behavioral Therapy Intervention for the Prevention of Suicidal Ideation in Medical Interns: A Randomized Controlled Trial

    PubMed Central

    Guille, Constance; Zhao, Zhuo; Krystal, John; Nichols, Breck; Brady, Kathleen; Sen, Srijan

    2016-01-01

    Importance In the United States, approximately one physician dies by suicide every day. Training physicians are at particularly high risk, with suicidal ideation increasing over four-fold during the first three months of internship year. Despite this dramatic increase, very few efforts have been made to prevent the escalation of suicidal thoughts among training physicians. Objective To assess the effectiveness of a Web-based Cognitive Behavioral Therapy (wCBT) program delivered prior to the start of internship year in the prevention of suicidal ideation in medical interns. Design, Setting and Participants A randomized controlled trial conducted at two university hospitals with 199 interns from multiple specialties during academic years 2009-10 or 2011-12. Interventions Interns were randomly assigned to study groups (wCBT, n=100; attention-control group (ACG), n=99), and completed study activities lasting 30-minutes each week for four weeks prior to starting internship year. Subjects assigned to wCBT completed online-CBT modules and subjects assigned to ACG received emails with general information about depression, suicidal thinking and local mental health providers. Main Outcome Measure The Patient Health Questionnaire (PHQ-9) was employed to assess suicidal ideation (i.e., “thoughts that you would be better off dead, or hurting yourself in some way”) prior to the start of intern year and at 3-month intervals throughout the year. Results 62.2% (199/320) of individuals agreed to take part in the study. During at least one time point over the course of internship year 12% (12/100) of interns assigned to wCBT endorsed suicidal ideation, compared to 21%(21/99) of interns assigned to ACG. After adjusting for covariates identified a priori that have previously shown to increase the risk for suicidal ideation, interns assigned to wCBT were 60% less likely to endorse suicidal ideation during internship year (RR: 0.40, 95% CI 0.17-0.91; p=0.03), compared to those assigned to ACG. Conclusion This study demonstrates that a free, easily accessible, brief wCBT program can help reduce the development of suicidal ideation among medical interns. Prevention programs with these characteristics could be easily disseminated to medical training program across the country. PMID:26535958

  1. Strategic Resource Use for Learning: A Self-Administered Intervention That Guides Self-Reflection on Effective Resource Use Enhances Academic Performance.

    PubMed

    Chen, Patricia; Chavez, Omar; Ong, Desmond C; Gunderson, Brenda

    2017-06-01

    Many educational policies provide learners with more resources (e.g., new learning activities, study materials, or technologies), but less often do they address whether students are using these resources effectively. We hypothesized that making students more self-reflective about how they should approach their learning with the resources available to them would improve their class performance. We designed a novel Strategic Resource Use intervention that students could self-administer online and tested its effects in two cohorts of a college-level introductory statistics class. Before each exam, students randomly assigned to the treatment condition strategized about which academic resources they would use for studying, why each resource would be useful, and how they would use their resources. Students randomly assigned to the treatment condition reported being more self-reflective about their learning throughout the class, used their resources more effectively, and outperformed students in the control condition by an average of one third of a letter grade in the class.

  2. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study.

    PubMed

    Wang, Man; Tong, Jian-hua; Zhu, Gang; Liang, Guang-ming; Yan, Hong-fei; Wang, Xiu-zhen

    2012-06-01

    To evaluate the efficacy of metformin for treatment of antipsychotic-induced weight gain. Seventy-two patients with first-episode schizophrenia who gained more than 7% of their predrug weight were randomly assigned to receive 1000 mg/d of metformin or placebo in addition to their ongoing treatment for 12 weeks using a double-blind study design. The primary outcome was change in body weight. The secondary outcomes included changes in body mass index, fasting glucose and insulin, and insulin resistance index. Of the 72 patients who were randomly assigned, 66 (91.6%) completed treatments. The body weight, body mass index, fasting insulin and insulin resistance index decreased significantly in the metformin group, but increased in the placebo group during the 12-week follow-up period. Significantly more patients in the metformin group lost their baseline weight by more than 7%, which was the cutoff for clinically meaningful weight loss. Metformin was tolerated well by majority patients. Metformin was effective and safe in attenuating antipsychotic-induced weight gain and insulin resistance in first-episode schizophrenia patients. Patients displayed good adherence to metformin. Copyright © 2012 Elsevier B.V. All rights reserved.

  3. Estimating peer effects in networks with peer encouragement designs.

    PubMed

    Eckles, Dean; Kizilcec, René F; Bakshy, Eytan

    2016-07-05

    Peer effects, in which the behavior of an individual is affected by the behavior of their peers, are central to social science. Because peer effects are often confounded with homophily and common external causes, recent work has used randomized experiments to estimate effects of specific peer behaviors. These experiments have often relied on the experimenter being able to randomly modulate mechanisms by which peer behavior is transmitted to a focal individual. We describe experimental designs that instead randomly assign individuals' peers to encouragements to behaviors that directly affect those individuals. We illustrate this method with a large peer encouragement design on Facebook for estimating the effects of receiving feedback from peers on posts shared by focal individuals. We find evidence for substantial effects of receiving marginal feedback on multiple behaviors, including giving feedback to others and continued posting. These findings provide experimental evidence for the role of behaviors directed at specific individuals in the adoption and continued use of communication technologies. In comparison, observational estimates differ substantially, both underestimating and overestimating effects, suggesting that researchers and policy makers should be cautious in relying on them.

  4. Estimating peer effects in networks with peer encouragement designs

    PubMed Central

    Eckles, Dean; Kizilcec, René F.; Bakshy, Eytan

    2016-01-01

    Peer effects, in which the behavior of an individual is affected by the behavior of their peers, are central to social science. Because peer effects are often confounded with homophily and common external causes, recent work has used randomized experiments to estimate effects of specific peer behaviors. These experiments have often relied on the experimenter being able to randomly modulate mechanisms by which peer behavior is transmitted to a focal individual. We describe experimental designs that instead randomly assign individuals’ peers to encouragements to behaviors that directly affect those individuals. We illustrate this method with a large peer encouragement design on Facebook for estimating the effects of receiving feedback from peers on posts shared by focal individuals. We find evidence for substantial effects of receiving marginal feedback on multiple behaviors, including giving feedback to others and continued posting. These findings provide experimental evidence for the role of behaviors directed at specific individuals in the adoption and continued use of communication technologies. In comparison, observational estimates differ substantially, both underestimating and overestimating effects, suggesting that researchers and policy makers should be cautious in relying on them. PMID:27382145

  5. A Patient-Centered Approach to Informed Consent: Results from a Survey and Randomized Trial.

    PubMed

    Krishnamurti, Tamar; Argo, Nichole

    2016-08-01

    Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement. This study aimed to develop and evaluate patient-centered, patient-designed paper and video informed consent formats. Two studies were conducted. In study 1, 118 self-identifying asthma patients recruited from a national, online pool completed survey tasks from their personal computers. Participants in study 1 were randomly assigned to examine sections of a standard informed consent document for an asthma trial and to select information they deemed critical to their decision making. In study 2, a sample of 83 self-identifying asthma patients completed experimental tasks in a university laboratory. Participants in study 2 were randomly assigned to a full informed consent document; a shortened, patient-designed informed consent document created from study 1; or a video with content matched to the shortened paper form. Study 1 yielded a more readable, concise version of a standard informed consent document (5 v. 17 pages). This shortened, patient-designed form closely met normative criteria for good clinical practice. In study 2, participants who viewed either the shortened paper consent or video reported greater engagement than those viewing the standard paper consent, without lowered performance on any other decision-relevant variables (i.e., comprehension, judged risk/benefit, feelings of trust). The video consent format did not cause increased enrollment. Results suggest that providing concise informed consent content, systematically developed from patients' self-reported information needs, may be more effective at engaging and informing clinical trial participants than the traditional consent approach, without detriment to trial comprehension, risk assessment, or enrollment. © The Author(s) 2016.

  6. The Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) in prostate cancer patients undergoing androgen deprivation therapy: study protocol for a randomized controlled trial.

    PubMed

    Focht, Brian C; Lucas, Alexander R; Grainger, Elizabeth; Simpson, Christina; Thomas-Ahner, Jennifer M; Clinton, Steven K

    2014-09-09

    Androgen deprivation therapy (ADT) is the foundation of treatment for men with metastatic prostate cancer and is now frequently incorporated into multimodality strategies for the curative treatment of locally advanced prostate cancer. Nevertheless, the catabolic effects of ADT result in meaningful adverse effects on physiological and quality of life outcomes, which may, in turn, increase the risk of functional decline, frailty, cardiovascular disease, and metabolic syndrome. Recent evidence demonstrates that lifestyle intervention promoting change in exercise and dietary behaviors is a promising approach, and may offset, or even reverse, the adverse effects accompanying ADT. Unfortunately, the limited existing studies of the effects of exercise and dietary interventions targeting patients with prostate cancer on ADT are characterized by high attrition rates and poor postintervention maintenance of treatment effects. Consequently, the Individualized Diet and Exercise Adherence Pilot Trial (IDEA-P) is designed to contrast the effects of a lifestyle intervention designed to promote independent self-management of exercise and dietary behavior with those of standard care disease management approach in the treatment of prostate cancer. A total of 40 patients with prostate cancer undergoing ADT will be randomly assigned to lifestyle intervention or standard care. Outcomes of interest in IDEA-P include changes in self-reported and objectively assessed physical function and physical activity, dietary behavior, body composition, muscular strength, and quality of life. Outcomes will be obtained at baseline, 2-month, and 3-month assessments by trial personnel blinded to participants' randomization assignment. Findings from this study will establish the feasibility and preliminary efficacy of an innovative lifestyle intervention designed to promote progressively independent self-regulated exercise and dietary behavior change in the treatment of patients with prostate cancer undergoing ADT. ClinicalTrials.gov NCT02050906.

  7. SOLITAIRE™ with the intention for thrombectomy (SWIFT) trial: design of a randomized, controlled, multicenter study comparing the SOLITAIRE™ Flow Restoration device and the MERCI Retriever in acute ischaemic stroke.

    PubMed

    Saver, J L; Jahan, R; Levy, E I; Jovin, T G; Baxter, B; Nogueira, R; Clark, W; Budzik, R; Zaidat, O O

    2014-07-01

    Self-expanding stent retrievers are a promising new device class designed for rapid flow restoration in acute cerebral ischaemia. The SOLITAIRE™ Flow Restoration device (SOLITAIRE) has shown high rates of recanalization in preclinical models and in uncontrolled clinical series. (1) To demonstrate non-inferiority of SOLITAIRE compared with a legally marketed device, the MERCI Retrieval System®; (2) To demonstrate safety, feasibility, and efficacy of SOLITAIRE in subjects requiring mechanical thrombectomy diagnosed with acute ischaemic stroke. DESIGN : Multicenter, randomized, prospective, controlled trial with blinded primary end-point ascertainment. Key entry criteria include: age 22-85; National Institute of Health Stroke Scale (NIHSS) ≥8 and <30; clinical and imaging findings consistent with acute ischaemic stroke; patient ineligible or failed intravenous tissue plasminogen activator; accessible occlusion in M1 or M2 middle cerebral artery, internal carotid artery, basilar artery, or vertebral artery; and patient able to be treated within 8 h of onset. Sites first participate in a roll-in phase, treating two patients with the SOLITAIRE device, before proceeding to the randomized phase. In patients unresponsive to the initially assigned therapy, after the angiographic component of the primary end-point is ascertained (reperfusion with the initial assigned device), rescue therapy with other reperfusion techniques is permitted. The primary efficacy end-point is successful recanalization with the assigned study device (no use of rescue therapy) and with no symptomatic intracranial haemorrhage. Successful recanalization is defined as achieving Thrombolysis In Myocardial Ischemia 2 or 3 flow in all treatable vessels. The primary safety end-point is the incidence of device-related and procedure-related serious adverse events. A major secondary efficacy end-point is time to achieve initial recanalization. Additional secondary end-points include clinical outcomes at 90 days and radiologic haemorrhagic transformation. © 2012 The Authors. International Journal of Stroke © 2012 World Stroke Organization.

  8. A Reengineered Hospital Discharge Program to Decrease Rehospitalization

    PubMed Central

    Jack, Brian W.; Chetty, Veerappa K.; Anthony, David; Greenwald, Jeffrey L.; Sanchez, Gail M.; Johnson, Anna E.; Forsythe, Shaula R.; O'Donnell, Julie K.; Paasche-Orlow, Michael K.; Manasseh, Christopher; Martin, Stephen; Culpepper, Larry

    2009-01-01

    Background: Emergency department visits and rehospitalization are common after hospital discharge. Objective: To test the effects of an intervention designed to minimize hospital utilization after discharge. Design: Randomized trial using block randomization of 6 and 8. Randomly arranged index cards were placed in opaque envelopes labeled consecutively with study numbers, and participants were assigned a study group by revealing the index card. Setting: General medical service at an urban, academic, safety-net hospital. Patients: 749 English-speaking hospitalized adults (mean age, 49.9 years). Intervention: A nurse discharge advocate worked with patients during their hospital stay to arrange follow-up appointments, confirm medication reconciliation, and conduct patient education with an individualized instruction booklet that was sent to their primary care provider. A clinical pharmacist called patients 2 to 4 days after discharge to reinforce the discharge plan and review medications. Participants and providers were not blinded to treatment assignment. Measurements: Primary outcomes were emergency department visits and hospitalizations within 30 days of discharge. Secondary outcomes were self-reported preparedness for discharge and frequency of primary care providers′ follow-up within 30 days of discharge. Research staff doing follow-up were blinded to study group assignment. Results: Participants in the intervention group (n = 370) had a lower rate of hospital utilization than those receiving usual care (n = 368) (0.314 vs. 0.451 visit per person per month; incidence rate ratio, 0.695 [95% CI, 0.515 to 0.937]; P = 0.009). The intervention was most effective among participants with hospital utilization in the 6 months before index admission (P = 0.014). Adverse events were not assessed; these data were collected but are still being analyzed. Limitation: This was a single-center study in which not all potentially eligible patients could be enrolled, and outcome assessment sometimes relied on participant report. Conclusion: A package of discharge services reduced hospital utilization within 30 days of discharge. PMID:19189907

  9. Impact of referral source and study applicants' preference for randomly assigned service on research enrollment, service engagement, and evaluative outcomes.

    PubMed

    Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

    2005-04-01

    The inability to blind research participants to their experimental conditions is the Achilles' heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants' preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Three Cox regression analyses measured the impact of applicants' service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice.

  10. The Healthy Teen Girls project: comparison of health education and STD risk reduction intervention for incarcerated adolescent females.

    PubMed

    Robertson, Angela A; Robertson, Angela R; St Lawrence, Janet; Morse, David T; Baird-Thomas, Connie; Liew, Hui; Gresham, Kathleen

    2011-06-01

    Adolescent girls incarcerated in a state reformatory (N = 246) were recruited and assigned to an 18-session health education program or a time-equivalent HIV prevention program. Cohorts were assigned to conditions using a randomized block design separated by a washout period to reduce contamination. Post intervention, girls in the HIV risk reduction program demonstrated the acquisition of risk-reduction behavioral skills and improved condom application skill. At a follow-up assessment approximately 9 months after release from the correctional facility, girls in both conditions reported fewer unprotected sexual intercourse occasions and less sex while under the influence of alcohol or other drugs.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2016-09-01

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

  13. A Pilot Study of Women’s Affective Responses to Common and Uncommon Forms of Aerobic Exercise

    PubMed Central

    Stevens, Courtney J.; Smith, Jane Ellen; Bryan, Angela D.

    2015-01-01

    Objective To test the extent to which participants exposed to an uncommon versus common exercise stimulus would result in more favourable affect at post task. Design Experimental design. Participants, (N = 120) American women aged 18–45 years, were randomly assigned to complete 30-minutes of either the uncommon (HOOP; n = 58) or common (WALK; n = 62) exercise stimulus. Main Outcome Measures Self-reported affect and intentions for future exercise were measured before and after the 30-minute exercise bout. Results Analyses of covariance (ANCOVA) were run to compare post-task affect across the HOOP and WALK conditions. At post-task, participants assigned to HOOP reported more positively valenced affect, higher ratings of positive activated affect, lower ratings of negative deactivated affect, and stronger intentions for future aerobic exercise compared to participants assigned to WALK. Conclusions Participants who completed an uncommon bout of aerobic exercise (HOOP) reported more favourable affect post-exercise, as well as stronger intentions for future exercise, compared to participants who completed a common bout of aerobic exercise (WALK). Future work using a longitudinal design is needed to understand the relationships between familiarity with an exercise stimulus, affective responses to exercise, motivation for future exercise behaviour, and exercise maintenance over time. PMID:26394246

  14. Stability of parental understanding of random assignment in childhood leukemia trials: an empirical examination of informed consent.

    PubMed

    Greenley, Rachel Neff; Drotar, Dennis; Zyzanski, Stephen J; Kodish, Eric

    2006-02-20

    To examine stability versus change in parental understanding of random assignment in randomized clinical trials (RCTs) for pediatric leukemia and to identify factors associated with changes in understanding. Eighty-four parents of children diagnosed with acute lymphoblastic leukemia or acute myeloid leukemia who were enrolled onto a pediatric leukemia RCT at one of six US children's hospitals participated. Parents were interviewed twice, once within 48 hours after the Informed Consent Conference (ICC; time 1 [T1]) and again 6 months later (time 2 [T2]). Interviews focused on parental understanding of key components of the RCT, including random assignment. Interviews were audiotaped, transcribed, and later analyzed. Changes in understanding of random assignment occurred in 19% of parents, with 17% of parents deteriorating in understanding from T1 to T2. Forty-nine percent of parents failed to understand random assignment at both times. Factors associated with understanding at both times included majority ethnicity, high socioeconomic status, parental reading of consent document, and presence of a nurse during the ICC. Physician discussion of specific components of the RCT was also associated with understanding at both times. Female caregivers and parents of low socioeconomic status were overrepresented among those who showed decay in understanding from T1 to T2. Parents showed little gain in understanding over time. Factors that predicted understanding at diagnosis as well as sustained understanding over time may be important intervention targets. Attention to both modifiable and nonmodifiable barriers is important for clinical practice.

  15. Efficient design of cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances.

    PubMed

    van Breukelen, Gerard J P; Candel, Math J J M

    2018-06-10

    Cluster randomized trials evaluate the effect of a treatment on persons nested within clusters, where treatment is randomly assigned to clusters. Current equations for the optimal sample size at the cluster and person level assume that the outcome variances and/or the study costs are known and homogeneous between treatment arms. This paper presents efficient yet robust designs for cluster randomized trials with treatment-dependent costs and treatment-dependent unknown variances, and compares these with 2 practical designs. First, the maximin design (MMD) is derived, which maximizes the minimum efficiency (minimizes the maximum sampling variance) of the treatment effect estimator over a range of treatment-to-control variance ratios. The MMD is then compared with the optimal design for homogeneous variances and costs (balanced design), and with that for homogeneous variances and treatment-dependent costs (cost-considered design). The results show that the balanced design is the MMD if the treatment-to control cost ratio is the same at both design levels (cluster, person) and within the range for the treatment-to-control variance ratio. It still is highly efficient and better than the cost-considered design if the cost ratio is within the range for the squared variance ratio. Outside that range, the cost-considered design is better and highly efficient, but it is not the MMD. An example shows sample size calculation for the MMD, and the computer code (SPSS and R) is provided as supplementary material. The MMD is recommended for trial planning if the study costs are treatment-dependent and homogeneity of variances cannot be assumed. © 2018 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.

  16. The Minicommunity Design to Assess Indirect Effects of Vaccination.

    PubMed

    Halloran, M Elizabeth

    2012-08-01

    We propose the minicommunity design to estimate indirect effects of vaccination. Establishing indirect effects of vaccination in unvaccinated subpopulations could have important implications for global vaccine policies. In the minicommunity design, the household or other small transmission unit serves as the cluster in which to estimate indirect effects of vaccination, similar to studies in larger communities to estimate indirect, total, and overall effects. Examples from the literature include studies in small transmission units to estimate indirect effects of pertussis, pneumococcal, influenza, and cholera vaccines. We characterize the minicommunity design by several methodologic considerations, including the assignment mechanism, ascertainment, the role of transmission outside the transmission unit, and the relation of the size of the transmission unit to number of people vaccinated. The minicommunity study for indirect effects is contrasted with studies to estimate vaccine effects on infectiousness and protective effects under conditions of household exposure within small transmission units. The minicommunity design can be easily implemented in individually randomized studies by enrolling and following-up members of households of the randomized individuals. The methodology for the minicommunity design for estimating indirect effects of vaccination deserves much future research.

  17. Randomized Multicenter Trial of the Effects of Melanoma-Associated Helper Peptides and Cyclophosphamide on the Immunogenicity of a Multipeptide Melanoma Vaccine

    PubMed Central

    Slingluff, Craig L.; Petroni, Gina R.; Chianese-Bullock, Kimberly A.; Smolkin, Mark E.; Ross, Merrick I.; Haas, Naomi B.; von Mehren, Margaret; Grosh, William W.

    2011-01-01

    Purpose This multicenter randomized trial was designed to test whether melanoma-associated helper peptides augment CD8+ T-cell responses to a melanoma vaccine and whether cyclophosphamide (CY) pretreatment augments CD4+ or CD8+ T-cell responses to that vaccine. Patients and Methods In all, 167 eligible patients with resected stage IIB to IV melanoma were randomly assigned to four vaccination study arms. Patients were vaccinated with 12 class I major histocompatibility complex–restricted melanoma peptides (12MP) to stimulate CD8+ T cells and were randomly assigned to receive a tetanus helper peptide or a mixture of six melanoma-associated helper peptides (6MHP) to stimulate CD4+ T cells. Before vaccination, patients were also randomly assigned to receive CY pretreatment or not. T-cell responses were assessed by an ex vivo interferon gamma ELISpot assay. Clinical outcomes and toxicities were recorded. Results Vaccination with 12MP plus tetanus induced CD8+ T-cell responses in 78% of patients and CD4+ T-cell responses to tetanus peptide in 93% of patients. Vaccination with 12MP plus 6MHP induced CD8+ responses in 19% of patients and CD4+ responses to 6MHP in 48% of patients. CY had no significant effect on T-cell responses. Overall 3-year survival was 79% (95% CI, 71% to 86%), with no significant differences (at this point) by study arm. Conclusion Melanoma-associated helper peptides paradoxically decreased CD8+ T-cell responses to a melanoma vaccine (P < .001), and CY pretreatment had no immunologic or clinical effect. Prior work showed immunologic and clinical activity of 6MHP alone. Possible explanations for negative effects on CD8 responses include modulation of homing receptor expression or induction of antigen-specific regulatory T cells. PMID:21690475

  18. High capacity low delay packet broadcasting multiaccess schemes for satellite repeater systems

    NASA Astrophysics Data System (ADS)

    Bose, S. K.

    1980-12-01

    Demand assigned packet radio schemes using satellite repeaters can achieve high capacities but often exhibit relatively large delays under low traffic conditions when compared to random access. Several schemes which improve delay performance at low traffic but which have high capacity are presented and analyzed. These schemes allow random acess attempts by users, who are waiting for channel assignments. The performance of these are considered in the context of a multiple point communication system carrying fixed length messages between geographically distributed (ground) user terminals which are linked via a satellite repeater. Channel assignments are done following a BCC queueing discipline by a (ground) central controller on the basis of requests correctly received over a collision type access channel. In TBACR Scheme A, some of the forward message channels are set aside for random access transmissions; the rest are used in a demand assigned mode. Schemes B and C operate all their forward message channels in a demand assignment mode but, by means of appropriate algorithms for trailer channel selection, allow random access attempts on unassigned channels. The latter scheme also introduces framing and slotting of the time axis to implement a more efficient algorithm for trailer channel selection than the former.

  19. 40 CFR 799.9120 - TSCA acute dermal toxicity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  20. 40 CFR 799.9120 - TSCA acute dermal toxicity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  1. 40 CFR 799.9110 - TSCA acute oral toxicity.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  2. 40 CFR 799.9110 - TSCA acute oral toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  3. 40 CFR 799.9120 - TSCA acute dermal toxicity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  4. 40 CFR 799.9110 - TSCA acute oral toxicity.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  5. 40 CFR 799.9110 - TSCA acute oral toxicity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  6. 40 CFR 799.9120 - TSCA acute dermal toxicity.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  7. 40 CFR 799.9110 - TSCA acute oral toxicity.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... number. A system to assign animals to test groups and control groups randomly is required. (E) Housing... randomization in assigning animals to test and control groups. (3) Rationale for selection of species, if other... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  8. 40 CFR 799.9120 - TSCA acute dermal toxicity.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... identification number. A system to randomly assign animals to test groups and control groups is required. (E... source of test animals. (2) Method of randomization in assigning animals to test and control groups. (3... CONTROL ACT (CONTINUED) IDENTIFICATION OF SPECIFIC CHEMICAL SUBSTANCE AND MIXTURE TESTING REQUIREMENTS...

  9. Can Virtual Reality Increase the Realism of Role Plays Used to Teach College Women Sexual Coercion and Rape-Resistance Skills?

    ERIC Educational Resources Information Center

    Jouriles, Ernest N.; McDonald, Renee; Kullowatz, Antje; Rosenfield, David; Gomez, Gabriella S.; Cuevas, Anthony

    2009-01-01

    The present study evaluated whether virtual reality (VR) can enhance the realism of role plays designed to help college women resist sexual attacks. Sixty-two female undergraduate students were randomly assigned to either the Role Play (RP) or Virtual Role Play (VRP) conditions, which were differentiated only by the use of VR technology in the VRP…

  10. Music Activities as a Meaningful Context for Teaching Elementary Students Mathematics: A Quasi-Experiment Time Series Design with Random Assigned Control Group

    ERIC Educational Resources Information Center

    An, Song A.; Tillman, Daniel A.

    2015-01-01

    The purpose of the current research was to examine the effects of a sequence of classroom activities that integrated mathematics content with music elements aimed at providing teachers an alternative approach for teaching mathematics. Two classes of third grade students (n = 56) from an elementary school in the west coast of the United States…

  11. The Efficacy of a Social Skills Group Intervention for Improving Social Behaviors in Children with High Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    DeRosier, Melissa E.; Swick, Danielle C.; Davis, Naomi Ornstein; McMillen, Janey Sturtz; Matthews, Rebecca

    2011-01-01

    This study tested the efficacy of a new social skills intervention, "S ocial S kills GR oup IN tervention-High Functioning Autism" ("S.S.GRIN-HFA"), designed to improve social behaviors in children with high functioning autism spectrum disorders. Fifty-five children were randomly assigned to "S.S.GRIN-HFA" treatment (n = 27) or control (i.e.,…

  12. A Comparison of Self Critique Using Video Tapes and Verbal Critique by the Instructor in Learning Psychomotor Skills. Final Report.

    ERIC Educational Resources Information Center

    McKay, Rose P.; Harrison, Omeera Anne

    A study was designed to determine if self-critique by videotapes of a practice session was as effective for teaching a nursing skill as were teacher critiques of the practice session. Seventy women nursing students were trichotomized by anxiety level and randomly assigned to either the self-critique with a procedure checklist treatment or to the…

  13. Use of a Survival Analysis Technique in Understanding Game Performance in Instructional Games. CRESST Report 812

    ERIC Educational Resources Information Center

    Kim, Jinok; Chung, Gregory K. W. K.

    2012-01-01

    In this study we compared the effects of two math game designs on math and game performance, using discrete-time survival analysis (DTSA) to model players' risk of not advancing to the next level in the game. 137 students were randomly assigned to two game conditions. The game covered the concept of a unit and the addition of like-sized fractional…

  14. Managing Lower Extremity Muscle Tone and Function in Children with Cerebral Palsy via Eight-Week Repetitive Passive Knee Movement Intervention

    ERIC Educational Resources Information Center

    Cheng, Hsin-Yi Kathy; Ju, Yan-Ying; Chen, Chia-Ling; Chang, Ya-Ju; Wong, Alice May-Kuen

    2013-01-01

    This study used a repeated measures design to assess the effect of an eight-week repetitive passive movement (RPM) intervention on lower extremity muscle tone and function in children with cerebral palsy (CP). Eighteen children (aged 9.5 [plus or minus] 2.1 years) with spastic CP were randomly assigned to a knee RPM intervention condition of 3…

  15. A Study Investigating the Effect of Treatment Developed by Integrating the 5E and Simulation on Pre-Service Science Teachers' Achievement in Photoelectric Effect

    ERIC Educational Resources Information Center

    Taslidere, Erdal

    2015-01-01

    The Current study investigated the effect of the 5E learning cycle in which the simulations were integrated on pre-service science teachers' achievement in photoelectric subject. Four sophomore level classes with their 140 students participated in the research and a quasi-experimental design was used. The classes were randomly assigned into one of…

  16. The Effects of Computer Technology in Assisting the Development of Literacy in Young Struggling Readers and Spellers

    ERIC Educational Resources Information Center

    Fasting, Rolf B.; Lyster, Solveig-Alma Halaas

    2005-01-01

    The aim of the present study is to evaluate the effect of MultiFunk, a computer program designed to assist reading, on the reading and spelling proficiency of struggling readers. Fifty-two below-average readers and spellers, in grades 5, 6 and 7, were randomly assigned as experimental and control groups (N = 26 + 26). In addition, 114 classmates,…

  17. Impact of Playing Exergames on Mood States: A Randomized Controlled Trial.

    PubMed

    Huang, Han-Chung; Wong, May-Kuen; Yang, Ya-Hui; Chiu, Hsin-Ying; Teng, Ching-I

    2017-04-01

    To examine how playing exergames impacts the mood states of university students and staff, and whether such an impact depends on gender and players' previous exercise time. This study was designed as a randomized controlled trial. It enrolled 337 participants and randomly assigned them to an intervention group (n = 168) or a control group (n = 167). A 2-week exergame program was designed for the participants in the intervention group. They were required to play exergames for 30 consecutive minutes each week for 2 weeks and respond to the items measuring vigor, happiness, and perceived stress. All measures were administered before and after the study. Repeated measures analysis of variances were conducted. Playing exergames enhanced vigor and happiness for participants in the intervention group. This group exhibited more positive change in vigor and happiness than the control group. This effect of playing exergames was not moderated by gender, age, occupation (student or staff), or previous exercise time. Playing exergames may induce positive mood states among university students and staff.

  18. Adaptive Designs for Randomized Trials in Public Health

    PubMed Central

    Brown, C. Hendricks; Have, Thomas R. Ten; Jo, Booil; Dagne, Getachew; Wyman, Peter A.; Muthén, Bengt; Gibbons, Robert D.

    2009-01-01

    In this article, we present a discussion of two general ways in which the traditional randomized trial can be modified or adapted in response to the data being collected. We use the term adaptive design to refer to a trial in which characteristics of the study itself, such as the proportion assigned to active intervention versus control, change during the trial in response to data being collected. The term adaptive sequence of trials refers to a decision-making process that fundamentally informs the conceptualization and conduct of each new trial with the results of previous trials. Our discussion below investigates the utility of these two types of adaptations for public health evaluations. Examples are provided to illustrate how adaptation can be used in practice. From these case studies, we discuss whether such evaluations can or should be analyzed as if they were formal randomized trials, and we discuss practical as well as ethical issues arising in the conduct of these new-generation trials. PMID:19296774

  19. Strategies for Improving Power in School-Randomized Studies of Professional Development.

    PubMed

    Kelcey, Ben; Phelps, Geoffrey

    2013-12-01

    Group-randomized designs are well suited for studies of professional development because they can accommodate programs that are delivered to intact groups (e.g., schools), the collaborative nature of professional development, and extant teacher/school assignments. Though group designs may be theoretically favorable, prior evidence has suggested that they may be challenging to conduct in professional development studies because well-powered designs will typically require large sample sizes or expect large effect sizes. Using teacher knowledge outcomes in mathematics, we investigated when and the extent to which there is evidence that covariance adjustment on a pretest, teacher certification, or demographic covariates can reduce the sample size necessary to achieve reasonable power. Our analyses drew on multilevel models and outcomes in five different content areas for over 4,000 teachers and 2,000 schools. Using these estimates, we assessed the minimum detectable effect sizes for several school-randomized designs with and without covariance adjustment. The analyses suggested that teachers' knowledge is substantially clustered within schools in each of the five content areas and that covariance adjustment for a pretest or, to a lesser extent, teacher certification, has the potential to transform designs that are unreasonably large for professional development studies into viable studies. © The Author(s) 2014.

  20. Treatment fidelity of brief motivational interviewing and health education in a randomized clinical trial to promote dental attendance of low-income mothers and children: Community-Based Intergenerational Oral Health Study "Baby Smiles".

    PubMed

    Weinstein, Philip; Milgrom, Peter; Riedy, Christine A; Mancl, Lloyd A; Garson, Gayle; Huebner, Colleen E; Smolen, Darlene; Sutherland, Marilynn; Nykamp, Ann

    2014-02-24

    Fidelity assessments are integral to intervention research but few published trials report these processes in detail. We included plans for fidelity monitoring in the design of a community-based intervention trial. The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy (mother) or the postpartum (child) period. Group assignment followed a 2 × 2 factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing (MI) or Health Education (HE) during pregnancy (prenatal) and then randomly reassigned to one of these groups for the postpartum intervention. The study setting was four county health departments in rural Oregon State, USA. Counseling was standardized using a step-by-step manual. Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions. The Yale Adherence and Competence Scale (YACS), modified for this study, was used to code the audio recordings of the counselors' delivery of both the MI and HE interventions. Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors, ICC for prenatal was .93, for postpartum the ICC was .75. Participants provided a second source of fidelity data. As a second source of fidelity data, the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions. Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition. Almost no MI behaviors were found in the HE condition. Differences in the length of time to deliver intervention were found; as expected, the HE intervention took less time. There were no differences between the overall participants' satisfaction ratings of the HE and MI sessions by individual counselor or overall (p > .05). Trial design, protocol specification, training, and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings.

  1. Protein Side-Chain Resonance Assignment and NOE Assignment Using RDC-Defined Backbones without TOCSY Data3

    PubMed Central

    Zeng, Jianyang; Zhou, Pei; Donald, Bruce Randall

    2011-01-01

    One bottleneck in NMR structure determination lies in the laborious and time-consuming process of side-chain resonance and NOE assignments. Compared to the well-studied backbone resonance assignment problem, automated side-chain resonance and NOE assignments are relatively less explored. Most NOE assignment algorithms require nearly complete side-chain resonance assignments from a series of through-bond experiments such as HCCH-TOCSY or HCCCONH. Unfortunately, these TOCSY experiments perform poorly on large proteins. To overcome this deficiency, we present a novel algorithm, called NASCA (NOE Assignment and Side-Chain Assignment), to automate both side-chain resonance and NOE assignments and to perform high-resolution protein structure determination in the absence of any explicit through-bond experiment to facilitate side-chain resonance assignment, such as HCCH-TOCSY. After casting the assignment problem into a Markov Random Field (MRF), NASCA extends and applies combinatorial protein design algorithms to compute optimal assignments that best interpret the NMR data. The MRF captures the contact map information of the protein derived from NOESY spectra, exploits the backbone structural information determined by RDCs, and considers all possible side-chain rotamers. The complexity of the combinatorial search is reduced by using a dead-end elimination (DEE) algorithm, which prunes side-chain resonance assignments that are provably not part of the optimal solution. Then an A* search algorithm is employed to find a set of optimal side-chain resonance assignments that best fit the NMR data. These side-chain resonance assignments are then used to resolve the NOE assignment ambiguity and compute high-resolution protein structures. Tests on five proteins show that NASCA assigns resonances for more than 90% of side-chain protons, and achieves about 80% correct assignments. The final structures computed using the NOE distance restraints assigned by NASCA have backbone RMSD 0.8 – 1.5 Å from the reference structures determined by traditional NMR approaches. PMID:21706248

  2. Early stage hot spot analysis through standard cell base random pattern generation

    NASA Astrophysics Data System (ADS)

    Jeon, Joong-Won; Song, Jaewan; Kim, Jeong-Lim; Park, Seongyul; Yang, Seung-Hune; Lee, Sooryong; Kang, Hokyu; Madkour, Kareem; ElManhawy, Wael; Lee, SeungJo; Kwan, Joe

    2017-04-01

    Due to limited availability of DRC clean patterns during the process and RET recipe development, OPC recipes are not tested with high pattern coverage. Various kinds of pattern can help OPC engineer to detect sensitive patterns to lithographic effects. Random pattern generation is needed to secure robust OPC recipe. However, simple random patterns without considering real product layout style can't cover patterning hotspot in production levels. It is not effective to use them for OPC optimization thus it is important to generate random patterns similar to real product patterns. This paper presents a strategy for generating random patterns based on design architecture information and preventing hotspot in early process development stage through a tool called Layout Schema Generator (LSG). Using LSG, we generate standard cell based on random patterns reflecting real design cell structure - fin pitch, gate pitch and cell height. The output standard cells from LSG are applied to an analysis methodology to assess their hotspot severity by assigning a score according to their optical image parameters - NILS, MEEF, %PV band and thus potential hotspots can be defined by determining their ranking. This flow is demonstrated on Samsung 7nm technology optimizing OPC recipe and early enough in the process avoiding using problematic patterns.

  3. The behavioral dynamics of clinical trials.

    PubMed

    Leventhal, H; Nerenz, D R; Leventhal, E A; Love, R R; Bendena, L M

    1991-01-01

    Two ways of approaching the design of long-term clinical trials are presented and contrasted. The first, termed the "static" view, emphasizes close adherence to formal rules of study design. The second, termed the "dynamic" view, emphasizes the behavioral aspects of patient participation in trials of long duration. The dynamic view is discussed in detail, with discussion of how recruitment of participants, random assignment to conditions, compliance with protocol, and measurement of outcomes are affected by behavioral dynamics. Data from a recently completed tamoxifen toxicity trial are used to illustrate the points and to focus the discussion of behavioral dynamics on the design of a chemoprevention trial for breast cancer using tamoxifen.

  4. Effects of leisure education on self-rated health among older adults.

    PubMed

    Chang, Liang-Chih; Yu, Ping; Jeng, Mei-Yuan

    2015-01-01

    This study examined whether a leisure education program could promote leisure autonomy and self-rated health (SRH) among older adults. A pretest-posttest randomized experimental design was conducted. Subjects were randomly assigned to either an experimental group (n = 30) or a control group (n = 30). Data related to leisure autonomy and SRH were collected shortly before and after the experiment. Pretest and posttest data were analyzed using an analysis of covariance. The results indicated that the average posttest scores of leisure autonomy and SRH in the experimental group were significantly higher than those in the control group. Implications of the results are discussed.

  5. Consequences of "Minimal" Group Affiliations in Children

    ERIC Educational Resources Information Center

    Dunham, Yarrow; Baron, Andrew Scott; Carey, Susan

    2011-01-01

    Three experiments (total N = 140) tested the hypothesis that 5-year-old children's membership in randomly assigned "minimal" groups would be sufficient to induce intergroup bias. Children were randomly assigned to groups and engaged in tasks involving judgments of unfamiliar in-group or out-group children. Despite an absence of information…

  6. The Effect of Aggressive Cartoons: Children's Interpersonal Play.

    ERIC Educational Resources Information Center

    Hapkiewicz, Walter G.; Roden, Aubrey H.

    Sixty second grade children were randomly assigned to same sex pairs and each pair was randomly assigned to one of three treatment groups: aggressive cartoon, nonaggressive cartoon, and no cartoon. Results indicated that there was no difference among the groups on measures of interpersonal aggression although boys exhibited significantly more…

  7. Compliance-Effect Correlation Bias in Instrumental Variables Estimators

    ERIC Educational Resources Information Center

    Reardon, Sean F.

    2010-01-01

    Instrumental variable estimators hold the promise of enabling researchers to estimate the effects of educational treatments that are not (or cannot be) randomly assigned but that may be affected by randomly assigned interventions. Examples of the use of instrumental variables in such cases are increasingly common in educational and social science…

  8. How to Improve the Peer Review Method: Free-Selection vs Assigned-Pair Protocol Evaluated in a Computer Networking Course

    ERIC Educational Resources Information Center

    Papadopoulos, Pantelis M.; Lagkas, Thomas D.; Demetriadis, Stavros N.

    2012-01-01

    This study provides field research evidence on the efficiency of a "free-selection" peer review assignment protocol as compared to the typically implemented "assigned-pair" protocol. The study employed 54 sophomore students who were randomly assigned into three groups: Assigned-Pair (AP) (the teacher assigns student works for review to student…

  9. A web-based approach to managing stress and mood disorders in the workforce.

    PubMed

    Billings, Douglas W; Cook, Royer F; Hendrickson, April; Dove, David C

    2008-08-01

    To evaluate the effectiveness of a web-based multimedia health promotion program for the workplace, designed to help reduce stress and to prevent depression, anxiety, and substance abuse. Using a randomized controlled trial design, 309 working adults were randomly assigned to the web-based condition or to a wait-list control condition. All participants were assessed on multiple self-reported outcomes at pretest and posttest. Relative to controls, the web-based group reduced their stress, increased their knowledge of depression and anxiety, developed more positive attitudes toward treatment, and adopted a more healthy approach to alcohol consumption. We found that a brief and easily adaptable web-based stress management program can simultaneously reduce worker stress and address stigmatized behavioral health problems by embedding this prevention material into a more positive stress management framework.

  10. Design and application of nickel-titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial.

    PubMed

    Chen, Xiao; Liu, Peng; Zhu, Xiaofei; Cao, Liehu; Zhang, Chuncai; Su, Jiacan

    2013-06-01

    We carried out this study to test the efficacy of the olecranon memory connector (OMC) in olecranon fractures. We designed a prospective randomised controlled trial involving 40 cases of olecranon fractures. From May 2004 to December 2009, 40 patients with olecranon fractures were randomly assigned into two groups. Twenty patients were treated with OMC, while another 20 patients were fixed with locking plates in our hospital. The DASH score, MEP score, range of motion and radiographs were used to evaluate the postoperative elbow function and complications. For MEP score, OMC was better than the locking plate; for DASH score, complication rate, and range of elbow motion, the two methods presented no significant difference. The study showed that OMC could be an effective alternative to treat olecranon fractures.

  11. Impact of the Good Behavior Game, a Universal Classroom–Based Behavior Intervention, on Young Adult Service Use for Problems with Emotions, Behavior, or Drugs or Alcohol

    PubMed Central

    Poduska, Jeanne; Kellam, Sheppard; Wang, Wei; Brown, C. Hendricks; Ialongo, Nicholas; Toyinbo, Peter

    2009-01-01

    Background The Good Behavior Game (GBG) is a classroom behavior management strategy focused on socializing children to the role of student and aimed at reducing early aggressive, disruptive behavior, a confirmed antecedent to service use. The GBG was tested in a randomized field trial in 19 elementary schools in two cohorts of children as they attended first and second grades. This article reports on the impact of the GBG on service use through young adulthood. Methods Three or four schools in each of five urban areas were matched and randomly assigned to one of three conditions: 1) GBG, 2) an intervention aimed at academic achievement, or 3) the standard program of the school system. Children were assigned to classrooms to ensure balance, and teachers and classrooms were randomly assigned to intervention conditions. Results This study provides evidence of a positive impact of a universal preventive intervention on later service use by males, although not by females, for problems with emotions, behavior, or drugs or alcohol. For both cohorts, males in GBG classrooms who had been rated as highly aggressive, disruptive by their teachers in the fall of first grade had a lower rate of school-based service use than their counterparts in control classrooms. Replication The design employed two cohorts of students. Although both first- and second-grade teachers received less training and support with the second cohorts of students than with the first cohort, the impact of GBG was similar across both cohorts. PMID:18249508

  12. Impact of Referral Source and Study Applicants’ Preference for Randomly Assigned Service on Research Enrollment, Service Engagement, and Evaluative Outcomes

    PubMed Central

    Macias, Cathaleene; Barreira, Paul; Hargreaves, William; Bickman, Leonard; Fisher, William; Aronson, Elliot

    2009-01-01

    Objective The inability to blind research participants to their experimental conditions is the Achilles’ heel of mental health services research. When one experimental condition receives more disappointed participants, or more satisfied participants, research findings can be biased in spite of random assignment. The authors explored the potential for research participants’ preference for one experimental program over another to compromise the generalizability and validity of randomized controlled service evaluations as well as cross-study comparisons. Method Three Cox regression analyses measured the impact of applicants’ service assignment preference on research project enrollment, engagement in assigned services, and a service-related outcome, competitive employment. Results A stated service preference, referral by an agency with a low level of continuity in outpatient care, and willingness to switch from current services were significant positive predictors of research enrollment. Match to service assignment preference was a significant positive predictor of service engagement, and mismatch to assignment preference was a significant negative predictor of both service engagement and employment outcome. Conclusions Referral source type and service assignment preference should be routinely measured and statistically controlled for in all studies of mental health service effectiveness to provide a sound empirical base for evidence-based practice. PMID:15800153

  13. Effects of interpretive nutrition labels on consumer food purchases: the Starlight randomized controlled trial.

    PubMed

    Ni Mhurchu, Cliona; Volkova, Ekaterina; Jiang, Yannan; Eyles, Helen; Michie, Jo; Neal, Bruce; Blakely, Tony; Swinburn, Boyd; Rayner, Mike

    2017-03-01

    Background: Nutrition labeling is a prominent policy to promote healthy eating. Objective: We aimed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases. Design: In this parallel-group randomized controlled trial, we enrolled household shoppers across New Zealand who owned smartphones and were aged ≥18 y. Eligible participants were randomly assigned (1:1:1) to receive either traffic light labels (TLLs), Health Star Rating labels (HSRs), or a control [nutrition information panel (NIP)]. Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens. The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period, which was measured by using the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC). Results: Between October 2014 and November 2015, 1357 eligible shoppers were randomly assigned to TLL ( n = 459), HSR ( n = 443), or NIP ( n = 455) labels. Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was -0.20 (95% CI: -0.94, 0.54; P = 0.60). The corresponding difference for HSR compared with NIP was -0.60 (95% CI: -1.35, 0.15; P = 0.12). In an exploratory per-protocol analysis of participants who used the labeling intervention more often than average ( n = 423, 31%), those who were assigned to TLL and HSR had significantly better NPSC scores [TLL compared with NIP: -1.33 (95% CI: -2.63, -0.04; P = 0.04); HSR compared with NIP: -1.70 (95% CI: -2.97, -0.43; P = 0.01)]. Shoppers who were randomly assigned to HSR and TLL also found the labels significantly more useful and easy to understand than the NIP (all P values <0.001). Conclusions: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases. However, shoppers who used interpretive labels found them to be significantly more useful and easy to understand, and compared with frequent NIP users, frequent TLL and HSR users had significantly healthier food purchases. This trial was registered at the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366446&isReview=true) as ACTRN12614000644662. © 2017 American Society for Nutrition.

  14. Effects of an alert system on implantable cardioverter defibrillator-related anxiety: rationale, design, and endpoints of the PANORAMIC multicentre trial.

    PubMed

    Duru, Firat; Dorian, Paul; Favale, Stefano; Perings, Christian; Pedersen, Susanne S; Willems, Vincent

    2010-05-01

    Implantable cardioverter defibrillators (ICD) can prevent sudden cardiac death by delivering high-energy shocks in patients at risk of life-threatening ventricular tachyarrhythmias. Patients may be anxious about receiving inappropriate shocks in case of device or lead system malfunction, or about failing to receive needed therapy for the same reason. New devices include programmable vibrating patient notifiers (PN), which, by warning patients of a possible device dysfunction, might lower device-related anxiety. PAtient NOtifier feature for Reduction of Anxiety: a Multicentre ICD study (PANORAMIC) is a multicentre, randomized, clinical trial designed to examine the effects of the awareness of an active vibrating alert system on device-related anxiety. The trial will randomly assign 356 patients in a 1:1 design to a control group (PN OFF) vs. a treatment group (PN ON). Patients will be followed for 12 months, with visits scheduled at 6 and 12 months. During clinical follow-up visits, the ICD will be interrogated, and all patients will complete the Hospital Anxiety and Depression Scale and a device-related anxiety questionnaire. The sensitivity and specificity of PN, the effect of personality on anxiety, using the Type D scale (DS14), the number of delivered appropriate and inappropriate ICD therapies, changes in anxiety related to the delivery of appropriate or inappropriate shocks, crossovers from the assigned group, the number of hospitalizations, and the mortality rate will also be assessed. ClinicalTrials.gov Identifier: NCT00559559.

  15. Using instrumental variables to disentangle treatment and placebo effects in blinded and unblinded randomized clinical trials influenced by unmeasured confounders

    NASA Astrophysics Data System (ADS)

    Chaibub Neto, Elias

    2016-11-01

    Clinical trials traditionally employ blinding as a design mechanism to reduce the influence of placebo effects. In practice, however, it can be difficult or impossible to blind study participants and unblinded trials are common in medical research. Here we show how instrumental variables can be used to quantify and disentangle treatment and placebo effects in randomized clinical trials comparing control and active treatments in the presence of confounders. The key idea is to use randomization to separately manipulate treatment assignment and psychological encouragement conversations/interactions that increase the participants’ desire for improved symptoms. The proposed approach is able to improve the estimation of treatment effects in blinded studies and, most importantly, opens the doors to account for placebo effects in unblinded trials.

  16. Effect of complementation of cattle cooling systems with feedline soakers on lactating dairy cows in a desert environment.

    PubMed

    Ortiz, X A; Smith, J F; Bradford, B J; Harner, J P; Oddy, A

    2011-02-01

    Two experiments were conducted on a commercial dairy farm in eastern Saudi Arabia to investigate the effects of Korral Kool (KK; Korral Kool Inc., Mesa, AZ) cattle cooling systems complemented with feedline soakers on core body temperature (CBT) of dairy cows. In both experiments, cows had access to KK 24h/d. In the first experiment, 7 primiparous and 6 multiparous lactating Holstein dairy cows were assigned to 1 of 2 pens, which were assigned randomly to treatment sequence over 4 d in a switchback design. Soakers were on (ON24) or off (OFF24) for 24h/d. For the second experiment, 20 multiparous lactating Holstein cows were assigned randomly to 1 of 2 pens, which were assigned randomly to treatment sequence in a switchback design. This experiment lasted 4 d and feedline soakers alternately remained off or were on (ON12) for 12h/d. In experiment 1, average ambient temperature was 30 ± 0.9°C and average relative humidity was 44 ± 14% (mean ± SD). Feedline soakers complementing KK systems for 24 h/d decreased the mean CBT of lactating dairy cows compared with KK systems alone (38.80 vs. 38.98 ± 0.061°C, respectively). A significant treatment by time interaction was found. The greatest treatment effects occurred at 2100 h; treatment means at this time were 39.26 and 38.85 ± 0.085°C for OFF24 and ON24 treatments, respectively. In experiment 2, average ambient temperature was 35 ± 1.5°C and average relative humidity was 33 ± 16%. Feedline soakers running for 12 h/d significantly decreased the mean 24-h CBT from 39.16 to 38.99 ± 0.084°C. Treatment by time interaction was also significant; the greatest treatment effects occurred at 1500 h, when ON12 reduced CBT from 39.38 to 38.81 ± 0.088°C. These results demonstrate that complementing the KK system with feedline soakers decreased the CBT of dairy cows housed in desert environments. However, the combined systems were not sufficient to lower CBT to normal temperatures in this extreme environment. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  17. The effect of asthma education program on knowledge of school teachers: a randomized controlled trial.

    PubMed

    Kawafha, Mariam M; Tawalbeh, Loai Issa

    2015-04-01

    The purpose of this study was to examine the effect of an asthma education program on schoolteachers' knowledge. Pre-test-post-test experimental randomized controlled design was used. A multistage-cluster sampling technique was used to randomly select governorate, primary schools, and schoolteachers. Schoolteachers were randomly assigned either to the experimental group (n = 36) and attended three educational sessions or to the control group (n = 38) who did not receive any intervention. Knowledge about asthma was measured using the Asthma General Knowledge Questionnaire for Adults (AGKQA). The results indicated that teachers in the experimental group showed significantly (p < .001) higher knowledge of asthma in the first post-test and the second post-test compared with those in the control group. Implementing asthma education enhanced schoolteachers' knowledge of asthma. The asthma education program should target schoolteachers to improve knowledge about asthma. © The Author(s) 2014.

  18. Design of a factorial experiment with randomization restrictions to assess medical device performance on vascular tissue

    PubMed Central

    2011-01-01

    Background Energy-based surgical scalpels are designed to efficiently transect and seal blood vessels using thermal energy to promote protein denaturation and coagulation. Assessment and design improvement of ultrasonic scalpel performance relies on both in vivo and ex vivo testing. The objective of this work was to design and implement a robust, experimental test matrix with randomization restrictions and predictive statistical power, which allowed for identification of those experimental variables that may affect the quality of the seal obtained ex vivo. Methods The design of the experiment included three factors: temperature (two levels); the type of solution used to perfuse the artery during transection (three types); and artery type (two types) resulting in a total of twelve possible treatment combinations. Burst pressures of porcine carotid and renal arteries sealed ex vivo were assigned as the response variable. Results The experimental test matrix was designed and carried out as a split-plot experiment in order to assess the contributions of several variables and their interactions while accounting for randomization restrictions present in the experimental setup. The statistical software package SAS was utilized and PROC MIXED was used to account for the randomization restrictions in the split-plot design. The combination of temperature, solution, and vessel type had a statistically significant impact on seal quality. Conclusions The design and implementation of a split-plot experimental test-matrix provided a mechanism for addressing the existing technical randomization restrictions of ex vivo ultrasonic scalpel performance testing, while preserving the ability to examine the potential effects of independent factors or variables. This method for generating the experimental design and the statistical analyses of the resulting data are adaptable to a wide variety of experimental problems involving large-scale tissue-based studies of medical or experimental device efficacy and performance. PMID:21599963

  19. Effectiveness of health education to increase screening for cervical cancer among eastern-band Cherokee Indian women in North Carolina.

    PubMed

    Dignan, M; Michielutte, R; Blinson, K; Wells, H B; Case, L D; Sharp, P; Davis, S; Konen, J; McQuellon, R P

    1996-11-20

    The North Carolina Native American Cervical Cancer Prevention Project was a 5-year, National Cancer Institute-funded trial of health education designed to increase screening for cervical cancer among Native-American women in North Carolina. This study was conducted to evaluate the effectiveness of this education program in the Eastern-Band Cherokee target population. Cherokee tribal lands were mapped and all households (N = 2223) were listed to ensure maximum coverage of the eligible population (women, aged 18 years and older, who were enrolled tribal members). Eligible women were identified by the use of a brief questionnaire administered to an adult member of the household. Of the 1279 households with eligible women, 1020 (79.8%) agreed to participate. The intervention was an individualized health education program delivered by female Cherokee lay health educators. The participants were randomly assigned to receive or not to receive the intervention (i.e., to program and control groups, respectively) by use of the Solomon Four-Group design. Data were collected in face-to-face interviews conducted in the participant's home. Of the 996 women who were ultimately enrolled, 540 were randomly assigned to receive a pretest (preintervention) interview that involved administration of a 96-item questionnaire designed to collect data on knowledge, intentions, and behaviors related to cervical cancer; of these 540 women, 263 were randomly assigned to receive the education program. The remaining 456 women did not receive the pretest, but 218 were randomly assigned to receive the education program. Six months after receiving the education program, the women in all four groups were administered a post-test that was identical to the pretest. Logistic regression was used to assess the effects of the pretest and the educational program. All P values resulted from two-sided statistical tests. Eight hundred and fifteen (81.8%) of the 996 participants completed the post-test interview. The remaining 181 women who were lost to follow-up were evenly distributed among the four study groups. At the post-test, 282 (73.2%) of the 385 women who received the education program reported having had a Pap smear following the intervention, compared with 275 (64%) of the 430 control subjects. Women who received the education program were more likely to answer all knowledge items correctly on the post-test (odds ratio [OR] = 2.18, 95% confidence interval [CI] = 1.08-4.39) and to report having obtained a Pap smear in the past year (OR = 2.06, 95% CI = 1.14-3.72) than women in the control groups. Women who received the education program exhibited a greater knowledge about cervical cancer prevention and were more likely to have reported having had a Pap smear within the past year than women who did not receive the program.

  20. Effects of individualized assignments on biology achievement

    NASA Astrophysics Data System (ADS)

    Kremer, Philip L.

    A pretest-posttest, randomized, two groups, experimental, factorial design compared effects of detailed and nondetailed assignments on biology achievement over seven and a half months. Detailed assignments (favoring field independence and induction) employed block diagrams and stepwise directions. Nondetailed assignments (favoring field dependence and deduction) virtually lacked these. The accessible population was 101 tenth grade preparatory school male students. The 95 students enrolled in first year biology constituted the sample. Two by three ANOVA was done on residualized posttest score means of the students. Totally, the detailed students achieved significantly higher than the nondetailed students. This significantly higher achievement was only true of detailed students in the middle thirds of the deviation intelligence quotient (DIQ) range and of the grade point average (G.P.A.) range after the breakdown into upper, middle, and lower thirds of intellectual capability (ability and achievement). The upper third detailed DIQ grouping indirectly achieved higher than its peers, whereas the lower detailed DIQ third achieved lower than its peers. Thus, high capability students apparently benefit from flow and block diagrams, inductions, field independence, and high structure, whereas low capability students may be hindered by these.

  1. The effect of yoga in stress reduction for dental students performing their first periodontal surgery: A randomized controlled study

    PubMed Central

    Shankarapillai, Rajesh; Nair, Manju Anathakrishnan; George, Roy

    2012-01-01

    Context: The dental students experience a lot of stress, which increase when they perform their first surgical procedure. Yoga as an anxiolytic tool in anxiety reduction has been practiced over centuries in India. Aim: To assess the efficacy of yoga in reducing the state trait anxiety of dental students before their first periodontal surgery performance. Settings and Design: A randomized controlled study using a two-way split plot design (pre-post-test) was conducted in the department of periodontics, Pacific Dental College, Udaipur, India. Materials and Methods: One hundred clinical dental students who were ready to perform their first periodontal surgery were selected. Students were randomly assigned to two groups and were given a 60-min session on stress reduction. Group A, yogic intervention group, were instructed to do yoga and their performances were monitored for a period of one week and Group B, control group, were given a lecture on stress reduction without any yoga instructions. The investigator who was unaware of the groups had taken the state trait anxiety score of the students three times a) before assigning them to each group, b) prior to the surgical procedure and c) immediately after the performance of surgery. Statistical Analysis Used: Analyses of variance (ANOVA) by SPSS V.16. Results: The statistical results showed a significant reduction in the VAS and state trait anxiety of Group A compared to Group B (ANOVA; P<0.001). Conclusions: This study concludes that Yogic breathing has a significant effect on the reduction of state trait anxiety level of dental students. PMID:22346066

  2. Acute changes of hip joint range of motion using selected clinical stretching procedures: A randomized crossover study.

    PubMed

    Hammer, Adam M; Hammer, Roger L; Lomond, Karen V; O'Connor, Paul

    2017-12-01

    Hip adductor flexibility and strength is an important component of athletic performance and many activities of daily living. Little research has been done on the acute effects of a single session of stretching on hip abduction range of motion (ROM). The aim of this study was to compare 3 clinical stretching procedures against passive static stretching and control on ROM and peak isometric maximal voluntary contraction (MVC). Using a randomized crossover study design, a total of 40 participants (20 male and 20 female) who had reduced hip adductor muscle length attended a familiarization session and 5 testing sessions on non-consecutive days. Following the warm-up and pre-intervention measures of ROM and MVC, participants were randomly assigned 1 of 3 clinical stretching procedures (modified lunge, multidirectional, and joint mobilization) or a static stretch or control condition. Post-intervention measures of ROM and MVC were taken immediately following completion of the assigned condition. An ANOVA using a repeated measure design with the change score was conducted. All interventions resulted in small but statistically significant (p < 0.05) increases (1.0°-1.7°) in ROM with no inter-condition differences except one. Multidirectional stretching was greater than control (p = 0.031). These data suggest that a single session of stretching has only a minimal effect on acute changes of hip abduction ROM. Although hip abduction is a frontal plane motion, to effectively increase the extensibility of the structures that limit abduction, integrating multi-planar stretches may be indicated. Copyright © 2017 Elsevier Ltd. All rights reserved.

  3. Family-School Intervention for Children with ADHD: Results of Randomized Clinical Trial

    PubMed Central

    Power, Thomas J.; Mautone, Jennifer A.; Soffer, Stephen L.; Clarke, Angela T.; Marshall, Stephen A.; Sharman, Jaclyn; Blum, Nathan J.; Glanzman, Marianne; Elia, Josephine; Jawad, Abbas F.

    2012-01-01

    Accumulating evidence highlights the importance of using psychosocial approaches to intervention for children with ADHD that target the family and school, as well as the intersection of family and school. Objective This study was designed to evaluate the effectiveness of a family-school intervention, referred to as Family-School Success (FSS), designed to improve the family and educational functioning of students in grades 2 through 6 who meet criteria for ADHD combined and inattentive types. Key components of FSS were conjoint behavioral consultation, daily report cards, and behavioral homework interventions. Methods FSS was provided over the course of 12 weekly sessions, which included 6 group sessions, 4 individualized family sessions, and 2 school-based consultations. Families participating in the study were given the choice of placing their children on medication; 43% of children were on medication at the time of random assignment. Children (n=199) were randomly assigned to FSS or a comparison group controlling for non-specific treatment effects. Outcomes were assessed at post intervention and 3-month follow-up. The analyses controlled for child medication status. Results Study findings indicated that FSS had a significant effect on the quality of the family-school relationship, homework performance, and parenting behavior. Conclusions The superiority of FSS was demonstrated even though about 40% of the participants in FSS and CARE were on an optimal dose of medication and there were significant Time effects on each measure. This relatively brief intervention was able to produce effect sizes that were comparable to those of the more intensive MTA behavioral intervention. PMID:22506793

  4. Circle of life: rationale, design, and baseline results of an HIV prevention intervention among young American Indian adolescents of the Northern Plains.

    PubMed

    Kaufman, Carol E; Mitchell, Christina M; Beals, Janette; Desserich, Jennifer A; Wheeler, Cindy; Keane, Ellen M; Whitesell, Nancy Rumbaugh; Sam, Angela; Sedey, Cory

    2010-03-01

    In spite of significant disparities in sexual health outcomes for American Indian youth, no studies exist examining the effectiveness of HIV-prevention interventions. Circle of Life is an HIV-prevention intervention specifically developed for American Indian middle-school youth. We describe the rationale, methodology, and baseline results of a longitudinal randomized trial of Circle of Life conducted among American Indian youth aged 11-15 in a reservation community. The innovative design includes two pre-intervention waves to determine patterns of behavior prior to the intervention that might be associated with a differential impact of the intervention on sexual risk. We used one-way analysis of variance and chi-square tests to test for significant differences between randomized group assignment at each baseline wave and generalized estimating equations (GEE) to test significant differences in the rate of change in outcomes by group longitudinally. We present the collaborative and adaptive strategies for consenting, assenting, and data collection methodology in this community. Achieved response rates are comparable to other similar studies. Results from the two baseline waves indicate that few outcomes significantly varied by randomized intervention assignment. Ten percent of youth reported having had sex at Wave 1, rising to 15% at Wave 2. Among those who had had sex, the majority (>70%) reported using a condom at last sex. The project is well positioned to carry out the longitudinal assessments of the intervention to determine the overall impact of the Circle of Life and the differential impact by pre-intervention patterns of behavior across youth.

  5. “Fair Play”: A Videogame Designed to Address Implicit Race Bias Through Active Perspective Taking

    PubMed Central

    Kaatz, Anna; Chu, Sarah; Ramirez, Dennis; Samson-Samuel, Clem; Carnes, Molly

    2014-01-01

    Abstract Objective: Having diverse faculty in academic health centers will help diversify the healthcare workforce and reduce health disparities. Implicit race bias is one factor that contributes to the underrepresentation of Black faculty. We designed the videogame “Fair Play” in which players assume the role of a Black graduate student named Jamal Davis. As Jamal, players experience subtle race bias while completing “quests” to obtain a science degree. We hypothesized that participants randomly assigned to play the game would have greater empathy for Jamal and lower implicit race bias than participants randomized to read narrative text describing Jamal's experience. Materials and Methods: University of Wisconsin–Madison graduate students were recruited via e-mail and randomly assigned to play “Fair Play” or read narrative text through an online link. Upon completion, participants took an Implicit Association Test to measure implicit bias and answered survey questions assessing empathy toward Jamal and awareness of bias. Results: As hypothesized, gameplayers showed the least implicit bias but only when they also showed high empathy for Jamal (P=0.013). Gameplayers did not show greater empathy than text readers, and women in the text condition reported the greatest empathy for Jamal (P=0.008). However, high empathy only predicted lower levels of implicit bias among those who actively took Jamal's perspective through gameplay (P=0.014). Conclusions: A videogame in which players experience subtle race bias as a Black graduate student has the potential to reduce implicit bias, possibly because of a game's ability to foster empathy through active perspective taking. PMID:26192644

  6. Effects of Students' Participation in Authoring of Multimedia Materials on Student Acquisition of Vocabulary.

    ERIC Educational Resources Information Center

    Nikolova, Ofelia R.

    2002-01-01

    Investigated the effects on vocabulary acquisition of student participation in authoring a multimedia institutional module. Sixty-two subjects were randomly assigned to two groups, and each group was randomly assigned to one of two treatments. Showed evidence that students learn vocabulary significantly better when they participate in the creation…

  7. Random Assignment and Informed Consent: A Case Study of Multiple Perspectives

    ERIC Educational Resources Information Center

    Walker, Robert; Hoggart, Lesley; Hamilton, Gayle

    2008-01-01

    Although random assignment is generally the preferred methodology in impact evaluations, it raises numerous ethical concerns, some of which are addressed by securing participants' informed consent. However, there has been little investigation of how consent is obtained in social experiments and the amount of information that can be conveyed--and…

  8. Does Autonomy over Teacher Hiring Affect Student Math and Science Achievement?

    ERIC Educational Resources Information Center

    Kim, Youngran

    2017-01-01

    This paper examines the causal effects of autonomy over teacher hiring on student math and science achievement using the random student assignment policy implemented in Korea. Under this policy, students were randomly assigned to different schools within their school districts which equalized the compositions of student bodies across schools.…

  9. Representing "Us" and "Them": Building Blocks of Intergroup Cognition

    ERIC Educational Resources Information Center

    Baron, Andrew Scott; Dunham, Yarrow

    2015-01-01

    Three experiments explored whether group membership affects the acquisition of richer information about social groups. Employing a minimal-groups paradigm, 6- to 8-year-olds were randomly assigned to 1 of 2 novel social groups. Experiment 1 demonstrated that immediately following random assignment to a novel group, children were more likely to…

  10. Entre Dos Mundos/Between Two Worlds: Youth Violence Prevention for Acculturating Latino Families

    ERIC Educational Resources Information Center

    Smokowski, Paul R.; Bacallao, Martica

    2009-01-01

    Objective: This study evaluated the efficacy of Entre Dos Mundos/Between Two Worlds (EDM) prevention for Latino adolescents. Method: In an experimental trial to compare implementation formats, 41 Latino families were randomly assigned to EDM action-oriented skills training groups, and 47 families were randomly assigned to unstructured EDM support…

  11. One-Year Outcomes of a Randomized Clinical Trial Treating Depression in Low-Income Minority Women

    ERIC Educational Resources Information Center

    Miranda, Jeanne; Green, Bonnie L.; Krupnick, Janice L.; Chung, Joyce; Siddique, Juned; Belin, Tom; Revicki, Dennis

    2006-01-01

    This study examines 1-year depressive symptom and functional outcomes of 267 predominantly low-income, young minority women randomly assigned to antidepressant medication, group or individual cognitive-behavioral therapy (CBT), or community referral. Seventy-six percent assigned to medications received 9 or more weeks of guideline-concordant doses…

  12. 75 FR 69126 - Proposed Information Collection Request (ICR) for the Workforce Investment Act Random Assignment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... Random Assignment Impact Evaluation of the Adult and Dislocated Worker Program; Comment Request AGENCY... fragmented system of employment and training programs under JTPA and providing universal access to basic (core) services. To determine whether the adult and dislocated worker services funded by Title I of the...

  13. Auditing the Assignments of Top-Level Semantic Types in the UMLS Semantic Network to UMLS Concepts

    PubMed Central

    He, Zhe; Perl, Yehoshua; Elhanan, Gai; Chen, Yan; Geller, James; Bian, Jiang

    2018-01-01

    The Unified Medical Language System (UMLS) is an important terminological system. By the policy of its curators, each concept of the UMLS should be assigned the most specific Semantic Types (STs) in the UMLS Semantic Network (SN). Hence, the Semantic Types of most UMLS concepts are assigned at or near the bottom (leaves) of the UMLS Semantic Network. While most ST assignments are correct, some errors do occur. Therefore, Quality Assurance efforts of UMLS curators for ST assignments should concentrate on automatically detected sets of UMLS concepts with higher error rates than random sets. In this paper, we investigate the assignments of top-level semantic types in the UMLS semantic network to concepts, identify potential erroneous assignments, define four categories of errors, and thus provide assistance to curators of the UMLS to avoid these assignments errors. Human experts analyzed samples of concepts assigned 10 of the top-level semantic types and categorized the erroneous ST assignments into these four logical categories. Two thirds of the concepts assigned these 10 top-level semantic types are erroneous. Our results demonstrate that reviewing top-level semantic type assignments to concepts provides an effective way for UMLS quality assurance, comparing to reviewing a random selection of semantic type assignments. PMID:29375930

  14. Auditing the Assignments of Top-Level Semantic Types in the UMLS Semantic Network to UMLS Concepts.

    PubMed

    He, Zhe; Perl, Yehoshua; Elhanan, Gai; Chen, Yan; Geller, James; Bian, Jiang

    2017-11-01

    The Unified Medical Language System (UMLS) is an important terminological system. By the policy of its curators, each concept of the UMLS should be assigned the most specific Semantic Types (STs) in the UMLS Semantic Network (SN). Hence, the Semantic Types of most UMLS concepts are assigned at or near the bottom (leaves) of the UMLS Semantic Network. While most ST assignments are correct, some errors do occur. Therefore, Quality Assurance efforts of UMLS curators for ST assignments should concentrate on automatically detected sets of UMLS concepts with higher error rates than random sets. In this paper, we investigate the assignments of top-level semantic types in the UMLS semantic network to concepts, identify potential erroneous assignments, define four categories of errors, and thus provide assistance to curators of the UMLS to avoid these assignments errors. Human experts analyzed samples of concepts assigned 10 of the top-level semantic types and categorized the erroneous ST assignments into these four logical categories. Two thirds of the concepts assigned these 10 top-level semantic types are erroneous. Our results demonstrate that reviewing top-level semantic type assignments to concepts provides an effective way for UMLS quality assurance, comparing to reviewing a random selection of semantic type assignments.

  15. The impact of rehabilitation and counseling services on the labor market activity of Social Security Disability Insurance (SSDI) beneficiaries.

    PubMed

    Weathers, Robert R; Bailey, Michelle Stegman

    2014-01-01

    We use data from a social experiment to estimate the impact of a rehabilitation and counseling program on the labor market activity of newly entitled Social Security Disability Insurance (SSDI) beneficiaries. Our results indicate that the program led to a 4.6 percentage point increase in the receipt of employment services within the first year following random assignment and a 5.1 percentage point increase in participation in the Social Security Administration's Ticket to Work program within the first three years following random assignment. The program led to a 5.3 percentage point increase, or almost 50 percent increase, in employment, and an $831 increase in annual earnings in the second calendar year after the calendar year of random assignment. The employment and earnings impacts are smaller and not statistically significant in the third calendar year following random assignment, and we describe SSDI rules that are consistent with this finding. Our findings indicate that disability reform proposals focusing on restoring the work capacity of people with disabilities can increase the disability employment rate.

  16. The Effectiveness of Computer Supported versus Real Laboratory Inquiry Learning Environments on the Understanding of Direct Current Electricity among Pre-Service Elementary School Teachers

    ERIC Educational Resources Information Center

    Baser, Mustafa; Durmus, Soner

    2010-01-01

    The purpose of this study was to compare the changes in conceptual understanding of Direct Current Electricity (DCE) in virtual (VLE) and real laboratory environment (RLE) among pre-service elementary school teachers. A pre- and post-test experimental design was used with two different groups. One of the groups was randomly assigned to VLE (n =…

  17. An Experimental Study of a Televised Science Series, Grades 1-4, Comparing the Quality and Sequence of Television and Classroom Questions with a Proposed Strategy of Science Instruction.

    ERIC Educational Resources Information Center

    Beisenherz, Paul Chalmers

    The effectiveness of a televised science series used in the Seattle metropolitan area was investigated, using factorial design to provide a treatment variable representing four degrees of utilization of TV science and non-TV science. Teachers and their intact classes were randomly assigned to one of four treatment groups: TV science only, plus…

  18. Imprint of DESI fiber assignment on the anisotropic power spectrum of emission line galaxies

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Pinol, Lucas; Cahn, Robert N.; Hand, Nick

    The Dark Energy Spectroscopic Instrument (DESI), a multiplexed fiber-fed spectrograph, is a Stage-IV ground-based dark energy experiment aiming to measure redshifts for 29 million Emission-Line Galaxies (ELG), 4 million Luminous Red Galaxies (LRG), and 2 million Quasi-Stellar Objects (QSO). The survey design includes a pattern of tiling on the sky, the locations of the fiber positioners in the focal plane of the telescope, and an observation strategy determined by a fiber assignment algorithm that optimizes the allocation of fibers to targets. This strategy allows a given region to be covered on average five times for a five-year survey, with amore » typical variation of about 1.5 about the mean, which imprints a spatially-dependent pattern on the galaxy clustering. We investigate the systematic effects of the fiber assignment coverage on the anisotropic galaxy clustering of ELGs and show that, in the absence of any corrections, it leads to discrepancies of order ten percent on large scales for the power spectrum multipoles. We introduce a method where objects in a random catalog are assigned a coverage, and the mean density is separately computed for each coverage factor. We show that this method reduces, but does not eliminate the effect. We next investigate the angular dependence of the contaminated signal, arguing that it is mostly localized to purely transverse modes. We demonstrate that the cleanest way to remove the contaminating signal is to perform an analysis of the anisotropic power spectrum P ( k ,μ) and remove the lowest μ bin, leaving μ > 0 modes accurate at the few-percent level. Here, μ is the cosine of the angle between the line-of-sight and the direction of k-vector . We also investigate two alternative definitions of the random catalog and show that they are comparable but less effective than the coverage randoms method.« less

  19. Prophylactic Catheter Ablation for the Prevention of Defibrillator Therapy

    PubMed Central

    Reddy, Vivek Y.; Reynolds, Matthew R.; Neuzil, Petr; Richardson, Allison W.; Taborsky, Milos; Jongnarangsin, Krit; Kralovec, Stepan; Sediva, Lucie; Ruskin, Jeremy N.; Josephson, Mark E.

    2008-01-01

    BACKGROUND For patients who have a ventricular tachyarrhythmic event, implantable cardioverter–defibrillators (ICDs) are a mainstay of therapy to prevent sudden death. However, ICD shocks are painful, can result in clinical depression, and do not offer complete protection against death from arrhythmia. We designed this randomized trial to examine whether prophylactic radiofrequency catheter ablation of arrhythmogenic ventricular tissue would reduce the incidence of ICD therapy. METHODS Eligible patients with a history of a myocardial infarction underwent defibrillator implantation for spontaneous ventricular tachycardia or fibrillation. The patients did not receive antiarrhythmic drugs. Patients were randomly assigned to defibrillator implantation alone or defibrillator implantation with adjunctive catheter ablation (64 patients in each group). Ablation was performed with the use of a substrate-based approach in which the myocardial scar is mapped and ablated while the heart remains predominantly in sinus rhythm. The primary end point was survival free from any appropriate ICD therapy. RESULTS The mortality rate 30 days after ablation was zero, and there were no significant changes in ventricular function or functional class during the mean (±SD) follow-up period of 22.5±5.5 months. Twenty-one patients assigned to defibrillator implantation alone (33%) and eight patients assigned to defibrillator implantation plus ablation (12%) received appropriate ICD therapy (antitachycardia pacing or shocks) (hazard ratio in the ablation group, 0.35; 95% confidence interval, 0.15 to 0.78, P = 0.007). Among these patients, 20 in the control group (31%) and 6 in the ablation group (9%) received shocks (P = 0.003). Mortality was not increased in the group assigned to ablation as compared with the control group (9% vs. 17%, P = 0.29). CONCLUSIONS In this randomized trial, prophylactic substrate-based catheter ablation reduced the incidence of ICD therapy in patients with a history of myocardial infarction who received ICDs for the secondary prevention of sudden death. (Current Controlled Trials number, ISRCTN62488166.) PMID:18160685

  20. Imprint of DESI fiber assignment on the anisotropic power spectrum of emission line galaxies

    NASA Astrophysics Data System (ADS)

    Pinol, Lucas; Cahn, Robert N.; Hand, Nick; Seljak, Uroš; White, Martin

    2017-04-01

    The Dark Energy Spectroscopic Instrument (DESI), a multiplexed fiber-fed spectrograph, is a Stage-IV ground-based dark energy experiment aiming to measure redshifts for 29 million Emission-Line Galaxies (ELG), 4 million Luminous Red Galaxies (LRG), and 2 million Quasi-Stellar Objects (QSO). The survey design includes a pattern of tiling on the sky, the locations of the fiber positioners in the focal plane of the telescope, and an observation strategy determined by a fiber assignment algorithm that optimizes the allocation of fibers to targets. This strategy allows a given region to be covered on average five times for a five-year survey, with a typical variation of about 1.5 about the mean, which imprints a spatially-dependent pattern on the galaxy clustering. We investigate the systematic effects of the fiber assignment coverage on the anisotropic galaxy clustering of ELGs and show that, in the absence of any corrections, it leads to discrepancies of order ten percent on large scales for the power spectrum multipoles. We introduce a method where objects in a random catalog are assigned a coverage, and the mean density is separately computed for each coverage factor. We show that this method reduces, but does not eliminate the effect. We next investigate the angular dependence of the contaminated signal, arguing that it is mostly localized to purely transverse modes. We demonstrate that the cleanest way to remove the contaminating signal is to perform an analysis of the anisotropic power spectrum P(k,μ) and remove the lowest μ bin, leaving μ > 0 modes accurate at the few-percent level. Here, μ is the cosine of the angle between the line-of-sight and the direction of vec k. We also investigate two alternative definitions of the random catalog and show that they are comparable but less effective than the coverage randoms method.

  1. Effects of angiotensin-converting enzyme inhibition on transient ischemia: the Quinapril Anti-Ischemia and Symptoms of Angina Reduction (QUASAR) trial.

    PubMed

    Pepine, Carl J; Rouleau, Jean-Lucien; Annis, Karen; Ducharme, Anique; Ma, Patrick; Lenis, Jacques; Davies, Richard; Thadani, Udho; Chaitman, Bernard; Haber, Harry E; Freedman, S Ben; Pressler, Milton L; Pitt, Bertram

    2003-12-17

    We sought to determine whether angiotensin-converting enzyme inhibition (ACE-I) (i.e., quinapril) prevents transient ischemia (exertional and spontaneous) in patients with coronary artery disease (CAD). It is known that ACE-I reduces the risk of death, myocardial infarction (MI), and other CAD-related outcomes in high-risk patients. Numerous studies have confirmed that ACE-I improves coronary flow and endothelial function. Whether ACE-I also decreases transient ischemia is unclear, because no studies have been adequately designed or sufficiently powered to evaluate this issue. Using a randomized, double-blinded, placebo-controlled, multicenter design, we enrolled 336 CAD patients with stable angina. None had uncontrolled hypertension, left ventricular (LV) dysfunction, or recent MI, and all developed electrocardiographic (ECG) evidence of ischemia during exercise. They were randomly assigned to one of two groups: 40 mg/day quinapril (n = 177) or placebo (n = 159) for 8 weeks. Patients then entered an additional eight-week treatment phase to examine the full dose range. Those assigned to 40 mg quinapril continued that dose and those assigned to placebo were titrated to 80 mg/day. Treadmill testing, the Seattle Angina Questionnaire, and ambulatory ECG monitoring were used to assess responses at baseline and at 8 and 16 weeks. The groups did not differ significantly at entry or in terms of indexes assessing myocardial ischemia at 8 or 16 weeks of treatment. In this low-risk population, ACE-I was not associated with serious adverse events. Our findings suggest short-term ACE-I in CAD patients without hypertension, LV dysfunction, or acute MI is not associated with significant effects on transient ischemia.

  2. Transcendental Meditation and Reduced Trauma Symptoms in Female Inmates: A Randomized Controlled Study

    PubMed Central

    Nidich, Sanford; Seng, Angela; Compton, Blaze; O’Connor, Tom; Salerno, John W; Nidich, Randi

    2017-01-01

    Context: Compared with the general population, trauma experiences are higher among incarcerated women. Objective: To evaluate the effects of Transcendental Meditation (TM) on trauma symptoms in female offenders. Design: Twenty-two inmates at the Coffee Creek Correctional Facility in Wilsonville, OR, with at least 4 months left of incarceration were enrolled in this randomized controlled pilot study. Subjects were randomly assigned to either the TM group (n = 11) or a wait-list control group (n = 11). Main Outcome Measures: Subjects were measured at baseline and 4-month posttest using the Posttraumatic Stress Disorder Checklist-Civilian version (PCL-C; primary outcome) with intrusive thoughts, avoidance, and hyperarousal subscales (secondary outcomes). Twenty of the subjects (10 in each group) took part in their treatment assignment and completed posttesting. Results: Significant reductions were found on total trauma (p < 0.036), intrusive thoughts (p < 0.026), and hyperarousal (p < 0.043) on the PCL-C. Effect sizes ranged from 0.65 to 0.99 for all variables. Eighty-one percent of the TM subjects were compliant with their program. Conclusion: The results of this study indicate feasibility of the TM program in a female prison population and suggest that TM may be an effective tool for decreasing trauma symptoms. Future large-scale research is warranted. PMID:28333611

  3. A Randomized Controlled Trial of Two Syntactic Treatment Procedures With Cantonese-Speaking, School-Age Children With Language Disorders.

    PubMed

    To, Carol K S; Lui, Hoi Ming; Li, Xin Xin; Lam, Gary Y H

    2015-08-01

    In this study, we aimed to evaluate the efficacy of sentence-combining (SC) and narrative-based (NAR) intervention approaches to syntax intervention using a randomized-controlled-trial design. Fifty-two Cantonese-speaking, school-age children with language impairment were assigned randomly to either the SC or the NAR treatment arm. Seven children did not receive treatment as assigned. Intervention in both arms targeted the same complex syntactical structures. The SC group focused on sentence combination training, whereas the NAR group made use of narratives in which the target structures were embedded. Pretest and posttest performances measured using a standardized language assessment were subjected to analyses of covariance mixed-effect-model analyses of variance. Children in both treatment arms demonstrated significant growth after 4 months of intervention. The main effect between treatment arms and time was not significant after controlling the pretest performance, suggesting that both treatment approaches showed similar effects. The main effect of time was significant. This study provided evidence to support language intervention in the school years in Cantonese-speaking children. However, neither approach was shown to be more efficacious than the other. Future researchers could examine the effects of a longer treatment period and include functional outcome measures.

  4. The effectiveness of propolis on gingivitis: a randomized controlled trial.

    PubMed

    Bretz, Walter A; Paulino, Niraldo; Nör, Jacques E; Moreira, Alexandre

    2014-12-01

    A randomized, double-blind, controlled clinical trial was conducted to evaluate the effectiveness of a propolis rinse on induced gingivitis by using the co-twin study design. Twenty-one twin pairs (n=42) were enrolled in a gingivitis study with oral hygiene promotion (14 days) and gingivitis induction (21 days). During the gingivitis induction phase, one member of the twin pair was randomly assigned to a 2% typified propolis rinse, and the other was assigned a color-matched 0.05% sodium fluoride plus 0.05% cetylpyridinium chloride rinse (positive control). Patients rinsed twice daily with 20 mL for 30 seconds for 21 days. Gingivitis was measured on days -14 (baseline), 0 (after hygiene phase), and 21 (after no-hygiene phase) by using the Papillary Bleeding Score (PBS) and by standard digital imaging of the gum tissues (G-parameter). The 38 persons who completed the study (age 13-22 years) were well balanced according to PBS at baseline and G-parameter after the initial hygiene phase. After 21 days without oral hygiene, the propolis rinse and positive control rinse groups did not differ significantly for average PBS measurements or G-parameter. Use of a 2% typified propolis rinse was equivalent to a positive control rinse during a 21-day no-hygiene period.

  5. CONTEXTUAL INTERFERENCE AND INTROVERSION/EXTRAVERSION IN MOTOR LEARNING.

    PubMed

    Meira, Cassio M; Fairbrother, Jeffrey T; Perez, Carlos R

    2015-10-01

    The Introversion/Extraversion dimension may interact with contextual interference, as random and blocked practice schedules imply distinct levels of variation. This study investigated the effect of different practice schedules in the acquisition of a motor skill in extraverts and introverts. Forty male undergraduate students (M = 24.3 yr., SD = 5.6) were classified as extraverts (n = 20) and introverts (n = 20) by the Eysenck Personality Questionnaire and allocated in one of two practice schedules with different levels of contextual interference: blocked (low contextual interference) and random (high contextual interference). Half of each group was assigned to a blocked practice schedule, and the other half was assigned to a random practice schedule. The design had two phases: acquisition and transfer (5 min. and 24 hr.). The participants learned variations of a sequential timing keypressing task. Each variation required the same sequence but different timing; three variations were used in acquisition, and one variation of intermediate length was used in transfer. Results for absolute error and overall timing error (root mean square error) indicated that the contextual interference effect was more pronounced for introverts. In addition, introverts who practiced according to the blocked schedule committed more errors during the 24-hr. transfer, suggesting that introverts did not appear to be challenged by a low contextual interference practice schedule.

  6. Three lessons from a randomized trial of massage and meditation at end of life: patient benefit, outcome measure selection, and design of trials with terminally ill patients.

    PubMed

    Downey, Lois; Engelberg, Ruth A; Standish, Leanna J; Kozak, Leila; Lafferty, William E

    2009-01-01

    Improving end-of-life care is a priority in the United States, but assigning priorities for standard care services requires evaluations using appropriate study design and appropriate outcome indicators. A recent randomized controlled trial with terminally ill patients produced no evidence of benefit from massage or guided meditation, when evaluated with measures of global quality of life or pain distress over the course of patient participation. However, reanalysis using a more targeted outcome, surrogates' assessment of patients' benefit from the study intervention, suggested significant gains from massage-the treatment patients gave their highest preassignment preference ratings. The authors conclude that adding a menu of complementary therapies as part of standard end-of-life care may yield significant benefit, that patient preference is an important predictor of outcome, and that modifications in trial design may be appropriate for end-of-life studies.

  7. Adaptive adjustment of the randomization ratio using historical control data

    PubMed Central

    Hobbs, Brian P.; Carlin, Bradley P.; Sargent, Daniel J.

    2013-01-01

    Background Prospective trial design often occurs in the presence of “acceptable” [1] historical control data. Typically this data is only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. Purpose We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al. [2], succeeded a similar trial reported by Saltz et al. [3], and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. Methods The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS) characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors [4] are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial’s frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Results Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure leads to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Limitations Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. Conclusions The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on pre-existing information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare. PMID:23690095

  8. Adaptive adjustment of the randomization ratio using historical control data.

    PubMed

    Hobbs, Brian P; Carlin, Bradley P; Sargent, Daniel J

    2013-01-01

    Prospective trial design often occurs in the presence of 'acceptable' historical control data. Typically, these data are only utilized for treatment comparison in a posteriori retrospective analysis to estimate population-averaged effects in a random-effects meta-analysis. We propose and investigate an adaptive trial design in the context of an actual randomized controlled colorectal cancer trial. This trial, originally reported by Goldberg et al., succeeded a similar trial reported by Saltz et al., and used a control therapy identical to that tested (and found beneficial) in the Saltz trial. The proposed trial implements an adaptive randomization procedure for allocating patients aimed at balancing total information (concurrent and historical) among the study arms. This is accomplished by assigning more patients to receive the novel therapy in the absence of strong evidence for heterogeneity among the concurrent and historical controls. Allocation probabilities adapt as a function of the effective historical sample size (EHSS), characterizing relative informativeness defined in the context of a piecewise exponential model for evaluating time to disease progression. Commensurate priors are utilized to assess historical and concurrent heterogeneity at interim analyses and to borrow strength from the historical data in the final analysis. The adaptive trial's frequentist properties are simulated using the actual patient-level historical control data from the Saltz trial and the actual enrollment dates for patients enrolled into the Goldberg trial. Assessing concurrent and historical heterogeneity at interim analyses and balancing total information with the adaptive randomization procedure lead to trials that on average assign more new patients to the novel treatment when the historical controls are unbiased or slightly biased compared to the concurrent controls. Large magnitudes of bias lead to approximately equal allocation of patients among the treatment arms. Using the proposed commensurate prior model to borrow strength from the historical data, after balancing total information with the adaptive randomization procedure, provides admissible estimators of the novel treatment effect with desirable bias-variance trade-offs. Adaptive randomization methods in general are sensitive to population drift and more suitable for trials that initiate with gradual enrollment. Balancing information among study arms in time-to-event analyses is difficult in the presence of informative right-censoring. The proposed design could prove important in trials that follow recent evaluations of a control therapy. Efficient use of the historical controls is especially important in contexts where reliance on preexisting information is unavoidable because the control therapy is exceptionally hazardous, expensive, or the disease is rare.

  9. Skeletal Health After Continuation, Withdrawal, or Delay of Alendronate in Men With Prostate Cancer Undergoing Androgen-Deprivation Therapy

    PubMed Central

    Greenspan, Susan L.; Nelson, Joel B.; Trump, Donald L.; Wagner, Julie M.; Miller, Megan E.; Perera, Subashan; Resnick, Neil M.

    2008-01-01

    Purpose Androgen-deprivation therapy (ADT) for prostate cancer is associated with bone loss and osteoporotic fractures. Our objective was to examine changes in bone density and turnover with sustained, discontinued, or delayed oral bisphosphonate therapy in men receiving ADT. Patients and Methods A total of 112 men with nonmetastatic prostate cancer receiving ADT were randomly assigned to alendronate 70 mg once weekly or placebo in a double-blind, partial-crossover trial with a second random assignment at year 2 for those who initially received active therapy. Outcomes included bone mineral density and bone turnover markers. Results Men initially randomly assigned to alendronate and randomly reassigned at year 2 to continue had additional bone density gains at the spine (mean, 2.3% ± 0.7) and hip (mean, 1.3% ± 0.5%; both P < .01); those randomly assigned to placebo in year 2 maintained density at the spine and hip but lost (mean, −1.9% ± 0.6%; P < .01) at the forearm. Patients randomly assigned to begin alendronate in year 2 experienced improvements in bone mass at the spine and hip, but experienced less of an increase compared with those who initiated alendronate at baseline. Men receiving alendronate for 2 years experienced a mean 6.7% (± 1.2%) increase at the spine and a 3.2% (± 1.5%) at the hip (both P < .05). Bone turnover remained suppressed. Conclusion Among men with nonmetastatic prostate cancer receiving ADT, once-weekly alendronate improves bone density and decreases turnover. A second year of alendronate provides additional skeletal benefit, whereas discontinuation results in bone loss and increased bone turnover. Delay in bisphosphonate therapy appears detrimental to bone health. PMID:18802155

  10. Safety of 6-month duration of dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes: Rationale and design of the Smart Angioplasty Research Team-safety of 6-month duration of Dual Antiplatelet Therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE) prospective multicenter randomized trial.

    PubMed

    Lee, Joo Myung; Cho, Deok-Kyu; Hahn, Joo-Yong; Song, Young Bin; Park, Taek Kyu; Oh, Ju-Hyeon; Lee, Jin Bae; Doh, Joon-Hyung; Kim, Sang-Hyun; Yang, Jeong Hoon; Choi, Jin-Ho; Choi, Seung-Hyuck; Lee, Sang Hoon; Gwon, Hyeon-Cheol

    2016-12-01

    Dual antiplatelet therapy (DAPT) is a fundamental treatment that optimizes clinical outcomes after percutaneous coronary intervention, especially in patients with acute coronary syndrome (ACS). Although current international guidelines recommend DAPT for at least 12 months after implantation of a drug-eluting stent in patients with ACS, these recommendations are not based on randomized controlled trials dedicated to ACS population. The SMART-DATE trial is a prospective, multicenter, randomized, and open-label study to demonstrate the noninferiority of 6-month DAPT compared with 12 months or longer DAPT in patients with ACS undergoing percutaneous coronary intervention. A total of 2,700 patients will undergo prospective, random assignment to either of the DAPT duration groups. To minimize the bias from different stent devices, the type of stents will be randomly assigned (everolimus-eluting stents, zotarolimus-eluting stents, or biolimus A9-eluting stents). The primary end point is a composite of all-cause death, myocardial infarction, and cerebrovascular events at 18 months after the index procedure. The major secondary end points are definite/probable stent thrombosis defined by the Academic Research Consortium and bleeding defined by Bleeding Academic Research Consortium type 2-5. The SMART-DATE randomized trial is the first study exploring the safety of 6-month DAPT compared with conventional 12-month or longer DAPT dedicated to patients with ACS after second-generation drug-eluting stent implantation. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Administration of steroids after 34 weeks gestation enhances fetal lung maturity profiles

    PubMed Central

    Shanks, Anthony; Gross, Gilad; Shim, Tammy; Allsworth, Jenifer; Bildirici, Ibrahim; Sadovsky, Yoel

    2013-01-01

    Objective To estimate the effect of antenatal glucocorticoid administration on fetal lung maturity in pregnancies with known fetal lung immaturity between the 34th and 37th weeks of gestation. Study Design Pregnancies between 340/7-366/7 weeks undergoing amniocentesis to determine fetal lung maturity were targeted. Women with negative results (TDx-FLM-II < 45 mg/g) were randomized to intramuscular (IM) glucocorticoid injection or no treatment. A repeat TDx-FLM-II test was obtained one week after enrollment. Results 32 women who met inclusion criteria were randomized. Seven women delivered within a week of testing for fetal lung maturity, and were excluded from the analysis. Ten received glucocorticoid and 15 did not. Women assigned to glucocorticoids had a mean increase TDx-FLM-II in one week of 28.37 mg/g. Women assigned to no-treatment had an increase of 9.76 mg/g (p <0.002). Conclusion A single course of IM glucocorticoids after 34 weeks in pregnancies with documented fetal lung immaturity significantly increases TDx- FLM-II. PMID:20478551

  12. Repeated Reading Intervention: Outcomes and Interactions with Readers' Skills and Classroom Instruction

    ERIC Educational Resources Information Center

    Vadasy, Patricia F.; Sanders, Elizabeth A.

    2008-01-01

    This study examined effects of a repeated reading intervention, Quick Reads, with incidental word-level scaffolding instruction. Second- and third-grade students with passage-reading fluency performance between the 10th and 60th percentiles were randomly assigned to dyads, which were in turn randomly assigned to treatment (paired tutoring, n = 82)…

  13. The Effect of Realistic Versus Imaginary Aggressive Models of Children's Interpersonal Play

    ERIC Educational Resources Information Center

    Hapkiewicz, Walter G.; Stone, Robert D.

    1974-01-01

    One hundred eighty elementary school children were randomly assigned to same sex pairs and randomly assigned to one of three treatment groups: real-life aggressive film, aggressive cartoon, or nonaggressive film. Results reveal that boys who viewed the realistic aggressive film were significantly more aggressive in play than boys who viewed the…

  14. WWC Review of the Report "Effects of Problem Based Economics on High School Economics Instruction"

    ERIC Educational Resources Information Center

    What Works Clearinghouse, 2012

    2012-01-01

    The study described in this report included 128 high school economics teachers from 106 schools in Arizona and California, half of whom were randomly assigned to the "Problem Based Economics Instruction" condition and half of whom were randomly assigned to the comparison condition. High levels of teacher attrition occurred after…

  15. The Social Security Administration's Youth Transition Demonstration Projects: Implementation Lessons from the Original Projects

    ERIC Educational Resources Information Center

    Martinez, John; Fraker, Thomas; Manno, Michelle; Baird, Peter; Mamun, Arif; O'Day, Bonnie; Rangarajan, Anu; Wittenburg, David

    2010-01-01

    This report focuses on the seven original Youth Transition Demonstration (YTD) projects selected for funding in 2003. Three of the original seven projects were selected for a national random assignment evaluation in 2005; however, this report only focuses on program operations prior to joining the random assignment evaluation for the three…

  16. PROMOTING SUPPORTIVE PARENTING IN NEW MOTHERS WITH SUBSTANCE-USE PROBLEMS: A PILOT RANDOMIZED TRIAL OF RESIDENTIAL TREATMENT PLUS AN ATTACHMENT-BASED PARENTING PROGRAM

    PubMed Central

    BERLIN, LISA J.; SHANAHAN, MEGHAN; CARMODY, KAREN APPLEYARD

    2015-01-01

    This pilot randomized trial tested the feasibility and efficacy of supplementing residential substance-abuse treatment for new mothers with a brief, yet rigorous, attachment-based parenting program. Twenty-one predominantly (86%) White mothers and their infants living together in residential substance-abuse treatment were randomly assigned to the program (n = 11) or control (n = 10) group. Program mothers received 10 home-based sessions of Dozier’s Attachment and Biobehavioral Catch-up (ABC) intervention. Postintervention observations revealed more supportive parenting behaviors among the randomly assigned ABC mothers. PMID:25424409

  17. Widespread sucralose exposure in a randomized clinical trial in healthy young adults12

    PubMed Central

    2017-01-01

    Background: Low-calorie sweeteners (LCSs) are found in many foods and beverages, but consumers may not realize their presence, and their role in appetite, weight, and health is controversial. Although consumption limits based on toxicologic safety are well established, the threshold required to exert clinically relevant metabolic effects is unknown. Objectives: This study aimed to determine whether individuals who do not report consumption of LCSs can be correctly characterized as “unexposed” and to investigate whether instructions to avoid LCSs are effective in minimizing exposure. Design: Eighteen healthy 18- to 35-y-old “nonconsumers” (<1 food or beverage with LCSs/mo) enrolled in a 2-wk trial designed to evaluate the effects of LCSs on the gut microbiota. The trial consisted of 3 visits. At baseline, participants were counseled extensively about avoiding LCSs. After the run-in, participants were randomly assigned to consume diet soda containing sucralose or carbonated water (control) 3 times/d for 1 wk. Food diaries were maintained throughout the study, and a spot urine sample was collected at each visit. Results: At baseline, 8 participants had sucralose in their urine (29.9–239.0 ng/mL; mean ± SD: 111.4 ± 91.5 ng/mL). After the run-in, sucralose was found in 8 individuals (2 of whom did not have detectable sucralose at baseline) and ranged from 25.0 to 1062.0 ng/mL (mean ± SD: 191.7 ± 354.2 ng/mL). Only 1 participant reported consumption of an LCS-containing food before her visit. After the intervention, sucralose was detected in 3 individuals randomly assigned to receive carbonated water (26–121 ng/mL; mean ± SD: 60.7 ± 52.4 ng/mL). Conclusions: Despite the selection of healthy volunteers with minimal reported LCS consumption, more than one-third were exposed to sucralose at baseline and/or before randomization, and nearly half were exposed after assignment to the control. This shows that instructions to avoid LCSs are not effective and that nondietary sources (e.g., personal care products) may be important contributors to overall exposure. This trial was registered at clinicaltrials.gov as NCT02877186. PMID:28228424

  18. Widespread sucralose exposure in a randomized clinical trial in healthy young adults.

    PubMed

    Sylvetsky, Allison C; Walter, Peter J; Garraffo, H Martin; Robien, Kim; Rother, Kristina I

    2017-04-01

    Background : Low-calorie sweeteners (LCSs) are found in many foods and beverages, but consumers may not realize their presence, and their role in appetite, weight, and health is controversial. Although consumption limits based on toxicologic safety are well established, the threshold required to exert clinically relevant metabolic effects is unknown. Objectives: This study aimed to determine whether individuals who do not report consumption of LCSs can be correctly characterized as "unexposed" and to investigate whether instructions to avoid LCSs are effective in minimizing exposure. Design: Eighteen healthy 18- to 35-y-old "nonconsumers" (<1 food or beverage with LCSs/mo) enrolled in a 2-wk trial designed to evaluate the effects of LCSs on the gut microbiota. The trial consisted of 3 visits. At baseline, participants were counseled extensively about avoiding LCSs. After the run-in, participants were randomly assigned to consume diet soda containing sucralose or carbonated water (control) 3 times/d for 1 wk. Food diaries were maintained throughout the study, and a spot urine sample was collected at each visit. Results: At baseline, 8 participants had sucralose in their urine (29.9-239.0 ng/mL; mean ± SD: 111.4 ± 91.5 ng/mL). After the run-in, sucralose was found in 8 individuals (2 of whom did not have detectable sucralose at baseline) and ranged from 25.0 to 1062.0 ng/mL (mean ± SD: 191.7 ± 354.2 ng/mL). Only 1 participant reported consumption of an LCS-containing food before her visit. After the intervention, sucralose was detected in 3 individuals randomly assigned to receive carbonated water (26-121 ng/mL; mean ± SD: 60.7 ± 52.4 ng/mL). Conclusions: Despite the selection of healthy volunteers with minimal reported LCS consumption, more than one-third were exposed to sucralose at baseline and/or before randomization, and nearly half were exposed after assignment to the control. This shows that instructions to avoid LCSs are not effective and that nondietary sources (e.g., personal care products) may be important contributors to overall exposure. This trial was registered at clinicaltrials.gov as NCT02877186. © 2017 American Society for Nutrition.

  19. The effect of sex education on adolescents' use of condoms: applying the Solomon four-group design.

    PubMed

    Kvalem, I L; Sundet, J M; Rivø, K I; Eilertsen, D A; Bakketeig, L S

    1996-02-01

    A school-based sex education program was developed in order to prevent sexually transmitted diseases and unwanted pregnancies. A Solomon four-group design, with random assignment to the different conditions, was used to evaluate an intervention based on cognitive social learning theory and social influence theory. The main goal of the intervention was to increase use of condoms. A stratified sample of 124 classes (2,411 students) was drawn at random from all the upper secondary schools (high schools/colleges) in one county in Norway. The results indicate a consistent interaction between pretest and intervention, which seems to have an effect on condom use. Pretest or intervention alone did not contribute to this effect. The interaction effect appeared among the students with few sexual partners. Several possible explanations to the observed interaction effect and the implication for future interventions are discussed.

  20. Strategies for dealing with missing data in clinical trials: from design to analysis.

    PubMed

    Dziura, James D; Post, Lori A; Zhao, Qing; Fu, Zhixuan; Peduzzi, Peter

    2013-09-01

    Randomized clinical trials are the gold standard for evaluating interventions as randomized assignment equalizes known and unknown characteristics between intervention groups. However, when participants miss visits, the ability to conduct an intent-to-treat analysis and draw conclusions about a causal link is compromised. As guidance to those performing clinical trials, this review is a non-technical overview of the consequences of missing data and a prescription for its treatment beyond the typical analytic approaches to the entire research process. Examples of bias from incorrect analysis with missing data and discussion of the advantages/disadvantages of analytic methods are given. As no single analysis is definitive when missing data occurs, strategies for its prevention throughout the course of a trial are presented. We aim to convey an appreciation for how missing data influences results and an understanding of the need for careful consideration of missing data during the design, planning, conduct, and analytic stages.

  1. Asset Ownership and Health and Mental Health Functioning Among AIDS-Orphaned Adolescents: Findings From a Randomized Clinical Trial in Rural Uganda

    PubMed Central

    Han, Chang-Keun; Neilands, Torsten B

    2010-01-01

    This study evaluated an economic empowerment intervention designed to promote life options, health and mental health functioning among AIDS-orphaned adolescents in rural Uganda. The study used an experimental design in which adolescents (N=267) were randomly assigned to receive an economic empowerment intervention or usual care for orphaned children. The study measured mental health functioning using 20 items of the Tennessee Self-Concept Scale (TSCS: 2)—a standardized measure for self-esteem—and measured overall health using a self-rated health measure. Data obtained at 10-month follow-up revealed significant positive effects of the economic empowerment intervention on adolescents’ self-rated health and mental health functioning. Additionally, health and mental health functioning were found to be positively associated with each other. The findings have implications for public policy and health programming for AIDS-orphaned adolescents. PMID:19520472

  2. Inter-rater agreement among orthodontists in a blocked experiment.

    PubMed

    Korn, E L; Baumrind, S

    1985-01-01

    Five orthodontists were asked to predict for 64 patients a particular dichotomous outcome of treatment based on pre-treatment X-ray films. The orthodontists rated the cases in blocks of size 4-6 with the knowledge of the number of positive outcomes in each block. We discuss the reasons why this blocked design is appropriate whenever clinicians are asked to rate cases which have not been randomly selected from a clinical practice similar to their own. We give a simple description of the inter-rater agreement for this type of blocked experiment as well as a procedure to test that the agreement is no better than that expected by random independent assignment.

  3. Concordance of Results from Randomized and Observational Analyses within the Same Study: A Re-Analysis of the Women's Health Initiative Limited-Access Dataset.

    PubMed

    Bolland, Mark J; Grey, Andrew; Gamble, Greg D; Reid, Ian R

    2015-01-01

    Observational studies (OS) and randomized controlled trials (RCTs) often report discordant results. In the Women's Health Initiative Calcium and Vitamin D (WHI CaD) RCT, women were randomly assigned to CaD or placebo, but were permitted to use personal calcium and vitamin D supplements, creating a unique opportunity to compare results from randomized and observational analyses within the same study. WHI CaD was a 7-year RCT of 1g calcium/400IU vitamin D daily in 36,282 post-menopausal women. We assessed the effects of CaD on cardiovascular events, death, cancer and fracture in a randomized design- comparing CaD with placebo in 43% of women not using personal calcium or vitamin D supplements- and in a observational design- comparing women in the placebo group (44%) using personal calcium and vitamin D supplements with non-users. Incidence was assessed using Cox proportional hazards models, and results from the two study designs deemed concordant if the absolute difference in hazard ratios was ≤0.15. We also compared results from WHI CaD to those from the WHI Observational Study(WHI OS), which used similar methodology for analyses and recruited from the same population. In WHI CaD, for myocardial infarction and stroke, results of unadjusted and 6/8 covariate-controlled observational analyses (age-adjusted, multivariate-adjusted, propensity-adjusted, propensity-matched) were not concordant with the randomized design results. For death, hip and total fracture, colorectal and total cancer, unadjusted and covariate-controlled observational results were concordant with randomized results. For breast cancer, unadjusted and age-adjusted observational results were concordant with randomized results, but only 1/3 other covariate-controlled observational results were concordant with randomized results. Multivariate-adjusted results from WHI OS were concordant with randomized WHI CaD results for only 4/8 endpoints. Results of randomized analyses in WHI CaD were concordant with observational analyses for 5/8 endpoints in WHI CaD and 4/8 endpoints in WHI OS.

  4. Concordance of Results from Randomized and Observational Analyses within the Same Study: A Re-Analysis of the Women’s Health Initiative Limited-Access Dataset

    PubMed Central

    Bolland, Mark J.; Grey, Andrew; Gamble, Greg D.; Reid, Ian R.

    2015-01-01

    Background Observational studies (OS) and randomized controlled trials (RCTs) often report discordant results. In the Women’s Health Initiative Calcium and Vitamin D (WHI CaD) RCT, women were randomly assigned to CaD or placebo, but were permitted to use personal calcium and vitamin D supplements, creating a unique opportunity to compare results from randomized and observational analyses within the same study. Methods WHI CaD was a 7-year RCT of 1g calcium/400IU vitamin D daily in 36,282 post-menopausal women. We assessed the effects of CaD on cardiovascular events, death, cancer and fracture in a randomized design- comparing CaD with placebo in 43% of women not using personal calcium or vitamin D supplements- and in a observational design- comparing women in the placebo group (44%) using personal calcium and vitamin D supplements with non-users. Incidence was assessed using Cox proportional hazards models, and results from the two study designs deemed concordant if the absolute difference in hazard ratios was ≤0.15. We also compared results from WHI CaD to those from the WHI Observational Study(WHI OS), which used similar methodology for analyses and recruited from the same population. Results In WHI CaD, for myocardial infarction and stroke, results of unadjusted and 6/8 covariate-controlled observational analyses (age-adjusted, multivariate-adjusted, propensity-adjusted, propensity-matched) were not concordant with the randomized design results. For death, hip and total fracture, colorectal and total cancer, unadjusted and covariate-controlled observational results were concordant with randomized results. For breast cancer, unadjusted and age-adjusted observational results were concordant with randomized results, but only 1/3 other covariate-controlled observational results were concordant with randomized results. Multivariate-adjusted results from WHI OS were concordant with randomized WHI CaD results for only 4/8 endpoints. Conclusions Results of randomized analyses in WHI CaD were concordant with observational analyses for 5/8 endpoints in WHI CaD and 4/8 endpoints in WHI OS. PMID:26440516

  5. Comparing Dynamic Treatment Regimes Using Repeated-Measures Outcomes: Modeling Considerations in SMART Studies

    PubMed Central

    Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie; Lynch, Kevin G.; Oslin, David W.; Pelham, William E.; Fabiano, Gregory; Almirall, Daniel

    2016-01-01

    A dynamic treatment regime (DTR) is a sequence of decision rules, each of which recommends a treatment based on a patient’s past and current health status. Sequential, multiple assignment, randomized trials (SMARTs) are multi-stage trial designs that yield data specifically for building effective DTRs. Modeling the marginal mean trajectories of a repeated-measures outcome arising from a SMART presents challenges, because traditional longitudinal models used for randomized clinical trials do not take into account the unique design features of SMART. We discuss modeling considerations for various forms of SMART designs, emphasizing the importance of considering the timing of repeated measures in relation to the treatment stages in a SMART. For illustration, we use data from three SMART case studies with increasing level of complexity, in autism, child attention deficit hyperactivity disorder (ADHD), and adult alcoholism. In all three SMARTs we illustrate how to accommodate the design features along with the timing of the repeated measures when comparing DTRs based on mean trajectories of the repeated-measures outcome. PMID:26638988

  6. Comparing dynamic treatment regimes using repeated-measures outcomes: modeling considerations in SMART studies.

    PubMed

    Lu, Xi; Nahum-Shani, Inbal; Kasari, Connie; Lynch, Kevin G; Oslin, David W; Pelham, William E; Fabiano, Gregory; Almirall, Daniel

    2016-05-10

    A dynamic treatment regime (DTR) is a sequence of decision rules, each of which recommends a treatment based on a patient's past and current health status. Sequential, multiple assignment, randomized trials (SMARTs) are multi-stage trial designs that yield data specifically for building effective DTRs. Modeling the marginal mean trajectories of a repeated-measures outcome arising from a SMART presents challenges, because traditional longitudinal models used for randomized clinical trials do not take into account the unique design features of SMART. We discuss modeling considerations for various forms of SMART designs, emphasizing the importance of considering the timing of repeated measures in relation to the treatment stages in a SMART. For illustration, we use data from three SMART case studies with increasing level of complexity, in autism, child attention deficit hyperactivity disorder, and adult alcoholism. In all three SMARTs, we illustrate how to accommodate the design features along with the timing of the repeated measures when comparing DTRs based on mean trajectories of the repeated-measures outcome. Copyright © 2015 John Wiley & Sons, Ltd.

  7. Credit with Health Education in Benin: A Cluster Randomized Trial Examining Impacts on Knowledge and Behavior

    PubMed Central

    Karlan, Dean; Thuysbaert, Bram; Gray, Bobbi

    2017-01-01

    We evaluate whether health education integrated into microcredit lending groups reduces health risks by improving health knowledge and self-reported behaviors among urban and rural borrowers in eastern Benin. In 2007, we randomly assigned 138 villages in the Plateau region of Benin to one of four variations of a group liability credit product, varying lending groups' gender composition and/or inclusion of health education using a 2 × 2 design. Women in villages receiving health education, regardless of gender composition of the groups, showed improved knowledge of malaria and of human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), but not of childhood illness danger signs. No significant changes in health behavior were observed except an increase in HIV/AIDS prevention behavior, a result predominantly driven by an increase in respondents' self-reported ability to procure a condom, likely an indicator of increased perceived access rather than improved preventative behavior. Women in villages assigned to mixed-gender groups had significantly lower levels of social capital, compared with villages assigned to female-only groups. This suggests there may be an important trade-off to consider for interventions seeking improved health outcomes and social capital through provision of services to mixed-gender groups. Although bundling health education with microcredit can expand health education coverage and lower service-delivery costs, the approach may not be sufficient to improve health behaviors. PMID:27895268

  8. Alcohol assessment among college students using wireless mobile technology.

    PubMed

    Bernhardt, Jay M; Usdan, Stuart; Mays, Darren; Martin, Ryan; Cremeens, Jennifer; Arriola, Kimberly Jacob

    2009-09-01

    This study used a two-group randomized design to assess the validity of measuring self-reported alcohol consumption among college students using the Handheld Assisted Network Diary (HAND), a daily diary assessment administered using wireless mobile devices. A convenience sample of college students was recruited at a large, public university in the southeastern United States and randomized into two groups. A randomly assigned group of 86 students completed the daily HAND assessment during the 30-day study and a Timeline Followback (TLFB) at 30-day follow-up. A randomly assigned group of 82 students completed the paper-and-pencil Daily Social Diary (DSD) over the same study period. Data from the daily HAND assessment were compared with the TLFB completed at follow-up by participants who completed the HAND using 95% limits of agreement analysis. Furthermore, individual growth models were used to examine differences between the HAND and DSD by comparing the total drinks, drinking days, and drinks per drinking day captured by the two assessments over the study period. Results suggest that the HAND captured similar levels of alcohol use compared with the TLFB completed at follow-up by the same participants. In addition, comparisons of the two study groups suggest that, controlling for baseline alcohol use and demographics, the HAND assessment captured similar levels of total drinks, drinking days, and drinks per drinking day as the paper-and-pencil DSD. The study findings support the validity of wireless mobile devices as a daily assessment of alcohol use among college students.

  9. A Randomized Controlled Trial to Improve Social Skills in Young Adults with Autism Spectrum Disorder: The UCLA PEERS(®) Program.

    PubMed

    Laugeson, Elizabeth A; Gantman, Alexander; Kapp, Steven K; Orenski, Kaely; Ellingsen, Ruth

    2015-12-01

    Research suggests that impaired social skills are often the most significant challenge for those with autism spectrum disorder (ASD), yet few evidence-based social skills interventions exist for adults on the spectrum. This replication trial tested the effectiveness of PEERS, a caregiver-assisted social skills program for high-functioning young adults with ASD. Using a randomized controlled design, 22 young adults 18-24 years of age were randomly assigned to a treatment (n = 12) or delayed treatment control (n = 10) group. Results revealed that the treatment group improved significantly in overall social skills, frequency of social engagement, and social skills knowledge, and significantly reduced ASD symptoms related to social responsiveness following PEERS. Most treatment gains were maintained at a 16-week follow-up assessment with new improvements observed.

  10. Menopausal quality of life: RCT of yoga, exercise, and omega-3 supplements.

    PubMed

    Reed, Susan D; Guthrie, Katherine A; Newton, Katherine M; Anderson, Garnet L; Booth-LaForce, Cathryn; Caan, Bette; Carpenter, Janet S; Cohen, Lee S; Dunn, Andrea L; Ensrud, Kristine E; Freeman, Ellen W; Hunt, Julie R; Joffe, Hadine; Larson, Joseph C; Learman, Lee A; Rothenberg, Robin; Seguin, Rebecca A; Sherman, Karen J; Sternfeld, Barbara S; LaCroix, Andrea Z

    2014-03-01

    The purpose of this study was to determine the efficacy of 3 nonhormonal therapies for the improvement of menopause-related quality of life in women with vasomotor symptoms. We conducted a 12-week 3 × 2 randomized, controlled, factorial design trial. Peri- and postmenopausal women, 40-62 years old, were assigned randomly to yoga (n = 107), exercise (n = 106), or usual activity (n = 142) and also assigned randomly to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules. We performed the following interventions: (1) weekly 90-minute yoga classes with daily at-home practice, (2) individualized facility-based aerobic exercise training 3 times/week, and (3) 0.615 g omega-3 supplement, 3 times/day. The outcomes were assessed with the following scores: Menopausal Quality of Life Questionnaire (MENQOL) total and domain (vasomotor symptoms, psychosocial, physical and sexual). Among 355 randomly assigned women who average age was 54.7 years, 338 women (95%) completed 12-week assessments. Mean baseline vasomotor symptoms frequency was 7.6/day, and the mean baseline total MENQOL score was 3.8 (range, 1-8 from better to worse) with no between-group differences. For yoga compared to usual activity, baseline to 12-week improvements were seen for MENQOL total -0.3 (95% confidence interval, -0.6 to 0; P = .02), vasomotor symptom domain (P = .02), and sexuality domain (P = .03) scores. For women who underwent exercise and omega-3 therapy compared with control subjects, improvements in baseline to 12-week total MENQOL scores were not observed. Exercise showed benefit in the MENQOL physical domain score at 12 weeks (P = .02). All women become menopausal, and many of them seek medical advice on ways to improve quality of life; little evidence-based information exists. We found that, among healthy sedentary menopausal women, yoga appears to improve menopausal quality of life; the clinical significance of our finding is uncertain because of the modest effect. Copyright © 2014 Mosby, Inc. All rights reserved.

  11. Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer.

    PubMed

    Skinner, Eila C; Fairey, Adrian S; Groshen, Susan; Daneshmand, Siamak; Cai, Jie; Miranda, Gus; Skinner, Donald G

    2015-08-01

    The need to prevent reflux in the construction of an orthotopic ileal neobladder is controversial. We designed the USC-STAR trial to determine whether the T-pouch neobladder that included an antireflux mechanism was superior to the Studer pouch in patients with bladder cancer undergoing radical cystectomy. This single center, randomized, controlled trial recruited patients with clinically nonmetastatic bladder cancer scheduled to undergo radical cystectomy with neobladder. Eligible patients were randomly assigned to undergo T-pouch or Studer ileal orthotopic neobladder. Treatment assignment was not masked. The primary end point was change in renal function from baseline to 3 years. The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was used to calculate the estimated glomerular filtration rate. Between February 2002 and November 2009, 237 patients were randomly assigned to T-pouch ileal orthotopic neobladder and 247 to Studer ileal orthotopic neobladder. Baseline characteristics did not differ between the groups. Between baseline and 3 years the estimated glomerular filtration rate decreased by 6.4 ml/minute/1.73 m(2) in the Studer group and 6.6 ml/minute/1.73 m(2) in the T-pouch group (p=0.35). Multivariable analysis showed that type of ileal orthotopic neobladder was not independently associated with 3-year renal function (p=0.63). However, baseline estimated glomerular filtration rate, age and urinary tract obstruction were independently associated with 3-year decline in renal function. Cumulative risk of urinary tract infection and overall late complications were not different between the groups, but the T-pouch was associated with an increased risk of secondary diversion related surgeries. T-pouch ileal orthotopic neobladder with an antireflux mechanism did not prevent a moderate reduction in renal function observed at 3 years compared to the Studer pouch, but did result in an increase in diversion related secondary surgical procedures. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  12. Prediction of aquatic toxicity mode of action using linear discriminant and random forest models.

    PubMed

    Martin, Todd M; Grulke, Christopher M; Young, Douglas M; Russom, Christine L; Wang, Nina Y; Jackson, Crystal R; Barron, Mace G

    2013-09-23

    The ability to determine the mode of action (MOA) for a diverse group of chemicals is a critical part of ecological risk assessment and chemical regulation. However, existing MOA assignment approaches in ecotoxicology have been limited to a relatively few MOAs, have high uncertainty, or rely on professional judgment. In this study, machine based learning algorithms (linear discriminant analysis and random forest) were used to develop models for assigning aquatic toxicity MOA. These methods were selected since they have been shown to be able to correlate diverse data sets and provide an indication of the most important descriptors. A data set of MOA assignments for 924 chemicals was developed using a combination of high confidence assignments, international consensus classifications, ASTER (ASessment Tools for the Evaluation of Risk) predictions, and weight of evidence professional judgment based an assessment of structure and literature information. The overall data set was randomly divided into a training set (75%) and a validation set (25%) and then used to develop linear discriminant analysis (LDA) and random forest (RF) MOA assignment models. The LDA and RF models had high internal concordance and specificity and were able to produce overall prediction accuracies ranging from 84.5 to 87.7% for the validation set. These results demonstrate that computational chemistry approaches can be used to determine the acute toxicity MOAs across a large range of structures and mechanisms.

  13. Relapse prevention interventions for smoking cessation.

    PubMed

    Hajek, Peter; Stead, Lindsay F; West, Robert; Jarvis, Martin; Hartmann-Boyce, Jamie; Lancaster, Tim

    2013-08-20

    A number of treatments can help smokers make a successful quit attempt, but many initially successful quitters relapse over time. Several interventions have been proposed to help prevent relapse. To assess whether specific interventions for relapse prevention reduce the proportion of recent quitters who return to smoking. We searched the Cochrane Tobacco Addiction Group trials register in May 2013 for studies mentioning relapse prevention or maintenance in title, abstracts or keywords. Randomized or quasi-randomized controlled trials of relapse prevention interventions with a minimum follow-up of six months. We included smokers who quit on their own, were undergoing enforced abstinence, or were participating in treatment programmes. We included trials that compared relapse prevention interventions with a no intervention control, or that compared a cessation programme with additional relapse prevention components with a cessation programme alone. Studies were screened and data extracted by one review author, and checked by a second. Disagreements were resolved by discussion or by referral to a third review author. Sixty-three studies met inclusion criteria but were heterogeneous in terms of populations and interventions. We considered 41 studies that randomly assigned abstainers separately from studies that randomly assigned participants before their quit date.Upon looking at studies of behavioural interventions that randomly assigned abstainers, we detected no benefit of brief and 'skills-based' relapse prevention methods for women who had quit smoking because of pregnancy, or for smokers undergoing a period of enforced abstinence during hospitalisation or military training. We also failed to detect significant effects of behavioural interventions in trials in unselected groups of smokers who had quit on their own or through a formal programme. Amongst trials randomly assigning smokers before their quit date and evaluating the effects of additional relapse prevention components, we found no evidence of benefit of behavioural interventions or combined behavioural and pharmacotherapeutic interventions in any subgroup. Overall, providing training in skills thought to be needed for relapse avoidance did not reduce relapse, but most studies did not use experimental designs best suited to the task and had limited power to detect expected small differences between interventions. For pharmacological interventions, extended treatment with varenicline significantly reduced relapse in one trial (risk ratio (RR) 1.18, 95% confidence interval (CI) 1.03 to 1.36). Pooling of six studies of extended treatment with bupropion failed to detect a significant effect (RR 1.15, 95% CI 0.98 to 1.35). Two small trials of oral nicotine replacement treatment (NRT) failed to detect an effect, but treatment compliance was low, and in two other trials of oral NRT in which short-term abstainers were randomly assigned, a significant effect of intervention was noted. At the moment, there is insufficient evidence to support the use of any specific behavioural intervention to help smokers who have successfully quit for a short time to avoid relapse. The verdict is strongest for interventions focused on identifying and resolving tempting situations, as most studies were concerned with these. Little research is available regarding other behavioural approaches.Extended treatment with varenicline may prevent relapse. Extended treatment with bupropion is unlikely to have a clinically important effect. Studies of extended treatment with nicotine replacement are needed.

  14. Critical Thinking and Reflection Exercises in a Biochemistry Course to Improve Prospective Health Professions Students’ Attitudes Toward Physician-Pharmacist Collaboration

    PubMed Central

    Cornell, Susan; Fjortoft, Nancy; Bjork, Bryan C.; Chandar, Nalini; Green, Jacalyn M.; La Salle, Sophie; Viselli, Susan M.; Burdick, Paulette; Lynch, Sean M.

    2013-01-01

    Objective. To determine the impact of performing critical-thinking and reflection assignments within interdisciplinary learning teams in a biochemistry course on pharmacy students’ and prospective health professions students’ collaboration scores. Design. Pharmacy students and prospective medical, dental, and other health professions students enrolled in a sequence of 2 required biochemistry courses. They were randomly assigned to interdisciplinary learning teams in which they were required to complete case assignments, thinking and reflection exercises, and a team service-learning project. Assessment. Students were asked to complete the Scale of Attitudes Toward Physician-Pharmacist Collaboration prior to the first course, following the first course, and following the second course. The physician-pharmacist collaboration scores of prospective health professions students increased significantly (p<0.001). Conclusions. Having prospective health professions students work in teams with pharmacy students to think and reflect in and outside the classroom improves their attitudes toward physician-pharmacist collaboration. PMID:24159210

  15. Decisions under distress: stress profiles influence anchoring and adjustment.

    PubMed

    Kassam, Karim S; Koslov, Katrina; Mendes, Wendy Berry

    2009-11-01

    People frequently make decisions under stress. Understanding how stress affects decision making is complicated by the fact that not all stress responses are created equal. Challenge states, for example, occur when individuals appraise a stressful situation as demanding, but believe they have the personal resources to cope, and are characterized by efficient cardiovascular reactivity and approach motivation. Threat states, in contrast, occur when situational demands are perceived to outweigh resources and are characterized by less efficient cardiovascular reactivity and withdrawal motivation. We randomly assigned participants to social-feedback conditions (i.e., positive or negative feedback) designed to engender challenge or threat, or a no-stress condition. Participants then completed an anchoring-and-adjustment questionnaire. Those assigned to the challenge condition adjusted more from self-generated anchors than those assigned to the threat condition. Cardiovascular responses mediated the relationship between condition and adjustment. This study demonstrates the importance of considering profiles of cardiovascular reactivity when examining the influence of stress on decision making.

  16. Efficacy of a Small-Group Intervention for Post-Incarcerated Black Men Who Have Sex with Men and Women (MSMW).

    PubMed

    Harawa, Nina T; Guentzel-Frank, Heather; McCuller, William Jason; Williams, John K; Millet, Gregorio; Belcher, Lisa; Joseph, Heather A; Bluthenthal, Ricky N

    2018-04-01

    We conducted a randomized controlled trial of a six-session behavioral intervention designed to reduce frequency of condomless sex and numbers of sex partners among recently incarcerated, bisexual Black men. One hundred participants were assigned to the small-group intervention, Men in Life Environments (MILE), and 112 were assigned to the control condition. Among those assigned to MILE, 69% attended at least one session, 88% of whom attended all sessions. At 3-months' follow-up, large reductions in risk behaviors were reported by both groups. Means for episodes of condomless sex in the previous 3 months declined from 27.7 to 8.0 for the intervention and 25.6 to 6.7 for the control group. Reductions were not greater for the intervention than those of the control group. Regression to the mean, respondent burden, and implementation issues, such as moving from office-based to field-based survey administration at follow-up, may have contributed to the large declines reported by both groups.

  17. Decisions Under Distress Stress Profiles Influence Anchoring and Adjustment

    PubMed Central

    Kassam, Karim S.; Koslov, Katrina; Mendes, Wendy Berry

    2009-01-01

    People frequently make decisions under stress. Understanding how stress affects decision making is complicated by the fact that not all stress responses are created equal. Challenge states, for example, occur when individuals appraise a stressful situation as demanding, but believe they have the personal resources to cope, and are characterized by efficient cardiovascular reactivity and approach motivation. Threat states, in contrast, occur when situational demands are perceived to outweigh resources and are characterized by less efficient cardiovascular reactivity and withdrawal motivation. We randomly assigned participants to social-feedback conditions (i.e., positive or negative feedback) designed to engender challenge or threat, or a no-stress condition. Participants then completed an anchoring-and-adjustment questionnaire. Those assigned to the challenge condition adjusted more from self-generated anchors than those assigned to the threat condition. Cardiovascular responses mediated the relationship between condition and adjustment. This study demonstrates the importance of considering profiles of cardiovascular reactivity when examining the influence of stress on decision making. PMID:19843261

  18. Editorial--Avoiding Unethical Helicobacter pylori Clinical Trials: Susceptibility-Based Studies and Probiotics as Adjuvants.

    PubMed

    Graham, David Y

    2015-10-01

    As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g., in a population with known clarithromycin resistance) is unethical. As susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance >0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies, and studies of adjuvants and probiotics. However, the journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors, we provide examples and suggestions regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. © 2015 John Wiley & Sons Ltd.

  19. Editorial - Avoiding unethical Helicobacter pylori clinical trials: Susceptibility-based studies and probiotics as adjuvants

    PubMed Central

    Graham, David Y.

    2016-01-01

    As a general rule, any clinical study where the result is already known or when the investigator(s) compares an assigned treatment against another assigned treatment known to be ineffective in the study population (e.g. in a population with known clarithromycin resistance) is unethical. Since susceptibility-based therapy will always be superior to empiric therapy in any population with a prevalence of antimicrobial resistance greater than 0%, any trial that randomizes susceptibility-based therapy with empiric therapy would be unethical. The journal Helicobacter welcomes susceptibility or culture-guided studies, studies of new therapies and of adjuvants and probiotics. However, the Journal will not accept for review any study we judge to be lacking clinical equipoise or which assign subjects to a treatment known to be ineffective, such as a susceptibility-based clinical trial with an empiric therapy comparator. To assist authors we provide examples and suggestion regarding trial design for comparative studies, for susceptibility-based studies, and for studies testing adjuvants or probiotics. PMID:26123529

  20. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

    PubMed Central

    Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

    2011-01-01

    Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

  1. Hypnosis, suggestions, and altered states of consciousness: experimental evaluation of the new cognitive-behavioral theory and the traditional trance-state theory of "hypnosis".

    PubMed

    Barber, T X; Wilson, S C

    1977-10-07

    Sixty-six subjects were tested on a new scale for evaluating "hypnotic-like" experiences (The Creative Imagination Scale), which includes ten standardized test-suggestions (e.g. suggestions for arm heaviness, finger anesthesia, time distortion, and age regression). The subjects were randomly assigned to one of three treatment groups (Think-With Instructions, trance induction, and Control), with 22 subjects to each group. The new Cognitive-Behavioral Theory predicted that subjects exposed to preliminary instructions designed to demonstrate how to think and imagine along with the suggested themes (Think-With Instructions) would be more responsive to test-suggestions for anesthesia, time distortion, age regression, and so on, than subjects exposed to a trance-induction procedure. On the other hand, the traditional Trance State Theory predicted that a trance induction would be more effective than Think-With Instructions in enhancing responses to such suggestions. Subjects exposed to the Think-With Instructions obtained significantly higher scores on the test-suggestions than those exposed either to the traditional trance-induction procedure or to the control treatment. Scores of subjects who received the trance-induction procedure were not significantly different from those of the subjects who received the control treatment. The results thus supported the new Cognitive-Behavioral Theory and contradicted the traditional Trance State Theory of hypnosis. Two recent experiments, by De Stefano and by Katz, confirmed the above experimental results and offered further support for the Cognitive-Behavioral Theory. In both recent experiments, subjects randomly assigned to a "Think-With Instructions" treatment were more responsive to test-suggestions than those randomly assigned to a traditional trance-induction treatment.

  2. A randomized controlled trial of the effect of prednisone omission from a multidrug chemotherapy protocol on treatment outcome in dogs with peripheral nodal lymphomas.

    PubMed

    Childress, Michael O; Ramos-Vara, José A; Ruple, Audrey

    2016-11-01

    OBJECTIVE To determine the effect of prednisone omission from a multidrug chemotherapy protocol on outcome in dogs with peripheral nodal lymphomas. DESIGN Single-center, nonblinded, parallel-group, randomized, controlled trial. ANIMALS 40 client-owned dogs with a histopathologically confirmed diagnosis of peripheral nodal lymphoma and an expected survival time of > 4 weeks with treatment. PROCEDURES Treatment consisted of a combination of L-asparaginase, cyclophosphamide, doxorubicin, vincristine, and prednisone (L-CHOP) or an identical protocol except for the omission of prednisone (L-CHO). The primary outcome of interest was progression-free survival time. Veterinary caregivers and assessors of outcome were not blinded to treatment assignment. Treatment assignment was concealed from the owners of study dogs prior to enrollment, but was revealed after written informed consent was provided. RESULTS The trial was terminated early because of slow enrollment. The 40 dogs successfully enrolled in the study were randomly assigned to the L-CHOP (n = 18) or L-CHO (22) group; results for all 40 dogs were analyzed with respect to the primary outcome. Median progression-free survival time was 142.5 days for dogs receiving L-CHO and 292 days for dogs receiving L-CHOP (hazard ratio, 1.79; 95% confidence interval, 0.85 to 3.75). Serious adverse events were more common among dogs receiving L-CHO. However, this difference was not significant. CONCLUSIONS AND CLINICAL RELEVANCE The exclusion of prednisone from the L-CHOP protocol did not appear to result in improved progression-free survival time for dogs with peripheral nodal lymphomas. However, the present trial was likely underpowered to detect a clinically meaningful difference in progression-free survival time between groups.

  3. A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder.

    PubMed

    van Dongen-Boomsma, Martine; Vollebregt, Madelon A; Slaats-Willemse, Dorine; Buitelaar, Jan K

    2013-08-01

    A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands. Forty-one children (aged 8-15 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to treatment with either EEG neurofeedback (n = 22) or placebo neurofeedback (n = 19) for 30 sessions, given as 2 sessions per week. The children were stratified by age, electrophysiologic state of arousal, and medication use. Everyone involved in the study, except the neurofeedback therapist and the principal investigator, was blinded to treatment assignment. The primary outcome was severity of ADHD symptoms on the ADHD Rating Scale IV, scored at baseline, during treatment, and at study end. Clinical improvement as measured by the Clinical Global Impressions-Improvement scale (CGI-I) was a secondary outcome. While total ADHD symptoms improved over time in both groups (F1,39 = 26.56, P < .001), there was no significant treatment effect, ie, group × time interaction (F1,39 = 0.36, P = .554); the same was true for clinical improvement as measured by the CGI-I (P = .092). No clinically relevant side effects were observed. Among the children and their parents, guessing treatment assignment was not better than chance level (P = .224 for children, P = .643 for parents). EEG neurofeedback was not superior to placebo neurofeedback in improving ADHD symptoms in children with ADHD. ClinicalTrials.gov identifier: NCT00723684. © Copyright 2013 Physicians Postgraduate Press, Inc.

  4. Health, nutrition and prosperity: a microeconomic perspective.

    PubMed Central

    Thomas, Duncan; Frankenberg, Elizabeth

    2002-01-01

    A positive correlation between health and economic prosperity has been widely documented, but the extent to which this reflects a causal effect of health on economic outcomes is very controversial. Two classes of evidence are examined. First, carefully designed random assignment studies in the laboratory and field provide compelling evidence that nutritional deficiency - particularly iron deficiency - reduces work capacity and, in some cases, work output. Confidence in these results is bolstered by a good understanding of the underlying biological mechanisms. Some random assignment studies indicate an improved yield from health services in the labour market. Second, observational studies suggest that general markers of nutritional status, such as height and body mass index (BMI), are significant predictors of economic success although their interpretation is confounded by the fact that they reflect influences from early childhood and family background. Energy intake and possibly the quality of the diet have also been found to be predictive of economic success in observational studies. However, the identification of causal pathways in these studies is difficult and involves statistical assumptions about unobserved heterogeneity that are difficult to test. Illustrations using survey data demonstrate the practical importance of this concern. Furthermore, failure to take into account the dynamic interplay between changes in health and economic status has led to limited progress being reported in the literature. A broadening of random assignment studies to measure the effects of an intervention on economic prosperity, investment in population-based longitudinal socioeconomic surveys, and application of emerging technologies for a better measure of health in these surveys will yield very high returns in improving our understanding of how health influences economic prosperity. PMID:11953788

  5. Randomized controlled trial of contingency management for stimulant use in community mental health patients with serious mental illness.

    PubMed

    McDonell, Michael G; Srebnik, Debra; Angelo, Frank; McPherson, Sterling; Lowe, Jessica M; Sugar, Andrea; Short, Robert A; Roll, John M; Ries, Richard K

    2013-01-01

    The primary objective of this study was to determine whether contingency management was associated with increased abstinence from stimulant drug use in stimulant-dependent patients with serious mental illness treated in a community mental health center. Secondary objectives were to determine whether contingency management was associated with reductions in use of other substances, psychiatric symptoms, HIV risk behavior, and inpatient service utilization. A randomized controlled design was used to compare outcomes of 176 outpatients with serious mental illness and stimulant dependence. Participants were randomly assigned to receive 3 months of contingency management for stimulant abstinence plus treatment as usual or treatment as usual with reinforcement for study participation only. Urine drug tests and self report, clinician-report, and service utilization outcomes were assessed during the 3-month treatment period and the 3-month follow-up period. Although participants in the contingency management condition were significantly less likely to complete the treatment period than those assigned to the control condition (42% compared with 65%), they were 2.4 times (95% CI=1.9–3.0)more likely to submit a stimulant-negative urine test during treatment. Compared with participants in the control condition,they had significantly lower levels of alcohol use, injection drug use, and psychiatric symptoms and were one-fifth as likely as those assigned to the control condition to be admitted for psychiatric hospitalization during treatment. They also reported significantly fewer days of stimulant drug use during the 3-month follow-up. When added to treatment as usual, contingency management is associated with large reductions in stimulant,injection drug, and alcohol use.Reductions in psychiatric symptoms and hospitalizations are important secondary benefits.

  6. Stopping vs. Continuing Aspirin before Coronary Artery Surgery.

    PubMed

    Myles, Paul S; Smith, Julian A; Forbes, Andrew; Silbert, Brendan; Jayarajah, Mohandas; Painter, Thomas; Cooper, D James; Marasco, Silvana; McNeil, John; Bussières, Jean S; Wallace, Sophie

    2016-02-25

    Most patients with coronary artery disease receive aspirin for primary or secondary prevention of myocardial infarction, stroke, and death. Aspirin poses a risk of bleeding in patients undergoing surgery, but it is unclear whether aspirin should be stopped before coronary artery surgery. We used a 2-by-2 factorial trial design to randomly assign patients who were scheduled to undergo coronary artery surgery and were at risk for perioperative complications to receive aspirin or placebo and tranexamic acid or placebo. The results of the aspirin trial are reported here. Patients were randomly assigned to receive 100 mg of aspirin or matched placebo preoperatively. The primary outcome was a composite of death and thrombotic complications (nonfatal myocardial infarction, stroke, pulmonary embolism, renal failure, or bowel infarction) within 30 days after surgery. Among 5784 eligible patients, 2100 were enrolled; 1047 were randomly assigned to receive aspirin and 1053 to receive placebo. A primary outcome event occurred in 202 patients in the aspirin group (19.3%) and in 215 patients in the placebo group (20.4%) (relative risk, 0.94; 95% confidence interval, 0.80 to 1.12; P=0.55). Major hemorrhage leading to reoperation occurred in 1.8% of patients in the aspirin group and in 2.1% of patients in the placebo group (P=0.75), and cardiac tamponade occurred at rates of 1.1% and 0.4%, respectively (P=0.08). Among patients undergoing coronary artery surgery, the administration of preoperative aspirin resulted in neither a lower risk of death or thrombotic complications nor a higher risk of bleeding than that with placebo. (Funded by the Australian National Health and Medical Research Council and others; Australia New Zealand Clinical Trials Registry number, ACTRN12605000557639.).

  7. Long-term effect of resistant starch on cancer risk in carriers of hereditary colorectal cancer: an analysis from the CAPP2 randomised controlled trial.

    PubMed

    Mathers, John C; Movahedi, Mohammad; Macrae, Finlay; Mecklin, Jukka-Pekka; Moeslein, Gabriela; Olschwang, Sylviane; Eccles, Diana; Evans, Gareth; Maher, Eamonn R; Bertario, Lucio; Bisgaard, Marie-Luise; Dunlop, Malcolm; Ho, Judy W C; Hodgson, Shirley; Lindblom, Annika; Lubinski, Jan; Morrison, Patrick J; Murday, Victoria; Ramesar, Raj; Side, Lucy; Scott, Rodney J; Thomas, Huw J W; Vasen, Hans; Gerdes, Anne-Marie; Barker, Gail; Crawford, Gillian; Elliott, Faye; Pylvanainen, Kirsi; Wijnen, Juul; Fodde, Riccardo; Lynch, Henry; Bishop, D Timothy; Burn, John

    2012-12-01

    Observational studies report that higher intake of dietary fibre (a heterogeneous mix including non-starch polysaccharides and resistant starches) is associated with reduced risk of colorectal cancer, but no randomised trials with prevention of colorectal cancer as a primary endpoint have been done. We assessed the effect of resistant starch on the incidence of colorectal cancer. In the CAPP2 study, individuals with Lynch syndrome were randomly assigned in a two-by-two factorial design to receive 600 mg aspirin or aspirin placebo or 30 g resistant starch or starch placebo, for up to 4 years. Randomisation was done with a block size of 16. Post-intervention, patients entered into double-blind follow-up; participants and investigators were masked to treatment allocation. The primary endpoint for this analysis was development of colorectal cancer in participants randomly assigned to resistant starch or resistant-starch placebo with both intention-to-treat and per-protocol analyses. This study is registered, ISRCTN 59521990. 463 patients were randomly assigned to receive resistant starch and 455 to receive resistant-starch placebo. At a median follow-up 52·7 months (IQR 28·9-78·4), 53 participants developed 61 primary colorectal cancers (27 of 463 participants randomly assigned to resistant starch, 26 of 455 participants assigned to resistant-starch placebo). Intention-to-treat analysis of time to first colorectal cancer showed a hazard ratio (HR) of 1·40 (95% CI 0·78-2·56; p=0·26) and Poisson regression accounting for multiple primary events gave an incidence rate ratio (IRR) of 1·15 (95% CI 0·66-2·00; p=0·61). For those completing 2 years of intervention, per-protocol analysis yielded a HR of 1·09 (0·55-2·19, p=0·80) and an IRR of 0·98 (0·51-1·88, p=0·95). No information on adverse events was gathered during post-intervention follow-up. Resistant starch had no detectable effect on cancer development in carriers of hereditary colorectal cancer. Dietary supplementation with resistant starch does not emulate the apparently protective effect of diets rich in dietary fibre against colorectal cancer. European Union, Cancer Research UK, Bayer Corporation, National Starch and Chemical Co, UK Medical Research Council, Newcastle Hospitals Trustees, Cancer Council of Victoria Australia, THRIPP South Africa, The Finnish Cancer Foundation, SIAK Switzerland, and Bayer Pharma. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Randomized Comparison of Systemic Anti-inflammatory Therapy Versus Fluocinolone Acetonide Implant for Intermediate, Posterior and Panuveitis: The Multicenter Uveitis Steroid Treatment Trial

    PubMed Central

    Kempen, John H.; Altaweel, Michael M.; Holbrook, Janet T.; Jabs, Douglas A.; Louis, Thomas A.; Sugar, Elizabeth A.; Thorne, Jennifer E.

    2011-01-01

    Objective To compare the relative effectiveness of systemic corticosteroids plus immunosuppression when indicated (systemic therapy) versus fluocinolone acetonide implant (implant therapy) for non-infectious intermediate, posterior or panuveitis (uveitis). Design Randomized controlled parallel superiority trial. Participants Patients with active/recently active uveitis. Methods Participants were randomized (allocation ratio 1:1) to systemic or implant therapy at 23 centers (three countries). Implant-assigned participants with bilateral uveitis were assigned to have each eye that warranted study treatment implanted. Treatment-outcome associations were analyzed by assigned treatment for all eyes with uveitis. Main Outcome Measures Masked examiners measured the primary outcome: change in best-corrected visual acuity from baseline. Secondary outcomes included patient-reported quality of life (QoL), ophthalmologist-graded uveitis activity, and local and systemic complications of uveitis or therapy. Reading Center graders and glaucoma specialists assessing ocular complications were masked. Participants, ophthalmologists, and coordinators were unmasked. Results Among 255 patients randomized to implant and systemic therapy (479 eyes with uveitis), evaluating changes from baseline to 24 months, the implant and systemic therapy groups respectively had +6.0 vs. +3.2 letters' improvement in visual acuity (p=0.16, 95% confidence interval on difference in improvement between groups: −1.2 to +6.7 letters, positive values favoring implant), +11.4 vs. +6.8 units' vision-related QoL improvement (p=0.043), +0.02 vs. −0.02 change in EuroQol-EQ5D health utility (p=0.060), and 12% vs. 29% had active uveitis (p=0.001). Over 24 months, implant-assigned eyes had a higher risk of cataract surgery (80%, hazard ratio (HR) = 3.3, p<0.0001), treatment for elevated intraocular pressure (61%, HR=4.2, p<0.0001), and glaucoma (17%, HR = 4.2, p=0.0008). Systemic-assigned patients had more prescription-requiring infections (0.60 vs. 0.36/person-year, p=0.034), without notable long-term consequences; systemic adverse outcomes otherwise were unusual in both groups, with minimal differences between groups. Conclusion In each treatment group, mean visual acuity improved over 24 months, with neither approach superior to a degree detectable with the study's power. Therefore, the specific advantages and disadvantages identified should dictate selection between the alternative treatments in consideration of individual patients' particular circumstances. Systemic therapy with aggressive use of corticosteroid-sparing immunosuppression was well-tolerated, suggesting that this approach is reasonably safe for local and systemic inflammatory disorders. PMID:21840602

  9. Does Professor Quality Matter? Evidence from Random Assignment of Students to Professors. NBER Working Paper No. 14081

    ERIC Educational Resources Information Center

    Carrell, Scott E.; West, James E.

    2008-01-01

    It is difficult to measure teaching quality at the postsecondary level because students typically "self-select" their coursework and their professors. Despite this, student evaluations of professors are widely used in faculty promotion and tenure decisions. We exploit the random assignment of college students to professors in a large body of…

  10. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  11. The Efficacy of Fast ForWord Language Intervention in School-Age Children with Language Impairment: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Gillam, Ronald B.; Loeb, Diane Frome; Hoffman, LaVae M.; Bohman, Thomas; Champlin, Craig A.; Thibodeau, Linda; Widen, Judith; Brandel, Jayne; Friel-Patti, Sandy

    2008-01-01

    Purpose: A randomized controlled trial was conducted to compare the language and auditory processing outcomes of children assigned to receive the Fast ForWord Language intervention (FFW-L) with the outcomes of children assigned to nonspecific or specific language intervention comparison treatments that did not contain modified speech. Method: Two…

  12. How Much Do the Effects of Education and Training Programs Vary across Sites? Evidence from Past Multisite Randomized Trials

    ERIC Educational Resources Information Center

    Weiss, Michael J.; Bloom, Howard S.; Verbitsky-Savitz, Natalya; Gupta, Himani; Vigil, Alma E.; Cullinan, Daniel N.

    2017-01-01

    Multisite trials, in which individuals are randomly assigned to alternative treatment arms within sites, offer an excellent opportunity to estimate the cross-site average effect of treatment assignment (intent to treat or ITT) "and" the amount by which this impact varies across sites. Although both of these statistics are substantively…

  13. Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

    PubMed Central

    Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

    2014-01-01

    Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

  14. Effects of a tobacco control intervention for teachers in India: results of the Bihar school teachers study.

    PubMed

    Sorensen, Glorian; Pednekar, Mangesh S; Sinha, Dhirendra N; Stoddard, Anne M; Nagler, Eve; Aghi, Mira B; Lando, Harry A; Viswanath, Kasisomayajula; Pawar, Pratibha; Gupta, Prakash C

    2013-11-01

    We assessed a school-based intervention designed to promote tobacco control among teachers in the Indian state of Bihar. We used a cluster-randomized design to test the intervention, which comprised educational efforts, tobacco control policies, and cessation support and was tailored to the local social context. In 2009 to 2011, we randomly selected 72 schools from participating school districts and randomly assigned them in blocks (rural or urban) to intervention or delayed-intervention control conditions. Immediately after the intervention, the 30-day quit rate was 50% in the intervention and 15% in the control group (P = .001). At the 9-month postintervention survey, the adjusted 6-month quit rate was 19% in the intervention and 7% in the control group (P = .06). Among teachers employed for the entire academic year of the intervention, the adjusted 6-month abstinence rates were 20% and 5%, respectively, for the intervention and control groups (P = .04). These findings demonstrate the potent impact of an intervention that took advantage of social resources among teachers, who can serve as role models for tobacco control in their communities.

  15. The effectiveness of breakfast recommendations on weight loss: a randomized controlled trial123

    PubMed Central

    Dhurandhar, Emily J; Dawson, John; Alcorn, Amy; Larsen, Lesli H; Thomas, Elizabeth A; Cardel, Michelle; Bourland, Ashley C; Astrup, Arne; St-Onge, Marie-Pierre; Hill, James O; Apovian, Caroline M; Shikany, James M; Allison, David B

    2014-01-01

    Background: Breakfast is associated with lower body weight in observational studies. Public health authorities commonly recommend breakfast consumption to reduce obesity, but the effectiveness of adopting these recommendations for reducing body weight is unknown. Objective: We tested the relative effectiveness of a recommendation to eat or skip breakfast on weight loss in adults trying to lose weight in a free-living setting. Design: We conducted a multisite, 16-wk, 3-parallel-arm randomized controlled trial in otherwise healthy overweight and obese adults [body mass index (in kg/m2) between 25 and 40] aged 20–65 y. Our primary outcome was weight change. We compared weight change in a control group with weight loss in experimental groups told to eat breakfast or to skip breakfast [no breakfast (NB)]. Randomization was stratified by prerandomization breakfast eating habits. A total of 309 participants were randomly assigned. Results: A total of 283 of the 309 participants who were randomly assigned completed the intervention. Treatment assignment did not have a significant effect on weight loss, and there was no interaction between initial breakfast eating status and treatment. Among skippers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.71 ± 1.16, −0.76 ± 1.26, and −0.61 ± 1.18 kg for the control, breakfast, and NB groups, respectively. Among breakfast consumers, mean (±SD) baseline weight-, age-, sex-, site-, and race-adjusted weight changes were −0.53 ± 1.16, −0.59 ± 1.06, and −0.71 ± 1.17 kg for the control, breakfast, and NB groups, respectively. Self-reported compliance with the recommendation was 93.6% for the breakfast group and 92.4% for the NB group. Conclusions: A recommendation to eat or skip breakfast for weight loss was effective at changing self-reported breakfast eating habits, but contrary to widely espoused views this had no discernable effect on weight loss in free-living adults who were attempting to lose weight. This trial was registered at clinicaltrails.gov as NCT01781780. PMID:24898236

  16. Development of the AGREE II, part 2: assessment of validity of items and tools to support application

    PubMed Central

    Brouwers, Melissa C.; Kho, Michelle E.; Browman, George P.; Burgers, Jako S.; Cluzeau, Françoise; Feder, Gene; Fervers, Béatrice; Graham, Ian D.; Hanna, Steven E.; Makarski, Julie

    2010-01-01

    Background We established a program of research to improve the development, reporting and evaluation of practice guidelines. We assessed the construct validity of the items and user’s manual in the β version of the AGREE II. Methods We designed guideline excerpts reflecting high-and low-quality guideline content for 21 of the 23 items in the tool. We designed two study packages so that one low-quality and one high-quality version of each item were randomly assigned to each package. We randomly assigned 30 participants to one of the two packages. Participants reviewed and rated the guideline content according to the instructions of the user’s manual and completed a survey assessing the manual. Results In all cases, content designed to be of high quality was rated higher than low-quality content; in 18 of 21 cases, the differences were significant (p < 0.05). The manual was rated by participants as appropriate, easy to use, and helpful in differentiating guidelines of varying quality, with all scores above the mid-point of the seven-point scale. Considerable feedback was offered on how the items and manual of the β-AGREE II could be improved. Interpretation The validity of the items was established and the user’s manual was rated as highly useful by users. We used these results and those of our study presented in part 1 to modify the items and user’s manual. We recommend AGREE II (available at www.agreetrust.org) as the revised standard for guideline development, reporting and evaluation. PMID:20513779

  17. Neural Mechanisms of Cognitive-Behavioral Therapy for Aggression in Children and Adolescents: Design of a Randomized Controlled Trial Within the National Institute for Mental Health Research Domain Criteria Construct of Frustrative Non-Reward

    PubMed Central

    Wyk, Brent C. Vander; Eilbott, Jeffrey A.; McCauley, Spencer A.; Ibrahim, Karim; Crowley, Michael J.; Pelphrey, Kevin A.

    2016-01-01

    Abstract Objective: We present the rationale and design of a randomized controlled trial of cognitive-behavioral therapy (CBT) for aggression in children and adolescents, which is conducted in response to the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) approach initiative. Specifically, the study is focused on the brain-behavior associations within the RDoC construct of frustrative non-reward. On the behavioral level, this construct is defined by reactions elicited in response to withdrawal or prevention of reward, most notably reactive aggression. This study is designed to test the functional magnetic resonance (fMRI) and electrophysiological (EEG) correlates of aggression and its reduction after CBT. Methods: Eighty children and adolescents with high levels of aggression across multiple traditional diagnostic categories, ages 8–16, will be randomly assigned to receive 12 sessions of CBT or 12 sessions of supportive psychotherapy. Clinical outcomes will be measured by the ratings of aggressive behavior collected at baseline, midpoint, and endpoint evaluations, and by the Improvement Score of the Clinical Global Impressions Scale assigned by an independent evaluator (blinded rater). Subjects will also perform a frustration-induction Go-NoGo task and a task of emotional face perception during fMRI scanning and EEG recording at baseline and endpoint. Results: Consistent with the NIMH strategic research priorities, if functional neuroimaging and EEG variables can identify subjects who respond to CBT for aggression, this can provide a neuroscience-based classification scheme that will improve treatment outcomes for children and adolescents with aggressive behavior. Conclusions: Demonstrating that a change in the key nodes of the emotion regulation circuitry is associated with a reduction of reactive aggression will provide evidence to support the validity of the frustrative non-reward construct. PMID:26784537

  18. Evaluation of a Modified User Guide for Hearing Aid Management.

    PubMed

    Caposecco, Andrea; Hickson, Louise; Meyer, Carly; Khan, Asaduzzaman

    2016-01-01

    This study investigated if a hearing aid user guide modified using best practice principles for health literacy resulted in superior ability to perform hearing aid management tasks, compared with the user guide in the original form. This research utilized a two-arm study design to compare the original manufacturer's user guide with a modified user guide for the same hearing aid--an Oticon Acto behind-the-ear aid with an open dome. The modified user guide had a lower reading grade level (4.2 versus 10.5), used a larger font size, included more graphics, and had less technical information. Eighty-nine adults ages 55 years and over were included in the study; none had experience with hearing aid use or management. Participants were randomly assigned either the modified guide (n = 47) or the original guide (n = 42). All participants were administered the Hearing Aid Management test, designed for this study, which assessed their ability to perform seven management tasks (e.g., change battery) with their assigned user guide. The regression analysis indicated that the type of user guide was significantly associated with performance on the Hearing Aid Management test, adjusting for 11 potential covariates. In addition, participants assigned the modified guide required significantly fewer prompts to perform tasks and were significantly more likely to perform four of the seven tasks without the need for prompts. The median time taken by those assigned the modified guide was also significantly shorter for three of the tasks. Other variables associated with performance on the Hearing Aid Management test were health literacy level, finger dexterity, and age. Findings indicate that the need to design hearing aid user guides in line with best practice principles of health literacy as a means of facilitating improved hearing aid management in older adults.

  19. Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

    PubMed

    Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

    2010-11-30

    Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be evaluated. Potential moderation by pre- and post-illness lifestyle, health and exercise-related attitudes, beliefs and motivation will also be assessed. Finally, the cost-effectiveness of both exercise interventions will be evaluated. This randomized controlled trial will be a rigorous test of effects of exercise programmes for cancer patients after chemotherapy, aiming to contribute to evidence-based practice in cancer rehabilitation programmes. This study is registered at the Netherlands Trial Register (NTR2153).

  20. [Design and validation of a questionnaire for psychosocial nursing diagnosis in Primary Care].

    PubMed

    Brito-Brito, Pedro Ruymán; Rodríguez-Álvarez, Cristobalina; Sierra-López, Antonio; Rodríguez-Gómez, José Ángel; Aguirre-Jaime, Armando

    2012-01-01

    To develop a valid, reliable and easy-to-use questionnaire for a psychosocial nursing diagnosis. The study was performed in two phases: first phase, questionnaire design and construction; second phase, validity and reliability tests. A bank of items was constructed using the NANDA classification as a theoretical framework. Each item was assigned a Likert scale or dichotomous response. The combination of responses to the items constituted the diagnostic rules to assign up to 28 labels. A group of experts carried out the validity test for content. Other validated scales were used as reference standards for the criterion validity tests. Forty-five nurses provided the questionnaire to the patients on three separate occasions over a period of three weeks, and the other validated scales only once to 188 randomly selected patients in Primary Care centres in Tenerife (Spain). Validity tests for construct confirmed the six dimensions of the questionnaire with 91% of total variance explained. Validity tests for criterion showed a specificity of 66%-100%, and showed high correlations with the reference scales when the questionnaire was assigning nursing diagnoses. Reliability tests showed agreement of 56%-91% (P<.001), and a 93% internal consistency. The Questionnaire for Psychosocial Nursing Diagnosis was called CdePS, and included 61 items. The CdePS is a valid, reliable and easy-to-use tool in Primary Care centres to improve the assigning of a psychosocial nursing diagnosis. Copyright © 2011 Elsevier España, S.L. All rights reserved.

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