Effectiveness of a group-based academic tutoring program for children in foster care: A randomized controlled trial

The consistently poor educational achievement of children in foster care has been associated with many negative outcomes including long term poor adult adjustment (e.g., higher rates of suicide, criminality, and substance abuse). The current study was undertaken to improve foster children's academic skills through academic remediation. Across this two year randomized study, 91 children in out of home foster or kinship care, between grades 1 and 8 inclusive, completed the study. One-half were randomly assigned to the 30-week direct-instruction small group tutoring condition, while the other half served as wait-list controls. A statistically significant increase in standard scores was found on reading decoding, spelling and mathematic skills for the children who received tutoring, but no differences were obtained on sentence comprehension. Significant effect sizes, in the small to moderate range, were also found in support of the tutoring condition across these three domains. The implications of these positive findings as they relate to improving educational achievement among children in foster care are discussed.     

Effectiveness of an empowerment program for adolescent second generation migrants: A cluster randomized controlled trial

Dutch adolescent second generation migrants are at increased risk of becoming marginalized and developing problem behavior. We tested the effectiveness of the Dutch multi-component empowerment program POWER that aims to prevent such problems. We hypothesized a positive intervention effect on participants' sense of mastery, coping skills, activities, conduct problems, and prosocial behavior. We conducted a cluster randomized controlled trial including a pretest and posttest with an intervention condition (n = 132) and a waitlist control condition (n = 116). Analyses showed that POWER was only effective in influencing the youngsters' participation in activities like sport, hobbies, and casual work. When implemented with high fidelity, POWER also influenced the level of conduct problems as well as their coping style. However, a more accurate registration of the implementation process would have been helpful and the program can potentially be further improved by clearly specifying which components of the program can be adapted and which must be delivered as intended.     

Exercise and health in frail elderly people: a review of randomized controlled trials

Frailty is a physiological syndrome that increases the risk of poor health. Although some research has been conducted to study the benefits of physical exercise in frail elderly populations, different operational definitions of frailty have been used, and this makes the studies difficult to compare. The present review was aimed at examining the influence of exercise on health in frail older adults. Studies using randomized controlled trials that administered an exercise program to a frail elderly population and that had an operational definition of frailty were selected from publications between January 2000 and October 2008. Information about the study population, frailty criteria, exercise program, principles of exercise training, randomization procedures, main and secondary outcome measures, study follow-up, and control group characteristics was taken from these studies, and the results from a final sample of 28 articles are discussed. Exercise training seems to be a safe and effective tool for promoting and maintaining optimal health levels in a wide variety of vulnerable older adults. However, the lack of studies on a well-defined frail older adult sample with selection procedures based on current knowledge in this field does not allow us, at the present time, to conclude that exercise influences health in this population. Further research is needed to confirm the benefits of exercise on health in frail older adults. The study population must be selected based on current knowledge in the area of frailty, and the design of the exercise program must be based on principles of training.     

Effects of physical,virtual reality-based,and brain exercise on physical,cognition, and preference in older persons: a randomized controlled trial

Background

Physical exercise (PE), virtual reality-based exercise (VRE), and brain exercise (BE) can influence physical and cognitive conditions in older persons. However, it is not known which of the three types of exercises provide the best effects on physical and cognitive status, and which exercise is preferred by older persons. This study compared the effects of PE, VRE, and BE on balance, muscle strength, cognition, and fall concern. In addition, exercise effort perception and contentment in older persons was evaluated.

Methods

Eighty-four older persons (n?=?84) were randomly selected for PE, VRE, BE, and control groups. The exercise groups received 8-week training, whereas the control group did not. Balance was assessed by Berg Balance Scale (BBS) and Timed Up and Go test (TUG), muscle strength by 5 Times Sit to Stand (5TSTS) and left and right hand grip strength (HGS), cognition by Montreal Cognitive Assessment (MoCA) and Timed Up and Go test Cognition (TUG-cog), fall concern by Fall Efficacy Scale International (FES-I), exercise effort perception by Borg category ratio scale (Borg CR-10), and exercise contentment by a questionnaire.

Results

After exercise, PE significantly enhanced TUG and 5TSTS to a greater extent than VRE (TUG; p?=?0.004, 5TSTS; p?=?0.027) and BE (TUG; p?=?0,012, 5TSTS; p?<?0.001). VRE significantly improved MoCA (p?<?0.001) and FES-I (p?=?0.036) compared to PE, and 5TSTS (p?<?0.001) and FES-I (p?=?0.011) were improved relative to BE. MoCA was significantly enhanced by BE compared to PE (p?<?0.001) and both MoCA and TUG-cog were improved compared to VRE (p?=?0.04). PE and VRE significantly (p < 0.001) increased Borg CR-10 in all exercise sessions, whereas BE showed a significant improvement (p?< 0.001) in the first 4 sessions. Participants had a significantly greater satisfaction with BE than controls (p?=?0.006), and enjoyed VRE and BE more than PE (p?< 0.001). Subjects in all exercise groups exhibited benefits compared to the control group (p?< 0.001).

Conclusions

PE provided the best results in physical tests, VRE produced measurable improvements in physical and cognition scores, while BE enhanced cognition ability in older persons. Older persons preferred VRE and BE compared to PE. Both exercises are suggested to older persons to improve physical and cognitive conditions.

     

Motivational interviewing as a mechanism for change in men who batter: a randomized controlled trial

The present study reports on the potential effectiveness of motivational interviewing (MI) in changing the way batterers think about their violent behavior. Thirty-three domestic violence offenders who were court-mandated to treatment were randomly assigned to MI or a control condition before attending their first mandated treatment group. Consistent with predictions, the MI group demonstrated generally more improvement on stages of change subscales than the control group. Further, the MI group demonstrated a significantly greater decrease in the extent to which they blamed their violence on external factors. Current data indicate that MI has the potential to increase batterers' motivation to change, although validation trials with larger sample sizes and more refined measures are required.     

The effect of functional circuit training on physical frailty in frail older adults: a randomized controlled trial

The purpose of this study was to evaluate whether a 12-wk functional circuit-training program (FCT) could alter markers of physical frailty in a group of frail community-dwelling adults. Fifty-one individuals (31 women, 20 men), mean age (± SD) 84 (± 2.9) yr, met frailty criteria and were randomly assigned into groups (FCT = 26, control group [CG] = 25). FCT underwent a 12-wk exercise program. CG met once a week for health education meetings. Measures of physical frailty, function, strength, balance, and gait speed were assessed at Weeks 0, 12, and 36. Physical-frailty measures in FCT showed significant (p < .05) improvements relative to those in CG (Barthel Index at Weeks 0 and 36: 73.41 (± 2.35) and 77.0 (± 2.38) for the FCT and 70.79 (± 2.53) and 66.73 (± 2.73) for the CG. These data indicate that an FCT program is effective in improving measures of function and reducing physical frailty among frail older adults.     

Project success' effects on substance use-related attitudes and behaviors: a randomized controlled trial in alternative high schools

Using a randomized controlled effectiveness trial, we examined the effects of Project SUCCESS on a range of secondary outcomes, including the program's mediating variables. Project SUCCESS, which is based both on the Theory of Reasoned Action and on Cognitive Behavior Theory, is a school-based substance use prevention program that targets high-risk students. We recruited two groups of alternative high schools in successive academic years, and randomly assigned schools in each group to either receive the intervention (n = 7) or serve as a control (n = 7). Students completed surveys prior to and following the administration of the program, and again 1 year later. Although participation in Project SUCCESS significantly increased students' perceptions of harm resulting from alcohol and marijuana use, students in the control group reported greater increases in peer support. We also found conflicting evidence in two opposing trends related to students' perceptions of the prevalence and acceptability of substance use. Therefore, the effects of Project SUCCESS on substance use-related beliefs and behaviors must be considered mixed.     

Sensitivity analyses for clustered data: An illustration from a large-scale clustered randomized controlled trial in education

In this paper, we demonstrate the importance of conducting well-thought-out sensitivity analyses for handling clustered data (data in which individuals are grouped into higher order units, such as students in schools) that arise from cluster randomized controlled trials (RCTs). This is particularly relevant given the rise in rigorous impact evaluations that use cluster randomized designs across various fields including education, public health and social welfare. Using data from a recently completed cluster RCT of a school-based teacher professional development program, we demonstrate our use of four commonly applied methods for analyzing clustered data. These methods include: (1) hierarchical linear modeling (HLM); (2) feasible generalized least squares (FGLS); (3) generalized estimating equations (GEE); and (4) ordinary least squares (OLS) regression with cluster-robust (Huber–White) standard errors. We compare our findings across each method, showing how inconsistent results – in terms of both effect sizes and statistical significance – emerged across each method and our analytic approach to resolving such inconsistencies.     

Influence of testosterone substitution on glycemic control and endothelial markers in men with newly diagnosed functional hypogonadism and type 2 diabetes mellitus: a randomized controlled trial

Abstract

Effects of testosterone (T) on the cardiovascular system of men remain controversial. The impact of T-replacement therapy (TRT) in men with functional hypogonadism and type 2 diabetes mellitus (T2DM) has to be elucidated. This study included 80 men (mean age 51.5?±?6.3 years) with newly diagnosed T2DM (according to ADA criteria) and functional hypogonadism (according to EAU criteria). Randomization: Group1 (n?=?40): TRT using 1%-transdermal T-gel (50?mg/day), Group2 (n?=?40) no TRT (controls). Dietary treatment applied to both. Parameters at baseline/after 9?months: anthropometric parameters, lipids and indicators of carbohydrate metabolism (fasting glucose, insulin, HbA1c, HOMA-IR), markers of adipose tissue and EnD (leptin, resistin, p- and e-selectin, ICAM- 1, VCAM- 1 and CRP). ANCOVA for repeated measurements revealed TRT to cause a significant decrease in waist circumference (WC), HOMA-IR and HbA1c vs controls (p?<?.001, p?=?.002, p?=?.004, respectively). Leptin declined in subjects receiving TRT vs controls (p?=?.04). Concentrations of resistin, ICAM-1, p-selectin and CRP decreased significantly vs controls (all p?<?.001); no effects for e-selectin and VCAM-1. Advanced age attenuated effects, higher delta testosterone levels augmented effects. Decrement of WC was related to decreasing markers of adipose tissue secretion/EnD. TRT in men with functional hypogonadism and T2DM improved carbohydrate metabolism and markers of endothelial dysfunction.     

A randomized controlled trial of the effects of mindfulness practice on doctoral candidate psychological status

Objectives: To examine the impact of guided mindfulness practice on psychological distress and psychological capital (hope, optimism, resilience, and efficacy) in doctoral candidates. Participants: Recruitment of a convenience sample of doctoral candidates occurred in July 2015 and participants were randomly allocated to the control or intervention group (38 and 34 participants completed the trial, respectively). Methods: A single-blinded, randomized controlled trial with intention-to-treat analysis was conducted. The intervention consisted of a daily guided mindfulness practice, using an audio CD. Indicators of psychological distress and psychological capital were measured pre- and post-trial with validated questionnaires. Results: Compared to the control group, the intervention group reported a statistically significantly reduction in depression (p?=?.045) and increased self-efficacy (p?=?.004), hope (p?=?.000), and resilience (p?=?.011). Conclusions: These results highlight the effectiveness of self-administered mindfulness practice on the psychological health of doctoral candidates, and the positive effect on psychological capital is reported as a key finding.     

Parent training in foster families with children with behavior problems: Follow-up results from a randomized controlled trial

The present randomized controlled trial examined the four months follow-up effectiveness of Parent Management Training Oregon (PMTO) for parents with foster children (aged 4–12) with severe externalizing behavior problems in long-term foster care arrangements. The aim of PMTO, a relative long and intensive (6–9 months, with weekly sessions) parent management training is to reduce children's problem behavior through improvement of parenting practices. We specifically investigated whether PMTO is effective to reduce foster parenting stress. It was expected that PMTO would reduce parenting stress in foster parents, improve the quality of parenting practices, and reduce children's problem behavior. Multi-informant (foster mothers, foster fathers, and teachers) data were used from 86 families. Multilevel analyses based on the intention to treat principle (retention rate 73%) showed that PMTO, compared to care as usual, had no significant direct, nor indirect or sleeper effects at follow-up on parenting stress, parenting behavior and child behavior problems. Earlier reported immediate effects of PMTO on reduced parenting stress at posttest disappeared at follow-up. Additional analyses on the role of non-specific intervention factors in PMTO effects showed that higher therapist fidelity scores resulted in stronger effects of PMTO on parenting responsiveness, parental explaining and autonomy granting. Unexpectedly, higher fidelity scores also predicted less decrease of parenting stress at follow-up.     

Effect of Seminar on Compassion on student self-compassion,mindfulness and well-being: A randomized controlled trial

ABSTRACT

Objective: Mindfulness-based interventions have been shown to have psychological benefits in college students. We explored the effects of an academic Seminar on Compassion on student psychological health. Participants: Forty-one participants (14 male, 27 female, mean age 19.8 ± 1.4 years) were assessed pre- and post- spring semesters 2013 and 2014. Methods: Students were randomized to the Seminar on Compassion or a wait-list control group. Participants completed self-report measures on anxiety, depression, perceived stress, self-compassion, compassion and mindfulness. Salivary alpha-amylase was also assessed. Results: At baseline, self-compassion and mindfulness were negatively correlated with depression, anxiety, and perceived stress. There were significant changes between the intervention and control group from Time 1 to Time 2 in mindfulness, self-compassion, compassion, and salivary alpha-amylase; however, there were no significant changes in depression, anxiety, and perceived stress. Conclusions: The course was effective in increasing mindfulness, self-compassion and compassion, and decreasing a salivary marker of stress.     

Physical activity does not alter prolactin levels in post-menopausal women: results from a dose-response randomized controlled trial

Background

Increased circulating levels of prolactin have been associated with increased risk of both in situ and invasive breast cancer. We investigated whether or not physical activity had a dose–response effect in lowering plasma levels of prolactin in postmenopausal women.

Methods

Four hundred previously inactive but healthy postmenopausal women aged 50–74 years of age were randomized to 150 or 300 min per week of aerobic physical activity in a year-long intervention. Prolactin was measured from fasting samples with a custom-plex multiplex assay.

Results

A high compared to moderate volume of physical activity did not reduce plasma prolactin levels in intention-to-treat (Treatment Effect Ratio (TER) 1.00, 95% Confidence Interval (CI) 0.95 – 1.06) or per-protocol analyses (TER 1.02, 95% CI 0.93 – 1.13).

Conclusions

It is unlikely that changes in prolactin levels mediate the reduced risk of breast cancer development in post-menopausal women associated with increased levels of physical activity.

Trial registration

clinicaltrials.gov identifier: NCT01435005.

     

Medical students' and tutors' experiences of directed and self-directed learning programs in evidence-based medicine: a qualitative evaluation accompanying a randomized controlled trial

This qualitative study aims to interpret the results of a randomized controlled trial comparing two educational programs (directed learning and self-directed learning) in evidence-based medicine (EBM) for medical students at the University of Oslo from 2002 to 2003. There is currently very little comparative educational research in this field. In the trial, no statistically significant differences between the study groups were shown for any outcomes considered (EBM knowledge, skills, and attitudes). Further analysis suggests that main reason for the negative trial results was that the majority of students learned equally effectively, whichever program they received, although implementation of the educational programs was not complete because of varying attendance. This study illustrates a stepwise evaluation model that might be useful in evaluating other socially complex interventions.     

Collaborative evaluation of a high school prevention curriculum: How methods of collaborative evaluation enhanced a randomized control trial to inform program improvement

Blending high-quality and rigorous research with pure evaluation practice can often be best accomplished through thoughtful collaboration. The evaluation of a high school drug prevention program (All Stars Senior) is an example of how perceived competing purposes and methodologies can coexist to investigate formative and summative outcome variables that can be used for program improvement. Throughout this project there were many examples of client learning from evaluator and evaluator learning from client. This article presents convincing evidence that collaborative evaluation can improve the design, implementation, and findings of the randomized control trial. Throughout this paper, we discuss many examples of good science, good evaluation, and other practical benefits of practicing collaborative evaluation. Ultimately, the authors created the term pre-formative evaluation to describe the period prior to data collection and before program implementation, when collaborative evaluation can inform program improvement.     

Stages of change and the group treatment of batterers: a randomized clinical trial

A stages-of-change motivational interviewing (SOCMI) treatment approach was compared with a standard cognitive behavioral therapy gender reeducation (CBTGR) approach in a sample of 528 English-speaking and Spanish-speaking male batterers who were randomly assigned to 49 26-week groups in either condition. Blind ratings of therapist adherence differentiated the two conditions. Language spoken neither predicted outcome nor interacted with treatment. The SOCMI curriculum led to significant reductions in female partners' reports of physical aggression at follow-up, but not to changes in self-reported aggression. Men who were initially less ready to change benefited more from the SOCMI approach while men who were more ready to change benefited more from the CBTGR approach. Results suggest the importance of tailoring abuser intervention programs to individuals' initial readiness to change.     

Sensory-motor training targeting motor dysfunction and muscle weakness in long-term care elderly combined with motivational strategies: a single blind randomized controlled study

Background

This study evaluated the effects of a combined innovative training regime consisting of stochastic resonance whole-body vibration (SR-WBV) and a dance video game (DVG) on physical performance and muscle strength in long-term-care dwelling elderly.

Methods

Thirthy long-term-care elderly were randomly allocated to an intervention group (IG; n?=?16) receiving combined SR-WBV training and DVG, or a sham group (SG; n?=?14). IG performed five sets one minute of SR-WBV, with one minute rest between sets (base frequency 3 Hz up to 6 Hz, Noise 4) during the first five weeks on three days per week. From week five to eight a DVG was added to SR-WBV for IG on three days per week. SG performed a five-set SR-WBV program (1 Hz, Noise 1) lasting five times one minute, with one minute rest in between, three days a week. From week five to eight stepping exercises on a trampoline were added on three days per week. Primary outcome: Short physical performance battery (SPPB). Secondary outcome: isometric maximal voluntary contraction (IMVC), and sub phases of IMVC (Fsub), isometric rate of force development (IRFD) and sub time phases of IRFD (IRFDsub) were measured at baseline, after four and eight weeks. ANOVA with repeated measures was used for analyses of time and interaction effects and MANOVA determined between group intervention effects.

Results

Between group effects revealed significant effects on the SPPB primary outcome after four weeks F(1, 27)?=?6.17; p?=?0.02) and after eight weeks F(1,27)?=?11.8; p?=?0.002). Secondary muscle function related outcome showed significant between group effects in IG on IRFD, Fsub 30 ms, 100 ms, 200 ms and IRFDsub 0-30 ms, 0-50 ms, 0-100 ms and 100-200 ms compared to SG (all p?<?0.05).

Conclusions

Eight weeks SR-WBV and DVG intervention improved lower extremity physical function and muscle strength compared to a sham intervention in long-term-care elderly. SR-WBV and DVG seems to be effective as a training regime for skilling up in long-term-care elderly.