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Purpose: Randomized controlled trials (RCTs) are often viewed as the "gold standard" for proving the efficacy and effectiveness of new interventions. However, some are skeptical of the generalizability of the findings that RCTs produce. The characteristics of those willing to participate in research studies have the potential to affect the generalizability of its findings. This study examined factors that could influence consent among families recruited to participate in a randomized field trial in a real-world child welfare setting. Methods: This study tested the Parent Management Training Oregon Model for children in foster care with serious emotional disturbance. It employed a post-randomization consent design, whereby the entire sample of eligible participants, not just those who are willing to consent to randomization, are included in the sample. Initial eligibility assessment data and data from the federally mandated reporting system for public child welfare agencies provided the pool of potential predictors of consent. Bivariate and multivariate analyses were conducted to identify statistically significant predictors of consent. Results: Being a dual reunification family was the most significant factor in predicting consent. Unmarried individuals, younger, female parents, cases where parental incarceration was the reason for removal and cases where the removal reason was not due to their children's behavioral problem(s) were also more likely to participate. Discussion: As one of the first research studies to examine predictors of consent to a randomized field study in child welfare settings, results presented here can act as a preliminary guide for conducting RCTs in child welfare settings. [ABSTRACT FROM AUTHOR]

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013–2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge. [ABSTRACT FROM AUTHOR]

Background and Objectives: The present study evaluated the effectiveness of a single clinician delivered brief intervention (BI) to reduce problem alcohol use and illicit substance use in an opiate-dependent methadone maintained cohort of patients attending for treatment. Methods: Four addiction treatment centers were randomly assigned to either treatment as usual (TAU; control group) or BI (intervention group). Clinicians screened patients using the alcohol, smoking, and substance involvement screening test (ASSIST) screening tool at baseline and again at three-month follow up. Fidelity checks were performed to ensure that training was delivered effectively and uniformly across all study sites. Feasibility of administering a BI within daily practice was assessed through intervention fidelity checks, patient satisfaction questionnaires and process evaluation. Results: A total of 465 patients were screened (66% of the overall eligible population) with a total of 433 (93%) ASSIST positive cases. Randomization was effective, with no differences in the control versus the intervention arms at baseline for key demographic or clinical indicators including substance us. There was a statistically significant difference between global risk score for the intervention (x = 39.36, sd = 25.91) group and the control group (x = 45.27, SD = 27.52) at 3-month follow-up (t(341) = −2.07, p <.05). Conclusions: This trial provides the first evidence that a single clinician delivered BI can result in a reduction in substance use within a methadone maintained opiate-dependent cohort, and this effect is sustained at three month follow up. [ABSTRACT FROM AUTHOR]

Objective. To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine. Design and setting. Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment. Intervention. The intervention was home visits with a general practitioner and municipal nurse within seven days of discharge focusing on medication, rehabilitation plan, functional level, and need for further health care initiatives. The visit was concluded by planning one or two further visits. Controls received standard health care services. Patients. People aged 65  years discharged from Holbæk University Hospital, Denmark, in 2012 considered at high risk of readmission. Main outcome measures. The primary outcome was readmission within 30 days. Secondary outcomes at 30 and 180 days included readmission, primary health care, and municipal services. Outcomes were register-based and analysis used the intention-to-treat principle. Results. A total of 270 and 261 patients were randomized to intervention and control groups, respectively. The groups were similar in baseline characteristics. In all 149 planned discharge follow-up visits were carried out (55%). Within 30 days, 24% of the intervention group and 23% of the control group were readmitted (p  0.93). No significant differences were found for any other secondary outcomes except that the intervention group received more municipal nursing services. Conclusion. This municipality-based follow-up intervention was only feasible in half the planned visits. The intervention as delivered had no effect on readmission or subsequent use of primary or secondary health care services. [ABSTRACT FROM AUTHOR]

Objectives. The objectives of this study were to determine the efficacy and safety of aripiprazole for treatment of psychosis, retention and abstinence in patients with methamphetamine dependence. Methods. This was a double-blind study where 37 methamphetamine dependent patients with history of psychosis were randomly assigned to receive aripiprazole (5-10 mg daily, N = 19) or placebo ( N = 18) for 8 weeks. Follow-up evaluation was scheduled on day 7, 14, 28, 42 day 56 after enrolment. Results. Participants on aripiprazole were retained significantly longer in treatment (48.7 days, SD =4.0) compared to placebo (37.1 days, SD =5.0). The Kaplan-Meier survival analysis showed that participants on aripiprazole were less likely to drop out of the study than the placebo group ( P =0.02, χ2 =5.3). Psychotic symptoms significantly decreased among those on aripiprazole as compared to placebo ( P < 0.05). However, no statistically significance was found between the two groups in maintaining abstinence (generalised estimation equation (GEE) analysis, P = 0.41). No serious adverse events were reported in either group. Conclusion. Aripiprazole was no more effective than placebo in maintaining abstinence from methamphetamine use. However, it facilitated treatment retention and reduced the severity of psychotic symptoms. Aripiprazole was found to be generally safe and well tolerated. [ABSTRACT FROM AUTHOR]