Background In cluster-randomized controlled trials (C-RCTs), covariate-constrained randomization (CCR) methods efficiently control imbalance in multiple baseline cluster-level variables, but the choice of imbalance metric to define the subset of “adequately balanced” possible allocation schemes for C-RCTs involving more than two arms and continuous variables is unclear. In an ongoing three-armed C-RCT, we chose the min(three Kruskal–Wallis [KW] test P values) > 0.30 as our metric. We use simulation studies to explore the performance of this and other metrics of baseline variable imbalance in CCR. Methods We simulated three continuous variables across three arms under varying allocation ratios and assumptions. We compared the performance of min(analysis of variance [ANOVA] P value) > 0.30, min(KW P value) > 0.30, multivariate analysis of variance (MANOVA) P value > 0.30, min(nine possible t test P values) > 0.30, and min(Wilcoxon rank-sum [WRS] P values) > 0.30. Results Pairwise comparison metrics ( t test and WRS) tended to be the most conservative, providing the smallest subset of allocation schemes (10%–13%) meeting criteria for acceptable balance. Sensitivity of the min( t test P values) > 0.30 for detecting non-trivial imbalance was 100% for both hypothetical and resampled simulation scenarios. The KW criterion maintained higher sensitivity than both the MANOVA and ANOVA criteria (89% to over 99%) but was not as sensitive as pairwise criteria. Conclusions Our criterion, the KW P value > 0.30, to signify “acceptable” balance was not the most conservative, but it appropriately identified imbalance in the majority of simulations. Since all are related, CCR algorithms involving any of these imbalance metrics for continuous baseline variables will ensure robust simultaneous control over multiple continuous baseline variables, but we recommend care in determining the threshold of “acceptable” levels of (im)balance. Trial registration This trial is registered on ClinicalTrials.gov (initial post: December 1, 2016; identifier: NCT02979444 ). Electronic supplementary material The online version of this article (10.1186/s13063-019-3324-5) contains supplementary material, which is available to authorized users.

BackgroundPostpartum depression is highly prevalent in low-income women and has significant health and mental health effects on mother and child. Home visiting (HV) programs provide services to large numbers of perinatal women in the United States and are a logical setting for delivering mental health services. Although there are interventions that reduce the risk of developing postpartum depression among low-income women, none have used nonhealth or nonmental health professionals as interventionists.ObjectiveThis study aimed to outline the protocol of a cluster randomized trial funded by the Patient-Centered Outcomes Research Institute that evaluates whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care. It will also examine if MB, when led by home visitors, is not inferior to MB delivered by mental health professionals (MHPs). MB has previously demonstrated efficacy when delivered by MHPs, and pilot work indicated promising results using home visitors to deliver the intervention.MethodsA cluster randomized trial is being conducted with 38 HV programs. Sixteen HV programs will deliver MB using MHPs, 16 will deliver MB using paraprofessional home visitors, and 6 will deliver usual HV services. The study employs a modified covariate-constrained randomization design at the site level. We anticipate recruiting 933 women aged ≥16 years enrolled in HV programs, who are 33 or more weeks’ gestation and speak either English or Spanish. Women in the 2 intervention arms will receive the 6-session MB group intervention. Baseline, postintervention, 12-week postpartum, and 24-week postpartum assessments will be conducted to assess client outcomes. The primary outcome will be the change in Quick Inventory of Depressive Symptomatology Self-Report 16 scores from baseline to 24-week follow-up. Secondary outcomes associated with core MB content will also be examined. Semistructured interviews will be conducted with home visitors and MHPs who are group facilitators and 90 study participants to gain data on intervention successes and challenges. Analyses will proceed at the participant level. Primary analyses for depressive symptoms score at 24 weeks postpartum will involve a linear mixed model, controlling for baseline symptoms and other covariates, and random effects to account for clustering.ResultsWe have recruited 838 women through the end of August 2018. Recruitment will be completed at the end of September 2018.ConclusionsThere is considerable potential to disseminate MB to HV programs throughout the United States. Should our results demonstrate home visitor efficacy when compared with usual care and/ noninferiority between home visitors and MHPs in improving mental health outcomes, no additional financial resources would be required for the existing HV staff to implement MB. Should this study determine that home visitors are less effective than MHPs, we will generate more wide-scale evidence on MB effectiveness when led by MHPs.Trial Registratio...

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Mothers and Babies (MB), a perinatal depression preventive intervention, has proven effective in decreasing depressive symptoms and preventing onset of major depression. An ongoing cluster-randomized trial is comparing the effectiveness of the six-session MB group intervention led by paraprofessionals versus mental health professionals. Twenty percent of all audio-recorded intervention sessions were randomly selected for fidelity checks. Analyses assessed mean facilitator adherence and competency overall, by study arm, and by session; and, examined site, facilitator, and client-specific effects. There were no significant differences found between study arms. Findings show paraprofessionals can deliver MB with similar fidelity as mental health professionals.

Due to the COVID-19 pandemic, regulations for substance use services changed to accommodate stay-at-home orders and physical distancing guidelines. Methods: Using in-depth interviews (N = 14) and framework analysis, we describe how policymakers developed, adopted, and implemented regulations governing services for substance use disorders during COVID-19, and how policymakers' perceived the impacts of these regulations in New York State. Results: During the COVID-19 pandemic, policymakers shifted to more inclusive approaches of knowledge generation and co-production of recommendations. Barriers to adoption and implementation of new regulations included medication/services supply, lack of integration, stigma, and overcriminalization. Conclusion: Findings from this study highlight the potential feasibility and benefits of co-produced policies for substance use services and the need for consistent service supply, better integration with health care services, reduced stigma, improved funding structures, best practice guidelines, criminal justice reform, and harm reduction support. These considerations should inform future policy maintenance and modifications to substance use services related to COVID-19.