Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression via the Mothers and Babies Course: Protocol for a Cluster-Randomized Controlled Trial

Abstract

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...

Comparing Fidelity Outcomes of Paraprofessional and Professional Delivery of a Perinatal Depression Preventive Intervention

“…Criteria for program selection included the ability to recruit a large number of pregnant clients in a 16-18 month period. Programs were randomized into one of three study arms: (1) MB group intervention led by paraprofessional home visitors; (2) MB group intervention led by MHPs; or, (3) control (see Jensen et al 2018, for more information on the randomization process). Clients were recruited through HV programs and the surrounding communities to participate in the research study.…”

“…Data reported here come from a cluster-RCT studying the comparative effectiveness of MHPs and paraprofessionals in delivering a group version of MB (Jensen et al 2018). Primary results for this study on preventing the onset of major depression and worsening of depressive symptoms are forthcoming.…”

Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework

“…Also, at the time of the study development readily accessible training courses were not focused on delivering interventions to pregnant women. Recent studies have highlighted the effectiveness of interpersonal psychotherapy and CBT interventions to prevent postnatal depression which can be delivered by nurses, midwives and health visitors in antenatal care settings and require brief initial training [ 45 , 46 ], and a brief midwife-led CBT intervention for maternal anxiety is in progress [ 82 ]. For this intervention, it was considered that the therapeutic intervention components (mind body and cognitive behavioural approaches) could be delivered through supported use of self-help resources.…”

Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables in cluster-randomized trials

“…Thus, if a site inaccurately reports baseline covariates used to control imbalance in the CCR algorithm, one would expect poor control over participant-level imbalance, with performance potentially reverting back to that of SR. This simulation study evaluates the methods of randomization for a Patient-Centered Outcomes Research Institute (PCORI)-funded study involving the Mothers and Babies (MB) intervention (AD-1507-31,473), which targets prevention and reduction of postpartum depression among low-income women [ 2 , 3 ].…”

“…The motivating study is a covariate-constrained CRT in which home visiting program sites were randomized to one of three study arms varying the delivery of the MB program [ 3 ]. For details on the motivation, study design, and analysis plan, see Jensen et al [ 3 ].…”