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

Background Postpartum 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. Objective This 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. Methods A 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. Results We have recruited 838 women through the end of August 2018. Recruitment will be completed at the end of September 2018. Conclusions There 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 Registration ClinicalTrials.gov NCT02979444; https://clinicaltrials.gov/ct2/show/NCT02979444 (Archived by Webcite at http://www.webcitation.org/archive.php) International Registered Report Identifier (IRRID) PRR1-10.2196/11624

The proposed study focuses on a priority area identified by PCORI (i.e., interventions for improving perinatal outcomes), Illinois Governor's Office on Early Childhood Development, the target population, clinicians and researchers. The findings will address a critical gap in current knowledge with policy implications (e.g., resource identification and allocation). This is a major strength.
The proposed study is innovative in comparing efficacy of MB delivered by paraprofessionals vs. usual care, and effectiveness of group-format MB intervention delivered by mental health professionals vs. paraprofessional home visitors.
Findings of three randomized controlled trials suggest significant reductions in depressive symptoms and effects on prevention of new cases of major depression among intervention (both clinician and home visitor led) participants compared to usual care participants. The team has developed a thoughtful dissemination plan with support of state-level officials which will result in timely improvements in practice and patient outcomes if positive findings are found (major).

Weaknesses:
Since depressive symptoms have direct and indirect impact on both mothers and their children's health and development, it would be beneficial to include children's data during the postpartum period to inform the potential effect of the intervention on children's short-term outcomes (minor).

Strengths:
A moderate strength is that addressing maternal depression has been identified by Federal agencies (Administration for Children & Families, 2006;Health Resources & Services Administration, 2013), and Home Visitation (HV) model developers (Prevent Child Abuse America, 2001), andHV researchers (Ammerman et al., 2010) as a much needed and highly impactful HV enhancement.
A major strength of the proposal is that it is innovative. It proposes the delivery of mental health services outside the public mental health system, is lower cost to deliver, and addresses many challenges postpartum women face in accessing services that are related to reimbursement. A major strength is that the research team has engaged in prior research activities focused on delivering behavioral health services via HV programs that have shown to be effective in reducing symptoms of depression in postpartum women.

Weaknesses:
A moderate weakness is that the applicant does not clearly demonstrate that the research questions address a critical gap in current knowledge as noted in systematic reviews, guideline development efforts, or previous research prioritizations. The application only includes general references to the study's fit into existing research portfolios without discussing a current gap in knowledge clearly. A minor weakness is that the applicant does not clearly demonstrate that patients have identified that research related to HV and the Mothers and Babies (MB) course is important overall. A moderate weakness is that the applicant does not clearly describe the potential study impact related to the number of perinatal women at risk for postpartum depression that do not engage in mental health services, or the percentage of these women estimated to be served through HV programs, as the study interventions will be focused on delivering mental health services through HV programs.

Strengths:
The proposed study is innovative and addresses a critical gap in knowledge in that it seeks to evaluate the effectiveness of the delivery of Mothers & Babies, an effective intervention to prevent postpartum depression, by paraprofessionals during home visits.
The research has been identified as important to community members who collaborate with this team of researchers. The findings of this comparative effectiveness study would provide sizable benefits to the prevention of postpartum depression in low-income women. It is likely that the findings from this study could be disseminated and implemented quickly in practice. There is a strong plan for disseminating the findings of the study.

Strengths:
The proposal makes a strong case that it would be advantageous to learn whether paraprofessionals can deliver an equivalent intervention to professionals. This is a major strength.
The proposal makes a strong case that the MB course, delivered by professionals, is effective. The proposal reports results from several randomized trials documenting the benefits of the intervention. This is a major strength.
If intervention by paraprofessionals is equivalent to professional intervention, this evidence-based intervention could be more broadly introduced. This is a major strength.

Weaknesses:
It is not clear how widespread home visits (HVs) are in other communities. If this is not a common practice then the ability to disseminate and implement the intervention would be limited. This is a moderate weakness.

Strengths:
The applicant has adequately justified the choice of comparison intervention based on the input from stakeholders; the comparison interventions are realistic options in the current practice.
The proposed sample size and power estimates are based on realistic and careful evaluations of the anticipated effect size.
The proposed plan and strategies for sample recruitment, enrollment and retention are feasible and well justified based on the applicants' prior work.
The applicant has proposed a rigorous study design in all aspects with realistic timeline and essential resources. The team members have the necessary expertise and experience to conduct the proposed research.
The applicant has provided strong justification for the study population targeted in this proposed research.

Weaknesses:
The applicant has not delineated a clear theoretical framework that illustrates relationship among intervention components, anticipated outcomes and measures (minor). The applicant has not fully described sample inclusion and exclusion criteria in the Methods section (e.g., significant cognitive limitation as an exclusion criterion is only mentioned in the "Protection of Human Subjects." How significant cognitive limitation is defined and measured is not mentioned either (minor). The applicant has proposed to measure participants' relationship with their partners. However, it is unclear whether existence of "partner/spouse/significant other" is one of the inclusion criteria for study participation (minor). Since the proposed study targets mothers with depressive symptoms and competing life priorities, it is important to consider participant burden of completing study activities, including the questionnaire. It would be helpful if the investigators addressed this concern in the proposal (minor).
Page 15: please describe briefly what "generally accepted practices for analyzing qualitative data" is (minor). The intervention effect may be strengthened by meaningfully engaging participants' partners/family (minor).

Strengths:
The research design is strong and has been improved on revision. This is a randomized trial that compares usual care, intervention by professionals, and intervention by paraprofessionals. This is a major strength. The inclusion of a usual care arm strengthens the proposal by allowing the investigators to determine whether paraprofessionals can attain results that are better than usual care.
The measures have been improved on revision. The change in depression measurement is well justified and improves the rigor of the project. The plan for recruitment appears feasible, given the extensive experience of the team in previous research with this population.

Weaknesses:
There is relatively little evidence for the efficacy of the paraprofessional arm of the study. Thus it is unclear how well this trial fits the definition of a comparative effectiveness study. This represents a moderate weakness.

Criterion 4: Patient-centeredness
Reviewer 1: Strengths: -There is a major strength that the proposed research focuses on questions that affect outcomes of interests to the target population, caregivers/family, clinicians, researchers and policy makers (major).
-The proposed research addresses key questions mentioned in PCORI's definition of patient-centered outcomes research (major).

Strengths:
A moderate strength of the proposal is that the it includes letters of support from several state HV programs that clearly demonstrate that program staff are supportive of implementing group versions of the MB programs.

Weaknesses:
A moderate weakness is that although stakeholder interest in the study topic is strong, patient interest in the topic of the MB program delivered in a group format is not described in detail in the proposal. A moderate weakness is that the applicant does not clearly describe how the proposed research addresses one or more of the key questions mentioned in PCORI's definition of PCOR, although the question focused on how clinicians and health care delivery systems can help patients make better decisions about care is indirectly addressed.

Strengths:
This proposal has demonstrated patient-centeredness in the development of the research question, the development of the proposal and the dissemination plan of the findings. It addresses the key question in PCORI's definition on what are the options for the prevention of postpartum depression in the community setting. Ethnically diverse and low-income women will benefit from the delivery of Mothers & Babies via home visits.

Strengths:
The proposal focuses on outcomes that are highly valued by stakeholders, based on the information presented in the proposal when these outcomes were evaluated by patients and families. The proposal addresses a major barrier to widespread application of a successful model. Although professionally administered depression intervention is effective, cost and availability of trained professionals has limited adaptation of the model. Using paraprofessionals, if proven successful, would diminish both of these barriers and make the program much more feasible to implement widely. The letters of support are strong and address every element of patient-centeredness.

Criterion 5: Patient and stakeholder engagement
Reviewer 1: Strengths: -The applicant has clearly described the process of engaging the target population and other stakeholders in revising the intervention, formulating research questions, defining target population, comparators and outcomes, implementing the research, evaluating the outcomes, and suggesting plans for dissemination (major strength).
-The roles of decision-making authority of all partners have been clearly stated based on their expertise and experience (major strength).
-The proposal has demonstrated the principles of reciprocal relationships, co-learning, partnership, trust, transparency, and honesty.

Strengths:
A major strength of the proposal is that the study topic focused on delivering the HB curriculum to address postpartum depression via group delivery of HP classes was initiated by stakeholders involved in the delivery of state Maternal Child Health HV programs. An Operations Team/Community Advisory Committee will be used to inform the study , and 9 of the 12 members are patients or stakeholders.

Weaknesses:
A moderate weakness is that the involvement of patients in developing the initial research questions is not clearly demonstrated in the proposal, although the applicant states that HV program staff represent the opinions of patients served by the programs. A minor weakness is that the Operations Team/Community Advisory Committee members are all from Illinois, and it isn't clear if the group will be expanded to reflect the geography covered by the study. A moderate weakness is that significant decision making authority related to the study will rest with the Executive Committee, and patients are not members of this Committee. A minor weakness is that the relationship between the Executive Committee, Operations Team/Community Advisory Committee, and National Advisory Committee, and authority of each committee is not clearly described. A minor weakness is that the plan for reciprocal relationships for stakeholder and patient engagement is not clearly described. A consensus decision making model will be used for the Operations Team/Community Advisory Committee, but how decisions made by this committee will filter up/across to the Executive Committee and National Advisory Committee is not clearly described.
A moderate weakness is that the description of co-learning for the study focuses on a description of education to be provided by the scientific research team members to the patient and stakeholder participants, and not vice versa. A minor weakness is that the proposal does not clearly describe how patients will be engaged in suggesting plans for dissemination of study outcomes to promote changes in practice.

Strengths:
There is evidence that patients' caregivers, patients and stakeholders were involved in the development of this proposal, will continue to be involved during the conduction of this study and will provide feedback in the dissemination phase. This engagement includes the training plans for the paraprofessionals in the delivery of the intervention. The proposal clearly articulates the reciprocal relationships, co-learning partnerships, trust, transparency and honesty. This study provided a clear description of the roles that stakeholders, patients and scientist.