Testing the effectiveness of adding group therapy to home visiting services on reducing postpartum depression in women with low incomes
METHODS: A cluster randomized trial was conducted in which 37 home visiting (HV) programs across 7 states were randomized to usual HV services, MB delivered by an HV paraprofessional (HVP), or MB delivered by an MHP. Clusters were defined and randomized at the HV program level whereby an individual...
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| Format: | eBook |
| Language: | English |
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[Washington, D.C.]
Patient-Centered Outcomes Research Institute (PCORI)
2021, 2021
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| Series: | Final research report
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| Online Access: | |
| Collection: | National Center for Biotechnology Information - Collection details see MPG.ReNa |
| Summary: | METHODS: A cluster randomized trial was conducted in which 37 home visiting (HV) programs across 7 states were randomized to usual HV services, MB delivered by an HV paraprofessional (HVP), or MB delivered by an MHP. Clusters were defined and randomized at the HV program level whereby an individual HV program served as the unit of randomization. Depressive symptom score at 24 weeks postpartum was the primary outcome, controlling for baseline symptoms, assessed using the Quick Inventory of Depressive Symptomatology (QIDS). Baseline assessments were conducted during pregnancy after study enrollment, with follow-up assessments extending to 24 weeks postpartum. A total of 1316 women were referred for assessment, of whom 874 enrolled. Eligibility criteria were aged ≥16 years, ≤33 weeks of gestation on referral, and Spanish or English speaking. Participants' mean age was 26.3 (+/-) 5.8 years, 70% belonged to a minority racial/ethnic group, and 71% had incomes <$25 000/year. BACKGROUND: Postpartum depression (PPD) is a common mental health concern that has well-documented negative effects on maternal and child health and disproportionately affects women with low income. Although efficacious interventions exist for preventing onset and worsening of depression among perinatal women, no studies have examined the efficacy of paraprofessionals in delivering a PPD preventive intervention to women with low income. OBJECTIVE: This study sought to determine whether pregnant women receiving the Mothers and Babies (MB) group-based intervention exhibited greater reductions in depressive symptoms than women receiving usual community-based services, and to examine whether the MB intervention delivered by paraprofessional home visitors would yield similar reductions in depressive symptoms to the MB intervention provided by mental health professionals (MHPs). While the HVP arm saw the largest drop in mean QIDS score from baseline (8.6 (+/-) 4.3) to 24 weeks postpartum (5.9 (+/-) 4.5), all arms showed an overall mean decrease in primary outcome, with the control arm ending at 5.8 (+/-) 4.6 and the MHP arm ending at 5.3 (+/-) 4.5 at 24 weeks postpartum. Overall, the 95% CI for primary outcome was 7.69 to 8.28 at baseline, 7.03 to 7.60 immediately postintervention, 5.65 to 6.31 at 12 weeks, and 5.32 to 6.00 at 24 weeks postpartum. Thus, we could not claim that either of the intervention arms showed superiority in decreasing depressive symptom scores compared with the control arm (P = .393 when comparing HVP vs control; P = .406 when comparing MHP vs control) at 24 weeks. However, we have evidence of noninferiority between MB delivered by an MHP vs an HVP. CONCLUSIONS: Although analyses from our superiority aim did not find a statistically significant difference between the 2 intervention arms and our control arm, our noninferiority analyses did find that HVPs using MB generated similar reductions in depressive symptoms as MHPs. Additionally, there were no significant differences in fidelity of implementation between HVPs and MHPs, suggesting that lay health professionals may be a viable approach to delivering PPD preventive interventions in community-based settings like HV. LIMITATIONS: There may have been a potential flooring effect in which there was less room to demonstrate improvement in symptom reduction given the lower-than-anticipated baseline depressive symptom scores of study participants. Among facilitators who delivered >1 MB cohort, interviews were conducted after the final cohort, potentially creating challenges in remembering experiences from earlier cohorts Semistructured interviews with 46 facilitators and 88 intervention participants assessed intervention feasibility and acceptability. We conducted fidelity analysis to examine facilitator adherence and competency. We excluded any participants from analyses who did not contribute any data after the initial baseline assessment, and we analyzed all participants according to the arm to which their site was randomized. RESULTS: A total of 824 women (94%) contributed data toward our primary analyses. Among women in the 2 active intervention arms, 53% received ≥4 intervention sessions. QIDS scores dropped from a mean 8.0 (+/-) 4.2 points to 5.7 (+/-) 4.5 points overall (scale range, 0-27 points), aggregated across all study arms. Our model-estimated mean difference in QIDS scores between intervention arms equaled 0.01 points (95% CI, −0.78 to 0.79), and the lower confidence limit remains above our prespecified margin of noninferiority (2 points). The interview data suggest that clients and facilitators found the MB content and group format acceptable, with no significant differences between intervention arms. Challenges included maintaining group attendance, addressing transportation issues, and managing group discussion. Facilitators found the intervention appropriate for pregnant clients, with some challenges presented for clients in crisis situations, experiencing housing instability, and with literacy and learning challenges. Fidelity analyses found no significant differences between HVPs and MHPs in facilitator adherence or competency. |
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| Physical Description: | 1 PDF file (80 pages) illustrations |