N/A
N=874
Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Perinatal Depression · PostPartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT02979444 ↗Enrolled (actual)
874
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum — 5.9; 5.3; 5.8; 6.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mothers and Babies Groups (Behavioral)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum |
5.9; 5.3; 5.8; 6.4; 5.5; 5.9 | — |
| SECONDARY The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum |
3.6; 3.8; 4.0; 3.6; 3.8; 4.1 | — |
| SECONDARY The Change in the Negative Mood Regulation Scale |
3.7; 3.8; 3.8; 3.7; 3.8; 3.9 | — |
| SECONDARY The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum |
3.8; 3.8; 4.1; 3.8; 3.9; 4.2 | — |
| SECONDARY The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum |
3.4; 3.5; 3.5; 3.4; 3.4; 3.5 | — |
Summary
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.
Eligibility Criteria
Inclusion Criteria
- The investigators will enroll only pregnant women in this study, given that the Mothers and Babies Course is delivered prenatally as a postpartum depression prevention intervention. The investigators will offer participation to prenatal home visiting clients, ages 16 and older, knowing the client base for home visiting programs includes pregnant teens.
Exclusion Criteria
- Women with high-risk medical and pregnancy conditions will be excluded since this may preclude women from regularly attending intervention sessions. The investigators will not exclude women based on race/ethnicity or based on demographic characteristics other than the ability to speak English or Spanish.
Data sourced from ClinicalTrials.gov (NCT02979444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.