N/A
N=252
Collaborative Perinatal Mental Health and Parenting Support in Primary Care
Parenting · Mother-child Relations
Bottom Line
View on ClinicalTrials.gov: NCT02724774 ↗Enrolled (actual)
252
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Change in Parent Sensitivity in Teaching — 36.73; 35.32 score on a scale — p=.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Promoting First Relationships® (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Parent Sensitivity in Teaching |
36.73; 35.32 | .026 sig |
| PRIMARY Change in Parent Sensitivity in Play |
6.45; 5.98 | .154 |
| PRIMARY Change in Maternal Confidence |
4.40; 4.36 | .516 |
| PRIMARY Change in Parent Understanding of Toddlers |
51.84; 48.67 | <0.001 sig |
| SECONDARY Change in Infant Interactive Quality |
2.23; 2.71 | 0.094 |
| SECONDARY Infant Behavioral Regulation: Externalizing T Score |
59.24; 62.54 | 0.029 sig |
| SECONDARY Infant Behavioral Regulation: Internalizing T Score |
53.64; 54.93 | .389 |
| SECONDARY Infant Behavioral Regulation: Dysregulation T Score |
54.82; 55.33 | .747 |
Summary
Treating mothers' perinatal depressive and other mental health symptoms alone does not prevent impaired parenting quality and adverse infant outcomes. The goal of this research is to conduct a randomized controlled trial to evaluate the effectiveness of adding a research-based 10-week home visiting parenting program to evidence-based mental health treatment, to counter the pernicious effects of mothers' symptoms on parenting quality and infant development. Participants will be English and Spanish-speaking low-income mothers who began publicly funded mental/behavioral health treatment in pregnancy at their primary care community health centers.
Eligibility Criteria
Inclusion Criteria
- Mothers with infants 6 weeks - 3 months old
- English or Spanish speaking
- Access to a telephone
- Currently or at some point during pregnancy received treatment for a mental health condition (counseling and/or medications) at a participating community health center in the Seattle, Washington area
Exclusion Criteria
- Currently experiencing an acute crisis (e.g., severe domestic violence, homelessness, hospitalization, imprisonment)
Data sourced from ClinicalTrials.gov (NCT02724774). 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.