A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care
- Conditions
- Efficacy, SelfDepression, PostpartumAnxiety
- Interventions
- Behavioral: Promoting First Relationships-BriefBehavioral: Perinatal Collaborative Care
- Registration Number
- NCT04998721
- Lead Sponsor
- University of Washington
- Brief Summary
The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.
- Detailed Description
Eligible and consenting participants will be randomized in a single blind manner (research visitor will be blinded to condition) at a 1:1 ratio to either MInD (parenting intervention and usual perinatal collaborative care) or usual collaborative care in their second trimester of pregnancy. Research assessments will be administered during pregnancy and post-partum.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- English speaking pregnant women between gestational age (GA) 13 - 24 weeks
- ≥ 18 years,
- EPDS score ≥10,
- Ability to send and receive text messages (TM)
- Severe substance use disorder in the past 6 months (score of 4 or above on the Alcohol Use Disorders Test AUDIT-C or a score of 6 or more on the Drug Abuse Screening Test (DAST).
- Active suicidal ideation as measured by follow up to a positive answer to question 10 on the EPDS.
- Bipolar disorder (Composite International Diagnostic Interview score ≥7) or psychotic disorder (assessed by chart review);
- Multiple gestation (assessed by self-report and medical record);
- Ongoing active treatment with psychotropic medications by mental health specialist (but not a PCP or Obstetrician).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maternal Infant Dyadic Care Perinatal Collaborative Care Perinatal collaborative care and Promoting First Relationships-Brief Maternal Infant Dyadic Care Promoting First Relationships-Brief Perinatal collaborative care and Promoting First Relationships-Brief Control Perinatal Collaborative Care Perinatal collaborative care only
- Primary Outcome Measures
Name Time Method Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS) Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum The EPDS is a ten-item self-report depression measure with higher scores indicating increased symptoms severity, total score ranging from 0 to 30 and is validated for use in the perinatal period.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Disability on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS) Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum WHODAS 2.0 is a 12 item assessment of overall functioning. The scores assigned to each of the items - "none" (0), "mild" (1) "moderate" (2), "severe" (3) and "extreme" (4) - are summed, total score ranging from 0 to 48.
Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR) Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum The SENR contains 16 items rated on 7-point scales regarding mothers' perceptions of their competence on basic skills required in caring for an infant (e.g., "I feel confident in my role as a parent," "I can soothe my baby easily when he or she is crying or fussing") In the prenatal assessment questions address how women expect to do once their infant is born (e.g., "I look forward to becoming a parent with confidence in my role as a parent," "I expect to be able to soothe my baby easily when he or she is crying or fussing"). Scores on the SENR are obtained by summing individual items to yield a total efficacy score, with higher scores reflecting greater feelings of efficacy.
Relative utilization of MInD vs usual CC Baseline through up to 6 Months Postpartum (up to maximum of 9 months) The investigators operationalize adequate treatment utilization as participating in a sufficient number of health care encounters to achieve a therapeutic effect: attendance at ≥6 care manager sessions (≥3 prenatal and ≥3 postpartum).
Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR) 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum The investigators will administer the Working Alliance Inventory (WAI-SR) to all enrolled women to assess strength of alliance with the therapist and compare mean change over time between MInD and usual CC groups.
Change from Postpartum Baseline in Dyadic Interaction 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum Dyadic interaction will be coded using the NCAST applied to mother and child interactive behavior during a 3-minute videotaped session.
Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF) 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum The BIMF is a 20-item self-report measure for use in the first year postpartum and can assess overall functioning in the context of new motherhood. It measures the functional domains of social support, management, mother-child interaction, infant care, self-care, adjustment, and psychological well-being (of the mother). It is measured only postpartum. A total score is generated from summing the 20 items and ranges from 0 to 120.
Trial Locations
- Locations (1)
Amritha Bhat
🇺🇸Seattle, Washington, United States