A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care

Purpose

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.

Conditions

  • Depression, Postpartum
  • Efficacy, Self
  • Anxiety

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • English speaking pregnant women between gestational age (GA) 13 - 24 weeks - ≥ 18 years, - EPDS score ≥10, - Ability to send and receive text messages (TM)

Exclusion Criteria

  • 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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Maternal Infant Dyadic Care
Perinatal collaborative care and Promoting First Relationships-Brief
  • Behavioral: Promoting First Relationships-Brief
    A brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum.
  • Behavioral: Perinatal Collaborative Care
    Collaborative Care (CC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.
Active Comparator
Control
Perinatal collaborative care only
  • Behavioral: Perinatal Collaborative Care
    Collaborative Care (CC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
University of Washington

Study Contact

Amritha Bhat, MD
2065433117
amritha@uw.edu

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.