Anxiety & Depression Association of America

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

Arm	Description	Assigned 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.