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

NCT04998721 | Unknown Phase 2 DMC

• 2 other identifiers: STUDY000114051R34MH124798-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Postpartum; Efficacy, Self; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Perinatal Depression Symptomology on the Edinburgh Postnatal Depression Scale (EPDS)

  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.

  Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum

Secondary Outcomes (6)

• 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

• Change from Postpartum Baseline in Dyadic Interaction

  6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum

• 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

• Change from Postpartum Baseline in Maternal Functioning on the Barkin Index of Maternal Functioning (BIMF)

  6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum

• Relative utilization of MInD vs usual CC

  Baseline through up to 6 Months Postpartum (up to maximum of 9 months)

Study Arms (2)

Maternal Infant Dyadic Care

EXPERIMENTAL

Perinatal collaborative care and Promoting First Relationships-Brief

Behavioral: Promoting First Relationships-Brief; Behavioral: Perinatal Collaborative Care

Control

ACTIVE COMPARATOR

Perinatal collaborative care only

Behavioral: Perinatal Collaborative Care

Interventions

Promoting First Relationships-Brief BEHAVIORAL

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.

Maternal Infant Dyadic Care

Perinatal Collaborative Care BEHAVIORAL

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.

Control; Maternal Infant Dyadic Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Amritha Bhat

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Amritha S Bhat, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amritha Bhat, MD

CONTACT

2065433117; amritha@uw.edu

Jamie Adachi, MPH

CONTACT

jadachi@uw.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 10, 2021
• Study Start: November 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: December 22, 2023

Record last verified: 2023-11

Locations

US (1)