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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression, Postpartum; Anxiety; Efficacy, Self
• Intervention / Treatment: Behavioral: Promoting First Relationships-Brief; Behavioral: Perinatal Collaborative Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amritha Bhat, MD; Phone Number: 2065433117; Email: amritha@uw.edu
• Study Contact Backup: Name: Jamie Adachi, MPH; Email: jadachi@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • Amritha Bhat
      • Contact: Amritha Bhat; Phone Number: 206-543-3117; Email: amritha@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Parental Self-Efficacy on the Self-Efficacy in a Nurturing Role (SENR)	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.	Baseline, 30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Change from Postpartum Baseline in Dyadic Interaction	Dyadic interaction will be coded using the NCAST applied to mother and child interactive behavior during a 3-minute videotaped session.	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)	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.	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)	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.	6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum
Relative utilization of MInD vs usual CC	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).	Baseline through up to 6 Months Postpartum (up to maximum of 9 months)
Perceived match of treatment to patient need using Working Alliance Inventory (WAI-SR)	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.	30-34 Weeks Gestational Age, 6 Weeks Postpartum, 3 Months Postpartum, 6 Months Postpartum

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Amritha S Bhat, MD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: STUDY00011405; 1R34MH124798-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No