Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome

Summary

Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant and new parents of infants with Down syndrome (MBDS). Background: Expectant and new parents of infants with Down syndrome are at high risk for perinatal depression. Perinatal depression is both independently, and exponentially associated with long-term adverse neurodevelopmental consequences for infants with Down syndrome. MB is a cognitive-behavioral intervention designed to prevent perinatal depression. MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effects sizes found across a series of randomized controlled trials (RCTs). However, research suggests that expectant and new parents of children with Down syndrome may have needs that standard MB does not address. Significance: This project will pilot a Down syndrome adaptation to MB, MBDS designed to target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant. Innovation: The proposed project is innovative in three ways. First, the investigators plan to conduct the first pilot of a perinatal depression prevention intervention specifically designed for expectant and new parents of infants with Down syndrome. Second, the investigators plan to include fathers, nonbinary, and transgender parents to target symptoms of depression, rather than as simply a support person for maternal depressive symptom reduction. Third, the investigators plan to use a group format to establish cohorts of families of infants with Down syndrome of similar developmental stages. Design: Human-centered design and an open trial will inform a subsequent small randomized controlled clinical pilot to test the feasibility of the study protocol in preparation for a larger randomized controlled trial (RCT). Population: New and expectant parents of infants with Down syndrome. Outcomes: All aspects of the study protocol (e.g., condition allocation, treatment and control condition procedures, data collection, etc.) will be operationalized in preparation for the subsequent RCT. The investigators will assess MBDS effectiveness on target mechanisms of grief/loss and social support; and assess whether changes in the target mechanisms are associated with changes in depressive symptoms and parental sensitivity and responsivity to the infant.

Conditions

• Depression

Interventions

BEHAVIORAL

Mothers and Babies

The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.

BEHAVIORAL

Mothers and Babies Down Syndrome

The investigators will test new Down syndrome content embedded within the standard Mothers and Babies content. The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Northwestern University

  lead OTHER

Principal Investigators

• Heather J Risser · Northwestern University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-05-30

Primary Completion

2028-07-30

Completion

2028-09-15

Countries

• United States

Study Locations