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

Starting soon · Not applicable

Conditions studied: Depression

In brief

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.

Key facts

Study ID

NCT07469176

Run by

Northwestern University

People needed

72

Starts

2026-09-15

Expected to finish

2028-09-15

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 years or older
• Expecting or parenting an infant with Down Syndrome (20 months gestation - 4 months old)
• Speaks and Reads English
• Has access to internet and videoconferencing

You may not qualify if…

• active suicidal ideation (indicated on the screener)
• Withdrawal criteria:
• Active suicide ideation indicated on any of the following: endorsement of BDI-II item 9, PHQ-9 item 9; PGS-Diagnosis item 3 Subscale II; statements to research staff); or
• BDI-II total score ranging from 20 - 63 indicating the participant endorses moderate to severe depressive symptoms and has a higher need for mental health services.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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