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

Goal: This R34 study will pilot an adaptation for the Mothers and Babies (MB) program for expectant mothers and new parents of infants with Down syndrome (MBDS). Background: Expectant mothers 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 mothers 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, we plan to conduct the first pilot of a perinatal depression prevention intervention specifically designed for expectant mothers and new parents of infants with Down syndrome. Second, we plan to include fathers to target symptoms of depression, rather than as simply a support person for maternal depressive symptom reduction. Third, we 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: Expectant mothers and new 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. We 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. Project Number: 1R34MH139788-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: HEATHER RISSER (+1 co-PI) | Institution: NORTHWESTERN UNIVERSITY, CHICAGO, IL | Award Amount: $720,000 | Activity Code: R34 | Study Section: Effectiveness of Mental Health Interventions Study Section[EMHI] View on NIH RePORTER: https://reporter.nih.gov/project-details/11118580