Mothers and Babies Program for Depression in Parents of Children With Down Syndrome
(MBDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Heather J Risser
Principal Investigator
Northwestern University
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Adaptation and Co-Design
Adaptation of the Mothers and Babies program for parents of infants with Down syndrome using a human-centered design approach
Open Trial
Conduct an open trial to assess feasibility and acceptability of the adapted virtual MBDS intervention
Follow-up
Participants are monitored for changes in depressive symptoms and parental sensitivity and responsivity to the infant
What Are the Treatments Tested in This Trial?
Interventions
- Mothers and Babies
- Mothers and Babies Down Syndrome
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
The standard 9-session Mother's and Babies content plus Down Syndrome specific content
Parents will receive treatment as Usual
The standard 9-session Mother's and Babies intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
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