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NCT07469176 · ClinicalTrials.gov registry record · NA
Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
A NA study, sponsored by Northwestern University.
- Not yet
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT07469176 is a NA study that has not yet begun recruiting, run by Northwestern University. The registered enrollment target is 72 participants.
The verdict
NCT07469176, a NA study, has not yet begun recruiting, sponsored by Northwestern University.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study 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 expecta
Interventions
- BEHAVIORAL Mothers and Babies
- BEHAVIORAL Mothers and Babies Down Syndrome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2026-05-30 |
| Est. Completion | 2028-09-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07469176
The ClinicalTrials.gov registry entry for NCT07469176 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Mothers and Babies is the first listed.
NCT07469176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07469176 about?
NCT07469176 is a clinical study titled "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 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 indepe...
What is the current status of trial NCT07469176?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2026-05-30. Estimated completion is 2028-09-15.
What interventions are being tested in trial NCT07469176?
The interventions under investigation include: Mothers and Babies (BEHAVIORAL), Mothers and Babies Down Syndrome (BEHAVIORAL).
Who is sponsoring clinical trial NCT07469176?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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