Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With Down Syndrome
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The investigators will conduct semi-structured interviews, aided by a pre-interview diary study, with individual parents and parent dyads of children with Down syndrome (N = 12)."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests a version of the Mothers and Babies program for people expecting or raising a baby with Down syndrome. The program aims to prevent depression during pregnancy and after birth by addressing grief, loss, and support from others.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older.
- You are expecting a baby with Down syndrome or parenting one up to 4 months old. The pregnancy timing is listed as “20 months gestation,” which needs clarification from the study team.
- You speak and read English.
- You have internet access and can join video calls.
Who can't join
- You report current thoughts of suicide on the screening form.
- After joining, you will be withdrawn if you report current thoughts of suicide on study forms or to study staff.
- After joining, you will be withdrawn if your score on a depression survey shows moderate to severe symptoms and a greater need for mental health care.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: -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.
Study sites (1)
IL
- Northwestern University · Chicago, IL 60302More trials in Chicago