NCT07469176

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Detailed description

SPECIFIC AIMS Down syndrome (Trisomy 21) is the most common genetic condition that causes Intellectual and Developmental Disability (IDD) in the U.S. with about 1 in 600 children born in the U.S. each year. Compared to children with other special health care needs, children with Down syndrome experience negative health outcomes and are twice as likely to have unmet health care and family support needs. Down syndrome can be diagnosed as early as 10 weeks gestation or as late as immediately after birth. Regardless of a pre- or post-natal diagnosis, expectant mothers and parents of infants with Down syndrome are at high risk for perinatal depression. Perinatal depression is one of the most common complications of pregnancy, affecting over half a million parents in the U.S. each year. Perinatal depression is associated with adverse obstetric and neonatal outcomes, including fetal growth restriction and preterm birth. These complications are responsible for most neonatal morbidity and mortality and can increase negative health outcomes for infants with Down syndrome. In addition, perinatal depression can interfere with infant attachment and brain development, further exacerbating learning and behavioral problems in children with Down syndrome. Thus, mitigation of perinatal depression in expectant mothers and new parents of children with Down syndrome is critical to child development and public health. Mothers and Babies (MB) is an empirically supported cognitive-behavioral intervention designed to prevent perinatal depression. MB consists of 9 weekly sessions, delivered individually or in a group setting. The United States Preventive Services Task Force recognized MB as one of the two most effective counseling interventions for perinatal depression prevention, with moderate to large effect sizes found across a series of randomized controlled trials (RCTs). However, expectant mothers and new parents of children with Down syndrome have critical needs that standard MB does not address. For example, parents report experiencing overwhelming emotions of grief, loss, and mourning when first learning about their child's Down syndrome diagnosis. As a parent of a child with Down syndrome, one of the MPIs knows that cultivating a strengths-based view of the Down syndrome diagnosis can reduce grief/loss and increase hope for the child's future. Parents of children with Down syndrome may also experience isolation. To combat isolation, parents need to hear about the thriving and supportive Down syndrome community, opportunities for their children to reach their potential, and the community supports available to them. The goal of this application is to adapt MB for expectant mothers and new parents of children with Down syndrome, adding intervention components designed to 1) reduce grief/loss and 2) increase social connection to the Down syndrome community. The investigators plan to co-design the Mothers and Babies Down Syndrome (MBDS) adaptation by adding specific content to reduce grief/loss and increase social support and convening MBDS in a group-based format, led by NADS staff and parent volunteers, and connecting families to larger Down Syndrome community networks. Aim 1: Adapt MB for parents of infants with Down syndrome using a human-centered design approach. Adaptation will be guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS process model, informed by mixed-methods approaches to engage parents of children with Down Syndrome. 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). The investigators will then engage parents in co-design workshops to adapt and refine MB for parents of children with Down syndrome. The investigators will use feedback from Aim 1 to adapt content and assist in developing implementation strategies for the MB Down Syndrome (MBDS) program. Aim 2: Conduct an open trial to assess feasibility and acceptability of the adapted virtual MBDS intervention with expectant mothers and new parents of children with Down syndrome (N = 12). At 4 time points (Baseline, mid- and post-intervention, and 3-month post intervention) the investigators will assess: 1) Acceptability (e.g., satisfaction, facilitators/barriers to participation, and reasons for not attending sessions); 2) Utility - how useful parents found the program to be, and parents' use of curricular elements; 3) Feasibility (number referred who met eligibility, enroll; time to complete assessments and group sessions; and self-reported feasibility). Aim 3: Conduct a 3-arm pilot RCT to test feasibility and preliminary effectiveness of the virtual MBDS adaptation, relative to the virtual standard, unadapted MB and usual care, with 60 expectant/new mothers of children with Down syndrome to examine whether the intervention leads to changes in the hypothesized 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. The goal of this R34 proposal is to adapt an existing evidence-based intervention to prevent perinatal depression for expectant mothers and new parents of children with Down syndrome. Feedback regarding adaptation, feasibility, acceptability, and preliminary metrics of effectiveness will inform the planned larger-scale effectiveness trial. The ultimate goal of this research program is to develop an effective and scalable perinatal depression prevention intervention that could be delivered by parents with lived experience.

Conditions

• Depression

Interventions

Type	Name	Description
BEHAVIORAL	Mothers and Babies	The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.
BEHAVIORAL	Mothers and Babies Down Syndrome	The investigators will test new Down syndrome content embedded within the standard Mothers and Babies content. The Mother and Babies (MB) Program uses principles of cognitive-behavioral therapy (CBT) and attachment theory to target depressive symptoms and perceived stress during the perinatal period. The 9-session intervention will be delivered in 25-minute virtual, weekly session. Each session has an overall objective and 3 to 4 key topics regarding a core cognitive-behavioral skill. Each session has been scripted and has associated resources and materials, and assigns homework (entitled, a "personal project"). Sessions teach parents to identify healthy and unhealthy thoughts and behaviors, modify unhealthy patterns, develop skills to manage stress, ask for what they need, increase behavioral activation and social support.

Timeline

• Start date: 2026-05-30
• Primary completion: 2028-07-30
• Completion: 2028-09-15
• First posted: 2026-03-13
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States