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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression
• Intervention / Treatment: Behavioral: Mothers and Babies; Behavioral: Mothers and Babies Down Syndrome

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Risser, PhD; Phone Number: 13128483019; Email: heather.risser@northwestern.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60302
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Mothers & Babies; The standard 9-session Mother's and Babies intervention	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.
Experimental: Mothers and Babies Down Syndrome; The standard 9-session Mother's and Babies content plus Down Syndrome specific content	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.
No Intervention: Treatment as Usuals; Parents will receive treatment as Usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perinatal Grief Scale - Diagnosis	The Perinatal Grief Scale-Diagnosis (PGS-D), the NIH Toolkit Emotion Support Test and NIH Toolkit Instrumental Support Test.31 The PGS-D was adapted from the Perinatal Grief Scale,32 a 33-item self-report measure used to assess the intensity of grief following perinatal loss. The PDGS is a 33-item self-report measure used to assess the intensity of grief following receipt of a diagnosis of Down Syndrome for their infant. Participants are asked to indicate their current level of agreement for each statement. Items are rated on a 5-point Likert type scale (0 = strongly agree to 5 = strongly disagree). A total score is determined by summing the ratings for all items. Total scores range from 33 to 165, with higher scores indicating more intense grief. The PGS also consists of 3 subscales: active grief, difficulty coping, and despair. Each subscale score ranges from 11 to 55.	Baseline, 5 weeks, 9 weeks, 21 weeks
Beck Depression Inventory - 2	The Beck Depression Inventory - II (BDI-II)33 is a 21-item self-report measure used to assess depressive symptoms in adults. Participants are asked to indicate which statement best describes how they felt during the past two weeks including today. Items are rated on a 4-point scale. A total score is determined by summing the ratings for all items. Total scores range from 0 to 63, with higher scores indicating greater depressive symptoms. Total scores ranging from 0 to 13 indicate minimal depressive symptoms, total scores ranging from 14 to 19 indicate mild depressive symptoms, total scores ranging from 20 to 28 indicate moderate depressive symptoms, and total scores ranging from 29 to 63 indicate severe depressive symptoms. The BDI-II has demonstrated high internal consistency (α = 0.91),34 acceptable test-retest reliability,35 strong convergent validity,33 and strong discriminant validity.	Baseline, 5 weeks, 9 weeks, 21 weeks
The Emotion Support Test	The Emotion Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer-adaptive self- report measure used to assess the perception that people in one's social network are available to listen to one's problems with empathy, caring, and understanding. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 4 = always). Raw scores are converted into a T-Score, with higher scores indicating more emotional support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of emotional support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of emotional support.	Baseline, 5 weeks, 9 weeks, 21 weeks
The Instrumental Support Test	The Instrumental Support Test, as part of the NIH Toolbox Emotion Battery, is an 8-item computer- adaptive self-report measure used to assess the perception that people in one's social network are available to provide material or functional aid in completing daily tasks if needed. Participants are asked to respond to each item on a 5-point Likert type scale (1 = rarely to 5 = always). Raw scores are converted into a T-Score, with higher scores indicating more reported support. Scores 1 SD or more below the mean (T ≤ 40) indicate low levels of instrumental support, and scores 1 SD or more above the mean (T ≥ 60) indicate high levels of instrumental support.	Baseline, 5 weeks, 9 weeks, 21 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale	The Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale is a 76-item observer report measure used to assess caregiver behavior and regulation towards their infant in typical daily interactions. Participants are asked to indicate the occurrence vs. non-occurrence of specific behaviors. Items are rated on a binary scale (0= no, 1 = yes). A total score is determined by summing ratings for all items. Total scores range from 0 to 76, with higher scores indicating more favorable parent-child interaction quality. The NCAST PCI Feeding Scale consists of 5 subscales: sensitivity to cues (scores range from 0 to 16), response to child's distress (scores range from 0 to 11), social-emotional growth fostering (scores range from 0 to 14), cognitive growth fostering (scores range from 0 to 9), clarity of cues (scores range from 0 to 10), and responsiveness to caregiver (scores range from 0 to 13).	21 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire- 9	The PHQ-2 is a brief self-report screening measure for depressive symptoms consisting of two items rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). These items are drawn from the longer PHQ-9 and were selected because they capture the core diagnostic features of depression: depressed mood and anhedonia. The PHQ-2 is widely used as an initial screening tool to identify individuals who may be experiencing major depression (Levis et al., 2020).	Baseline, 5 weeks, 9 weeks, 21 weeks
Generalized Anxiety Disorder - 7	The GAD-7 (Generalized Anxiety Disorder-7) is a 7-item, self-report questionnaire designed to measure the severity of generalized anxiety disorder. It assesses symptoms, such as uncontrollable worry, restlessness and other symptoms of anxiety experienced over the past two weeks. Response options are provided on a 4-point Likert-type scale (0-3), representing the number of days experiencing symptoms. Higher scores indicate higher levels of anxiety.	Baseline, 5 weeks, 9 weeks, 21 weeks
The World Health Organization Disability Assessment Schedule 2.0	The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item (or 12-item), self-administered, or interviewer-guided questionnaire used to measure health and disability across cultures. It assesses functioning over the past 30 days in six domains: cognition, mobility, self-care, getting along, life activities, and participation.	Baseline, 5 weeks, 9 weeks, 21 weeks

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Heather J Risser, Northwestern University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 15, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: New/expectant parents; Parents of infants with Down syndrome; pregnant with baby with Down syndrome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: R34MH139788 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data Sharing Plan Per the notice specifications, investigators will share data via the National Institute of Mental Health Data Archive (NDA). Investigators will collect demographic data necessary to create a Global Unique Identifier (GUID) according to NIMH guidelines. They will also use NIMH tools to generate and submit relevant data and data dictionaries. The investigators will amend informed consent documents to align with NIMH data sharing processes and plans using plain language. The investigators will establish a process to certify the quality of all data generated, document certification, and review data accuracy after submission to the data sharing platform. The descriptive/raw data will be submitted semi-annually (every January 15 and July 15), and all other data will be submitted after publication, or prior to the end of the grant, whichever occurs first.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No