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

NCT07469176 | Not Yet Recruiting DMC

• 1 other identifier: R34MH139788
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

New/expectant parents; Parents of infants with Down syndrome; pregnant with baby with Down syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Nursing Childhood Assessment Satellite Training (NCAST) Parent-Child Interaction (PCI) Feeding Scale

  21 weeks

Other Outcomes (3)

• Patient Health Questionnaire- 9

  Baseline, 5 weeks, 9 weeks, 21 weeks

• Generalized Anxiety Disorder - 7

  Baseline, 5 weeks, 9 weeks, 21 weeks

• The World Health Organization Disability Assessment Schedule 2.0

  Baseline, 5 weeks, 9 weeks, 21 weeks

Study Arms (3)

Standard Mothers & Babies

ACTIVE COMPARATOR

The standard 9-session Mother's and Babies intervention

Behavioral: Mothers and Babies; Behavioral: Mothers and Babies Down Syndrome

Mothers and Babies Down Syndrome

EXPERIMENTAL

The standard 9-session Mother's and Babies content plus Down Syndrome specific content

Behavioral: Mothers and Babies

Treatment as Usuals

NO INTERVENTION

Parents will receive treatment as Usual

Interventions

Mothers and Babies BEHAVIORAL

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.

Mothers and Babies Down Syndrome; Standard Mothers & Babies

Mothers and Babies Down Syndrome BEHAVIORAL

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.

Standard Mothers & Babies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60302, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Heather J Risser

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Risser, PhD

CONTACT

13128483019; heather.risser@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Aim 2: Open trial (single-group) Aim 3: RCT (3 arms; original intervention, adapted intervention, materials only)

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): September 15, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)