Intervention program for families with a child who has developmental disabilities
Official title: Families of Youth with Developmental Disabilities: a Theory-Based Intervention
Run by University of Notre Dame · NCT03495440 · Data updated 2026-11-12
This study is testing a program that helps families with a child who has developmental disabilities by providing support and skills to improve their relationships and reduce stress.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Notre Dame Academic / other |
| Locations | 2 sites (Fort Wayne, Indiana and 1 other locations) |
| Status | Recruiting |
| Started | August 4, 2017 |
| Main results expected | December 31, 2024 |
| Study ends | December 31, 2024 |
| Registry record updated | November 15, 2024 |
| Trial ID | NCT03495440 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include families with a child who has an intellectual or developmental disability, including parents and typically developing siblings aged 11 to 17.
✕Probably not a fit
Families without a child with an intellectual or developmental disability or those who do not meet the inclusion criteria may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This intervention program aims to support families that include a child with an intellectual or developmental disability by providing psychoeducation and communication coaching over a four-week period. Families will be randomly assigned to either receive the intervention or self-study materials, with assessments conducted before and after the program. The study seeks to improve family dynamics, emotional security, and adaptive functioning for all family members, particularly focusing on parents and typically developing siblings. The long-term goal is to enhance the availability of evidence-based family-systems approaches to reduce stress and conflict in these families.
Why it matters
Potential benefit: If successful, this program could significantly improve the emotional well-being and communication within families of children with developmental disabilities.
How similar studies have gone: Previous studies using similar psycho-educational and communication training approaches have shown promising results, indicating potential efficacy for this intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age. * Participants must be able to understand and respond to survey questions in English * Parents must be cohabitating, with both participating children living in their home. * Individual with IDD falls into one or more of the following categories: 1) meets criteria for an intellectual disability, which would mean a measured IQ of 70-75 or lower and a measured Adaptive Functioning score of 70-75 or lower, 2) meets criteria for an Autism Spectrum Disorder based on an evaluation using the ADOS-2, SCQ, and expert clinical judgment based on DSM-5 ASD criteria, or 3) has a medically verified genetic condition (e.g., Down syndrome, Fragile X syndrome, Williams syndrome, Angelman syndrome, others) that is generally considered to be a developmental disability, and shows cognitive or adaptive functioning deficits (70-75 or below) although not necessarily deficits in both categories as would be needed for an Intellectual Disability diagnosis. Exclusion Criteria: * Siblings identified as typically developing will be excluded 1) with a score of 10 or higher on the SCQ-L, if a subsequent ADOS suggests that they have an ASD diagnosis, or 2) with a WASI-II score of 75 or lower.
Where it's running
-
Wm. J. Shaw Center for Children and Families
South Bend, Indiana, United States Recruiting -
Wm. J. Shaw Center for Children and Families
Fort Wayne, Indiana, United States Not yet recruiting
Study contacts
- Principal investigator: Edward M Cummings, PhD — University of Notre Dame
- Study coordinator: Edward M Cummings, PhD
- Email: ecumming@nd.edu
- Phone: 574-631-4947
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.