Intervention program for families with a child who has developmental disabilities
Families of Youth with Developmental Disabilities: a Theory-Based Intervention
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | University of Notre Dame Academic / other |
| Locations | 2 sites (Fort Wayne, Indiana and 1 other locations) |
| Trial ID | NCT03495440 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies using similar psycho-educational and communication training approaches have shown promising results, indicating potential efficacy for this intervention.
Eligibility criteria
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 this trial is running
Fort Wayne, Indiana and 1 other locations
- Wm. J. Shaw Center for Children and Families — Fort Wayne, Indiana, United States (Not_yet_recruiting)
- Wm. J. Shaw Center for Children and Families — South Bend, Indiana, United States (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.