Families of Youth with Developmental Disabilities: a Theory-Based Intervention

Recruiting now · Not applicable

Conditions studied: Family Conflict, Marital Conflict, Communication

In brief

This study is designed to evaluate a preventive intervention program designed to support families (parents and typically developing adolescent siblings) that include a child with an intellectual and/or developmental disability. Participant families will be randomly assigned to either the treatment condition, in which they will receive psychoeducation and communication coaching over a four-week period, or the control condition, in which they will receive self-study materials. All subjects will participate in a pre-test assessment and three post-test assessments over the course of the year.

Key facts

Study ID

NCT03495440

Run by

University of Notre Dame

People needed

150

Starts

2017-08-04

Expected to finish

2024-12-31

Last updated by the study team

2024-11-15

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Wm. J. Shaw Center for Children and Families — South Bend, Indiana, United States (enrolling)
• Wm. J. Shaw Center for Children and Families — Fort Wayne, Indiana, United States

Full record on ClinicalTrials.gov

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