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Families of Youth with Developmental Disabilities: a Theory-Based Intervention
Who can join
All ages · All sexes · Healthy volunteers welcome
Full eligibility 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.
About the study
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.
What is being tested
- Center Sessions (behavioral)
- At-home (behavioral)
Sponsor: University of Notre Dame · Participants: 150 · Started: Aug 4, 2017
Contact the study team
- Edward M Cummings, PhD · Phone: 574-631-4947
- Kathleen N Bergman, PhD · Phone: 574-631-0956
Official record on ClinicalTrials.gov — NCT03495440
Locations in the U.S.
| Indiana | Wm. J. Shaw Center for Children and Families, Fort Wayne (Not yet recruiting) Wm. J. Shaw Center for Children and Families, South Bend |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.