What this study is
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's being tested
- Center Sessions
Intervention · BEHAVIORAL
Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
- At-home
Intervention · BEHAVIORAL
Self-study resources paired with regular contact with study personnel.
Study details
- Sponsor
- University of Notre Dame
- Conditions
- Family Conflict · Marital Conflict · Communication
- Enrolling
- 150 people
- Starts
- 2017-08-04
- Est. completion
- 2024-12-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex ALLHealthy volunteers AcceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Kathleen N Bergman, PhD · Contact574-631-0956kbergman@nd.edu
Wm. J. Shaw Center for Children and Families
Fort Wayne, Indiana, United States
Not yet recruitingWm. J. Shaw Center for Children and Families
South Bend, Indiana, United States
- E. M Cummings, PhD · Contact574-631-4947ecumming@nd.edu
Recruiting
Study team
Sponsor
University of Notre Dame
Study ID 16-1246
Principal investigator
Edward M Cummings, PhD
University of Notre Dame
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.