Families of Youth with Developmental Disabilities: a Theory-Based Intervention
University of Notre Dame · NCT03495440
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Any age listed · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 150
- US sites recruiting
- 1
- Study start
- August 4, 2017
- Record last updated
- November 15, 2024
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Center Sessions; At-home
Conditions: Family Conflict; Marital Conflict; Communication
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
Wm. J. Shaw Center for Children and Families
South Bend, IN 46814
Site contact: Kathleen N Bergman, PhD · 574-631-0956 · kbergman@nd.edu
Study contacts (from the official record)
- Edward M Cummings, PhD · 574-631-4947 · ecumming@nd.edu
- Kathleen N Bergman, PhD · 574-631-0956 · kbergman@nd.edu
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