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

University of Notre Dame · NCT03495440

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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
Families of Youth with Developmental Disabilities: a Theory-Based… (NCT03495440) | Bored Studies