RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-08-04
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03495440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants in all conditions will include mothers, fathers, TD siblings between 11 and 17 years old, and individuals with IDD of any age.
  2. * Participants must be able to understand and respond to survey questions in English
  3. * Parents must be cohabitating, with both participating children living in their home.
  4. * 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.
  1. * 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.

Contacts and Locations

Study Contact

Edward M Cummings, PhD
CONTACT
574-631-4947
ecumming@nd.edu
Kathleen N Bergman, PhD
CONTACT
574-631-0956
kbergman@nd.edu

Principal Investigator

Edward M Cummings, PhD
PRINCIPAL_INVESTIGATOR
University of Notre Dame

Study Locations (Sites)

Wm. J. Shaw Center for Children and Families
Fort Wayne, Indiana, 46814
United States
Wm. J. Shaw Center for Children and Families
South Bend, Indiana, 46814
United States

Collaborators and Investigators

Sponsor: University of Notre Dame

  • Edward M Cummings, PhD, PRINCIPAL_INVESTIGATOR, University of Notre Dame

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-04
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-08-04
Study Completion Date2024-12-31

Terms related to this study

Keywords Provided by Researchers

  • Emotional Security
  • Intellectual Disability
  • Developmental Disability

Additional Relevant MeSH Terms

  • Family Conflict
  • Marital Conflict
  • Communication