Families of Youth with Developmental Disabilities: a Theory-Based Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Notre Dame
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Center Sessions
BehavioralProgram to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
At-home
BehavioralSelf-study resources paired with regular contact with study personnel.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Center SessionsExperimental treatment 1 intervention
Group B: At-homeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT)
15-item parent self-report questionnaire measuring indices of marital satisfaction, including matters of disagreement, relationship dynamics, and happiness.
Time frame
1 year2
Change in hostile interparental conflict -- O'Leary Porter Scales (OPS)
10-item parent self-report questionnaire designed to measure overt marital hostility exhibited in front of the children.
Time frame
1 year3
Change in family functioning -- Family Environment Scale (FES)
27-item self-report measure that assesses dimensions of family functioning, specifically, the social domain of family relationships (cohesion, expressiveness, and conflict) to be completed by parents and typically developing siblings.
Time frame
1 year4
Change in typically developing siblings' perception of interparental conflict -- Children's Perception of Inter-parental Conflict (CPIC)
19-item self-report questionnaire that captures three dimensions of marital conflict (frequency, intensity, and resolution) perceived by children.
Time frame
1 yearSecondary outcomes
1
Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II
Parent report measure describing skills and skill development in individuals with intellectual and/or developmental disabilities. Subscales focus on four domains: (1) Communication, (b) Daily Living Skills, (c) Socialization, and (d) Motor Skills. The domain composite scores make up the overall Adaptive Behavior Composite. The Internalizing and Externalizing subscales, and one subset of items labeled "Other" make up the optional Maladaptive Behavior Index. This index provides a measure of undesirable behaviors that may interfere with an individual's adaptive behavior.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov