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

NCT03495440 | Recruiting DMC

• 1 other identifier: 16-1246
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Family Conflict; Marital Conflict; Communication

Keywords

Emotional Security; Intellectual Disability; Developmental Disability

Outcome Measures

Primary Outcomes (14)

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• 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.

  1 year

• Change in typically developing siblings' levels of attachment to parents -- Inventory of Parent and Peer Attachment (IPPA)

  25-item self-report questionnaire designed to assess adolescents' perceptions of the positive and negative affective dimension of relationships with their parents and peers. Typically developing siblings complete two forms (father and mother) on three scales: trust, communication, and alienation.

  1 year

• Change in typically developing siblings' emotional security -- Security in the Subsystem (SIS) and Security in the Family System (SIFS)

  The SIS is a child-report of the feelings and behaviors experienced when witnessing marital conflict. The SIFS is a self-report measure of adolescents' security in the family as a whole. Scores will be used in latent variables as a broad indicator of typically developing siblings' emotional security.

  1 year

• Change in typically developing siblings' adjustment -- Strengths and Difficulties Questionnaire (SDQ)

  25-item parent-report measure of prosocial behavior and psychopathology in their children.

  1 year

• Change in typically developing siblings' behavior -- Youth Self-Report (YSR)

  Adolescent self-report measure of perceived externalizing and internalizing behaviors.

  1 year

• Change in typically developing siblings' depressive symptomatology -- Child Depression Inventory (CDI)

  27-item self-report questionnaire measuring the extent of depression symptoms in children.

  1 year

• Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II)

  Parent self-report measure used to assess the severity of depression symptoms.

  1 year

• Change in parents' problem drinking behaviors -- Parental Alcohol Experiences scale (PAE)

  Parent self-report measure that provides a continuous measure of parental problem drinking.

  1 year

• Change in the quality of family conflict interactions -- Family Interactions Coding System (FICS)

  Video recorded quadratic (parent, TD sibling, child with IDD) interactions during which families discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.

  1 year

• Change in the quality of couples' conflict interactions -- Family Interactions Coding System (FICS)

  Video recorded dyadic (interparental) interactions during which couples discuss a topic of conflict are coded using an observational coding system to assess overall levels of constructiveness, destructiveness and resolution.

  1 year

• Change in family interactions in the home -- Daily Diaries

  Parents complete 15 daily diaries following the 6-month and 12-month follow up assessments comprising of self-reports on the occurrence and quality of daily interparental and parent-child interactions.

  6 months

Secondary Outcomes (1)

• Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II

  1 year

Study Arms (2)

Center Sessions

EXPERIMENTAL

Treatment condition in which participants receive psychoeducation and communication coaching.

Behavioral: Center Sessions

At-home

ACTIVE COMPARATOR

Active, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own.

Behavioral: At-home

Interventions

Center Sessions BEHAVIORAL

Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.

Center Sessions

At-home BEHAVIORAL

Self-study resources paired with regular contact with study personnel.

At-home

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• University of Notre Dame: lead

Study Sites (2)

Wm. J. Shaw Center for Children and Families

Fort Wayne, Indiana, 46814, United States

NOT YET RECRUITING

Wm. J. Shaw Center for Children and Families

South Bend, Indiana, 46814, United States

RECRUITING

MeSH Terms

Conditions

Communication; Intellectual Disability; Developmental Disabilities

Condition Hierarchy (Ancestors)

Behavior; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Edward M Cummings, PhD

  University of Notre Dame

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Edward M Cummings, PhD

CONTACT

574-631-4947; ecumming@nd.edu

Kathleen N Bergman, PhD

CONTACT

574-631-0956; kbergman@nd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: April 12, 2018
• Study Start: August 4, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)