Families of Youth With Developmental Disabilities: A Theory-Based Intervention

Communication Clinical Trial

Official title:

Families of Youth With Developmental Disabilities: A Theory-Based Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03495440
• Other study ID #: 16-1246
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2017
• Est. completion date: August 31, 2024

Study information

• Verified date: March 2024
• Source: University of Notre Dame
• Contact: Edward M Cummings, PhD
• Phone: 574-631-4947
• Email: ecumming[@]nd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A critical need exists for an evidence-based program to ameliorate the impact of family stress and conflict on the overall well-being of parents and TD siblings, as well as individuals with IDD. Our objective in this study is to test the efficacy for parents, TD siblings, and children with IDD of an adaptation of the psycho-educational and communication training approach used in a previously validated prevention/intervention program for community families, and to examine the mechanisms associated with change processes that occur as a result of the 4-week program. Our long-term goal is to increase the availability and affordability of empirically-supported family-systems approaches to reduce family stress and conflict in families of individuals with IDD. Our central hypothesis is that participation in the program will support the identified needs of families with a child with IDD, improve the well-being and adjustment of parents, increase emotional security and adjustment for TD siblings, and be associated with improvements in adaptive functioning for individuals with IDD. This central hypothesis is supported by promising qualitative evidence and preliminary analyses from an ongoing pilot study using the adapted curriculum included in the present proposal. Our rationale is that providing a family-systems approach to improving the family environment will support the well-being of each family member, including the child with IDD. The specific aims are: (1) determining the efficacy of the program for parents, (2a) determining the efficacy of the program for typically developing siblings, (2b) testing process models, guided by the Emotional Security Theory (EST; Davies & Cummings, 1994), to explain how and why and for whom and when changes occur as a result of the program, and (3) examining the impact of the program on individuals with IDD. Families (n=150) that include a child with IDD and a TD sibling between 11 and 17 years of age, will be randomly assigned to one of two groups: (1) parent and typically developing sibling intervention, or (2) resource only control. Multi-method assessments of all family members will be obtained at pre- and post-intervention visits, and 6-month and 1-year follow-ups. The approach is innovative because it addresses multiple family members' needs, tests theory about explanatory models for program impact, and utilizes a brief, psycho-educational format and a RCT design to evaluate its efficacy. This research is significant because it will create an inexpensive model program for family-system-level interventions for families of children with IDD, benefiting parents, siblings and the child with IDD, including evaluations of program effectiveness in standing community centers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Communication
• Developmental Disabilities
• Family Conflict
• Marital Conflict

Intervention

Behavioral:
• Center Sessions
Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
• At-home
Self-study resources paired with regular contact with study personnel.

Locations

Country	Name	City	State
United States	Wm. J. Shaw Center for Children and Families	Fort Wayne	Indiana
United States	Wm. J. Shaw Center for Children and Families	South Bend	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in typically developing siblings' behavior -- Youth Self-Report (YSR)	Adolescent self-report measure of perceived externalizing and internalizing behaviors.	1 year
Primary	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
Primary	Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II)	Parent self-report measure used to assess the severity of depression symptoms.	1 year
Primary	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
Primary	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
Primary	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
Primary	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	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.	1 year