Recruiting

Observational Study

Sponsor:

University of Notre Dame

Code:

NCT03495440

Conditions

Family Conflict

Marital Conflict

Communication

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Center Sessions

At-home

Study Details

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

Study ID

NCT03495440

Start date

Aug 4, 2017

Status verified date

Nov, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Center Sessions

Treatment condition in which participants receive psychoeducation and communication coaching.

active comparator: At-home

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

Interventions

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.

Primary outcome measure

  • Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT) [ Time Frame: 1 year ]
  • Change in hostile interparental conflict -- O'Leary Porter Scales (OPS) [ Time Frame: 1 year ]
  • Change in family functioning -- Family Environment Scale (FES) [ Time Frame: 1 year ]
  • Change in typically developing siblings' perception of interparental conflict -- Children's Perception of Inter-parental Conflict (CPIC) [ Time Frame: 1 year ]
  • Change in typically developing siblings' levels of attachment to parents -- Inventory of Parent and Peer Attachment (IPPA) [ Time Frame: 1 year ]
  • Change in typically developing siblings' emotional security -- Security in the Subsystem (SIS) and Security in the Family System (SIFS) [ Time Frame: 1 year ]
  • Change in typically developing siblings' adjustment -- Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: 1 year ]
  • Change in typically developing siblings' behavior -- Youth Self-Report (YSR) [ Time Frame: 1 year ]
  • Change in typically developing siblings' depressive symptomatology -- Child Depression Inventory (CDI) [ Time Frame: 1 year ]
  • Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II) [ Time Frame: 1 year ]
  • Change in parents' problem drinking behaviors -- Parental Alcohol Experiences scale (PAE) [ Time Frame: 1 year ]
  • Change in the quality of family conflict interactions -- Family Interactions Coding System (FICS) [ Time Frame: 1 year ]
  • Change in the quality of couples' conflict interactions -- Family Interactions Coding System (FICS) [ Time Frame: 1 year ]
  • Change in family interactions in the home -- Daily Diaries [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Edward M Cummings, PhD

574-631-4947ecumming@nd.edu

Kathleen N Bergman, PhD

574-631-0956kbergman@nd.edu

Locations

Wm. J. Shaw Center for Children and Families

Recruiting

South Bend, Indiana, United States, 46814

Contacts

Kathleen N Bergman, PhD

574-631-0956kbergman@nd.edu

E. M Cummings, PhD

574-631-4947ecumming@nd.edu

More Information

Sponsor

University of Notre Dame

Last update posted

Nov 15, 2024

Last verified

Nov, 2024

Keywords

  • Emotional Security
  • Intellectual Disability
  • Developmental Disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Notre Dame on 2024-11-15.