NCT03495440 · University of Notre Dame
Families of Youth with Developmental Disabilities: a Theory-Based Intervention
What this study is about
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.
View original scientific 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.
Interventions
BEHAVIORAL
Center Sessions
Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
BEHAVIORAL
At-home
Self-study resources paired with regular contact with study personnel.
Primary outcome measures
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT)
Time frame: 1 year
15-item parent self-report questionnaire measuring indices of marital satisfaction, including matters of disagreement, relationship dynamics, and happiness.
Change in hostile interparental conflict -- O'Leary Porter Scales (OPS)
Time frame: 1 year
10-item parent self-report questionnaire designed to measure overt marital hostility exhibited in front of the children.
Change in family functioning -- Family Environment Scale (FES)
Time frame: 1 year
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.
Change in typically developing siblings' perception of interparental conflict -- Children's Perception of Inter-parental Conflict (CPIC)
Time frame: 1 year
19-item self-report questionnaire that captures three dimensions of marital conflict (frequency, intensity, and resolution) perceived by children.
Change in typically developing siblings' levels of attachment to parents -- Inventory of Parent and Peer Attachment (IPPA)
Time frame: 1 year
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.
Change in typically developing siblings' emotional security -- Security in the Subsystem (SIS) and Security in the Family System (SIFS)
Time frame: 1 year
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.
Change in typically developing siblings' adjustment -- Strengths and Difficulties Questionnaire (SDQ)
Time frame: 1 year
25-item parent-report measure of prosocial behavior and psychopathology in their children.
Change in typically developing siblings' behavior -- Youth Self-Report (YSR)
Time frame: 1 year
Adolescent self-report measure of perceived externalizing and internalizing behaviors.
Change in typically developing siblings' depressive symptomatology -- Child Depression Inventory (CDI)
Time frame: 1 year
27-item self-report questionnaire measuring the extent of depression symptoms in children.
Change on parents' depressive symptomatology - Beck Depression Inventory (BDI-II)
Time frame: 1 year
Parent self-report measure used to assess the severity of depression symptoms.
Change in parents' problem drinking behaviors -- Parental Alcohol Experiences scale (PAE)
Time frame: 1 year
Parent self-report measure that provides a continuous measure of parental problem drinking.
Change in the quality of family conflict interactions -- Family Interactions Coding System (FICS)
Time frame: 1 year
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.
Change in the quality of couples' conflict interactions -- Family Interactions Coding System (FICS)
Time frame: 1 year
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.
Change in family interactions in the home -- Daily Diaries
Time frame: 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Fort Wayne, Indiana
- South Bend, Indiana
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 15, 2024 · Source of record for eligibility and locations