Families of Youth With Developmental Disabilities: A Theory-Based Intervention
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|ClinicalTrials.gov Identifier: NCT03495440|
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : September 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Family Conflict Marital Conflict Communication||Behavioral: Center Sessions Behavioral: At-home||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Families of Youth With Developmental Disabilities: A Theory-Based Intervention|
|Actual Study Start Date :||August 4, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
Experimental: Center Sessions
Treatment condition in which participants receive psychoeducation and communication coaching.
Behavioral: Center Sessions
Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
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.
Self-study resources paired with regular contact with study personnel.
- 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.
- Change in adaptive functioning for individuals with IDD - Vineland Adaptive Behavior Scales II [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495440
|Contact: Edward M Cummings, PhDfirstname.lastname@example.org|
|Contact: Kathleen N Bergman, PhDemail@example.com|
|United States, Indiana|
|Wm. J. Shaw Center for Children and Families||Not yet recruiting|
|Fort Wayne, Indiana, United States, 46814|
|Contact: Kathleen N Bergman, PhD 574-631-0956 firstname.lastname@example.org|
|Wm. J. Shaw Center for Children and Families||Recruiting|
|South Bend, Indiana, United States, 46814|
|Contact: Kathleen N Bergman, PhD 574-631-0956 email@example.com|
|Contact: E. M Cummings, PhD 574-631-4947 firstname.lastname@example.org|
|Principal Investigator:||Edward M Cummings, PhD||University of Notre Dame|