Clinical Trials Logo

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03495440
Study type Interventional
Source University of Notre Dame
Contact Edward M Cummings, PhD
Phone 574-631-4947
Status Recruiting
Phase N/A
Start date August 4, 2017
Completion date May 31, 2022

See also
  Status Clinical Trial Phase
Completed NCT03221985 - ESM Pilot: Mobile Phones and Psychology N/A
Completed NCT02619474 - The Effect of Whiteboards on Patient Satisfaction N/A
Completed NCT03203018 - Health Literacy and Cardiovascular Knowledge Workshop in Women From Disadvantaged Communities N/A
Completed NCT02267265 - Pilot Study of Novel Postpartum Educational Video Intervention N/A
Completed NCT02695316 - Barrier-free Communication in Maternity Care of Allophone Migrants N/A
Completed NCT01933789 - Improving Communication About Serious Illness N/A
Completed NCT01697137 - Patient and Physician Intervention to Increase Organ Donation N/A
Completed NCT01459744 - An Intervention to Improve Implantable Cardioverter-Defibrillator Deactivation Conversations N/A
Recruiting NCT01170000 - Timely End-of-Life Communication to Parents of Children With Brain Tumors N/A
Completed NCT01040975 - Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight N/A
Completed NCT03044145 - The Cultural Formulation Interview-Engagement Aid N/A
Completed NCT02937597 - E-learning Proficiency Based Progression Training Programme for Clinical Communication on ISBAR Performance (eISBAR) N/A
Recruiting NCT02585921 - Organ Donation Interventions Among High Students N/A
Completed NCT02586779 - Effectiveness of WhatsApp (a Messenger Program) Usage in Emergency Department (ED) N/A
Completed NCT02284022 - Clinical Validation Protocol for BCI for the Communication of Patients Suffering From Neuromuscular Disorders. N/A
Completed NCT01501006 - Social and Behavioral Influence (SBI)
Completed NCT02277899 - Primary Care, Communication, and Improving Children's Health N/A
Recruiting NCT03651596 - Leveraging mHealth Messaging to Promote Adherence in Teens With CKD N/A
Active, not recruiting NCT03711071 - Ideas, Concerns, Expectations. Implementing Patient-centered Communication N/A
Active, not recruiting NCT01972308 - A Patient Advocate to Improve Real-world Asthma Management for Inner City Adults N/A