Families of Youth with Developmental Disabilities: a Theory-Based Intervention
Part of paid clinical trials in Fort Wayne, Indiana.
- Sponsor
- University of Notre Dame
- Study ID
- NCT03495440
- Status
- Recruiting
Conditions
- Communication
- Family Conflict
- Marital Conflict
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Accepted
Interventions
- Center Sessions — BEHAVIORALProgram to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
- At-home — BEHAVIORALSelf-study resources paired with regular contact with study personnel.
Study Details
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.
Key Dates
- Start date
- Aug 4, 2017
- Status verified
- Nov 2024
- Primary completion
- Dec 31, 2024
- Completion
- Dec 31, 2024
Study Design
- Enrollment
- 150 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Center SessionsTreatment condition in which participants receive psychoeducation and communication coaching.
- Active Comparator: At-homeActive, self-study control condition in which participants receive regular communication with study personnel and self-study materials to review on their own.
Primary Outcome Measure
Change in marital satisfaction -- Short Marital Adjustment Scale (SMAT) [ Time Frame: 1 year ]
Central Contacts
- Edward M Cummings, PhD574-631-4947
- Kathleen N Bergman, PhD574-631-0956
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wm. J. Shaw Center for Children and Families | Fort Wayne | Indiana | 46814 | |
| Wm. J. Shaw Center for Children and Families | South Bend | Indiana | 46814 |
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