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Families of Youth with Developmental Disabilities: a Theory-Based Intervention
NCT03495440 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- BEHAVIORAL Center Sessions
- BEHAVIORAL At-home
Study Locations (2)
Indiana
- Wm. J. Shaw Center for Children and Families — Fort Wayne
- Wm. J. Shaw Center for Children and Families — South Bend
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2017-08-04 |
| Est. Completion | 2024-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03495440
The ClinicalTrials.gov registry entry for NCT03495440 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Notre Dame, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Communication appearing as the primary indexed condition, and to 2 interventions — of which Center Sessions is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03495440 reports 2 study locations spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03495440 about?
NCT03495440 is a clinical study titled "Families of Youth with Developmental Disabilities: a Theory-Based Intervention". 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 c...
What is the current status of trial NCT03495440?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2017-08-04. Estimated completion is 2024-12-31.
What conditions does trial NCT03495440 study?
This clinical trial studies the following conditions: Communication, Family Conflict, Marital Conflict. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03495440?
The interventions under investigation include: Center Sessions (BEHAVIORAL), At-home (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03495440?
This trial is sponsored by University of Notre Dame, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03495440 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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