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Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes
NCT04637581 · View on ClinicalTrials.gov ↗
Study Summary
The investigators propose a Hybrid Type 1 effectiveness-implementation quasi-experimental trial. Participants are drawn from two different communities contemporaneously. The intervention participants in one community receive a Wraparound intervention. Comparison group participants drawn from a second matched community receive treatment as usual. With this design, the investigators aim to study outcomes associated with the intervention as well as explore important facilitators and barriers associated with the implementation and other factors associated with reach / participation, engagement and acceptability. Wraparound is a structured 12-month family-driven "process" that is guided by family goals, includes a team of supports to wrap around families, and coordinates care for families. Wraparound has been primarily delivered and tested with families of older-age children with severe emotional and behavioral needs in an attempt to prevent residential placement. The investigators are interested in testing the model in a sample of families (n=160) affected by substance use disorders who have children placed outside the home or are at risk of such placement. The investigators hypothesize that families receiving Wraparound will obtain better parenting and family functioning outcomes (primary outcome); child safety, permanency, and well-being; and parental recovery than families receiving treatment as usual. The investigators will also explore factors associated with higher levels of engagement and outcomes, including family characteristics, referral sources and hand-off, and similarly, explore barriers and facilitators associated with engagement and/or outcomes.
Conditions Studied
Interventions
- BEHAVIORAL Wraparound
Study Locations (4)
New Hampshire
- Dept of Children Youth and Families — Claremont
- NH Claremont District Family Courts — Claremont
- TLC Family Resource Center — Claremont
- Dartmouth-Hithcock — Lebanon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04637581
The ClinicalTrials.gov registry entry for NCT04637581 describes a study currently listed as completed. 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 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dartmouth-Hitchcock Medical Center, which has 396 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention — of which Wraparound 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: NCT04637581 reports 4 study locations spanning 1 distinct geographic area — top geographies include New Hampshire. 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 NCT04637581 about?
NCT04637581 is a clinical study titled "Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes". The investigators propose a Hybrid Type 1 effectiveness-implementation quasi-experimental trial. Participants are drawn from two different communities contemporaneously. The intervention participants in one community receive a Wraparound intervention. Comparison group participants drawn from a secon...
What is the current status of trial NCT04637581?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2020-11-16. Estimated completion is 2024-09-30.
What conditions does trial NCT04637581 study?
This clinical trial studies the following conditions: Depression, Stress Disorders, Post-Traumatic, Substance-Related Disorders, Child Abuse, Child Neglect. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04637581?
The interventions under investigation include: Wraparound (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04637581?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04637581 being conducted?
This trial has 4 study locations across New Hampshire. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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