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NCT04637581 · ClinicalTrials.gov registry record · NA
Wraparound for High-risk Families with Substance Use Disorders: Examining Family, Child, and Parent Outcomes
A NA study of Depression and Stress Disorders, Post-Traumatic, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
- 4
- Study locations
NCT04637581: Completed NA study of Depression and Stress Disorders, Post-Traumatic, sponsored by Dartmouth-Hitchcock Medical Center.
NCT04637581 is a NA study of Depression and Stress Disorders, Post-Traumatic that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 73 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04637581, a NA study of Depression and Stress Disorders, Post-Traumatic, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
assesses 5 parenting constructs:1) inappropriate expectations of child,2) lack of empathy towards child's needs,3)belief in corporal punishment, 4) reverses parent-child roles, 5) restricts child's power and independence. Range for each scale is 1-10. Lower numbers indicate higher abuse risk.
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 |
What the finished NCT04637581 record still lists
NCT04637581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (91% lower).
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.
NCT04637581 reports a single indexed study location in New Hampshire.
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.
What interventions are being tested in trial NCT04637581?
The interventions under investigation include: Wraparound (BEHAVIORAL).
Who is sponsoring clinical trial NCT04637581?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04637581's enrollment target sits among peer trials
73 397th of 679 higher than 279 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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