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NCT05384223 · ClinicalTrials.gov registry record · NA
Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens
A NA study of PTSD and Substance Use Disorders, sponsored by Medical University of South Carolina.
- Active
- Registry status
- NA
- Development phase
- 212
- Enrollment target
- 2
- Study locations
NCT05384223: Active NA study of PTSD and Substance Use Disorders, sponsored by Medical University of South Carolina.
NCT05384223 is a NA study of PTSD and Substance Use Disorders that is active but no longer recruiting, run by Medical University of South Carolina. The registered enrollment target is 212 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (30% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05384223, a NA study of PTSD and Substance Use Disorders, is active but no longer recruiting, sponsored by Medical University of South Carolina.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 212 participants
- Enrollment target
- 2
- Study locations
Study Summary
Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Despite this well-established link, standard care for adolescents with co-occurring SUP and PTSD for the last several decades has been to treat these problems separately. This compartmentalized approach to treatment creates a burden on teens and families, raises unique challenges to clinicians in both mental health and addiction domains, and may contribute to high rates of SUP relapse among adolescents with co-occurring PTSD. To address this problem, our team recently completed a rigorous National Institute on Drug Abuse (NIDA)-funded randomized controlled trial (RCT) supporting the efficacy of an integrative, exposure-based treatment we developed, Risk Reduction through Family Therapy (RRFT), in greater long term reductions in SUP, as well as PTSD avoidance and hyperarousal symptoms, in comparison to standard treatment in a large teen sample. The proposed RCT, with an effectiveness-implementation Hybrid Type I design, substantially builds on that prior research by proposing to 1) evaluate whether RRFT's clinical effectiveness for reducing SUP and PTSD can be extended to youth in outpatient substance use treatment settings-where youth are presenting for SUP treatment and where clinicians often have less experience treating PTSD (Aim 1); 2)evaluate the cost-effectiveness of RRFT and to explore inner context variables (e.g., perceived treatment acceptability, attitudes, and satisfaction among the participating adolescents, caregivers, agency leaders, and therapists and barriers to and facilitators of implementation) that might affect RRFT implementation in diverse practice settings(Aim 2). The proposed effectiveness-implementation trial will recruit adolescents (13-18 years) with a history of psychosocial trauma presenting with SUP and PTSD symptoms for ou
Primary Outcome
The Timeline Follow Back (TLFB) is a validated, subjective measure that uses a calendar for people to provide estimates of substance use (drugs/alcohol) on a daily basis, retrospectively. Key dates and calendars are used to aid in memory recall. The measure is beneficial in both clinical and research environments. Over time, the TLFB looks for a decrease in substance use. Higher numbers of substance use are indicative of greater substance use.
Conditions Studied
Interventions
- BEHAVIORAL RRFT (Risk Reduction through Family Therapy)
- BEHAVIORAL ENCOMPASS (Integrated Treatment for Adolescents and Young Adults)
Study Locations (2)
Colorado
- CU Medicine Psychiatry - Outpatient Clinic - Aurora
- ARTS - Synergy Outpatient Services - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2022-10-15 |
| Est. Completion | 2027-02-28 |
| Phase | NA |
What the registry record for NCT05384223 still lists
NCT05384223 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (30% lower).
The record links to 2 conditions, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which RRFT (Risk Reduction through Family Therapy) is the first listed.
NCT05384223 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05384223 about?
NCT05384223 is a clinical study titled "Evaluation of RRFT for Co-occurring SUD and PTSD Among Teens". Psychosocial traumatic events during childhood, serve as strong and consistent predictors of substance use problems (SUP) during adolescence and adulthood.PTSD that extends from such trauma often co-occurs with SUP. Despite this well-established link, standard care for adolescents with co-occurring ...
What is the current status of trial NCT05384223?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 212 participants. The study started on 2022-10-15. Estimated completion is 2027-02-28.
What conditions does trial NCT05384223 study?
This clinical trial studies the following conditions: PTSD, Substance Use Disorders.
What interventions are being tested in trial NCT05384223?
The interventions under investigation include: RRFT (Risk Reduction through Family Therapy) (BEHAVIORAL), ENCOMPASS (Integrated Treatment for Adolescents and Young Adults) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05384223?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05384223 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05384223's enrollment target sits among peer trials
212 24th of 154 higher than 131 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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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