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NCT01823250 · ClinicalTrials.gov registry record · Phase 2
Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
NCT01823250 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 190 participants.
The verdict
NCT01823250, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
Study Summary
This Stage II randomized trial tests Culturally Informed \& Flexible Family Based Treatment for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and yielding promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no treatments have met criteria for "Well Established" in the treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth and families is complicated by the fact that these families often differ from mainstream populations in culture-related values, beliefs and behaviors that can directly impact engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a more powerful treatment capable of addressing these issues began with a Stage 1 study that led to the development of a multi-component treatment that includes a flexible manual that allows treatment tailoring to the unique characteristics of individual families. CIFFTA integrates innovative culturally-based, individually-based, and family-based components to: 1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and increase family protective factors (e.g., strong parent-child attachment), 2) teach adolescents skills to effectively manage interpersonal conflicts and stressors and to increase motivation to change, 3) deliver psycho-educational and culturally congruent material (e.g., modules on immigration stressors) to youth and parents both separately and together, and 4) deliver the intervention using a flexible treatment manual that allows the clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational modules and themes) to the unique characteristics and needs of the Hispanic family. This Stage II randomized trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family Therapy. The study tests CI
Interventions
- BEHAVIORAL Group Therapy
- BEHAVIORAL Family Therapy based on Structural Family Therapy
- BEHAVIORAL Psychoeducational Sessions
- BEHAVIORAL Individual Adolescent Therapy Sessions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2011-01 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01823250
The ClinicalTrials.gov registry entry for NCT01823250 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Group Therapy is the first listed.
NCT01823250 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01823250 about?
NCT01823250 is a clinical study titled "Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial". This Stage II randomized trial tests Culturally Informed \& Flexible Family Based Treatment for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and yielding promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no t...
What is the current status of trial NCT01823250?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2011-01. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01823250?
The interventions under investigation include: Group Therapy (BEHAVIORAL), Family Therapy based on Structural Family Therapy (BEHAVIORAL), Psychoeducational Sessions (BEHAVIORAL), Individual Adolescent Therapy Sessions (BEHAVIORAL).
Who is sponsoring clinical trial NCT01823250?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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