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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: Completed Phase 2 study, sponsored by University of Miami.

NCT01823250 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Drug use will be assessed using the Time-Line Follow-Back Drug Use Recording Method (TLFB) and a Urine Drug Screen kit. The latter is a self contained testing unit which combines a temperature sensitive collection cup with built in assays for sample adulterants and 9 specific drugs of abuse. The TLFB has been adapted for adolescents and obtains retrospective adolescent reports of daily substance use by using a calendar to stimulate recall. It gathers information on specific substances used, amou

Interventions

  • BEHAVIORAL Group Therapy
  • BEHAVIORAL Family Therapy based on Structural Family Therapy
  • BEHAVIORAL Psychoeducational Sessions
  • BEHAVIORAL Individual Adolescent Therapy Sessions

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2011-01
Est. Completion 2015-12
Phase Phase 2
University of Miami

721 total trials

What the finished NCT01823250 record still lists

NCT01823250 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).

The record links to 0 conditions, and to 4 interventions - of which Group Therapy is the first listed.

NCT01823250 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01823250's enrollment target sits among peer trials

190 353rd of 2000 higher than 1,646 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01823250, the US trial registry maintained by the National Library of Medicine. NCT01823250 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.