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NCT00198874 · ClinicalTrials.gov registry record · Phase 2

Youth Drug Abuse Family and Cognitive-Behavioral Therapy

A Phase 2 study of Drug Abuse, sponsored by University of Florida.

Completed
Registry status
Phase 2
Development phase
296
Enrollment target
1
Study location

NCT00198874 is a Phase 2 study of Drug Abuse that has completed, run by University of Florida. The registered enrollment target is 296 participants, roughly in line with the 312-participant average among 21 other Drug Abuse trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT00198874, a Phase 2 study of Drug Abuse, has completed, sponsored by University of Florida.

COMPLETED
Registry status
Phase 2
Development phase
296 participants
Enrollment target
1
Study location

Study Summary

This Stage II study is in response to NIDA's Behavioral Therapies Development Program (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a multisystems treatment for adolescent drug abuse with promising efficacy results. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of family systems and cognitive-behavioral IFCBT components on posttreatment drug abuse problem severity, problem behavior, psychiatric distress, and academic achievement of adolescent drug abusers. Innovative analytic strategies are subsequently used to evaluate the degree to which successful outcomes are attributable to specific familial and cognitive-behavioral change processes targeted by IFCBT components. The possibility of effect-modification also is considered, with a focus on neurocognitive, psychiatric comorbidity, and demographic factors. Namely, we seek to understand how variations in specific client characteristics, such as executive dysfunctions or psychiatric comorbidity, might explain why treatments work for some drug abusing youths but not others. In addition to promising findings on IFCBT efficacy, this Stage II proposal benefits from the development and Stage I study application of (a) treatment manuals; (b) therapist training procedures; (c) therapist adherence and competence tools; (d) a neuropsychological battery to assess cognitive functions; (e) a psychodiagnostic battery to assess comorbid psychiatric disorders; and (f) a study assessment battery comprised of therapeutic process and outcome measures. This revised application has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. The lack of adolescent drug treatment research continues to be a serious gap in the addictions literature despite alarmingly high rates of drug abuse among youth and the range of morbidities and m

Conditions Studied

Interventions

  • OTHER Education
  • BEHAVIORAL Integrated Family and Cognitive-Behavioral Therapy

Study Locations (1)

Maryland

  • Johns Hopkins Bloomberg School of Public Health - Baltimore

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2005-01
Est. Completion 2011-12
Phase Phase 2

Sponsor

University of Florida

1,106 total trials

What the Registry Record Tells You About NCT00198874

The ClinicalTrials.gov registry entry for NCT00198874 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 312-participant average among 21 other Drug Abuse trials with a reported enrollment target. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Drug Abuse appearing as the primary indexed condition, and to 2 interventions - of which Education is the first listed.

NCT00198874 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00198874 about?

NCT00198874 is a clinical study titled "Youth Drug Abuse Family and Cognitive-Behavioral Therapy". This Stage II study is in response to NIDA's Behavioral Therapies Development Program (PA-99-107). A randomized clinical trial is proposed to evaluate the direct, mediated, and moderated effects of Integrated Family and Cognitive-Behavioral Therapy (IFCBT), a multisystems treatment for adolescent dr...

What is the current status of trial NCT00198874?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2005-01. Estimated completion is 2011-12.

What conditions does trial NCT00198874 study?

This clinical trial studies the following conditions: Drug Abuse.

What interventions are being tested in trial NCT00198874?

The interventions under investigation include: Education (OTHER), Integrated Family and Cognitive-Behavioral Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00198874?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00198874 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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