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NCT00198939 · ClinicalTrials.gov registry record · Phase 1

Neurological Influences on Drug Prevention Intervention

A Phase 1 study of Youths At-risk for Drug Use/Abuse, sponsored by University of Florida.

Completed
Registry status
Phase 1
Development phase
330
Enrollment target
1
Study location

NCT00198939: Completed Phase 1 study of Youths At-risk for Drug Use/Abuse, sponsored by University of Florida.

NCT00198939 is a Phase 1 study of Youths At-risk for Drug Use/Abuse that has completed, run by University of Florida. The registered enrollment target is 330 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (450% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00198939, a Phase 1 study of Youths At-risk for Drug Use/Abuse, has completed, sponsored by University of Florida.

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

Study Summary

In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster parenting skills followed by brief family therapy to foster adaptive family communication and age-appropriate roles. The Teen Achievement Intervention is comprised of a clinician-delivered learning strategy curriculum to foster academic achievement followed by a similar yet peer-facilitated curriculum to foster self-efficacy and prosocial peer networks. In the first study aim, we seek to evaluate the separate and possibly synergistic effects of the Family Management and Teen Achievement components on post intervention drug use, problem behavior, psychological distress, and academic achievement of indicated youth. Innovative analytic strategies are subsequently used to elucidate mediated pathways by which the interventions might reduce drug involvement and problem behavior by promoting changes in targeted skills and behavior change processes. The possibility of effect-modification also is considered, with a focus on neurocognitive, internalizing/externalizing, and demographic factors, in an effort to discern why interventions work for some youth but not others. This application revision has sought to address well-taken concerns cited by the reviewers while maintaining proposal strengths. In response to a key limitation, this revision includes further specification of anticipated relationships between neurocognitive variables, skill acquisition levels, and prevention intervention outcomes among indicated youth. Study hypotheses on specific neurocognitive effects are informed by empirical findings and the clinical experience of investigative team members specializing in neuropsychology. If successful, this project should improve prevention practices by identifying malleable be

Primary Outcome

Personal Experience Inventory (PEI) is a youth self-report drug use inventory that assesses the frequency and quantity of substance use and drug abuse risk factors, such as deviant behavior and peer drug use.

Interventions

  • OTHER Psychoeducation
  • BEHAVIORAL Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Study Locations (1)

Maryland

  • Johns Hopkins Bloomberg School of Public Health - Baltimore

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2005-01
Est. Completion 2011-12
Phase Phase 1
University of Florida

1,106 total trials

What the finished NCT00198939 record still lists

NCT00198939 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (450% higher).

The record links to 1 condition, with Youths At-risk for Drug Use/Abuse appearing as the primary indexed condition, and to 2 interventions - of which Psychoeducation is the first listed.

NCT00198939 reports a single indexed study location in Maryland.

Frequently Asked Questions

What is clinical trial NCT00198939 about?

NCT00198939 is a clinical study titled "Neurological Influences on Drug Prevention Intervention". In this R01 study, a randomized clinical trial is proposed to evaluate the efficacy of a drug abuse prevention intervention for indicated middle school youth that coordinates family and teen-based components. The Family Management Intervention is comprised of a parent-focused curriculum to foster pa...

What is the current status of trial NCT00198939?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 330 participants. The study started on 2005-01. Estimated completion is 2011-12.

What conditions does trial NCT00198939 study?

This clinical trial studies the following conditions: Youths At-risk for Drug Use/Abuse.

What interventions are being tested in trial NCT00198939?

The interventions under investigation include: Psychoeducation (OTHER), Integrated Family and Cognitive-Behavioral Drug Prevention Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT00198939?

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

Where is trial NCT00198939 being conducted?

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

How this trial's enrollment target compares

Where NCT00198939's enrollment target sits among peer trials

330 110th of 2000 higher than 1,890 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00198939, the US trial registry maintained by the National Library of Medicine. NCT00198939 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.