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Clinical Trials/NCT00198939
NCT00198939
Completed
Phase 1

Neurological Influences on Drug Prevention Intervention

University of Florida1 site in 1 country330 target enrollmentJanuary 2005

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Youths At-risk for Drug Use/Abuse
Sponsor
University of Florida
Enrollment
330
Locations
1
Primary Endpoint
Alcohol use abstinence and frequency
Status
Completed
Last Updated
13 years ago

Overview

Brief 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 behavior change processes fostered by effective interventions. Improving our understanding of how individual characteristics of indicated youth, such as neurocognitive deficits or externalizing problems, influence the development of skills during interventions and subsequent outcomes may also help to improve existing prevention interventions. The significance of the proposed study is underscored further by the substantial size of the targeted population of indicated youth, and the range of morbidities and mortality that often result when early warning signs of drug abuse are not addressed.

Registry
clinicaltrials.gov
Start Date
January 2005
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 11 to 15 year old middle school students

Exclusion Criteria

  • Acute suicidal, homicidal, psychotic ideation
  • Problem severity indicating outpatient or residential treatment

Outcomes

Primary Outcomes

Alcohol use abstinence and frequency

Time Frame: 3, 6, 9, 12, and 18 month Follow-up assement

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.

Marijuana use abstinence and frequency

Time Frame: 3, 6, 9, 12, and 18 Month Follow-up Assessment

The 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.

Other drug use abstinence and frequency

Time Frame: 3, 6, 9, 12, 18 month Follow-up Assessment

The Adolescent Stage of Change Scale (ASCS) consists of items to measure youths' motivation to change drug use behavior. Urine will also be analyzed for the presence of drugs, such as cannabinoids, cocaine, opiates, amphetamine, methamphetamine, MDMA, benzodiazepines, and barbiturates using gas chromatography/mass spectrometry methods.

Secondary Outcomes

  • Academic achievement(3,6,9,12, and 18 month assessment)
  • Family functioning(3,6,9,12, and 18 month follow-up assessment)
  • Learning Strategy Skill(3,6,9,12, and 18 month assessment)
  • Legal Involvement(3,6,9, 12, and 18 month follow-up assessment)

Study Sites (1)

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