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Sponsor study identifier
Secondary identifiers
interventional
330
1 country
1
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2011
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 20, 2005
Actual (reported)December 2011
Actual (reported)December 2011
Actual (reported)Alcohol use abstinence and frequency
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.
3, 6, 9, 12, and 18 month Follow-up assement
Marijuana use abstinence and frequency
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.
3, 6, 9, 12, and 18 Month Follow-up Assessment
Other drug use abstinence and frequency
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.
3, 6, 9, 12, 18 month Follow-up Assessment
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
Drug education curriculum was delivered to participants assigned to this condition.
The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
Participants assigned to the Family Therapy arm received a family-centered intervention to support targeted adolescent behavior change. The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases.
The family therapy component of IFCBT includes engagement, active treatment, and maintenance phases. The cognitive program focuses on harmful effects of drugs and strategies to better manage drug abuse risks. The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205, United States
Latimer WW, Winters KC, D'Zurilla T, Nichols M. Integrated family and cognitive-behavioral therapy for adolescent substance abusers: a stage I efficacy study. Drug Alcohol Depend. 2003 Sep 10;71(3):303-17. doi: 10.1016/s0376-8716(03)00171-6.
William W. Latimer, PhD, MPH
Johns Hopkins Bloomberg School of Public Health
330 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
January 2005
Date type not reportedThis date has not been verified as actual or estimated.
Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components.
Drug education curriculum was delivered to participants assigned to this condition.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
December 2011
Actual (reported)Study Completion
December 2011
Actual (reported)Last Updated
September 28, 2012
Record last verified: 2012-09
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Source: ClinicalTrials.gov.
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