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Neurological Influences on Drug Prevention Intervention

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ClinicalTrials.gov Identifier: NCT00198939
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 28, 2012
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Johns Hopkins University
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date September 28, 2012
Study Start Date  ICMJE January 2005
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Alcohol use abstinence and frequency
  • Marijuana use abstinence and frequency
  • Other drug use abstinence and frequency
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2012)
  • Academic achievement [ Time Frame: 3,6,9,12, and 18 month assessment ]
    The Interview on Sociodemographic Characteristics is administered to collect information on grades, academic achievement, days truant, school behavior problems, detention, suspension, and expulsion.
  • Family functioning [ Time Frame: 3,6,9,12, and 18 month follow-up assessment ]
    The Family Assessment Measure (FAM) is a self-report tool for parents and children that measures change processes targeted by the family systems component of IFCBT, including appropriate role performance, parental control, and communication.
  • Learning Strategy Skill [ Time Frame: 3,6,9,12, and 18 month assessment ]
    The Motivated Strategies for Learning Questionnaire (MSLQ) assesses adolescents' motivation to learn in school and use of effective learning strategies that are addressed during the Learning Strategy Training module of IFCBT.
  • Legal Involvement [ Time Frame: 3,6,9, 12, and 18 month follow-up assessment ]
    The parent and adolescent versions of the Missouri Assessment for Genetics Interview for Children (MAGIC) address diagnostic symptoms associated with DSM-IV criteria including conduct disorder and antisocial personality disorder and includes questions on legal involvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Academic achievement
  • Family functioning
  • Learning Strategy Skill
  • Legal Involvement
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurological Influences on Drug Prevention Intervention
Official Title  ICMJE Neurological Influences on Drug Prevention Intervention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Youths At-risk for Drug Use/Abuse
Intervention  ICMJE
  • Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
    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.
  • Other: Psychoeducation
    Drug education curriculum was delivered to participants assigned to this condition.
Study Arms  ICMJE
  • Active Comparator: Psychoeducation
    Drug education curriculum was delivered to participants assigned to this condition.
    Intervention: Other: Psychoeducation
  • Experimental: Conitive Behavorial Therapy
    The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
    Intervention: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
  • Experimental: Family Therapy
    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.
    Intervention: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
  • Experimental: Intergrated Family and Cognitve Behavioral Therapy
    Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components.
    Intervention: Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2012)
330
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
250
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 11 to 15 year old middle school students

Exclusion Criteria:

  • Acute suicidal, homicidal, psychotic ideation
  • Problem severity indicating outpatient or residential treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198939
Other Study ID Numbers  ICMJE 5R01DA015075-03( U.S. NIH Grant/Contract )
5R01DA015075-03 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Johns Hopkins University
Investigators  ICMJE
Principal Investigator: William W. Latimer, PhD, MPH Johns Hopkins Bloomberg School of Public Health
PRS Account University of Florida
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP