Neurological Influences on Drug Prevention Intervention

This study has been completed.
Sponsor:
Collaborators:
Johns Hopkins University
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00198939
First received: September 13, 2005
Last updated: September 27, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Youths At-risk for Drug Use/Abuse
Behavioral: Integrated Family and Cognitive-Behavioral Drug Prevention Intervention
Other: Psychoeducation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Neurological Influences on Drug Prevention Intervention

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Alcohol use abstinence and frequency [ Time Frame: 3, 6, 9, 12, and 18 month Follow-up assement ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Academic achievement [ Time Frame: 3,6,9,12, and 18 month assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 330
Study Start Date: January 2005
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psychoeducation
Drug education curriculum was delivered to participants assigned to this condition.
Other: Psychoeducation
Drug education curriculum was delivered to participants assigned to this condition.
Experimental: Conitive Behavorial Therapy
The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.
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.
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.
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.
Experimental: Intergrated Family and Cognitve Behavioral Therapy
Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components.
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.

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198939

Locations
United States, Maryland
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
University of Florida
Johns Hopkins University
Investigators
Principal Investigator: William W. Latimer, PhD, MPH Johns Hopkins Bloomberg School of Public Health
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00198939     History of Changes
Other Study ID Numbers: 5R01DA015075-03, 5R01DA015075-03
Study First Received: September 13, 2005
Last Updated: September 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
drug prevention
adolescence
middle school
randomized trial
family therapy
cognitive-behavioral
efficacy
selected youth
indicated youth

ClinicalTrials.gov processed this record on July 22, 2014