Neurological Influences on Drug Prevention Intervention

NCT00198939 | Completed Phase 1

• 1 other identifier: 5R01DA015075-03
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Youths At-risk for Drug Use/Abuse

Keywords

drug prevention; adolescence; middle school; randomized trial; family therapy; cognitive-behavioral; efficacy; selected youth; indicated youth

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (4)

• 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 Arms (4)

Psychoeducation

ACTIVE COMPARATOR

Drug education curriculum was delivered to participants assigned to this condition.

Other: Psychoeducation

Conitive Behavorial Therapy

EXPERIMENTAL

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

Family Therapy

EXPERIMENTAL

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

Intergrated Family and Cognitve Behavioral Therapy

EXPERIMENTAL

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

Interventions

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention BEHAVIORAL

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.

Conitive Behavorial Therapy; Family Therapy; Intergrated Family and Cognitve Behavioral Therapy

Psychoeducation OTHER

Drug education curriculum was delivered to participants assigned to this condition.

Psychoeducation

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 15 year old middle school students

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• National Institutes of Health (NIH): collaborator
• Johns Hopkins University: collaborator

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 12957348 BACKGROUND

Study Officials

• William W. Latimer, PhD, MPH

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

US (1)