Neurological Influences on Drug Prevention Intervention

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Youths At-risk for Drug Use/Abuse

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Psychoeducation

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

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type OTHER

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

Conitive Behavorial Therapy

The cognitive-behavioral program introduces youths to problem-solving behavior change principles and study skills to promote school achievement.

Group Type EXPERIMENTAL

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Intervention Type 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.

Intergrated Family and Cognitve Behavioral Therapy

Participants assigned to the IFCBT arm received the Cognitive Behavioral Therapy and Family Therapy intervention components.

Group Type EXPERIMENTAL

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Psychoeducation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 11 to 15 year old middle school students

Exclusion Criteria

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William W. Latimer, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 12957348 (View on PubMed)

Other Identifiers

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5R01DA015075-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01DA015075-03

Identifier Type: NIH

Identifier Source: org_study_id

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Neurological Influences on Drug Prevention Intervention

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Psychoeducation

Psychoeducation

Conitive Behavorial Therapy

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Family Therapy

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Intergrated Family and Cognitve Behavioral Therapy

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Interventions

Integrated Family and Cognitive-Behavioral Drug Prevention Intervention

Psychoeducation

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

National Institutes of Health (NIH)

Johns Hopkins University

University of Florida

Responsible Party

Principal Investigators

William W. Latimer, PhD, MPH

Locations

Johns Hopkins Bloomberg School of Public Health

Countries

References

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.

Other Identifiers

5R01DA015075-03

5R01DA015075-03