Official Title: “Brief Intervention for Drug Abusing Students”

The purpose of this clinical trail is to evaluate the efficacy of a brief, cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug abuse (MMDA). This school-based initiative employs a collaborative effort between the University of Minnesota researchers and the St. Paul Public Schools. This intervention aims to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and problem-solving skills.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: May 2008

The purpose of this clinical trail is to evaluate the efficacy of a brief, cognitive-behavioral therapeutic intervention for adolescents reporting mild or moderate drug abuse (MMDA). This school-based initiative employs a collaborative effort between the University of Minnesota researchers and the St. Paul Public Schools. This intervention aims to reduce post-treatment drug use behaviors and enhance drug-use resistant cognitions and problem-solving skills.

Specifically, we propose a randomized clinical trial to evaluate the efficacy of a cognitive-behavioral therapy on key process and outcome dimensions among school-based youth with mild-to-moderate drug abuse (MMDA). The experimental treatment is designated Brief Cognitive Behavioral Intervention (BCBI) given its theoretical foundation in stage of change theory used to coordinate modules on Rational-Emotive Therapy and Problem Solving Therapy.

BCBI will be compared against a second experimental treatment that consists of BCBI and a single parent session (BCBI+P) and an assessment only condition (control). The importance of clarifying mechanisms in drug treatment research will be explored with respect to a limited number of treatment and individual factors that have emerged as promising mediating and moderating factors, such as cognitive and problem solving factors, parenting practices, and peer group influences.

Intervention(s) in this Clinical Trial

• Behavioral: brief intervention (cognitive-behavioral therapy)
  • Consists of 60 minute individual sessions delivered with a therapist using a motivational interviewing (MI) style. Session 1 focuses on eliciting information about the students' substance use and related consequences based on the assessment, their perception of level of willingness to change, examining the cause and benefits of change using the decisional balance exercise, and discussing what goals for change the student would like to select and pursue. Session 2 reviewed the students' progress with the agreed upon goals, identifying high risk situations associated with clients difficulty in achieving the goals, discussing strategies to address barriers toward goal attainment, reviewing where the client is in the stage of change process, and negotiating either the continuation of goals or advancing to more ambitious goals of substance use reduction. Session 3 involved delivering the same MI interviewing style to the primary parent or guardian (student is not present).

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • One arm was a 2-session brief intervention with both sessions involving only the adolescent. Each session was a 60 minute individual session with the counselor.
• Active Comparator: 2
  • The other arm was a 3-session brief intervention, with 2 sessions involving the adolescent and one session with the parent. Each of these individual sessions were 60 minutes.

Primary Measures

• Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.
  • Time Frame: 1 year post treatment
    Safety Issue?: No

Secondary Measures

• HIV and sexual risk behaviors at the same time period.
  • Time Frame: 1 year post treatment
    Safety Issue?: No

Inclusion Criteria:

• 1. student at a local school
• 2. meets DSM-IV criteria for a substance abuse disorder for at least one drug
• 3. student and parent both agree to participate in the intervention study

Exclusion Criteria:

• 1. meets criteria for at least one DSM-IV substance dependence disorder
• 2. meets criteria for a psychotic disorder or a learning disability

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: 19 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Minnesota

Overall Clinical Trial Officials and Contacts

Ken C Winters, Ph.D. Principal Investigator University of Minnesota  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00350909

Study ID Number: 0308S51681

ClinicalTrials.gov Identifier: NCT00350909

Health Authority: United States: Institutional Review Board