- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350909
Brief Intervention for Drug Abusing Adolescents
Brief Intervention for Drug Abusing Students
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- student at a local school
- meets DSM-IV criteria for a substance abuse disorder for at least one drug
- student and parent both agree to participate in the intervention study
Exclusion Criteria:
- meets criteria for at least one DSM-IV substance dependence disorder
- meets criteria for a psychotic disorder or a learning disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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).
Other Names:
|
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.
|
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).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.
Time Frame: 1 year post treatment
|
1 year post treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HIV and sexual risk behaviors at the same time period.
Time Frame: 1 year post treatment
|
1 year post treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ken C Winters, Ph.D., University of Minnesota
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0308S51681
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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