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Sponsored by: |
University of Minnesota |
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Information provided by: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT00350909 |
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.
Condition | Intervention | Phase |
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Drug Abuse |
Behavioral: brief intervention (cognitive-behavioral therapy) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Brief Intervention for Drug Abusing Students |
Enrollment: | 160 |
Study Start Date: | September 2005 |
Study Completion Date: | July 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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.
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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).
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2: Active Comparator
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.
|
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).
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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.
Ages Eligible for Study: | 13 Years to 19 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55454 |
Principal Investigator: | Ken C Winters, Ph.D. | University of Minnesota |
Responsible Party: | Dept. of Psychiatry, University of Minnesota ( Ken Winters, ph.D. ) |
Study ID Numbers: | 0308S51681 |
Study First Received: | July 7, 2006 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00350909 |
Health Authority: | United States: Institutional Review Board |
drug abuse |
Mental Disorders Substance-Related Disorders Disorders of Environmental Origin |