Brief Intervention for Drug Abusing Adolescents

Drug Abuse Clinical Trial

Official title:

Brief Intervention for Drug Abusing Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00350909
• Other study ID #: 0308S51681
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2006
• Last updated: October 16, 2008
• Start date: September 2005
• Est. completion date: July 2008

Study information

• Verified date: October 2008
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Drug Abuse

Intervention

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).

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.		1 year post treatment	No
Secondary	HIV and sexual risk behaviors at the same time period.		1 year post treatment	No