NCT00350909

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

Enrollment Period

2.7 years

First QC Date

July 7, 2006

Last Update Submit

October 16, 2008

Conditions

Drug Abuse

Keywords

drug abuse

Outcome Measures

Primary Outcomes (1)

  • Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.

    1 year post treatment

Secondary Outcomes (1)

  • HIV and sexual risk behaviors at the same time period.

    1 year post treatment

Study Arms (2)

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.

Behavioral: brief intervention (cognitive-behavioral therapy)

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)

Interventions

brief intervention (cognitive-behavioral therapy)BEHAVIORAL

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).

Also known as: cognitive-behavioral therapy- motivational interviewing
12

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • Piehler TF, Winters KC. Decision-making style and response to parental involvement in brief interventions for adolescent substance use. J Fam Psychol. 2017 Apr;31(3):336-346. doi: 10.1037/fam0000266. Epub 2016 Dec 8.

    PMID: 27929312DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis InterventionCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • Ken C Winters, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 11, 2006

Study Start

September 1, 2005

Primary Completion

May 1, 2008

Study Completion

July 1, 2008

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

US(1)