Drug AbusePhase 2NCT00350909
Brief Intervention for Drug Abusing Adolescents
A Phase 2 study testing brief intervention (cognitive-behavioral therapy) in people with Drug Abuse, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Abuse
- What is being tested?
- brief intervention (cognitive-behavioral therapy)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Jul 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- meets criteria for at least one DSM-IV substance dependence disorder
- meets criteria for a psychotic disorder or a learning disability
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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.
- Conditions
- Drug Abuse
- Being tested
- brief intervention (cognitive-behavioral therapy)
- Keywords
- drug abuse
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief intervention (cognitive-behavioral therapy)Behavioural
Also called cognitive-behavioral therapy- motivational interviewing
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: brief intervention (cognitive-behavioral therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.
Measured: 1 year post treatment
Secondary outcomes (1)
HIV and sexual risk behaviors at the same time period.
Measured: 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startSep 2005
- Primary completionMay 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Ken C Winters, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350909
- Sponsor's protocol ID
- 0308S51681
- Status last verified
- Oct 2008
- First submitted
- 7 Jul 2006
- Last updated
- 20 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27929312
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for Drug Abusing Students
- ClinicalTrials.gov ID
- NCT00350909
- Acronym / sponsor ID
- 0308S51681
- Conditions
- Drug Abuse
- Keywords
- drug abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- May 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: brief intervention (cognitive-behavioral therapy)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. |
| 2 | Active comparator | Behavioral: brief intervention (cognitive-behavioral therapy)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. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- meets criteria for at least one DSM-IV substance dependence disorder
- meets criteria for a psychotic disorder or a learning disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brief intervention (cognitive-behavioral therapy)Also: cognitive-behavioral therapy- motivational interviewingConsists 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). | Behavioural | 1, 2 |
Primary outcome
Drug use frequency and quantity at 1-, 3- and 12-months post-intervention.
Time frame: 1 year post treatment
1 secondary outcome
HIV and sexual risk behaviors at the same time period.
Time frame: 1 year post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2008.
- Derived from this study: PubMed 27929312Piehler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken C Winters, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brief intervention (cognitive-behavioral therapy) in people with Drug Abuse, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug use frequency and quantity at 1-, 3- and 12-months post-intervention. (time frame: 1 year post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350909, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2008; AzTrials last refreshed its copy on 31 Oct 2026.