Teen Marijuana Check-Up

October 25, 2016 updated by: Denise Walker

Reaching and Motivating Change in Teen Marijuana Smokers

This study will test a behavioral intervention tailored for adolescents who smoke marijuana and have concerns about their use. The study's purpose is to determine whether this intervention (two-sessions of motivational enhancement intervention followed by 12 months of optional skills training) will be more effective in reducing the use of this drug if augmented by three periodic motivational enhancement treatment check-in sessions as compared to three periodic computer-based check-in sessions.

HYPOTHESES: (1) Participants in the motivational enhancement treatment check-ins (MCI) condition will reduce their use of marijuana more than participants in the computer based (Comp) condition and report fewer negative consequences. These differences are expected to be greater at later follow-ups (i.e, 9, 12, and 15 months) after repeated check-ins exert a cumulative effect. (2)Engagement in CBT sessions will be greater for those in the MCI condition and will partially mediate the effect on marijuana related outcome indices. (3) The MCI intervention will lead to increased self-efficacy, and decreased normative perceptions of marijuana use by other teens that will also partially mediate the effect of the intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The goal of this trial is to evaluate the efficacy of an enhanced Teen Marijuana Check-Up protocol to reach and intervene with non-treatment seeking adolescents who use marijuana heavily. Two hundred fifty adolescents who use marijuana heavily will receive a 2-session individual motivational enhancement therapy. All participants will also be offered the opportunity, over a 12-month period, to repeatedly re-initiate marijuana counseling. Participants will be randomly assigned to receive one of two types of periodic follow-up contacts: Motivational interviewing-based Marijuana Check-Ins (MCI) or Computer Based Control (Comp) sessions.

All participants will be reassessed at the 6, 9, 12, and 15-month anniversaries of enrollment. Following their initial motivational enhancement therapy, the 125 experimental condition participants will additionally have a motivational enhancement treatment "check-in" session with their counselor at the 4, 7, and 10-month anniversaries of enrollment intended to reinforce the maintenance of treatment gains and motivate continued success, increase motivation to change for participants who did not meet their marijuana use goals, and/or prompt utilization of cognitive-behavioral treatment (CBT) sessions as needed. The 125 comparison participants will complete a computer based questionnaire at the same time intervals to serve as an attentional control.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
252

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age (14-19 years old),
  2. grade level (9th through 11th) and
  3. marijuana use.

Exclusion Criteria:

Individuals will be excluded if:

  1. they are not fluent in English,
  2. they have a thought disorder that precludes full participation,
  3. they refuse to accept randomization to condition,
  4. they are high school seniors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Computer Check-In Control
The Computer Check-In gives the participant contact with the research therapist, an assessment of marijuana use and the current impact of use, and a reminder about optional support sessions.
Behavioral: Marijuana Check-Ins
The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
Experimental: Marijuana Check-Ins
The MCI, a MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
Behavioral: Marijuana Check-Ins
The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
frequency (number of days) of marijuana use
Time Frame: 60 days
Global Appraisal of Individual Needs - I (self-report measure)
60 days
treatment utilization
Time Frame: 90 days
Global Appraisal of Individual Needs - I
90 days
marijuana abuse/dependence symptoms
Time Frame: 60 days
Global Appraisal of Individual Needs - I
60 days
engagement in cognitive behavioral skills training sessions
Time Frame: 90 days
Frequency of attendance at optional in-school counseling sessions
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
self-efficacy
Time Frame: 90 days
Self-efficacy scale that assesses self-efficacy for avoiding marijuana use
90 days
normative perceptions of peer marijuana use
Time Frame: 90 days
Descriptive perceived norms concerning the frequency of marijuana use by other adolescents of the participant's age
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Denise Walker

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Denise D Walker, PhD, University of Washington School of Social Work

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 37852-G
  • 2R01DA014296-09A1 (U.S. NIH Grant/Contract)

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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