- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03655574
Substance Use Interventions for Truant Adolescents (GOALS)
Brief Individual and Parent Interventions for Substance Use in Truant Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adolescents who use marijuana and are truant from school are a high-risk population with increased likelihood of substance use disorders, criminal justice involvement, and long-term impairments in vocational, family, and peer domains.
This study will test a theory-driven intervention for early adolescent marijuana using, truant youth identified through Rhode Island Truancy and Family Courts. Adolescents will be randomly assigned to one of the 2 conditions: a motivational interview versus psychoeducation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Family Court
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Providence, Rhode Island, United States, 02912
- Brown Univerity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the target child is in 6th-10th grade at the start of the project and living at home with at least one parent/guardian,
- the teen must report 6 or more incidences of marijuana use in the last 90 days (an approximation of biweekly use)
- by law, the teen must have at least 20 unexcused absences in an academic year to be in truancy court, and (4) parental consent and teen assent are obtained.
Exclusion Criteria:
- the family is not able to speak and understand English or Spanish well enough to complete study procedures
- developmental delay, as determined by school placements outside the regular classroom, that would affect comprehension of the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Motivational + Family Check-up (MET+FCU)
The MET individual session covers three constructs; 1) intentions to use marijuana; 2) normative beliefs about peer substance use; and 3) attitudes towards peer substance use. These same three constructs are also addressed with respect to truancy. In addition, motivation to abstain from substance use is discussed. The FCU session with teens and parents/caregivers begins by collecting self-report measures and conducting a videotaped Family Assessment Task (FAsTask) to assess parent-teen interactions. The FAsTask is the basis of FCU feedback. There are four specific phases of the feedback session: 1) Self-assessment, 2) Support and clarification, 3) Feedback, and, 4) Action plan. |
In the MET session, motivational strategies of individualized normative feedback, examining decisional balance, and providing information/advice will be used to support goals for behavior change and to examine barriers to changes.
There are four specific phases of the FCU session: (1) Self-assessment: Parents are asked if they learned anything about their family from participating in the assessment.
(2) Support and clarification: The interviewer supports the parent's self-assessment efforts, assesses their level of understanding, and clarifies issues within the family.
(3) Feedback: A summary form of the assessment is reviewed.
(4) Action Plan: Throughout the session, the counselor works with the parent to develop a brief, written Action Plan about communication and monitoring.
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Placebo Comparator: Psychoeducation
An interventionist will review a set of educational materials with the parents regarding teen marijuana use, effects of marijuana on the brain, body and behavior, risks associated with marijuana use, how to tell if a teen is engaging in marijuana use or truancy, and parenting skills.
A comparable set of materials will be reviewed with the adolescent.
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Psychoeducation about substances is provided to teens and parents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Frequency of Marijuana Use
Time Frame: Last 90 days at baseline, and 3, 6, and 12 months
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Total number of marijuana use days .
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Last 90 days at baseline, and 3, 6, and 12 months
|
|
Change in Quantity of Marijuana Use per Occasion of Use
Time Frame: Last 90 days at baseline and 3, 6, and 12 months
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Average quantity of marijuana use per day
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Last 90 days at baseline and 3, 6, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Days truant from school
Time Frame: Last 90 days at baseline, and 3, 6, and 12 months
|
School attendance based on objective school records
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Last 90 days at baseline, and 3, 6, and 12 months
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Change in Days truant from school, self-report
Time Frame: Last 90 days at baseline, and 3, 6, and 12 months
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School attendance based on self-report
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Last 90 days at baseline, and 3, 6, and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anthony Spirito, Ph.D., Brown University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1802001993
- 1R01DA045396-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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