- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170026
Individual and Family Motivational Interviews for Substance Using Truant Teens
July 2, 2013 updated by: Anthony Spirito, Brown University
This application will provide a test of one potential model for adding substance use assessment and brief intervention into a truancy court program.
The primary goal of this study is to determine whether a motivational intervention will reduce substance use among adolescents referred to truancy court for school attendance problems.
In this treatment development application, an open trial with 20 families referred by truancy court will first be conducted.
This trial will be used to adapt an existing motivational intervention to include material relevant to school attendance and performance.
Then 100 families participating in the Rhode Island Truancy Court Program with adolescents between the ages of 13-16 years who report using substances will be randomly assigned to receive the experimental intervention plus standard truancy court procedures or psychoeducation plus standard truancy court procedures.
The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational interview.
The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance.
Follow-up interviews will be conducted at 3 and 6 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
-
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
Ages Eligible for Study
13 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- between the ages of 13-16 at the start of the project and living at home with at least one parent/guardian,
- t- score of 70 or above on one of the diagnostic-oriented scales (internalizing or externalizing problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off),
- the child must report 6 or more incidences of substance use in the last 90 days,
- parental consent and child assent are obtained.
Exclusion Criteria:
- adolescent meets diagnostic criteria for substance dependence suggesting need for more intensive services,
- the family is not able to speak and understand English or Spanish well enough to complete study procedures.
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family Check-up/Individual MI
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use plus 2 session Individual Motivational Intervention for the adolescent
|
The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational interview.
The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance.
Other Names:
|
Active Comparator: Psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use
|
Families in PE will return for the same number of visits as the IMI and FCU sessions of the IMI/FCU condition.
An interventionist will review a set of educational materials with the parents regarding teen SU use, truancy and risk behaviors and parenting a teenager.
A similar set of materials will be reviewed with the adolescent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
marijuana use
Time Frame: 3 month follow-up
|
Self-report of marijuana use in the prior 30 days
|
3 month follow-up
|
marijuana use
Time Frame: 6 month follow-up
|
Self-report of marijuana use in the prior 30 days
|
6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risky sexual behavior
Time Frame: 3 month follow-up
|
Self-report of risky sexual behavior such as unprotected sex
|
3 month follow-up
|
Risky sexual behavior
Time Frame: 6 month follow-up
|
Self-report of risky sexual behavior such as unprotected sex
|
6 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony Spirito, PhD, Brown Medicl School
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
August 1, 2010
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
July 22, 2010
First Submitted That Met QC Criteria
July 26, 2010
First Posted (Estimate)
July 27, 2010
Study Record Updates
Last Update Posted (Estimate)
July 4, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
July 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 R34 DA0029871
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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