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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01170026
Other study ID # 1 R34 DA0029871
Secondary ID
Status Completed
Phase Phase 1
First received July 22, 2010
Last updated July 2, 2013
Start date August 2010
Est. completion date July 2013

Study information

Verified date July 2012
Source Brown University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date July 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 16 Years
Eligibility Inclusion Criteria:

1. between the ages of 13-16 at the start of the project and living at home with at least one parent/guardian,

2. 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),

3. the child must report 6 or more incidences of substance use in the last 90 days,

4. parental consent and child assent are obtained.

Exclusion Criteria:

1. adolescent meets diagnostic criteria for substance dependence suggesting need for more intensive services,

2. the family is not able to speak and understand English or Spanish well enough to complete study procedures.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Family Check-up/ Individual MI
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.
Individual and family psychoeducation
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

Locations

Country Name City State
United States Brown University Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary marijuana use Self-report of marijuana use in the prior 30 days 3 month follow-up No
Primary marijuana use Self-report of marijuana use in the prior 30 days 6 month follow-up No
Secondary Risky sexual behavior Self-report of risky sexual behavior such as unprotected sex 3 month follow-up No
Secondary Risky sexual behavior Self-report of risky sexual behavior such as unprotected sex 6 month follow-up No
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