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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03655574
Other study ID # 1802001993
Secondary ID 1R01DA045396-01A
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source Brown University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates a brief motivation-building intervention for parents and teens to reduce truancy and substance use. It is hypothesized that the motivational intervention will result in better outcomes compared to an education-only intervention.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date April 30, 2024
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Intervention

Behavioral:
Motivational + Family Check-up (MET+FCU)
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.
Other:
Psychoeducation
Psychoeducation about substances is provided to teens and parents.

Locations

Country Name City State
United States Brown Univerity Providence Rhode Island
United States Rhode Island Family Court Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Brown University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Frequency of Marijuana Use Total number of marijuana use days . Last 90 days at baseline, and 3, 6, and 12 months
Primary Change in Quantity of Marijuana Use per Occasion of Use Average quantity of marijuana use per day Last 90 days at baseline and 3, 6, and 12 months
Secondary Change in Days truant from school School attendance based on objective school records Last 90 days at baseline, and 3, 6, and 12 months
Secondary Change in Days truant from school, self-report School attendance based on self-report Last 90 days at baseline, and 3, 6, and 12 months
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