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Substance Use Interventions for Truant Adolescents (GOALS)

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ClinicalTrials.gov Identifier: NCT03655574
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : August 12, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Brown University

Brief 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.

Condition or disease Intervention/treatment Phase
Adolescent Problem Behavior Truancy; Unsocialized Marijuana Abuse Truancy; Socialized Substance Abuse Alcohol Abuse Behavioral: Motivational + Family Check-up (MET+FCU) Other: Psychoeducation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will not be informed about which intervention arm they receive. Assessors will have the condition of the participant masked.
Primary Purpose: Treatment
Official Title: Brief Individual and Parent Interventions for Substance Use in Truant Adolescents
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arm Intervention/treatment
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.

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.

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.
Other: Psychoeducation
Psychoeducation about substances is provided to teens and parents.




Primary Outcome Measures :
  1. Change in Frequency of Marijuana Use [ Time Frame: Last 90 days at baseline, and 3, 6, and 12 months ]
    Total number of marijuana use days .

  2. Change in Quantity of Marijuana Use per Occasion of Use [ Time Frame: Last 90 days at baseline and 3, 6, and 12 months ]
    Average quantity of marijuana use per day


Secondary Outcome Measures :
  1. 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

  2. Change in Days truant from school, self-report [ Time Frame: Last 90 days at baseline, and 3, 6, and 12 months ]
    School attendance based on self-report



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655574


Contacts
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Contact: Anthony Spirito, Ph.D. (401) 444-1924 anthony_spirito@brown.edu
Contact: Kathleen Kemp, PhD (401) 793-8269 kkemp@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Family Court Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kathleen Kemp, PhD    401-793-8269    kkemp@lifespan.org   
Contact: Kevin Richard, BA    401-458-5262    KRichard@courts.ri.gov   
Brown Univerity Recruiting
Providence, Rhode Island, United States, 02912
Principal Investigator: Anthony Spirito, PhD         
Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Anthony Spirito, Ph.D. Brown University
  Study Documents (Full-Text)

Documents provided by Brown University:
Informed Consent Form  [PDF] February 5, 2020

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Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT03655574    
Other Study ID Numbers: 1802001993
1R01DA045396-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 12, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The final study protocol will contain the information necessary to reproduce the findings in other populations. The protocol will include a copy of this grant application including Specific Aims and study population; recruitment and enrollment information; the measures collected and coding of the measures and subscales; the clinician intervention procedures; data analyses; syntax for data summary, and data analysis plans
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: I year after completion of all data collection
Access Criteria: Contact PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
Brief intervention
Behavioral intervention
Juvenile justice
Motivational enhancement
Additional relevant MeSH terms:
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Substance-Related Disorders
Marijuana Abuse
Alcoholism
Problem Behavior
Chemically-Induced Disorders
Mental Disorders
Alcohol-Related Disorders
Behavioral Symptoms