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Substance Use Interventions for Truant Adolescents (GOALS)

Primary Purpose

Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Motivational + Family Check-up (MET+FCU)

Psychoeducation

About this trial

This is an interventional treatment trial for Adolescent Problem Behavior focused on measuring Brief intervention, Behavioral intervention, Juvenile justice, Motivational enhancement

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Rhode Island Family CourtRecruiting
Brown UniverityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Motivational + Family Check-up (MET+FCU)

Psychoeducation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Frequency of Marijuana Use

Total number of marijuana use days .

Change in Quantity of Marijuana Use per Occasion of Use

Average quantity of marijuana use per day

Secondary Outcome Measures

Change in Days truant from school

School attendance based on objective school records

Change in Days truant from school, self-report

School attendance based on self-report

Full Information

NCT ID

NCT03655574

First Posted

August 1, 2018

Last Updated

September 6, 2023

Sponsor

Brown University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT03655574

Brief Title

Substance Use Interventions for Truant Adolescents

Acronym

GOALS

Official Title

Brief Individual and Parent Interventions for Substance Use in Truant Adolescents

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2019 (Actual)

Primary Completion Date

October 30, 2023 (Anticipated)

Study Completion Date

April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Brown University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adolescent Problem Behavior, Truancy; Unsocialized, Marijuana Abuse, Truancy; Socialized, Substance Abuse, Alcohol Abuse

Keywords

Brief intervention, Behavioral intervention, Juvenile justice, Motivational enhancement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Two-arm randomized controlled trial

Masking

ParticipantOutcomes Assessor

Masking Description

Participants will not be informed about which intervention arm they receive. Assessors will have the condition of the participant masked.

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Motivational + Family Check-up (MET+FCU)

Arm Type

Experimental

Arm Description

Arm Title

Psychoeducation

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Motivational + Family Check-up (MET+FCU)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Psychoeducation

Intervention Description

Psychoeducation about substances is provided to teens and parents.

Primary Outcome Measure Information:

Title

Change in Frequency of Marijuana Use

Description

Total number of marijuana use days .

Time Frame

Last 90 days at baseline, and 3, 6, and 12 months

Title

Change in Quantity of Marijuana Use per Occasion of Use

Description

Average quantity of marijuana use per day

Time Frame

Last 90 days at baseline and 3, 6, and 12 months

Secondary Outcome Measure Information:

Title

Change in Days truant from school

Description

School attendance based on objective school records

Time Frame

Last 90 days at baseline, and 3, 6, and 12 months

Title

Change in Days truant from school, self-report

Description

School attendance based on self-report

Time Frame

Last 90 days at baseline, and 3, 6, and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Anthony Spirito, Ph.D.

Phone

(401) 444-1924

anthony_spirito@brown.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Kathleen Kemp, PhD

Phone

(401) 793-8269

kkemp@lifespan.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anthony Spirito, Ph.D.

Organizational Affiliation

Brown University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rhode Island Family Court

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathleen Kemp, PhD

Phone

401-793-8269

kkemp@lifespan.org

First Name & Middle Initial & Last Name & Degree

Kevin Richard, BA

Phone

401-458-5262

KRichard@courts.ri.gov

Facility Name

Brown Univerity

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02912

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anthony Spirito, PhD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

IPD Sharing Time Frame

I year after completion of all data collection

IPD Sharing Access Criteria

Contact PI

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