NCT03655574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

August 1, 2018

Last Update Submit

May 31, 2024

Conditions

Keywords

Brief interventionBehavioral interventionJuvenile justiceMotivational enhancement

Outcome Measures

Primary Outcomes (2)

  • Change in Frequency of Marijuana Use

    Total number of marijuana use days .

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

  • 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 Outcomes (2)

  • Change in Days truant from school

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

  • Change in Days truant from school, self-report

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

Study Arms (2)

Motivational + Family Check-up (MET+FCU)

EXPERIMENTAL

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)

Psychoeducation

PLACEBO COMPARATOR

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

Interventions

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.

Motivational + Family Check-up (MET+FCU)

Psychoeducation about substances is provided to teens and parents.

Psychoeducation

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Family Court

Providence, Rhode Island, 02903, United States

Location

Brown Univerity

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Marijuana AbuseSubstance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Anthony Spirito, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will not be informed about which intervention arm they receive. Assessors will have the condition of the participant masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2018

First Posted

August 31, 2018

Study Start

January 1, 2019

Primary Completion

October 30, 2023

Study Completion

April 30, 2024

Last Updated

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
I year after completion of all data collection
Access Criteria
Contact PI

Locations