NCT03107117

Brief Summary

Due to the "unmet needs" of substance abuse treatment among court involved but non-incarcerated (CINI) adolescents and their parents, reaching and engaging CINI adolescents in intervention programs addressing marijuana use is important given the significant risk that continued substance use poses for re-arrest and detention. This study will examine the feasibility of implementing one potential model for increasing access to substance use interventions in a juvenile justice setting by using: 1) a computer- assisted intervention addressing marijuana use for adolescents, and 2) a computer program on strategies to improve management of teens who misuse drugs for parents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

March 31, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

5.2 years

First QC Date

March 31, 2017

Last Update Submit

March 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow Back Interview (TLFB)

    The Timeline Follow-back Interview is a widely used research tool with good reliability and validity for various groups of individuals. Marijuana and alcohol consumption information is collected using a calendar format with temporal cues (e.g., holidays) to assist in recall of days when marijuana and alcohol were used. Data from the TLFB will be summarized to yield the total number of marijuana and alcohol use days.

    90 days

Secondary Outcomes (1)

  • Marijuana and alcohol problems

    90 days

Study Arms (2)

Computer counseling

EXPERIMENTAL

a computer-assisted adolescent motivational intervention called e-toke plus an online parenting program - Parenting Wisely

Behavioral: Computer Counseling

Standard care

ACTIVE COMPARATOR

Standard care is typically referral to counseling for substance use

Behavioral: Standard Care

Interventions

two computer counseling online programs for a teen and a parent

Computer counseling
Standard CareBEHAVIORAL

A referral for substance use counseling

Standard care

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • teen age 14 to 17, inclusive, living at home with at least one parent/guardian
  • teen report of history of marijuana use and a positive brief screen during intake procedures \* parental consent/ child assent; and, 4) one parent willing to participate in intervention

You may not qualify if:

  • developmental delay
  • teen or parents are not able to adequately speak and understand English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rhode Island Family Court

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Anthony Spirito, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Blind to treatment condition to which subject is assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: a computer-assisted adolescent motivational interview plus an online parenting program for substance abuse will be compared to usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 11, 2017

Study Start

October 1, 2017

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Analysis files will be constructed from the stored electronic data and will be stripped of identifying information with the Safe Harbor method. Specifically, youth and their parents will be identified with a family identifier and person identifier number that is randomly generated and not related to any element of their personal identifying information. No names, addresses, telephone numbers, fax numbers, email addresses, social security numbers, medical records, etc. will be retained. Dates will contain only year and a randomly generated day-of-the-year. We will only share it with external investigators when a data use agreement (DUA) is executed between the Brown University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction. The data will be made available on April 1, 2021 by the PI

Locations