Computer-Assisted Brief Intervention (JJMISCOPE)

March 4, 2023 updated by: Anthony Spirito, Brown University

Computer-Assisted Brief Intervention Protocol for Marijuana Using Juvenile Offenders

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Four out of five youth in the juvenile justice system show evidence of being under the influence during their offenses, and over half test positive for substances at the time of their arrest. Further, 92% of arrested juveniles who tested positive for drugs tested positive for marijuana. Although some treatment programs for juvenile offenders exist, most have focused on detained and incarcerated juveniles, who only represent one third of arrested youth. As a result, little is known about how to improve the continuum of care for the remaining two-thirds of this population, which consists of court involved but non-incarcerated youth (CINI). Court recommendations and referrals for CINI have mostly relied on outside community-based services, thus decreasing the likelihood CINI youth and their families will take the additional steps to seek intervention. Given that motivational interventions (MI) are brief, relatively easy to implement and have a greater reach than typical substance use treatment programs, researchers have recently directed their focus to interactive, computer-delivered MI protocols to further increase their reach as well as facilitate their implementation. Online interventions can be delivered at a lower cost, with less demand on staff time for training, and increased protocol fidelity, portability, and ease of use. While counselor-delivered MIs for adolescent substance use have been tested fairly widely, only a few studies have been published on the efficacy of computer-assisted MIs. Further, little research has focused on the efficacy of such interventions with marijuana using adolescents in general, and more specifically with CINI adolescents. In addition, combining such interventions for adolescents with brief parenting interventions is important but yet rarely implemented. Therefore, this application proposes to examine the feasibility and acceptability of integrating a computer-assisted,, brief intervention protocol into the juvenile intake procedures at the Rhode Island Family Court (RIFC) for marijuana using adolescents and their parents. Following an open trial of the brief protocol, , 80 adolescents who screen positive for marijuana use at juvenile intake will be recruited from the RIFC and randomly assigned to one of two conditions: 1) a computer-assisted adolescent MI plus an online parenting program ; or 2) usual care. Outcomes will be examined at 3 and 6-month follow-ups. This small trial will provide some initial evidence regarding utility of this protocol with CINI youth and whether a larger, fully powered trial is indicated in the future.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Family Court

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Computer counseling
a computer-assisted adolescent motivational intervention called e-toke plus an online parenting program - Parenting Wisely
Behavioral: Computer Counseling
two computer counseling online programs for a teen and a parent
Active Comparator: Standard care
Standard care is typically referral to counseling for substance use
Behavioral: Standard Care
A referral for substance use counseling

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time Line Follow Back Interview (TLFB)
Time Frame: 90 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Marijuana and alcohol problems
Time Frame: 90 days
Marijuana and alcohol use problems will be assessed using items from the Add Health longitudinal study on symptoms of abuse and dependence including problems at school, home; physical fights; and physical symptoms such as vomiting and "hang over."
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DA042247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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