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TECH App Marijuana Use Intervention for Court-Involved Adolescents (TECH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05979272
Recruitment Status : Recruiting
First Posted : August 7, 2023
Last Update Posted : August 8, 2023
Sponsor:
Collaborators:
Brown University
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Sarah Helseth, Northwestern University

Study Description
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Brief Summary:
The study is about helping teens who are involved in the court system to cut down or quit using marijuana. Teens may be asked to test out an experimental smartphone app, called TECH, that will be used only by teens in this study. This app is a private online community where teens can work towards changing their substance use and other behavior with the help of other anonymous teens. We will use this information to learn how the app may help teens make a change and to improve the TECH app.

Condition or disease Intervention/treatment Phase
Cannabis Use Adolescent Behavioral: Treatment as usual Behavioral: Teen Empowerment through Computerized Health (TECH) app Not Applicable

Detailed Description:

This multiphase study will establish the feasibility, acceptability, and preliminary efficacy of a novel smartphone app that leverages both intrapersonal and interpersonal mechanisms to promote cannabis-related behavior change among CINI youth ages 14-17. The app, Teen Empowerment through Computerized Health (TECH), will be evaluated as an adjunct to treatment as usual (TAU) at the local family court. Phase 1 (completed Fall 2021) included a series of semi-structured interviews with key individuals, to inform how clinical goals (e.g., reduced cannabis use) will map onto usage goals (e.g., goal-setting, peer networking), features (e.g., expert-moderated forum, notifications) and workflow. Then, Phase 2 (completed Fall 2022) beta tested and iteratively refined the TECH prototype with 10 court-involved, non-incarcerated (CINI) youth. In the current phase of the work, Phase 3, we will conduct a pilot randomized control trial (RCT) with 60 CINI youth to test the TECH app (TAU+TECH) relative to TAU-only.

Specific aims are:

Aim 1. Apply the Behavior Intervention Theory model to develop a user-driven tool (i.e., TECH) that capitalizes on how, why, and when CINI youth would most prefer to engage with a smartphone app to reduce cannabis use.

~Aim 1 was achieved in Phase 1 qualitative interviews with CINI youth, their parents, and behavioral health app developers.

Aim 2. Examine the feasibility and acceptability of the TECH user-driven smartphone app.

~Hypothesis 1 is that TECH will be feasible and acceptable to CINI youth, as measured via enrollment and withdrawal rates, app usage data, and exit interviews. Aim 2 will be achieved through Phase 2 beta testing (n = 10) and Phase 3's pilot RCT (n = 60) with CINI youth.

Aim 3. Test the preliminary efficacy of the TECH smartphone app as an adjunct to TAU (TECH + TAU vs. TAU-only) on cannabis use (primary outcome).

~Hypothesis 2 is that, relative to CINI youth who receive TAU-only, the TAU+TECH group will demonstrate greater reductions in cannabis use. Aim 3 will be achieved via Phase 3's pilot RCT (n = 60 CINI youth).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development and Preliminary Testing of an Adjunct Smartphone App to Reduce Marijuana Use in Court-Involved, Non-Incarcerated Adolescents
Actual Study Start Date : June 21, 2023
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TAU-only
Treatment as usual
 Behavioral: Treatment as usual
Treatment as Usual at the local family court, which includes a brief, computerized motivation enhancement intervention. All CINI youth will receive TAU, regardless of condition.
Experimental: TAU + TECH
Treatment as usual, plus TECH app
 Behavioral: Treatment as usual
Treatment as Usual at the local family court, which includes a brief, computerized motivation enhancement intervention. All CINI youth will receive TAU, regardless of condition.

Behavioral: Teen Empowerment through Computerized Health (TECH) app
An adjunct smartphone app (i.e., TECH) developed to support TAU. All participants randomly assigned to TAU+TECH will receive the TECH app.


Outcome Measures
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Primary Outcome Measures :
  1. Change in days of cannabis use (Preliminary Efficacy) [ Time Frame: Last 90 days at baseline, and 1-, 3-, and 6-months ]
    Self-report of total days of cannabis use, via Timeline Followback Interview


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 14 years to 18 years
  • Able to speak and read English
  • Have access to a smartphone
  • Self-report past-year cannabis use
  • If a minor, able to provide parental consent and child assent

Exclusion Criteria for all participants is limited to conditions that would preclude active participation in an intervention study of a mobile app (e.g., psychosis, cognitive impairment, visual impairment).

Contacts and Locations
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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): NCT05979272


Locations
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United States, Illinois
Northwestern University Feinberg School of Medicine Active, not recruiting
Chicago, Illinois, United States, 60614
Rhode Island Hospital Active, not recruiting
Chicago, Illinois, United States, 60614
United States, Rhode Island
Rhode Island Family Court Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kathleen Kemp, PhD    401-793-8269    techstudy@brown.edu   
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Contact: Sarah Helseth, PhD    401-863-6881    techstudy@brown.edu   
Sponsors and Collaborators
Northwestern University
Brown University
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
More Information
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Publications:

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Responsible Party: Sarah Helseth, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT05979272    
Other Study ID Numbers: SP0078326
K23DA048062 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: August 8, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Sarah Helseth, Northwestern University:
Court-involved
cannabis use
adolescent
marijuana use
digital health
 mHealth
smartphone
juvenile justice
juvenile legal
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders