TECH App Marijuana Use Intervention for Court-Involved Adolescents

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05979272
Collaborator
Brown University (Other), Rhode Island Hospital (Other), National Institute on Drug Abuse (NIDA) (NIH)
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Study Details

Study Description

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
  • Behavioral: Treatment as usual
  • Behavioral: Teen Empowerment through Computerized Health (TECH) app
N/A

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

Study Type:
Interventional
Anticipated 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 :
Jun 21, 2023
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Primary Outcome Measures

  1. Change in days of cannabis use (Preliminary Efficacy) [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

Criteria

Ages Eligible for Study:
14 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60614
2 Rhode Island Hospital Chicago Illinois United States 60614
3 Rhode Island Family Court Providence Rhode Island United States 02903
4 Brown University Providence Rhode Island United States 02912

Sponsors and Collaborators

  • Northwestern University
  • Brown University
  • Rhode Island Hospital
  • National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Sarah Helseth, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT05979272
Other Study ID Numbers:
  • SP0078326
  • K23DA048062
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sarah Helseth, Assistant Professor, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2023