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

• ClinicalTrials.gov Identifier: NCT05979272
• Recruitment Status: Recruiting
• First Posted: August 7, 2023
• Last Update Posted: August 8, 2023
• Sponsor: Northwestern University
• Collaborators: Brown University; Rhode Island Hospital; National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Sarah Helseth, Northwestern University

Tracking Information

• First Submitted Date: July 31, 2023
• First Posted Date: August 7, 2023
• Last Update Posted Date: August 8, 2023
• Actual Study Start Date: June 21, 2023
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 31, 2023)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: TECH App Marijuana Use Intervention for Court-Involved Adolescents
• Official Title: Development and Preliminary Testing of an Adjunct Smartphone App to Reduce Marijuana Use in Court-Involved, Non-Incarcerated Adolescents
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cannabis Use
• Adolescent

Intervention

• 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.

Study Arms

• Active Comparator: TAU-only
  Treatment as usual
  Intervention: Behavioral: Treatment as usual
• Experimental: TAU + TECH
  Treatment as usual, plus TECH app
  Interventions:

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

• Publications *: Helseth SA, Guigayoma J, Price D, Spirito A, Clark MA, Barnett NP, Becker SJ. Developing a Smartphone-Based Adjunct Intervention to Reduce Cannabis Use Among Juvenile Justice-Involved Adolescents: Protocol for a Multiphase Study. JMIR Res Protoc. 2022 Mar 11;11(3):e35402. doi: 10.2196/35402.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 31, 2023): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2025
• Estimated Primary Completion Date: March 2025 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 14 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05979272
• Other Study ID Numbers: SP0078326; K23DA048062 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sarah Helseth, Northwestern University
• Original Responsible Party: Same as current
• Current Study Sponsor: Northwestern University
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: Northwestern University
• Verification Date: August 2023