Clinical trial NCT05979272: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Adolescent
Keywords: Court-involved
cannabis use
adolescent
marijuana use
digital health
mHealth
smartphone
juvenile justice
juvenile legal
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Brown University
name: Rhode Island Hospital
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Change in days of cannabis use (Preliminary Efficacy)
timeFrame: Last 90 days at baseline, and 1-, 3-, and 6-months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rhode Island Hospital
state: Illinois
city: Providence
country: United States
facility: Rhode Island Family Court
state: Rhode Island
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
References:
citation: 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.