- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05979272
TECH App Marijuana Use Intervention for Court-Involved Adolescents (TECH)
Development and Preliminary Testing of an Adjunct Smartphone App to Reduce Marijuana Use in Court-Involved, Non-Incarcerated Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60614
- Northwestern University Feinberg School of Medicine
-
Chicago, Illinois, United States, 60614
- Rhode Island Hospital
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02912
- Brown University
-
Providence, Rhode Island, United States, 02903
- Rhode Island Family Court
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: TAU-only
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
|
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.
An adjunct smartphone app (i.e., TECH) developed to support TAU.
All participants randomly assigned to TAU+TECH will receive the TECH app.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Last 90 days at baseline, and 1-, 3-, and 6-months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Helseth SA, Piper KN, Dunne CJ, Kemp K, Barnett NP, Clark MA, Spirito A, Becker SJ. User-centered Design of an Adjunct Smartphone App to Reduce Cannabis Use among Youth Diverted from the Juvenile Legal System. Res Child Adolesc Psychopathol. 2025 Dec;53(12):1797-1811. doi: 10.1007/s10802-025-01370-6. Epub 2025 Sep 9.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP0078326
- K23DA048062 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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