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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis Use Adolescent | Behavioral: Treatment as usual Behavioral: Teen Empowerment through Computerized Health (TECH) app | Not Applicable |
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 (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 |
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. |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 14 Years to 18 Years (Child, Adult) |
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).
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
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 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Court-involved cannabis use adolescent marijuana use digital health |
mHealth smartphone juvenile justice juvenile legal |
Marijuana Abuse Marijuana Use Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |