TECH App Marijuana Use Intervention for Court-Involved Adolescents (TECH)
Primary Purpose
Cannabis Use, Adolescent
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment as usual
Teen Empowerment through Computerized Health (TECH) app
Sponsored by
About this trial
This is an interventional treatment trial for Cannabis Use focused on measuring Court-involved, cannabis use, adolescent, marijuana use, digital health, mHealth, smartphone, juvenile justice, juvenile legal
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).
Sites / Locations
- Northwestern University Feinberg School of Medicine
- Rhode Island Hospital
- Rhode Island Family CourtRecruiting
- Brown UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
TAU-only
TAU + TECH
Arm Description
Treatment as usual
Treatment as usual, plus TECH app
Outcomes
Primary Outcome Measures
Change in days of cannabis use (Preliminary Efficacy)
Self-report of total days of cannabis use, via Timeline Followback Interview
Secondary Outcome Measures
Full Information
NCT ID
NCT05979272
First Posted
July 31, 2023
Last Updated
August 7, 2023
Sponsor
Northwestern University
Collaborators
Brown University, Rhode Island Hospital, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05979272
Brief Title
TECH App Marijuana Use Intervention for Court-Involved Adolescents
Acronym
TECH
Official Title
Development and Preliminary Testing of an Adjunct Smartphone App to Reduce Marijuana Use in Court-Involved, Non-Incarcerated Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Brown University, Rhode Island Hospital, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis Use, Adolescent
Keywords
Court-involved, cannabis use, adolescent, marijuana use, digital health, mHealth, smartphone, juvenile justice, juvenile legal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAU-only
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
TAU + TECH
Arm Type
Experimental
Arm Description
Treatment as usual, plus TECH app
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teen Empowerment through Computerized Health (TECH) app
Intervention Description
An adjunct smartphone app (i.e., TECH) developed to support TAU. All participants randomly assigned to TAU+TECH will receive the TECH app.
Primary Outcome Measure Information:
Title
Change in days of cannabis use (Preliminary Efficacy)
Description
Self-report of total days of cannabis use, via Timeline Followback Interview
Time Frame
Last 90 days at baseline, and 1-, 3-, and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rhode Island Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Rhode Island Family Court
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Kemp, PhD
Phone
401-793-8269
Email
techstudy@brown.edu
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Helseth, PhD
Phone
401-863-6881
Email
techstudy@brown.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35275086
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.
Results Reference
background
Learn more about this trial
TECH App Marijuana Use Intervention for Court-Involved Adolescents
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