Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06997120
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goals of this hybrid type 2 randomized controlled trial (RCT) are to evaluate the effectiveness and individual-level implementation of a 1-month app-based meditation program with youth on probation in Cook County, IL. The primary questions it is designed to answer are:
1. Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?
2. Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?
3. Will youth adequately adhere to the meditation app?
1. Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?
2. Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?
3. Will youth adequately adhere to the meditation app?
Detailed Description:
This remote study will enroll 300 youth on probation in Cook County, IL, which encompasses Chicago and its surrounding suburbs. Youth will be individually randomized to use either the meditation app or an active control app matched for time/structure daily for 30 days. Health outcomes will be self-reported at baseline, 1 month, and 6 months, and in real time via 1-week "bursts" of ecological momentary assessment (EMA) at baseline and 1 month (i.e., approximately overlapping with the last week of app use). Objective adherence to both apps will be captured automatically via in-app analytics.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DA061795 | NIH | None | https://reporter.nih.gov/quic… | View |