Behavioral HealthNCT06997120
Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System
A study testing Bodhi AIM (intervention group) in people with Behavioral Health, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavioral Health
- What is being tested?
- Bodhi AIM (intervention group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-20 years old
- In probation programming (i.e., in legal programming but not detained) in Cook County
- Have access to an Apple/Android smartphone
- Understand and provide assent/consent
- Have legal guardian permission (if under 18 years old)
- English-speaking, due to norming of instruments
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Ashley D Kendall, PhD, 312-355-1836, akendall@uic.edu
Ashley D Kendall, PhD
About this study
Official title: Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth
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:
- Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?
- Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?
- Will youth adequately adhere to the meditation app?
Read the 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.
- Conditions
- Behavioral Health
- Being tested
- Bodhi AIM (intervention group), HIB (control group)
- Keywords
- Juvenile legal system, Meditation, Mindfulness, Smartphone, Mobile health (mHealth), Ecological momentary assessment (EMA), Substance use, Mental health
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodhi AIM (intervention group)Behavioural
AIM (Action In Mindfulness) is a smartphone app that teaches users to establish a daily meditation practice via a 30-day "path," with each day consisting of a brief audio- or video-guided file. In addition to the 30 daily path files, users have access to a menu of "to go" audio-guided meditation practices that they may access any time to prepare for particular situations.
HIB (control group)Behavioural
HIB (Health In Balance) is a smartphone app that is matched to AIM for time and structure, but includes health promotion content (e.g., educational information on substance use) in place of the meditation content featured in AIM. Like AIM, HIB includes a 30-day "path" of audio and video files, along with a menu of "to go" audio files that users may access any time to review key intervention concepts.
| Study group | Role | What they receive |
|---|---|---|
| Bodhi AIM | Experimental | Participants randomized to the intervention arm will receive the Bodhi AIM meditation app. Receives: Behavioral: Bodhi AIM (intervention group) |
| HIB | Active comparator | Participants randomized to the active control arm will receive the HIB health promotion app. Receives: Behavioral: HIB (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis use problems
The Cannabis Use Disorder Identification Test - Revised (CUDIT-R) includes 8 items, each rated on a 4-point scale; higher total scores indicate greater cannabis use problems
Measured: baseline, 1 month, 6 months
App adherence
App files played per objective in-app analytics data
Measured: 1 month
Secondary outcomes (9)
Sexual behaviors
A modified AIDS Risk Behavior Assessment (ARBA) will be used to create a sexual behavior summary score; higher scores indicate more sexual risk behaviors
Measured: baseline, 1 month, 6 months
Negative mood regulation
The Negative Mood Regulation (NMR) scale includes 14 items, each rated on a 5-point scale; higher total scores indicate greater beliefs one can regulate negative mood states
Measured: baseline, 1 month, 6 months
Anxiety
The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of anxiety; higher total scores indicate greater anxiety symptoms
Measured: baseline, 1 month, 6 months
Depression
The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of depression; higher total scores indicate greater depression symptoms
Measured: baseline, 1 month, 6 months
Self-efficacy
The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of self-efficacy; higher total scores indicate greater sense of self-efficacy
Measured: baseline, 1 month, 6 months
Alcohol use problems
The Alcohol Trouble Scale (ATS) includes 10 items, each rated on a binary (yes/no) scale; higher scores indicate greater alcohol use problems
Measured: baseline, 1 month, 6 months
Real-time mood states
The International Positive Affect Negative Affect Schedule Short Form (I-PANAS-SF) includes 10 items, each rated on a 5-point scale; higher total scores indicate greater positive or negative moods, respectively at the time of ecological momentary assessment (EMA)
Measured: baseline, 1 month
Real-time cannabis use
2 items indicating yes/no to cannabis use (1) now and (2) in the past 3 hours at the time of ecological momentary assessment (EMA)
Measured: baseline, 1 month
Real-time alcohol use
2 items indicating yes/no to alcohol use (1) now and (2) in the past 3 hours at the time of ecological momentary assessment (EMA)
Measured: baseline, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start5 Jun 2025
- Primary completion31 May 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) Bodhi AIM (Action In Mindfulness), a 30-day meditation app, or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ashley D Kendall, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997120
- Sponsor's protocol ID
- 2025-0066
- Other IDs
- R01DA061795
- Status last verified
- Mar 2026
- First submitted
- 20 May 2025
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be placed in one or more electronic databases which could be used for other research studies.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth
- ClinicalTrials.gov ID
- NCT06997120
- Acronym / sponsor ID
- 2025-0066
- Conditions
- Behavioral Health
- Keywords
- Juvenile legal system, Meditation, Mindfulness, Smartphone, Mobile health (mHealth), Ecological momentary assessment (EMA), Substance use, Mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?
- Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) Bodhi AIM (Action In Mindfulness), a 30-day meditation app, or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure.
| Arm | Type | Receives |
|---|---|---|
| Bodhi AIM | Experimental | Behavioral: Bodhi AIM (intervention group)Participants randomized to the intervention arm will receive the Bodhi AIM meditation app. |
| HIB | Active comparator | Behavioral: HIB (control group)Participants randomized to the active control arm will receive the HIB health promotion app. |
Who may qualify
- Ages
- 13 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 13-20 years old
- In probation programming (i.e., in legal programming but not detained) in Cook County
- Have access to an Apple/Android smartphone
- Understand and provide assent/consent
- Have legal guardian permission (if under 18 years old)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bodhi AIM (intervention group)AIM (Action In Mindfulness) is a smartphone app that teaches users to establish a daily meditation practice via a 30-day "path," with each day consisting of a brief audio- or video-guided file. In addition to the 30 daily path files, users have access to a menu of "to go" audio-guided meditation practices that they may access any time to prepare for particular situations. | Behavioural | Bodhi AIM |
| HIB (control group)HIB (Health In Balance) is a smartphone app that is matched to AIM for time and structure, but includes health promotion content (e.g., educational information on substance use) in place of the meditation content featured in AIM. Like AIM, HIB includes a 30-day "path" of audio and video files, along with a menu of "to go" audio files that users may access any time to review key intervention concepts. | Behavioural | HIB |
Primary outcome
Cannabis use problems
Time frame: baseline, 1 month, 6 months
The Cannabis Use Disorder Identification Test - Revised (CUDIT-R) includes 8 items, each rated on a 4-point scale; higher total scores indicate greater cannabis use problems
App adherence
Time frame: 1 month
App files played per objective in-app analytics data
9 secondary outcomes
Sexual behaviors
Time frame: baseline, 1 month, 6 months
Negative mood regulation
Time frame: baseline, 1 month, 6 months
Anxiety
Time frame: baseline, 1 month, 6 months
Depression
Time frame: baseline, 1 month, 6 months
Self-efficacy
Time frame: baseline, 1 month, 6 months
Alcohol use problems
Time frame: baseline, 1 month, 6 months
Real-time mood states
Time frame: baseline, 1 month
Real-time cannabis use
Time frame: baseline, 1 month
Real-time alcohol use
Time frame: baseline, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified data may be placed in one or more electronic databases which could be used for other research studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bodhi AIM (intervention group) in people with Behavioral Health, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis use problems (time frame: baseline, 1 month, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.