Behavioral HealthNCT05146167
Feasibility Testing 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 Chicago at 1 site in United States.
Trial summary
This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in the juvenile legal system. The primary questions it is designed to answer are: 1. Will youth adequately adhere to the 1-month meditation app? 2. Read more about this study
- Who is it for?
- Ages 13 to 18 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
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2022to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 years old
- In probation programming (i.e., in legal programming but not detained) in Cook County, IL
- 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.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention
This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in the juvenile legal system. The primary questions it is designed to answer are:
- Will youth adequately adhere to the 1-month meditation app?
- Is it feasible to collect data remotely from youth on their self-reported cannabis use, sexual health, and mental health at baseline, 1, and 6 months?
Read the detailed description
The investigators aim enroll 75 youth in Cook County, IL 13-18 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline questionnaire, 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 active control app matched to Bodhi AIM for time and structure. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.
- Conditions
- Behavioral Health
- Being tested
- Bodhi AIM (intervention group), HIB (control group)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodhi AIM (intervention group)Behavioural
Bodhi AIM (Action In Mindfulness) is a smartphone-based 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 (e.g., attending a party).
HIB (control group)Behavioural
HIB (Health In Balance) is a smartphone-based app that is matched to Bodhi 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 Bodhi AIM. Like Bodhi 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.
App Adherence
Days of objective app usage
Measured: 1 month
Percentage of Participants Who Complete the Cannabis Use Measure at Each Time Point
Percentage of participants who complete the cannabis use measure at each time point; cannabis use is measured with the Cannabis Use Disorders Identification Test-Revised
Measured: Baseline, 1 month, 6 months
Percentage of Participants Who Complete the Sexual Health Measure at Each Time Point
Percentage of participants who complete the sexual health measure at each time point; sexual health is measured with a modified version of the AIDS Risk Behavior Assessment
Measured: Baseline, 1 month, 6 months
Percentage of Participants Who Complete the Mental Health Symptoms Measure at Each Time Point
Percentage of participants who complete the mental health symptoms measure at each time point; mental health symptoms are measured with the Youth Self Report
Measured: Baseline, 1 month, 6 months
Secondary outcomes (2)
Percentage of Participants Who Complete Other Substance Use Measures at Each Time Point
Percentage of participants who complete other substance use measures at each time point; the other substance use measures include the Young Adult Alcohol Problem Scale, the Alcohol Trouble Scale, the Hangover Symptoms Scale, and a modified Substance Use Self-Efficacy Scale
Measured: Baseline, 1 month, 6 months
Percentage of Participants Who Complete Other Mental Health Measures at Each Time Point
Percentage of participants who complete other mental health measures at each time point; the other mental health measures include the Reactive-Proactive Aggression Questionnaire, the Short-Form Buss-Perry Aggression Questionnaire, the Negative Mood Regulation Scale, the Connor-Davidson Resilience Scale-10, and the Five Facets of Mindfulness Questionnaire-15
Measured: Baseline, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start5 Apr 2022
- Primary completion15 Oct 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Behavioral HealthStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ashley D Kendall, University of Illinois Chicago
- Investigators
- Ashley D Kendall, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146167
- Sponsor's protocol ID
- 2018-0889
- Other IDs
- R00DA047890
- Status last verified
- Apr 2025
- First submitted
- 8 Nov 2021
- Last updated
- 28 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention
- ClinicalTrials.gov ID
- NCT05146167
- Acronym / sponsor ID
- 2018-0889
- Conditions
- Behavioral Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Posted 28 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in the juvenile legal system. The primary questions it is designed to answer are:
- Will youth adequately adhere to the 1-month meditation app?
- Is it feasible to collect data remotely from youth on their self-reported cannabis use, sexual health, and mental health at baseline, 1, and 6 months?
Detailed description
The investigators aim enroll 75 youth in Cook County, IL 13-18 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline questionnaire, 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 active control app matched to Bodhi AIM for time and structure. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.
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 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 13-18 years old
- In probation programming (i.e., in legal programming but not detained) in Cook County, IL
- 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)Bodhi AIM (Action In Mindfulness) is a smartphone-based 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 (e.g., attending a party). | Behavioural | Bodhi AIM |
| HIB (control group)HIB (Health In Balance) is a smartphone-based app that is matched to Bodhi 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 Bodhi AIM. Like Bodhi 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
App Adherence
Time frame: 1 month
Days of objective app usage
Percentage of Participants Who Complete the Cannabis Use Measure at Each Time Point
Time frame: Baseline, 1 month, 6 months
Percentage of participants who complete the cannabis use measure at each time point; cannabis use is measured with the Cannabis Use Disorders Identification Test-Revised
Percentage of Participants Who Complete the Sexual Health Measure at Each Time Point
Time frame: Baseline, 1 month, 6 months
Percentage of participants who complete the sexual health measure at each time point; sexual health is measured with a modified version of the AIDS Risk Behavior Assessment
Percentage of Participants Who Complete the Mental Health Symptoms Measure at Each Time Point
Time frame: Baseline, 1 month, 6 months
Percentage of participants who complete the mental health symptoms measure at each time point; mental health symptoms are measured with the Youth Self Report
2 secondary outcomes
Percentage of Participants Who Complete Other Substance Use Measures at Each Time Point
Time frame: Baseline, 1 month, 6 months
Percentage of Participants Who Complete Other Mental Health Measures at Each Time Point
Time frame: Baseline, 1 month, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data may be made available upon reasonable request.
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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. This study is not recruiting at the moment.
Ashley D Kendall, PhD principal investigator
University of Illinois Chicago
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 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: finished, as of the sponsor's last update on 28 Oct 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?
Yes. Results are posted in the registry (first posted 28 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App Adherence (time frame: 1 month). The study lists 4 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 28 Oct 2026.