Behavioral HealthNCT07674303
Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System
A study testing Bodhi AIM and HIB in people with Behavioral Health, run by University of Illinois Chicago at 1 site in United States.
Trial summary
This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. 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 and HIB
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2026to Jun 2028
- 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 or related programming (i.e., in legal programming but not detained) in Oregon or New York State
- 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
- There are no exclusion criteria.
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 Chicago
Chicago, Illinois, 60612
Ashley D Kendall, PhD, 312-355-1836, akendall@uic.edu
Ashley D Kendall, PhD
About this study
Official title: Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App
This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.
Read the detailed description
The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, 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. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.
- Conditions
- Behavioral Health
- Being tested
- Bodhi AIM, HIB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bodhi AIMBehavioural
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).
HIBBehavioural
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 |
| HIB | Active comparator | Participants randomized to the active control arm will receive the HIB health promotion app. Receives: Behavioral: HIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
App adherence (binary)
Percentage of participants who play at least one file on their study app after baseline.
Measured: 1 month
App adherence (continuous)
Average number of daily app files played over the 1-month intervention period.
Measured: 1 month
Secondary outcomes (7)
Enrollment
Number of participants enrolled
Measured: Baseline
Randomization
Percentage of participants randomized to each arm who play at least one app file
Measured: Baseline
Retention
Percentage of participants who attend (yes/no) each follow-up visit
Measured: 1 month, 6 months
Health questionnaire completion
Percentage of participants who complete the questionnaire measures of psychological wellbeing (PROMIS Pediatric Bank v1.0 Positive Affect, NIH Toolbox Pediatric Item Bank v3.0 Self-Efficacy CAT) and psychological distress (PROMIS Pediatric Item Bank GenPop v3.0 Anxiety, PROMIS Pediatric Item Bank GenPop v3.0 Depressive Symptoms, PROMIS Pediatric Bank v 1.0 Psychological Stress Experiences) at each time point
Measured: Baseline, 1 month, 6 months
Acceptability of Intervention Measure (AIM)
Four-item scale assessing perceived acceptability of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater acceptability.
Measured: 1 month
Intervention Appropriateness Measure (IAM)
Four-item scale assessing perceived appropriateness of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater appropriateness.
Measured: 1 month
Feasibility of Intervention Measure (FIM)
Four-item scale assessing perceived feasibility of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater feasibility.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start30 Jul 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (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.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Ashley D Kendall, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674303
- Sponsor's protocol ID
- 2024-0437
- Other IDs
- R01AT012892
- Status last verified
- Jul 2026
- First submitted
- 3 Jun 2026
- Last updated
- 7 Aug 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 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App
- ClinicalTrials.gov ID
- NCT07674303
- Acronym / sponsor ID
- 2024-0437
- Conditions
- Behavioral Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Jun 2026 (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.
This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.
Detailed description
The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, 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. 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 AIMParticipants randomized to the intervention arm will receive the Bodhi AIM meditation app. |
| HIB | Active comparator | Behavioral: HIBParticipants 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 or related programming (i.e., in legal programming but not detained) in Oregon or New York State
- Have access to an Apple/Android smartphone
- Understand and provide assent/consent
- Have legal guardian permission (if under 18 years old)
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
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 AIMBodhi 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 |
| HIBHIB (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 (binary)
Time frame: 1 month
Percentage of participants who play at least one file on their study app after baseline.
App adherence (continuous)
Time frame: 1 month
Average number of daily app files played over the 1-month intervention period.
7 secondary outcomes
Enrollment
Time frame: Baseline
Randomization
Time frame: Baseline
Retention
Time frame: 1 month, 6 months
Health questionnaire completion
Time frame: Baseline, 1 month, 6 months
Acceptability of Intervention Measure (AIM)
Time frame: 1 month
Intervention Appropriateness Measure (IAM)
Time frame: 1 month
Feasibility of Intervention Measure (FIM)
Time frame: 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 7 Aug 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 and HIB 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 1 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 7 Aug 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?
Contact Ashley D Kendall, PhD (312-355-1836, akendall@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App adherence (binary) (time frame: 1 month). 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 7 Aug 2026.