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NCT Number: NCT07674303

Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System

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.

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Key information

Conditions

Behavioral Health

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location contact

Ashley D Kendall, PhD

CONTACT

[email protected]

312-355-1836

Ashley D Kendall, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • There are no exclusion criteria.

Treatment and study plan

Bodhi AIM

Behavioral

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

Behavioral

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.

Primary outcomes

  1. App adherence (binary)

    Time frame: 1 month

    Percentage of participants who play at least one file on their study app after baseline.

  2. App adherence (continuous)

    Time frame: 1 month

    Average number of daily app files played over the 1-month intervention period.

Secondary outcomes

  1. Enrollment

    Time frame: Baseline

    Number of participants enrolled

  2. Randomization

    Time frame: Baseline

    Percentage of participants randomized to each arm who play at least one app file

  3. Retention

    Time frame: 1 month, 6 months

    Percentage of participants who attend (yes/no) each follow-up visit

  4. Health questionnaire completion

    Time frame: Baseline, 1 month, 6 months

    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

  5. Acceptability of Intervention Measure (AIM)

    Time frame: 1 month

    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.

  6. Intervention Appropriateness Measure (IAM)

    Time frame: 1 month

    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.

  7. Feasibility of Intervention Measure (FIM)

    Time frame: 1 month

    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.

Other outcomes

  1. Ecological momentary assessment (EMA) completion

    Time frame: Baseline, 1 month

    Percentage of EMA reports made out of total EMA prompts sent at each EMA burst

Study contacts

Contact information is provided by the study sponsor or research team.

Ashley D Kendall, PhD

CONTACT

[email protected]

312-355-1836

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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