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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT012892 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bodhi AIM | Experimental | Participants randomized to the intervention arm will receive the Bodhi AIM meditation app. |
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| HIB | Active Comparator | Participants randomized to the active control arm will receive the HIB health promotion app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| App adherence (binary) | Percentage of participants who play at least one file on their study app after baseline. | 1 month |
| App adherence (continuous) | Average number of daily app files played over the 1-month intervention period. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment | Number of participants enrolled | Baseline |
| Randomization | Percentage of participants randomized to each arm who play at least one app file |
| Measure | Description | Time Frame |
|---|---|---|
| Ecological momentary assessment (EMA) completion | Percentage of EMA reports made out of total EMA prompts sent at each EMA burst | Baseline, 1 month |
Inclusion Criteria:
Exclusion Criteria:
- There are no exclusion criteria.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ashley D Kendall, PhD | Contact | 312-355-1836 | akendall@uic.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois Chicago | Chicago | Illinois | 60612 | United States |
De-identified data may be placed in one or more electronic databases which could be used for other research studies.
Data sharing will generally coincide with publication of the study's main findings and is intended to take place within 1 year after acceptance of the primary manuscripts.
To be determined
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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.
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Both participants and outcome assessors will be blind to condition through completion of the baseline assessments. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at any of the follow-up time points until after the quantitative measures are complete.
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| 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. |
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| Baseline |
| Retention | Percentage of participants who attend (yes/no) each follow-up visit | 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 | 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. | 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. | 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. | 1 month |