Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06997120
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both participants and outcome assessors will be blind to condition through completion of the baseline assessment including the first week-long EMA burst. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at either of the follow-up time points until after the quantitative measures are complete.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cannabis use problems', 'timeFrame': 'baseline, 1 month, 6 months', 'description': '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'}, {'measure': 'App adherence', 'timeFrame': '1 month', 'description': 'App files played per objective in-app analytics data'}], 'secondaryOutcomes': [{'measure': 'Sexual behaviors', 'timeFrame': 'baseline, 1 month, 6 months', 'description': 'A modified AIDS Risk Behavior Assessment (ARBA) will be used to create a sexual behavior summary score; higher scores indicate more sexual risk behaviors'}, {'measure': 'Negative mood regulation', 'timeFrame': 'baseline, 1 month, 6 months', 'description': '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'}, {'measure': 'Anxiety', 'timeFrame': 'baseline, 1 month, 6 months', 'description': 'The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of anxiety; higher total scores indicate greater anxiety symptoms'}, {'measure': 'Depression', 'timeFrame': 'baseline, 1 month, 6 months', 'description': 'The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of depression; higher total scores indicate greater depression symptoms'}, {'measure': 'Self-efficacy', 'timeFrame': 'baseline, 1 month, 6 months', 'description': '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'}, {'measure': 'Alcohol use problems', 'timeFrame': 'baseline, 1 month, 6 months', 'description': 'The Alcohol Trouble Scale (ATS) includes 10 items, each rated on a binary (yes/no) scale; higher scores indicate greater alcohol use problems'}, {'measure': 'Real-time mood states', 'timeFrame': 'baseline, 1 month', 'description': '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)'}, {'measure': 'Real-time cannabis use', 'timeFrame': 'baseline, 1 month', 'description': '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)'}, {'measure': 'Real-time alcohol use', 'timeFrame': 'baseline, 1 month', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Juvenile legal system', 'Meditation', 'Mindfulness', 'Smartphone', 'Mobile health (mHealth)', 'Ecological momentary assessment (EMA)', 'Substance use', 'Mental health'], 'conditions': ['Behavioral Health']}, 'descriptionModule': {'briefSummary': '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:\n\n1. Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?\n2. Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?\n3. Will youth adequately adhere to the meditation app?', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 13-20 years old\n* In probation programming (i.e., in legal programming but not detained) in Cook County\n* Have access to an Apple/Android smartphone\n* Understand and provide assent/consent\n* Have parental consent (if under 18 years old)\n* English-speaking, due to norming of instruments'}, 'identificationModule': {'nctId': 'NCT06997120', 'briefTitle': 'Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth', 'orgStudyIdInfo': {'id': '2025-0066'}, 'secondaryIdInfos': [{'id': 'R01DA061795', 'link': 'https://reporter.nih.gov/quickSearch/R01DA061795', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bodhi AIM', 'description': 'Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.', 'interventionNames': ['Behavioral: Bodhi AIM (intervention group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HIB', 'description': 'Participants randomized to the active control arm will receive the HIB health promotion app.', 'interventionNames': ['Behavioral: HIB (control group)']}], 'interventions': [{'name': 'Bodhi AIM (intervention group)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Bodhi AIM']}, {'name': 'HIB (control group)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['HIB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashley D Kendall, PhD', 'role': 'CONTACT', 'email': 'akendall@uic.edu', 'phone': '312-355-1836'}, {'name': 'Ashley D Kendall, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'timeFrame': "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.", 'ipdSharing': 'YES', 'description': 'De-identified data may be placed in one or more electronic databases which could be used for other research studies.', 'accessCriteria': 'To be determined'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ashley D Kendall', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}