Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 11:07 PM
Study NCT ID:
NCT01650233
Status:
COMPLETED
Last Update Posted:
2018-01-18
First Post:
2012-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Wellness for Young Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-16', 'studyFirstSubmitDate': '2012-07-20', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Behavior', 'timeFrame': '6 months', 'description': 'Assessed by teacher-rated behavior ratings.'}], 'primaryOutcomes': [{'measure': 'psychological symptoms', 'timeFrame': '6 months', 'description': 'Psychological symptoms assessed include anxiety, hostility, and depression.'}, {'measure': 'coping', 'timeFrame': '6 months', 'description': 'Coping assessed includes rumination and typically positive and negative coping approaches.'}], 'secondaryOutcomes': [{'measure': 'Sleep', 'timeFrame': '6 months', 'description': 'Sleep was measured using diary and actigraphy.'}, {'measure': 'stress', 'timeFrame': '6 months', 'description': 'Stress was measured using self-report and salivary cortisol.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress-exposed Urban Male Youth']}, 'referencesModule': {'references': [{'pmid': '24029559', 'type': 'DERIVED', 'citation': 'Sibinga EM, Perry-Parrish C, Chung SE, Johnson SB, Smith M, Ellen JM. School-based mindfulness instruction for urban male youth: a small randomized controlled trial. Prev Med. 2013 Dec;57(6):799-801. doi: 10.1016/j.ypmed.2013.08.027. Epub 2013 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the impact of a mindfulness-based stress reduction program compared with a health education program for urban middle-school male youth on outcomes of psychological symptoms, coping, stress, sleep, and behavior.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7th or 8th graders at St. Ignatius Loyola Academy in 2009-2010 academic year.\n* Parent/guardian consents\n* Student assents\n\nExclusion Criteria (as assessed by school staff):\n\n* significant psychopathology\n* significant developmental delay\n* significant substance abuse with behavioral consequences\n* significant behavioral problems\n* foster care due to consent restrictions)'}, 'identificationModule': {'nctId': 'NCT01650233', 'briefTitle': 'Improving Wellness for Young Men', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Improving Wellness for Young Men', 'orgStudyIdInfo': {'id': 'NA_00028889'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness-based stress reduction', 'description': 'The mindfulness-based stress reduction (MBSR) program was previously adapted for urban youth and here further adapted to 12 weekly 50-minute classes for use in school.', 'interventionNames': ['Behavioral: Mindfulness-based stress reduction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy Topics', 'description': 'An age-appropriate health education curriculum was used as a non-specific group comparison for the MBSR program to control for the effects of: positive adult instruction, interactive peer group instruction, learning new material, group size and location, time, and attention.', 'interventionNames': ['Behavioral: Mindfulness-based stress reduction']}], 'interventions': [{'name': 'Mindfulness-based stress reduction', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Healthy Topics', 'Mindfulness-based stress reduction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'St. Ignatius Loyola Academy', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}