Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT02157493
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2014-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Entrepreneurship Program for American-Indian Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-12', 'studyFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decreased substance use as measured by Youth Risk Behavior Survey (YRBS) in treatment vs. control group at 24 months follow-up', 'timeFrame': '24 months follow-up'}], 'secondaryOutcomes': [{'measure': 'Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 24 months follow-up', 'timeFrame': '24 months follow-up'}, {'measure': 'Increased academic achievement as measured by school records and Across Time Orientation measure in treatment vs. control group at 24 months follow-up', 'timeFrame': '24 months follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['American Indian', 'Adolescents', 'Entrepreneurship', 'Paraprofessional', 'Life skills'], 'conditions': ['Depressive Symptoms', 'Substance Use']}, 'descriptionModule': {'briefSummary': 'This study will use a randomized controlled design to evaluate whether a youth entrepreneurship/life-skills intervention for reservation-based American Indian adolescents (ages 13-15) improves psychosocial, behavioral health, educational, and economic outcomes from baseline for up to 3 years follow-up as compared to a recreational sports league control condition.', 'detailedDescription': 'Intervention activities will be held over a 3 night/4 day residential camp and 6 weekend workshops during the academic year. The control condition will consist of a recreational sports league held on 3 Saturdays, also during the academic year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Indian ethnicity and primary residence within the Fort Apache Indian Reservation.\n* Participants must be 13-15 years old, enrolled as a student at one of the participating high schools, and must have parent/guardian consent for participation in the study.\n\nExclusion Criteria:\n\n* Youth that are currently enrolled in foster care will not be eligible to participate in the study.\n* Those unable to participate in any of the evaluation assessments or intervention components will also be excluded.'}, 'identificationModule': {'nctId': 'NCT02157493', 'briefTitle': 'Evaluation of an Entrepreneurship Program for American-Indian Youth', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Evaluation of an Entrepreneurship Program on Psychosocial, Behavioral Health, Educational and Economic Outcomes Among American-Indian Youth', 'orgStudyIdInfo': {'id': 'U261IHS0080-01-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arrowhead Business Group Curriculum', 'description': 'The Arrowhead Business Group (ABG) Curriculum is a 22-session youth entrepreneurship/life-skills intervention delivered by trained American Indian paraprofessionals from the community to mixed-gender groups of approximately 25 youth. The intervention is delivered over a 3 night/4 day camp along with weekend workshops once a month for 6 months during the academic year. Depending on the time of enrollment, subjects will receive follow-up assessments at 6-month intervals for up to 36-months post-intervention. (Subjects in this cohort will also receive the activities associated with the control condition.)', 'interventionNames': ['Behavioral: Arrowhead Business Group Curriculum', 'Behavioral: Recreational League Control Condition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recreational League Control Condition', 'description': 'The Recreational League Control Condition will be led by local American Indian study staff who are experienced with Johns Hopkins camps and community-based Apache sports programs. Sports and recreational activities will be conducted on 3 Saturdays during the academic year to mixed gender groups of approximately 50 participants.', 'interventionNames': ['Behavioral: Recreational League Control Condition']}], 'interventions': [{'name': 'Arrowhead Business Group Curriculum', 'type': 'BEHAVIORAL', 'description': 'Arrowhead Business Group (ABG) is a culturally tailored entrepreneurship/life-skills intervention, which features instruction from American Indian paraprofessionals in an effort to decrease drug use, depressive symptoms, hopelessness and other high-risk behaviors among youth while improving their school performance and college/career aspirations.', 'armGroupLabels': ['Arrowhead Business Group Curriculum']}, {'name': 'Recreational League Control Condition', 'type': 'BEHAVIORAL', 'description': 'The control condition will consist of a recreational sports league that will be led by local American Indian study staff who are experienced with Johns Hopkins camps and community-based Apache sports programs. Activities will be conducted on 3 Saturdays during the academic year to mixed gender groups of approximately 50 participants.', 'armGroupLabels': ['Arrowhead Business Group Curriculum', 'Recreational League Control Condition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85941', 'city': 'Whiteriver', 'state': 'Arizona', 'country': 'United States', 'facility': 'Johns Hopkins Center for American Indian Health - Whiteriver Office', 'geoPoint': {'lat': 33.83699, 'lon': -109.96427}}], 'overallOfficials': [{'name': 'Allison Barlow, PhD, MPH, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Center for American Indian Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Native American Research Center for Health', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}