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Evaluation of an Entrepreneurship Program for American-Indian Youth

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ClinicalTrials.gov Identifier: NCT02157493
Recruitment Status : Active, not recruiting
First Posted : June 6, 2014
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Substance Use Behavioral: Arrowhead Business Group Curriculum Behavioral: Recreational League Control Condition Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of an Entrepreneurship Program on Psychosocial, Behavioral Health, Educational and Economic Outcomes Among American-Indian Youth
Study Start Date : April 2014
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arrowhead Business Group Curriculum
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.)
Behavioral: Arrowhead Business Group Curriculum
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.

Behavioral: Recreational League Control Condition
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.

Active Comparator: Recreational League Control Condition
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.
Behavioral: Recreational League Control Condition
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.




Primary Outcome Measures :
  1. Decreased substance use as measured by Youth Risk Behavior Survey (YRBS) in treatment vs. control group at 24 months follow-up [ Time Frame: 24 months follow-up ]

Secondary Outcome Measures :
  1. Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 24 months follow-up [ Time Frame: 24 months follow-up ]
  2. Increased academic achievement as measured by school records and Across Time Orientation measure in treatment vs. control group at 24 months follow-up [ Time Frame: 24 months follow-up ]


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Ages Eligible for Study:   13 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • American Indian ethnicity and primary residence within the Fort Apache Indian Reservation.
  • 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.

Exclusion Criteria:

  • Youth that are currently enrolled in foster care will not be eligible to participate in the study.
  • Those unable to participate in any of the evaluation assessments or intervention components will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157493


Locations
United States, Arizona
Johns Hopkins Center for American Indian Health - Whiteriver Office
Whiteriver, Arizona, United States, 85941
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Allison Barlow, PhD, MPH, MA Johns Hopkins Center for American Indian Health

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02157493     History of Changes
Other Study ID Numbers: U261IHS0080-01-00
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
American Indian
Adolescents
Entrepreneurship
Paraprofessional
Life skills

Additional relevant MeSH terms:
Depression
Behavioral Symptoms