Back to resultsEvaluation of an Entrepreneurship Program for American-Indian Youth
Primary Purpose
Depressive Symptoms, Substance Use
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arrowhead Business Group Curriculum
Recreational League Control Condition
Sponsored by
About this trial
This is an interventional prevention trial for Depressive Symptoms focused on measuring American Indian, Adolescents, Entrepreneurship, Paraprofessional, Life skills
Eligibility 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.
Sites / Locations
- Johns Hopkins Center for American Indian Health - Whiteriver Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arrowhead Business Group Curriculum
Recreational League Control Condition
Arm 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.)
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.
Outcomes
Primary Outcome Measures
Decreased substance use as measured by Youth Risk Behavior Survey (YRBS) in treatment vs. control group at 24 months follow-up
Secondary Outcome Measures
Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 24 months follow-up
Increased academic achievement as measured by school records and Across Time Orientation measure in treatment vs. control group at 24 months follow-up
Full Information
NCT ID
NCT02157493
First Posted
June 4, 2014
Last Updated
January 4, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
1. Study Identification
Unique Protocol Identification Number
NCT02157493
Brief Title
Evaluation of an Entrepreneurship Program for American-Indian Youth
Official Title
Evaluation of an Entrepreneurship Program on Psychosocial, Behavioral Health, Educational and Economic Outcomes Among American-Indian Youth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Substance Use
Keywords
American Indian, Adolescents, Entrepreneurship, Paraprofessional, Life skills
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arrowhead Business Group Curriculum
Arm Type
Experimental
Arm 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.)
Arm Title
Recreational League Control Condition
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Arrowhead Business Group Curriculum
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Recreational League Control Condition
Intervention 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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Barlow, PhD, MPH, MA
Organizational Affiliation
Johns Hopkins Center for American Indian Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Center for American Indian Health - Whiteriver Office
City
Whiteriver
State/Province
Arizona
ZIP/Postal Code
85941
Country
United States
12. IPD Sharing Statement
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Evaluation of an Entrepreneurship Program for American-Indian Youth
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