Evaluation of an Entrepreneurship Program for American-Indian Youth

January 12, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

Evaluation of an Entrepreneurship Program on Psychosocial, Behavioral Health, Educational and Economic Outcomes Among American-Indian Youth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

449

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Whiteriver, Arizona, United States, 85941
        • Johns Hopkins Center for American Indian Health - Whiteriver Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 24 months follow-up
24 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Collaborators

Native American Research Centers for Health (NARCH)

Investigators

  • Principal Investigator: Allison Barlow, PhD, MPH, MA, Johns Hopkins Center for American Indian Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

June 25, 2019

Study Registration Dates

First Submitted

June 4, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimated)

June 6, 2014

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U261IHS0080-01-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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