Evaluation of an Entrepreneurship Program for American-Indian Youth

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157493
• Other study ID #: U261IHS0080-01-00
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: June 25, 2019

Study information

• Verified date: January 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 449
• Est. completion date: June 25, 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Substance Use
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Center for American Indian Health - Whiteriver Office	Whiteriver	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Native American Research Centers for Health (NARCH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased substance use as measured by Youth Risk Behavior Survey (YRBS) in treatment vs. control group at 24 months follow-up		24 months follow-up
Secondary	Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 24 months follow-up		24 months follow-up
Secondary	Increased academic achievement as measured by school records and Across Time Orientation measure in treatment vs. control group at 24 months follow-up		24 months follow-up