NCT02157493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
449

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

4.3 years

First QC Date

June 4, 2014

Last Update Submit

January 12, 2024

Conditions

Keywords

American IndianAdolescentsEntrepreneurshipParaprofessionalLife skills

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Decreased depressive symptoms on Patient Health Questionnaire-9 (PHQ-9) in treatment vs. control group at 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

    24 months follow-up

Study Arms (2)

Arrowhead Business Group Curriculum

EXPERIMENTAL

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 CurriculumBehavioral: Recreational League Control Condition

Recreational League Control Condition

ACTIVE COMPARATOR

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

Interventions

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.

Arrowhead Business Group Curriculum

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.

Arrowhead Business Group CurriculumRecreational League Control Condition

Eligibility Criteria

Age13 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Center for American Indian Health - Whiteriver Office

Whiteriver, Arizona, 85941, United States

Location

MeSH Terms

Conditions

DepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Allison Barlow, PhD, MPH, MA

    Johns Hopkins Center for American Indian Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 6, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2018

Study Completion

June 25, 2019

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations