NCT04979481

Brief Summary

The BRAVE study is a randomized controlled trial carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2,330 AI/AN teens and young adults nationwide (15-24 years old) via social media channels and text message and enrolled 1,030 to participate in the 9-month study. Teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and promote cultural pride and resilience; or 8 weeks of Science Technology Engineering and Math (STEM) text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine; and then received the other set of messages. Retention in the study was high, with 87% of participants completing both BRAVE and STEM intervention arms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,030

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

September 8, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

July 14, 2021

Last Update Submit

August 31, 2021

Conditions

Keywords

adolescent

Outcome Measures

Primary Outcomes (4)

  • Health

    Changes in mean scores of perceived mental, physical, and spiritual health

    Up to 8 months

  • Resilience

    Proportion of respondents that report higher mean scores on resilience

    Up to 8 months

  • Positive Coping

    Proportion of respondents that report higher mean scores of coping skills

    Up to 8 months

  • Self-esteem

    Proportion of respondents who report higher mean scores of self-satisfaction, having good qualities, pride, self-worth, and self-respect

    Up to 8 months

Study Arms (2)

BRAVE Intervention Arm

EXPERIMENTAL

The BRAVE campaign included 3-5 text messages per week, including 1 role model video per week and a related image.

Behavioral: BRAVE

STEM Control Arm

ACTIVE COMPARATOR

The STEM campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image.

Behavioral: STEM

Interventions

BRAVEBEHAVIORAL

The BRAVE campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image. The role model videos (1-3 minutes each) featured relatable characters experiencing and addressing violent behavior, alcohol misuse, and suicidality (through the eyes of a perpetrator, an intimate partner violence survivor, and a peer bystander), intended to demonstrated important coping and help-seeking skills.

BRAVE Intervention Arm
STEMBEHAVIORAL

The STEM campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image. The series promoted STEM career pathways and highlighted Native professionals in Science, Technology, Engineering, Math, and Medical careers.

STEM Control Arm

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • The study included self-identified American Indian and Alaska Native youth
  • Age 15-24 years old

You may not qualify if:

  • Participants were required to have a cell phone with text message capabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NPAIHB

Portland, Oregon, 97021, United States

Location

Related Publications (4)

  • Craig Rushing S, Kelley A, Hafner S, Stephens D, Singer M, Bingham D, Caughlan C, Fatupaito B, Gaston A, Ghost Dog T, Smith P, Love Brown D, McCray C. The BRAVE Study: Formative Research to Design a Multimedia Intervention for American Indian and Alaska Native Young Adults. Am Indian Alsk Native Ment Health Res. 2021;28(1):71-102. doi: 10.5820/aian.2801.2021.71.

    PMID: 33844480BACKGROUND
  • Stephens D, Peterson R, Singer M, Johnson J, Rushing SC, Kelley A. Recruiting and Engaging American Indian and Alaska Native Teens and Young Adults in a SMS Help-Seeking Intervention: Lessons Learned from the BRAVE Study. Int J Environ Res Public Health. 2020 Dec 16;17(24):9437. doi: 10.3390/ijerph17249437.

  • Wrobel J, Silvasstar J, Peterson R, Sumbundu K, Kelley A, Stephens D, Craig Rushing S, Bull S. Text Messaging Intervention for Mental Wellness in American Indian and Alaska Native Teens and Young Adults (BRAVE Study): Analysis of User Engagement Patterns. JMIR Form Res. 2022 Feb 25;6(2):e32138. doi: 10.2196/32138.

  • Craig Rushing S, Kelley A, Bull S, Stephens D, Wrobel J, Silvasstar J, Peterson R, Begay C, Ghost Dog T, McCray C, Love Brown D, Thomas M, Caughlan C, Singer M, Smith P, Sumbundu K. Efficacy of an mHealth Intervention (BRAVE) to Promote Mental Wellness for American Indian and Alaska Native Teenagers and Young Adults: Randomized Controlled Trial. JMIR Ment Health. 2021 Sep 15;8(9):e26158. doi: 10.2196/26158.

MeSH Terms

Interventions

Microscopy, Electron, Scanning Transmission

Intervention Hierarchy (Ancestors)

Microscopy, Electron, TransmissionMicroscopy, ElectronMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Stephanie Craig Rushing, PhD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Teens and young adults enrolled in the study received either: 8 weeks of BRAVE text messages or 8 weeks of STEM text messages; and then crossed over to the other arm and received the next set of messages.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

July 14, 2021

First Posted

July 28, 2021

Study Start

August 23, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

September 8, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

There is no plan in place at this time.

Locations