- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04979481
BRAVE Study: Designing and Evaluating Technologies to Promote Adolescent Mental Health (BRAVE)
We R Native: Designing and Evaluating Technologies to Promote Adolescent Mental Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There are approximately 2.1 million self-identified American Indian and Alaska Native (AI/AN or Native) youth under the age of 24 living in the United States. Like many teens, AI/AN youth report frequent technology use and poor mental health outcomes, including trauma, stress, anxiety, depression, and suicidality.
To support Native youth, the Northwest Portland Area Indian Health Board (NPAIHB) launched We R Native in 2012, a holistic health resource for Native youth, by Native youth (www.weRnative.org).
While this broad reach and utilization is promising, more focused research is needed to better understand the acceptability and usability of the mental health messages delivered by We R Native, and systematic research is needed to determine whether We R Native's messages actually improve mental health and resilience, teach mental health skills (like coping skills, mindfulness, help-seeking, and use of suicide prevention chat-lines, etc.), and promote healthy social norms - all protective factors against suicide and substance abuse.
Housed at the Colorado School of Public Health, the mission of the mHealth Impact Lab is to facilitate the rapid and rigorous development, implementation, and evaluation of mobile and digital technology for health promotion and disease prevention that address inequalities in health outcomes.
The research teams tested whether We R Native's BRAVE messages improved self-efficacy and behaviors related to mental health, resilience, and cultural pride; as well as the relative impact of user engagement.
The BRAVE study will improve the relevance, efficacy, and utilization of mental health resources delivered through We R Native' messaging channels - reaching a high-risk, underserved population - and will create new mechanisms to monitor and evaluate the impact of mHealth interventions. Both teams are committed to sharing resultant data collection tools and processes with those working in the field.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97021
- NPAIHB
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The study included self-identified American Indian and Alaska Native youth
- Age 15-24 years old
Exclusion Criteria:
-Participants were required to have a cell phone with text message capabilities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BRAVE Intervention Arm
The BRAVE campaign included 3-5 text messages per week, including 1 role model video per week and a related image.
|
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.
|
|
Active Comparator: STEM Control Arm
The STEM campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health
Time Frame: Up to 8 months
|
Changes in mean scores of perceived mental, physical, and spiritual health
|
Up to 8 months
|
|
Resilience
Time Frame: Up to 8 months
|
Proportion of respondents that report higher mean scores on resilience
|
Up to 8 months
|
|
Positive Coping
Time Frame: Up to 8 months
|
Proportion of respondents that report higher mean scores of coping skills
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Up to 8 months
|
|
Self-esteem
Time Frame: Up to 8 months
|
Proportion of respondents who report higher mean scores of self-satisfaction, having good qualities, pride, self-worth, and self-respect
|
Up to 8 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephanie Craig Rushing, PhD, Principal Investigator
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1384639
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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