Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04979481
Other study ID # 1384639
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 23, 2019
Est. completion date August 31, 2020

Study information

Verified date August 2021
Source Northwest Portland Area Indian Health Board
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1030
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 24 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
BRAVE
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.
STEM
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.

Locations

Country Name City State
United States NPAIHB Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Northwest Portland Area Indian Health Board mHealth Impact Lab

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Health Changes in mean scores of perceived mental, physical, and spiritual health Up to 8 months
Primary Resilience Proportion of respondents that report higher mean scores on resilience Up to 8 months
Primary Positive Coping Proportion of respondents that report higher mean scores of coping skills Up to 8 months
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05130944 - Feasibility of Community Psychosocial Intervention for Women N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05490979 - The Impact of Dyad Exercises on Well-being and Connection in Young Adults N/A
Not yet recruiting NCT05963893 - Promoting a Healthy Life Through Gender Equity
Completed NCT03849924 - Enhancing One's Sense of Self Using Self-Affirmation N/A
Active, not recruiting NCT05541653 - The IGNITE Study on Concentrated Investment in Black Neighborhoods N/A
Completed NCT03303326 - Arab American Women's Health Study N/A
Not yet recruiting NCT05542537 - Nurturing Healthy Teachers N/A
Completed NCT02785471 - Assessing Online Interventions for Men's' Mental Health and Wellbeing N/A
Completed NCT02683811 - Effectiveness of the Updated Version of the School-based Program Diario Della Salute (DDS-2) N/A
Withdrawn NCT05605028 - A Mental Health Intervention for a Community Program Called the PowerObesity N/A
Not yet recruiting NCT04537676 - Patient Empowerment Study
Recruiting NCT06324318 - Parenting in 2 Worlds Multisite Trial Phase 2
Completed NCT05455905 - Voice Biomarkers Predictive of Depression and Anxiety
Completed NCT03368014 - "Fun.Feel.Share" Lyrics-writing and Singing Show N/A
Completed NCT05109923 - Onnit Labs New Mood Supplementation in Healthy College Students N/A
Not yet recruiting NCT05825040 - Randomized Controlled Trial on Precision Mental Health N/A
Completed NCT06044363 - Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders N/A
Not yet recruiting NCT06023342 - Examining Engagement Predictors of Health and Fitness App Uptake and Subscription in the General Population
Recruiting NCT04790162 - Heartfulness Meditation to Improve Resilience Among Health Care Students: A 90 Day Program N/A