Mental Health Wellness 1BRAVENCT04979481
BRAVE Study: Designing and Evaluating Technologies to Promote Adolescent Mental Health
A study testing BRAVE and STEM in people with Mental Health Wellness 1, run by Northwest Portland Area Indian Health Board at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 15 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- BRAVE and STEM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The study included self-identified American Indian and Alaska Native youth
- Age 15-24 years old
Who cannot join
- -Participants were required to have a cell phone with text message capabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: We R Native: Designing and Evaluating Technologies to Promote Adolescent Mental Health
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.
Read the 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.
- Conditions
- Mental Health Wellness 1
- Being tested
- BRAVE, STEM
- Keywords
- adolescent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRAVEBehavioural
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.
STEMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: STEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health
Changes in mean scores of perceived mental, physical, and spiritual health
Measured: Up to 8 months
Resilience
Proportion of respondents that report higher mean scores on resilience
Measured: Up to 8 months
Positive Coping
Proportion of respondents that report higher mean scores of coping skills
Measured: 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
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start23 Aug 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1,030 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwest Portland Area Indian Health Board
- Sponsor type
- University, hospital or other
- Collaborators
- mHealth Impact Lab
- Responsible party
- Principal investigator, Stephanie Craig Rushing, Northwest Portland Area Indian Health Board
- Investigators
- Stephanie Craig Rushing, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979481
- Sponsor's protocol ID
- 1384639
- Acronym
- BRAVE
- Status last verified
- Aug 2021
- First submitted
- 14 Jul 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan in place at this time.
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.
PubMed 33844480Stephens 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.
PubMed 33339260Wrobel 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.
PubMed 35212633Craig 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.
PubMed 34524092
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- We R Native: Designing and Evaluating Technologies to Promote Adolescent Mental Health
- ClinicalTrials.gov ID
- NCT04979481
- Acronym / sponsor ID
- BRAVE / 1384639
- Conditions
- Mental Health Wellness 1
- Keywords
- adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (actual)
- Lead sponsor
- Northwest Portland Area Indian Health BoardUniversity, hospital or other
- Collaborators
- mHealth Impact Lab
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| BRAVE Intervention Arm | Experimental | Behavioral: BRAVEThe BRAVE campaign included 3-5 text messages per week, including 1 role model video per week and a related image. |
| STEM Control Arm | Active comparator | Behavioral: STEMThe STEM campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- The study included self-identified American Indian and Alaska Native youth
- Age 15-24 years old
Key exclusion criteria (1 listed)
- -Participants were required to have a cell phone with text message capabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRAVEThe 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. | Behavioural | BRAVE Intervention Arm |
| STEMThe 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. | Behavioural | STEM Control Arm |
Primary outcome
Health
Time frame: Up to 8 months
Changes in mean scores of perceived mental, physical, and spiritual health
Resilience
Time frame: Up to 8 months
Proportion of respondents that report higher mean scores on resilience
Positive Coping
Time frame: Up to 8 months
Proportion of respondents that report higher mean scores of coping skills
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Background: PubMed 33844480Craig 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.
- Results publication: PubMed 33339260Stephens 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.
- Derived from this study: PubMed 35212633Wrobel 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.
- Derived from this study: PubMed 34524092Craig 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.
- Individual participant dataSharing planned: No. There is no plan in place at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie Craig Rushing, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRAVE and STEM in people with Mental Health Wellness 1, run by Northwest Portland Area Indian Health Board at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health (time frame: Up to 8 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979481, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2021.