BRAVE Study: Designing and Evaluating Technologies to Promote Adolescent Mental Health (BRAVE)

August 31, 2021 updated by: Stephanie Craig Rushing, Northwest Portland Area Indian Health Board

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1030

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97021
        • NPAIHB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwest Portland Area Indian Health Board

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
mHealth Impact Lab

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephanie Craig Rushing, PhD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1384639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan in place at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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