Mental HealthNCT05998005
First Face Training Evaluation in Tribal Communities
A study testing First Face Training Program in people with Mental Health and Substance-Related Disorders, run by Cambridge Health Alliance at 9 sites in United States.
Trial summary
The goal of this study is to evaluate a culturally grounded training curriculum, First Face for Mental Health, in Tribal communities, using a waitlist controlled trial design. This curriculum will train Tribal community members in how to respond to youth and adults experiencing mental health crises and serve as a… Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Substance-Related Disorders
- What is being tested?
- First Face Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 9 sitesUnited States
- Study dates
- 30 Aug 2023to 14 May 2026
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age 14 or older
- Living or working in one of the seven Tribal Nations affiliated with the Healing Lodge of the Seven Nations, including Northwestern United States, including the Coeur d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians
Who cannot join
- Age 13 or younger
- Not living or working in one of the seven Tribal Nations affiliated with the Healing Lodge of the Seven Nations, including Northwestern United States, including the Coeur d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Kootenai Tribe of Idaho
Bonners Ferry, Idaho, 83805
Kalispel Tribe of Indians
Cusick, Washington, 99119
Nez Perce Tribe
Lapwai, Idaho, 83540
Division on Addiction, Cambridge Health Alliance
Malden, Massachusetts, 02148
Confederated Tribes of the Colville Reservation
Nespelem, Washington, 99155
Confederated Tribes of the Umatilla Indian Reservation
Pendleton, Oregon, 97801
Coeur d'Alene Tribe
Plummer, Idaho, 83851
Healing Lodge of the Seven Nations
Spokane Valley, Washington, 99212
Spokane Tribe of Indians
Wellpinit, Washington, 99040
About this study
Official title: Assessing Cultures of Recovery in Tribal Communities - Research Core - Training Evaluation
The goal of this study is to evaluate a culturally grounded training curriculum, First Face for Mental Health, in Tribal communities, using a waitlist controlled trial design. This curriculum will train Tribal community members in how to respond to youth and adults experiencing mental health crises and serve as a bridge between these individuals and the help they need. The main questions the study aims to answer are:
- Does the training increase mental health knowledge, capacity and ability to respond to mental health situations, perceived competence to respond, and actual responsive actions among trainees?
- Does the training decrease mental health stigmatizing attitudes and increase cultural identity among trainees?
Participants will complete surveys before and after completing the First Face training, across five time points over the course of two years. Half of the participants will receive the training initially, and half will receive it six months later. Researchers will compare the two groups to examine whether the trainees demonstrate changes in the outcomes of interest compared to the waitlist control group during the first six months, and whether both groups demonstrate sustained changes after the first six months (i.e., once both groups have received training).
Read the detailed description
For the First Face Training Evaluation study, the researchers will build upon our previous work by evaluating a culturally grounded community mental health training curriculum, First Face for Mental Health. The researchers developed First Face in collaboration with stakeholders from seven Tribal nations to reflect these communities' cultural traditions and values. First Face is a culturally-appropriate community-based mental health training for lay persons and others living and working in Tribal communities that prepares learners to provide assistance to someone having a mental health crisis. By training more individuals in a community to identify, intervene, and connect struggling individuals with the support they need, community culture can be transformed to recognize and address mental health crises.
The overall goal for this First Face Training Evaluation Study (the Research Core component of the Assessing Cultures of Recovery in Tribal Communities Native American Research Centers for Health [NARCH] Center grant issued by NIH) is to evaluate the impact of First Face training both on the trainees and within the Tribal communities as a whole. This Registration covers the evaluation of trainee effects.
The Training Evaluation study will evaluate First Face training using a waitlist control design, implemented in seven tribes, which includes five assessment time points for both initial trainees (n=350) and waitlist controls (n=350). These assessments will measure knowledge about mental health and addiction, as well as the ability and confidence of individuals to respond appropriately to mental health crises.
The researchers will recruit participants from the seven tribes via community-wide announcements and information provided through multiple departments and organizations within each tribe. The Healing Lodge research team and Working Group members will work directly and in person with the tribes to facilitate this recruitment. The researchers will recruit the sample proportional to the size of each tribe (e.g., 30 from the smallest tribe; 280 from the largest). They will assign participants within each tribe as they sign up for the study to either the initial training group or the waitlist control group, based on participant preference, or if no preference, random assignment. To ensure a final recruitment of 700 who are able to attend the trainings, the researchers will attempt to recruit 1,000 initially, allowing a 30% attrition rate for individuals who cannot attend any of the offered training dates.
Multiple trainings of 15-30 individuals will occur separately within each tribe. As shown int he timeline, 350 individuals in the initial training group will receive training and complete a baseline and post-training survey at the time of training. At that same time, the 350 individuals in the waitlist control group will complete an online pre-baseline survey. Six months later, the waitlist control group will undergo training (again, multiple trainings of 15-30 individuals will occur separately within each tribe) and complete baseline and post-training surveys. At the same time, the 350 individuals in the initial training group will complete an online 6 month follow-up survey. Six months later, both groups will complete online surveys - the initial training group will complete their 12-month follow-up and the waitlist control group will complete their 6-month follow-up. Twelve months later, both groups will again complete online surveys -- the initial training group will complete a 24-month follow-up and the waitlist control group will complete an 18-month follow-up.
Note: This study was originally posted as a randomized waitlist control design. We originally intended to block randomize participants within each Tribe to either the initial training group or the waitlist control group as they signed up for the study (and after they had signed the consent form), using a block size of 4. However, across Tribes, it became clear that this type of randomization was not feasible. Organizations within the Tribes where we have gotten permission to advertise and recruit desire for their employees who choose to participate to all take the training at the same time. In many cases, these organizations are providing the time off for their employees to participate. As a result, we are changing our approach to a primarily sequential recruitment procedure. The benefit of the change to randomization is that it allows the Tribal communities to better dictate how they would like to participate in this research and stays true to the principals of Tribal Participatory Research that we follow.
- Conditions
- Mental Health, Substance-Related Disorders
- Being tested
- First Face Training Program
- Keywords
- addiction, mental health, AI/AN, native american, american indian, mental health training program, training evaluation, NARCH, native american research centers for health, addictive behaviors, tribal participatory research, TPR
- Medical subject headings
- Psychological Well-Being, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First Face Training ProgramBehavioural
First Face for Mental Health is a culturally-appropriate community-based mental health training for lay persons and others that prepares learners to provide assistance to someone having a mental health crisis. The course takes approximately 8 hours to complete.
| Study group | Role | What they receive |
|---|---|---|
| Initial training group | Experimental | Participants who are initially trained in the First Face training program Receives: Behavioral: First Face Training Program |
| Waitlist-control group | Other | Participants who are trained in the First Face training program 6 months after the initial training group Receives: Behavioral: First Face Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Knowledge
A novel 22-item summed index (possible range from 0 to 22) derived from the First Face Training course to measure knowledge about mental health. Each multiple choice question focuses on a different mental health knowledge item and has one correct answer. Each participant will receive 1 point for each correct answer and 0 points for each incorrect answer. Higher scores indicate a better outcome (i.e., more knowledge about mental health).
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Ability to Respond Measured via Situational Judgement Tasks
A novel 7-item measure tapping respondents' ability to respond to and help people experiencing mental health problems (i.e., measured via situational judgment tasks). This measure includes 7 unique vignettes with 5 response options each. Response options are each assigned a value from 1 (least ability to respond) to 5 (greatest ability to respond), and then all are summed to create an overall ability to respond score, with a possible range of 7 to 35. Higher values indicate a better ability to respond to and help people experiencing mental health problems.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Perceived Competence to Respond
A 10-item measure that taps respondents' confidence in their competence to respond to and help people experiencing mental health problems (i.e., Confidence in Recognizing, Intervening and Connecting Individual(s) with Resources Scale; adapted from Talbot et al., 2017). Each response option has a possible range of 1 (Not at all confident) to 5 (Very confident), and a mean will be calculate from all 10 items to yield a scale with a possible range of 1 to 5. Higher values indicate greater perceived competence respond to and help people experiencing mental health problems.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Responsive Actions
Novel measures including 2 items to assess interventions in potential mental health crisis situations in the past 30 days. The first asks "In what ways did you intervene (select all that apply)?", with 4 possible options and an "Other (please specify):" option, and the second asks "What happened after you intervened (select all that apply)?" with 5 possible options and an "Other (please specify):" option. We will report frequencies for these two items at each time point, as these measures are not intended to be summed or averaged into a scale.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Secondary outcomes (3)
Mental Health Stigma Measure 1
A 22-item scale measuring respondents' stigma toward people experiencing mental health problems (i.e., adapted from the Mental Illness Stigma Scale in Day et al., 2007). Each item has response categories ranging from Completely disagree (coded as 1) to Completely agree (coded as 5), and a mean of all 22 items is calculated to create the scale. The scale has a possible range of 1 to 5, and higher values indicate higher levels of mental health stigma.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Mental Health Stigma Measure 2
A 21-item scale measuring respondents' stigma toward people experiencing mental health problems (i.e., the Attitudes toward Serious Mental Illness Scale; Watson et al., 2005). Each item has response categories ranging from Completely disagree (coded as 1) to Completely agree (coded as 5), and a mean of all 21 items is calculated to create the scale. The scale has a possible range of 1 to 5, and higher values indicate higher levels of mental health stigma.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Cultural Identity
A 6-item scale to measure strength of respondents' cultural identity (i.e., adapted from the Multigroup Ethnic Identity Measure - Revised; Phinney \& Ong, 2007), which we adapted for this AI/AN population. Each item has 5 responses ranging from Strongly disagree (coded as 1) to Strongly agree (coded as 5), and a mean is calculated from all 6 items to create the scale. The possible range is 1 to 5, and higher values indicate a stronger cultural identity.
Measured: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start30 Aug 2023
- Primary completion14 May 2026
- Study completion14 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- Waitlist-control design
- Masking
- None (open label)
- Enrolment
- 554 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Healing Lodge of the Seven Nations
- Responsible party
- Sponsor
- Investigators
- Sarah E. Nelson, Ph.D., Principal investigator, Cambridge Health AllianceMartina Whelshula, Ph.D., Principal investigator, Healing Lodge of the Seven Nations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998005
- Sponsor's protocol ID
- 1S06GM146095-01-8249
- Other IDs
- 1S06GM146095
- Status last verified
- Jun 2026
- First submitted
- 25 Jul 2023
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each Tribe would need to agree to have their data shared for an IPD plan to be put in place. This has not yet happened, though we will work toward it.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Cultures of Recovery in Tribal Communities - Research Core - Training Evaluation
- ClinicalTrials.gov ID
- NCT05998005
- Acronym / sponsor ID
- 1S06GM146095-01-8249
- Conditions
- Mental Health, Substance-Related Disorders
- Keywords
- addiction, mental health, AI/AN, native american, american indian, mental health training program, training evaluation, NARCH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 554 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Healing Lodge of the Seven Nations
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 14 May 2026 (actual)
- Study completion
- 14 May 2026 (actual)
- First posted
- 18 Aug 2023 (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 goal of this study is to evaluate a culturally grounded training curriculum, First Face for Mental Health, in Tribal communities, using a waitlist controlled trial design. This curriculum will train Tribal community members in how to respond to youth and adults experiencing mental health crises and serve as a bridge between these individuals and the help they need. The main questions the study aims to answer are:
- Does the training increase mental health knowledge, capacity and ability to respond to mental health situations, perceived competence to respond, and actual responsive actions among trainees?
- Does the training decrease mental health stigmatizing attitudes and increase cultural identity among trainees?
Participants will complete surveys before and after completing the First Face training, across five time points over the course of two years. Half of the participants will receive the training initially, and half will receive it six months later. Researchers will compare the two groups to examine whether the trainees demonstrate changes in the outcomes of interest compared to the waitlist control group during the first six months, and whether both groups demonstrate sustained changes after the first six months (i.e., once both groups have received training).
Detailed description
For the First Face Training Evaluation study, the researchers will build upon our previous work by evaluating a culturally grounded community mental health training curriculum, First Face for Mental Health. The researchers developed First Face in collaboration with stakeholders from seven Tribal nations to reflect these communities' cultural traditions and values. First Face is a culturally-appropriate community-based mental health training for lay persons and others living and working in Tribal communities that prepares learners to provide assistance to someone having a mental health crisis. By training more individuals in a community to identify, intervene, and connect struggling individuals with the support they need, community culture can be transformed to recognize and address mental health crises.
The overall goal for this First Face Training Evaluation Study (the Research Core component of the Assessing Cultures of Recovery in Tribal Communities Native American Research Centers for Health [NARCH] Center grant issued by NIH) is to evaluate the impact of First Face training both on the trainees and within the Tribal communities as a whole. This Registration covers the evaluation of trainee effects.
The Training Evaluation study will evaluate First Face training using a waitlist control design, implemented in seven tribes, which includes five assessment time points for both initial trainees (n=350) and waitlist controls (n=350). These assessments will measure knowledge about mental health and addiction, as well as the ability and confidence of individuals to respond appropriately to mental health crises.
The researchers will recruit participants from the seven tribes via community-wide announcements and information provided through multiple departments and organizations within each tribe. The Healing Lodge research team and Working Group members will work directly and in person with the tribes to facilitate this recruitment. The researchers will recruit the sample proportional to the size of each tribe (e.g., 30 from the smallest tribe; 280 from the largest). They will assign participants within each tribe as they sign up for the study to either the initial training group or the waitlist control group, based on participant preference, or if no preference, random assignment. To ensure a final recruitment of 700 who are able to attend the trainings, the researchers will attempt to recruit 1,000 initially, allowing a 30% attrition rate for individuals who cannot attend any of the offered training dates.
Multiple trainings of 15-30 individuals will occur separately within each tribe. As shown int he timeline, 350 individuals in the initial training group will receive training and complete a baseline and post-training survey at the time of training. At that same time, the 350 individuals in the waitlist control group will complete an online pre-baseline survey. Six months later, the waitlist control group will undergo training (again, multiple trainings of 15-30 individuals will occur separately within each tribe) and complete baseline and post-training surveys. At the same time, the 350 individuals in the initial training group will complete an online 6 month follow-up survey. Six months later, both groups will complete online surveys - the initial training group will complete their 12-month follow-up and the waitlist control group will complete their 6-month follow-up. Twelve months later, both groups will again complete online surveys -- the initial training group will complete a 24-month follow-up and the waitlist control group will complete an 18-month follow-up.
Note: This study was originally posted as a randomized waitlist control design. We originally intended to block randomize participants within each Tribe to either the initial training group or the waitlist control group as they signed up for the study (and after they had signed the consent form), using a block size of 4. However, across Tribes, it became clear that this type of randomization was not feasible. Organizations within the Tribes where we have gotten permission to advertise and recruit desire for their employees who choose to participate to all take the training at the same time. In many cases, these organizations are providing the time off for their employees to participate. As a result, we are changing our approach to a primarily sequential recruitment procedure. The benefit of the change to randomization is that it allows the Tribal communities to better dictate how they would like to participate in this research and stays true to the principals of Tribal Participatory Research that we follow.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist-control design
| Arm | Type | Receives |
|---|---|---|
| Initial training group | Experimental | Behavioral: First Face Training ProgramParticipants who are initially trained in the First Face training program |
| Waitlist-control group | Other | Behavioral: First Face Training ProgramParticipants who are trained in the First Face training program 6 months after the initial training group |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age 14 or older
- Living or working in one of the seven Tribal Nations affiliated with the Healing Lodge of the Seven Nations, including Northwestern United States, including the Coeur d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians
Key exclusion criteria (2 listed)
- Age 13 or younger
- Not living or working in one of the seven Tribal Nations affiliated with the Healing Lodge of the Seven Nations, including Northwestern United States, including the Coeur d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians
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 |
|---|---|---|
| First Face Training ProgramFirst Face for Mental Health is a culturally-appropriate community-based mental health training for lay persons and others that prepares learners to provide assistance to someone having a mental health crisis. The course takes approximately 8 hours to complete. | Behavioural | Initial training group, Waitlist-control group |
Primary outcome
Mental Health Knowledge
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
A novel 22-item summed index (possible range from 0 to 22) derived from the First Face Training course to measure knowledge about mental health. Each multiple choice question focuses on a different mental health knowledge item and has one correct answer. Each participant will receive 1 point for each correct answer and 0 points for each incorrect answer. Higher scores indicate a better outcome (i.e., more knowledge about mental health).
Ability to Respond Measured via Situational Judgement Tasks
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
A novel 7-item measure tapping respondents' ability to respond to and help people experiencing mental health problems (i.e., measured via situational judgment tasks). This measure includes 7 unique vignettes with 5 response options each. Response options are each assigned a value from 1 (least ability to respond) to 5 (greatest ability to respond), and then all are summed to create an overall ability to respond score, with a possible range of 7 to 35. Higher values indicate a better ability to respond to and help people experiencing mental health problems.
Perceived Competence to Respond
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
A 10-item measure that taps respondents' confidence in their competence to respond to and help people experiencing mental health problems (i.e., Confidence in Recognizing, Intervening and Connecting Individual(s) with Resources Scale; adapted from Talbot et al., 2017). Each response option has a possible range of 1 (Not at all confident) to 5 (Very confident), and a mean will be calculate from all 10 items to yield a scale with a possible range of 1 to 5. Higher values indicate greater perceived competence respond to and help people experiencing mental health problems.
Responsive Actions
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Novel measures including 2 items to assess interventions in potential mental health crisis situations in the past 30 days. The first asks "In what ways did you intervene (select all that apply)?", with 4 possible options and an "Other (please specify):" option, and the second asks "What happened after you intervened (select all that apply)?" with 5 possible options and an "Other (please specify):" option. We will report frequencies for these two items at each time point, as these measures are not intended to be summed or averaged into a scale.
3 secondary outcomes
Mental Health Stigma Measure 1
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Mental Health Stigma Measure 2
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
Cultural Identity
Time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up
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 18 Jun 2026.
- Project Details on NIH RePORT for this funded grant (Assessing Cultures of Recovery in Tribal Communities - Research Core)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Each Tribe would need to agree to have their data shared for an IPD plan to be put in place. This has not yet happened, though we will work toward it.
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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.
Sarah E. Nelson, Ph.D. principal investigator
Cambridge Health Alliance
Martina Whelshula, Ph.D. principal investigator
Healing Lodge of the Seven Nations
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First Face Training Program in people with Mental Health and Substance-Related Disorders, run by Cambridge Health Alliance at 9 sites 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 2 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 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Mental Health Knowledge (time frame: Pre-baseline (6 months before Baseline); Baseline (0 months); Post-training (0 months); 6 month Follow-up; 12 month Follow-up; 18 month Follow-up; 24 month Follow-up). 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?
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 18 Jun 2026.