AddictionNCT06290180

Healing Lodge First Face Training Evaluation Study

A study testing First Face for Mental Heatlh in people with Addiction and Depression/Anxiety, run by Cambridge Health Alliance at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate a culturally grounded training program, xaʔtus (meaning First Face) for Mental Health. This program will train community members in how to recognize and respond to youth and adults experiencing mental health crises and ways to serve as a bridge between these individuals and the… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Addiction, Depression/Anxiety, Trauma, Psychological
What is being tested?: First Face for Mental Heatlh
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteUnited States
Study dates: 4 Apr 2024to 30 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Employment at the Healing Lodge of the Seven Nations
Selection to participate in First Face for Mental Health training

Who cannot join

° Previous completion of First Face for Mental Health training

Trial locations and contacts

1 site in 1 country.

United States1 site

Healing Lodge of the Seven Nations
Spokane Valley, Washington, 99212

Other trials in United States

About this study

To evaluate First Face, the investigators will ask all trainees to complete surveys before and after training, and again 3 months later. These surveys will measure knowledge about mental health and addiction, as well as the ability and confidence to respond appropriately to mental health crises. The study will help the investigators understand whether the First Face training program influences mental health and attitudes, as well as responses to mental health crisis situations.

Read the detailed description

With funding from the National Institutes for Health, the investigators created First Face for Mental Health. First Face is a culturally-appropriate community-based mental health training that prepares trainees to provide assistance to someone having a mental health crisis. The more community members within Tribal nations who are trained in a culturally sensitive program to provide support to youth in recovery and members struggling with mental health problems or crises, the better positioned that community is to create a supportive recovery environment for its youth. The investigators are in the process of launching First Face trainings and evaluations among several Tribal communities. Additionally, they will be training staff from the Healing Lodge of the Seven Nations (HL) in the First Face program. This particular application concerns the evaluation of First Face training among HL staff. The investigators will measure primary and secondary outcomes at pre-training, post-training, and 3-month follow-up.

Conditions: Addiction, Depression/Anxiety, Trauma, Psychological, Self-harm
Being tested: First Face for Mental Heatlh
Keywords: mental health, prevention, addiction, substance use disorders
Medical subject headings: Behavior, Addictive, Depression, Anxiety Disorders, Psychological Trauma, Self-Injurious Behavior, Psychological Well-Being, Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

First Face for Mental HeatlhBehavioural
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 groups in NCT06290180
Study group	Role	What they receive
Healing Lodge First Face Training Evaluation Study	Experimental	All participants in this evaluation will be assigned to the First Face for Mental Health training condition. The investigators will use a pre-post design to measure change in relevant outcomes from pre-training, to post-training, to 3-months post-training. Receives: Behavioral: First Face for Mental Heatlh

What is being measured

The primary outcome is the main question the study is designed to answer.

Attitudes Towards Serious Mental Illness - Adolescent Version
The Attitudes Towards Serious Mental Illness - Adolescent Version (ATSMI-AV) is a validated 21-item self-report scale designed to measure attitudes towards mental illness. Participants respond on a 5-point Likert scale. The scale measures five aspects of mental health attitudes: threat, social construction/concern, wishful thinking, categorical thinking and out of control. The investigators will calculate an overall score as well as factor-specific scores, if they observe adequate internal reliability.
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 Higher scores indicate higher levels of stigma towards mental illness.
Measured: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training
First Face Knowledge Assessment
This is a 12-question quiz testing participants' knowledge of concepts taught in the First Face training. Some questions offer the opportunity to earn more than one point. The investigators will score each response as correct or incorrect and sum scores (possible range = 0-17) on each occasion. Higher scores indicate better knowledge of First Face concepts.
Measured: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training
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). Each response option has a possible range of 1 (Not at all confident) to 5 (Very confident), and a mean score will be calculated 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: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training

Secondary outcomes (4)

Satisfaction With Training
One item administered immediately post-training asking about satisfaction with training (from 1 ("very dissatisfied") to 7 ("very satisfied")), with higher scores indicating greater satisfaction.
Measured: Post-training (i.e. immediately after training)
Use of First Face Learnings
Yes/no measure assessing whether participants used their training at all (in either personal or professional life) in the 3 months following training.
Measured: 3-months post-training
Intended Use of First Face Learnings in Personal Life
Participants will report how likely they are to use the First Face training in the personal life on a 4-point scale from Not at all to To a great extent.
Measured: Post-training (i.e. immediately after training)
Intended Use of First Face Learnings in Professional Life
Participants will report how likely they are to use the First Face training in the professional life on a 4-point scale from Not at all to To a great extent.
Measured: Post-training (i.e. immediately after training)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Apr 202430 Apr 2025

First posted4 Mar 2024
Study start4 Apr 2024
Primary completion30 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for AddictionStudies 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: Not applicable
Intervention model: Single group
Model description: Pre/post/3-month follow-up model
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06290180
Sponsor's protocol ID: 13632
Other IDs: 1S06GM146095
Status last verified: Dec 2025
First submitted: 13 Feb 2024
Last updated: 2 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: This study will be governed by a Data Sharing Agreement between the Healing Lodge of the Seven Nations and Cambridge Health Alliance. That Agreement is still pending.

Publications

Watson AC, Miller FE, Lyons JS. Adolescent attitudes toward serious mental illness. J Nerv Ment Dis. 2005 Nov;193(11):769-72. doi: 10.1097/01.nmd.0000185885.04349.99.
PubMed 16260937
Talbot JA, Ziller EC, Szlosek DA. Mental Health First Aid in Rural Communities: Appropriateness and Outcomes. J Rural Health. 2017 Jan;33(1):82-91. doi: 10.1111/jrh.12173. Epub 2016 Jan 28.
PubMed 26817852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Healing Lodge First Face Training Evaluation Study
ClinicalTrials.gov ID: NCT06290180
Acronym / sponsor ID: 13632
Conditions: Addiction, Depression/Anxiety, Trauma, Psychological, Self-harm
Keywords: mental health, prevention, addiction, substance use disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Cambridge Health AllianceUniversity, hospital or other
Collaborators: National Institute of General Medical Sciences (NIGMS)
Study start: 4 Apr 2024 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 4 Mar 2024 (actual)
Results: Posted 2 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Pre/post/3-month follow-up model

Arm	Type	Receives
Healing Lodge First Face Training Evaluation Study	Experimental	Behavioral: First Face for Mental HeatlhAll participants in this evaluation will be assigned to the First Face for Mental Health training condition. The investigators will use a pre-post design to measure change in relevant outcomes from pre-training, to post-training, to 3-months post-training.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Employment at the Healing Lodge of the Seven Nations
Selection to participate in First Face for Mental Health training

Key exclusion criteria (1 listed)

° Previous completion of First Face for Mental Health training

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 for Mental HeatlhFirst 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	Healing Lodge First Face Training Evaluation Study

Primary outcome

Attitudes Towards Serious Mental Illness - Adolescent Version
Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training
The Attitudes Towards Serious Mental Illness - Adolescent Version (ATSMI-AV) is a validated 21-item self-report scale designed to measure attitudes towards mental illness. Participants respond on a 5-point Likert scale. The scale measures five aspects of mental health attitudes: threat, social construction/concern, wishful thinking, categorical thinking and out of control. The investigators will calculate an overall score as well as factor-specific scores, if they observe adequate internal reliability. 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 Higher scores indicate higher levels of stigma towards mental illness.
First Face Knowledge Assessment
Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training
This is a 12-question quiz testing participants' knowledge of concepts taught in the First Face training. Some questions offer the opportunity to earn more than one point. The investigators will score each response as correct or incorrect and sum scores (possible range = 0-17) on each occasion. Higher scores indicate better knowledge of First Face concepts.
Perceived Competence to Respond
Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training
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). Each response option has a possible range of 1 (Not at all confident) to 5 (Very confident), and a mean score will be calculated 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.

4 secondary outcomes

Satisfaction With Training
Time frame: Post-training (i.e. immediately after training)
Use of First Face Learnings
Time frame: 3-months post-training
Intended Use of First Face Learnings in Personal Life
Time frame: Post-training (i.e. immediately after training)
Intended Use of First Face Learnings in Professional Life
Time frame: Post-training (i.e. immediately after training)

Results and safety

Results posted to the registry on 2 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention group	92	47

Primary outcome: Attitudes Towards Serious Mental Illness - Adolescent Version

Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training. Mean (Standard Error). Unit: Score on a scale

Measure	Healing Lodge First Face Training Evaluation Study n = 38
Pre-training	2.05 (0.11)
Post-training	1.94 (0.10)
3-month follow-up	1.96 (0.11)

Population analysed: Some missing data, some participants lost to attrition.

Primary outcome: First Face Knowledge Assessment

Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training. Mean (Standard Error). Unit: Score on a scale

Measure	Healing Lodge First Face Training Evaluation Study n = 39
Pre-training	9.18 (0.42)
Post-training	13.04 (0.53)
3-month follow-up	12.26 (0.58)

Primary outcome: Perceived Competence to Respond

Time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training. Mean (Standard Error). Unit: Score on a scale

Measure	Healing Lodge First Face Training Evaluation Study n = 37
Pre-training	4.17 (0.14)
Post-training	4.44 (0.09)
3-month follow-up	4.28 (0.13)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until the end of follow-up, up to 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healing Lodge First Face Training Evaluation Study	0 of 90 (0%)	0 of 90 (0%)	0 of 90

Limitations and caveats (from the sponsor): Major limitations of this study include the lack of a comparison group and the lack of a longer-term follow-up. Future studies with more rigorous designs are needed before we can draw firm conclusions about the impact of First Face training, including whether positive effects on knowledge and perceived situational competence are sustained beyond the period immediately following training. Future research could compare First Face training against a waitlist control.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16260937Watson AC, Miller FE, Lyons JS. Adolescent attitudes toward serious mental illness. J Nerv Ment Dis. 2005 Nov;193(11):769-72. doi: 10.1097/01.nmd.0000185885.04349.99.
Background: PubMed 26817852Talbot JA, Ziller EC, Szlosek DA. Mental Health First Aid in Rural Communities: Appropriateness and Outcomes. J Rural Health. 2017 Jan;33(1):82-91. doi: 10.1111/jrh.12173. Epub 2016 Jan 28.
Individual participant dataSharing planned: Undecided. This study will be governed by a Data Sharing Agreement between the Healing Lodge of the Seven Nations and Cambridge Health Alliance. That Agreement is still pending.

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing First Face for Mental Heatlh in people with Addiction and Depression/Anxiety, run by Cambridge Health Alliance 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 2 Dec 2025. 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?

Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Attitudes Towards Serious Mental Illness - Adolescent Version (time frame: Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training). The study lists 3 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 NCT06290180, which also lists 2 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 2 Dec 2025.