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| ID | Type | Description | Link |
|---|---|---|---|
| 1S06GM146095 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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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 help they need. All Healing Lodge staff are being asked to complete First Face training.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First Face for Mental Heatlh | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-training (i.e. immediately after training) |
| Use of First Face Learnings |
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Inclusion Criteria:
Exclusion Criteria:
° Previous completion of First Face for Mental Health training
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healing Lodge of the Seven Nations | Spokane Valley | Washington | 99212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16260937 | Background | 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. | |
| 26817852 | Background | 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. |
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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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All participants were assigned to complete the First Face training; there was no comparison group.
Pre- and post-training data were collected in April and December, 2024. During 2024, the Healing Lodge employed 107 unique staff members. All were instructed that they were required to complete a First Face training. In total, 102 employees (95.3% of the year-round total) completed the First Face training. Not all trainees enrolled in the study. A total of 92 trainees in the study. Follow-up data were collected until April, 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention group | All participants were assigned to receive the First Face for Mental Health training. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Healing Lodge First Face Training Evaluation Study | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | We did not collect age data in this study. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some missing data, some participants lost to attrition. | Posted | Mean | Standard Error | Score on a scale | Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training |
|
From enrollment until the end of follow-up, up to 3 months.
No events to report.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healing Lodge First Face Training Evaluation Study | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Gray | Cambridge Health Alliance | (617) 575-5612 | hgray@cha.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 17, 2025 | Sep 9, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2024 | Feb 21, 2024 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2024 | Feb 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D000067073 | Psychological Trauma |
| D016728 | Self-Injurious Behavior |
| D000092862 | Psychological Well-Being |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
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Pre/post/3-month follow-up model
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|
Yes/no measure assessing whether participants used their training at all (in either personal or professional life) in the 3 months following training. |
| 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. | 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. | Post-training (i.e. immediately after training) |
As mentioned above, we did not collect age data in this study.
| Count of Participants |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Reside on a reservation | Count of Participants | Participants |
|
| Years working with at-risk youth | Mean | Standard Deviation | Years |
|
| Department | Count of Participants | Participants |
|
| OG000 |
| Healing Lodge First Face Training Evaluation Study |
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. |
|
|
| Primary | 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. | Posted | Mean | Standard Error | Score on a scale | Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | Score on a scale | Included at pre-training, post-training (i.e. immediately after training), and 3-months post-training |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Post-training (i.e. immediately after training) |
|
|
|
| Secondary | 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. | Some missing data | Posted | Count of Participants | Participants | 3-months post-training |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Post-training (i.e. immediately after training) |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Post-training (i.e. immediately after training) |
|
|
|
| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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| D001523 |
| Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D010549 | Personal Satisfaction |
| D064419 | Chemically-Induced Disorders |
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