- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05998005
First Face Training Evaluation in Tribal Communities
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).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sarah E. Nelson, Ph.D.
- Phone Number: 617-575-5616
- Email: sarah_nelson@hms.harvard.edu
Study Contact Backup
- Name: Hannah Tomeo
- Phone Number: 509-795-8344
- Email: info@firstface.org
Study Locations
-
-
Idaho
-
Bonners Ferry, Idaho, United States, 83805
- Recruiting
- Kootenai Tribe of Idaho
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
Lapwai, Idaho, United States, 83540
- Recruiting
- Nez Perce Tribe
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
Plummer, Idaho, United States, 83851
- Recruiting
- Coeur d'Alene Tribe
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
-
Massachusetts
-
Malden, Massachusetts, United States, 02148
- Not yet recruiting
- Division on Addiction, Cambridge Health Alliance
-
Contact:
- Sarah E Nelson, PhD
- Phone Number: 617-575-5616
- Email: sarah_nelson@hms.harvard.edu
-
Principal Investigator:
- Sarah E Nelson, PhD
-
Sub-Investigator:
- Eric R Louderback, PhD
-
-
Oregon
-
Pendleton, Oregon, United States, 97801
- Recruiting
- Confederated Tribes of the Umatilla Indian Reservation
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
-
Washington
-
Cusick, Washington, United States, 99119
- Recruiting
- Kalispel Tribe of Indians
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
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Nespelem, Washington, United States, 99155
- Recruiting
- Confederated Tribes of the Colville Reservation
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
Spokane Valley, Washington, United States, 99212
- Not yet recruiting
- Healing Lodge of the Seven Nations
-
Contact:
- Hannah Tomeo
- Phone Number: 509-795-8344
- Email: info@firstface.org
-
Principal Investigator:
- Martina Whelshula, PhD
-
Wellpinit, Washington, United States, 99040
- Recruiting
- Spokane Tribe of Indians
-
Contact:
- Hannah Tomeo
- Email: info@firstface.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Initial training group
Participants who are initially trained in the First Face training program
|
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.
|
|
Other: Waitlist-control group
Participants who are trained in the First Face training program 6 months after the initial training group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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
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.
|
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
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.
|
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
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah E. Nelson, Ph.D., Cambridge Health Alliance
- Principal Investigator: Martina Whelshula, Ph.D., Healing Lodge of the Seven Nations
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1S06GM146095-01-8249
- 1S06GM146095 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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