Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1000 participants
INTERVENTIONAL
2023-08-30
2026-06-01
Brief Summary
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* 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).
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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Initial training group
Participants who are initially trained in the First Face training program
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.
Waitlist-control group
Participants who are trained in the First Face training program 6 months after the initial training group
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
ALL
Yes
Sponsors
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National Institute of General Medical Sciences (NIGMS)
NIH
Healing Lodge of the Seven Nations
UNKNOWN
Cambridge Health Alliance
OTHER
Responsible Party
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Principal Investigators
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Sarah E. Nelson, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Cambridge Health Alliance
Martina Whelshula, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Healing Lodge of the Seven Nations
Locations
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Kootenai Tribe of Idaho
Bonners Ferry, Idaho, United States
Nez Perce Tribe
Lapwai, Idaho, United States
Coeur d'Alene Tribe
Plummer, Idaho, United States
Division on Addiction, Cambridge Health Alliance
Malden, Massachusetts, United States
Confederated Tribes of the Umatilla Indian Reservation
Pendleton, Oregon, United States
Kalispel Tribe of Indians
Cusick, Washington, United States
Confederated Tribes of the Colville Reservation
Nespelem, Washington, United States
Healing Lodge of the Seven Nations
Spokane Valley, Washington, United States
Spokane Tribe of Indians
Wellpinit, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form: Informed Consent Form
Document Type: Informed Consent Form: Parental Permission Form
Document Type: Informed Consent Form: Assent Form Age 14-17
Related Links
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Project Details on NIH RePORT for this funded grant (Assessing Cultures of Recovery in Tribal Communities - Research Core)
Other Identifiers
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1S06GM146095-01-8249
Identifier Type: -
Identifier Source: org_study_id
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