Clinical trial NCT05998005: First Face Training Evaluation in Tribal Communities
Official title: Assessing Cultures of Recovery in Tribal Communities - Research Core - Training Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health
Substance-Related Disorders
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
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: Healing Lodge of the Seven Nations
First posted: 2023-08-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist-control design
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental Health Knowledge
timeFrame: 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
measure: Ability to Respond Measured via Situational Judgement Tasks
timeFrame: 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
measure: Perceived Competence to Respond
timeFrame: 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
measure: Responsive Actions
timeFrame: 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:
measure: Mental Health Stigma Measure 1
timeFrame: 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
measure: Mental Health Stigma Measure 2
timeFrame: 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
measure: Cultural Identity
timeFrame: 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
Other outcomes:
Locations:
city: Bonners Ferry
country: United States
facility: Kootenai Tribe of Idaho
state: Idaho
city: Lapwai
country: United States
facility: Nez Perce Tribe
state: Idaho
city: Plummer
country: United States
facility: Coeur d'Alene Tribe
state: Idaho
city: Malden
country: United States
facility: Division on Addiction, Cambridge Health Alliance
state: Massachusetts
city: Pendleton
country: United States
facility: Confederated Tribes of the Umatilla Indian Reservation
state: Oregon
city: Cusick
country: United States
facility: Kalispel Tribe of Indians
state: Washington
city: Nespelem
country: United States
facility: Confederated Tribes of the Colville Reservation
state: Washington
city: Spokane Valley
country: United States
facility: Healing Lodge of the Seven Nations
state: Washington
city: Wellpinit
country: United States
facility: Spokane Tribe of Indians
state: Washington
Study officials:
affiliation: Cambridge Health Alliance
name: Sarah E. Nelson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Healing Lodge of the Seven Nations
name: Martina Whelshula, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: