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First Face Training Evaluation in Tribal Communities

Primary Purpose

Mental Health, Substance-Related Disorders

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
First Face Training Program
Sponsored by
Cambridge Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health focused on measuring 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

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kootenai Tribe of Idaho
  • Nez Perce Tribe
  • Coeur d'Alene Tribe
  • Division on Addiction, Cambridge Health Alliance
  • Confederated Tribes of the Umatilla Indian Reservation
  • Kalispel Tribe of Indians
  • Confederated Tribes of the Colville Reservation
  • Healing Lodge of the Seven Nations
  • Spokane Tribe of Indians

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Initial training group

Waitlist-control group

Arm Description

Participants who are initially trained in the First Face training program

Participants who are trained in the First Face training program 6 months after the initial training group

Outcomes

Primary Outcome Measures

Mental Health Knowledge
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).
Ability to Respond Measured via Situational Judgement Tasks
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.
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; 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.
Responsive Actions
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.

Secondary Outcome Measures

Mental Health Stigma Measure 1
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.
Mental Health Stigma Measure 2
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.
Cultural Identity
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.

Full Information

First Posted
July 25, 2023
Last Updated
September 21, 2023
Sponsor
Cambridge Health Alliance
Collaborators
National Institute of General Medical Sciences (NIGMS), Healing Lodge of the Seven Nations
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1. Study Identification

Unique Protocol Identification Number
NCT05998005
Brief Title
First Face Training Evaluation in Tribal Communities
Official Title
Assessing Cultures of Recovery in Tribal Communities - Research Core - Training Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 30, 2023 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cambridge Health Alliance
Collaborators
National Institute of General Medical Sciences (NIGMS), Healing Lodge of the Seven Nations

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 randomized 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 be randomized to 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 randomized 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 block randomize participants within each tribe as they sign up for the study to either the initial training group or the waitlist control group, using a block size of 4. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Waitlist-control design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Initial training group
Arm Type
Experimental
Arm Description
Participants who are initially trained in the First Face training program
Arm Title
Waitlist-control group
Arm Type
Other
Arm Description
Participants who are trained in the First Face training program 6 months after the initial training group
Intervention Type
Behavioral
Intervention Name(s)
First Face Training Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mental Health Knowledge
Description
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).
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
Title
Ability to Respond Measured via Situational Judgement Tasks
Description
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.
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
Title
Perceived Competence to Respond
Description
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.
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
Title
Responsive Actions
Description
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.
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
Secondary Outcome Measure Information:
Title
Mental Health Stigma Measure 1
Description
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.
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
Title
Mental Health Stigma Measure 2
Description
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.
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
Title
Cultural Identity
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah E. Nelson, Ph.D.
Organizational Affiliation
Cambridge Health Alliance
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martina Whelshula, Ph.D.
Organizational Affiliation
Healing Lodge of the Seven Nations
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kootenai Tribe of Idaho
City
Bonners Ferry
State/Province
Idaho
ZIP/Postal Code
83805
Country
United States
Facility Name
Nez Perce Tribe
City
Lapwai
State/Province
Idaho
ZIP/Postal Code
83540
Country
United States
Facility Name
Coeur d'Alene Tribe
City
Plummer
State/Province
Idaho
ZIP/Postal Code
83851
Country
United States
Facility Name
Division on Addiction, Cambridge Health Alliance
City
Malden
State/Province
Massachusetts
ZIP/Postal Code
02148
Country
United States
Facility Name
Confederated Tribes of the Umatilla Indian Reservation
City
Pendleton
State/Province
Oregon
ZIP/Postal Code
97801
Country
United States
Facility Name
Kalispel Tribe of Indians
City
Cusick
State/Province
Washington
ZIP/Postal Code
99119
Country
United States
Facility Name
Confederated Tribes of the Colville Reservation
City
Nespelem
State/Province
Washington
ZIP/Postal Code
99155
Country
United States
Facility Name
Healing Lodge of the Seven Nations
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99212
Country
United States
Facility Name
Spokane Tribe of Indians
City
Wellpinit
State/Province
Washington
ZIP/Postal Code
99040
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Each Tribe would need to agree to have their data shared for an IPD plan to be put in place. This has not yet happened, though we will work toward it.
Links:
URL
https://reporter.nih.gov/search/Fm725t7UakSYoX28Fmgljg/project-details/10437495
Description
Project Details on NIH RePORT for this funded grant (Assessing Cultures of Recovery in Tribal Communities - Research Core)

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First Face Training Evaluation in Tribal Communities

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