NCT05998005

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Aug 2023Jun 2026

First Submitted

Initial submission to the registry

July 25, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

August 30, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

2.8 years

First QC Date

July 25, 2023

Last Update Submit

August 13, 2024

Conditions

Keywords

addictionmental healthAI/ANnative americanamerican indianmental health training programtraining evaluationNARCHnative american research centers for healthaddictive behaviorstribal participatory researchTPR

Outcome Measures

Primary Outcomes (4)

  • 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).

    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

    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

    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

    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 Outcomes (3)

  • Mental Health Stigma Measure 1

    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

    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

    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

Study Arms (2)

Initial training group

EXPERIMENTAL

Participants who are initially trained in the First Face training program

Behavioral: First Face Training Program

Waitlist-control group

OTHER

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

Behavioral: First Face Training Program

Interventions

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.

Initial training groupWaitlist-control group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Kootenai Tribe of Idaho

Bonners Ferry, Idaho, 83805, United States

RECRUITING

Nez Perce Tribe

Lapwai, Idaho, 83540, United States

RECRUITING

Coeur d'Alene Tribe

Plummer, Idaho, 83851, United States

RECRUITING

Division on Addiction, Cambridge Health Alliance

Malden, Massachusetts, 02148, United States

NOT YET RECRUITING

Confederated Tribes of the Umatilla Indian Reservation

Pendleton, Oregon, 97801, United States

RECRUITING

Kalispel Tribe of Indians

Cusick, Washington, 99119, United States

RECRUITING

Confederated Tribes of the Colville Reservation

Nespelem, Washington, 99155, United States

RECRUITING

Healing Lodge of the Seven Nations

Spokane Valley, Washington, 99212, United States

NOT YET RECRUITING

Spokane Tribe of Indians

Wellpinit, Washington, 99040, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive Behavior

Study Officials

  • Sarah E. Nelson, Ph.D.

    Cambridge Health Alliance

    PRINCIPAL INVESTIGATOR
  • Martina Whelshula, Ph.D.

    Healing Lodge of the Seven Nations

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E. Nelson, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Waitlist-control design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

August 18, 2023

Study Start

August 30, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 15, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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.

Locations