xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998005</url>
    </required_header>
    <id_info>
      <org_study_id>1S06GM146095-01-8249</org_study_id>
      <secondary_id>1S06GM146095</secondary_id>
      <nct_id>NCT05998005</nct_id>
    </id_info>
    <brief_title>First Face Training Evaluation in Tribal Communities</brief_title>
    <official_title>Assessing Cultures of Recovery in Tribal Communities - Research Core - Training Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cambridge Health Alliance</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of General Medical Sciences (NIGMS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
      <collaborator>
        <agency>Healing Lodge of the Seven Nations</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cambridge Health Alliance</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to evaluate a culturally grounded training curriculum, First Face&#xD;
        for Mental Health, in Tribal communities, using a waitlist controlled randomized trial&#xD;
        design. This curriculum will train Tribal community members in how to respond to youth and&#xD;
        adults experiencing mental health crises and serve as a bridge between these individuals and&#xD;
        the help they need. The main questions the study aims to answer are:&#xD;
  &#xD;
          -  Does the training increase mental health knowledge, capacity and ability to respond to&#xD;
             mental health situations, perceived competence to respond, and actual responsive actions&#xD;
             among trainees?&#xD;
  &#xD;
          -  Does the training decrease mental health stigmatizing attitudes and increase cultural&#xD;
             identity among trainees?&#xD;
  &#xD;
        Participants will complete surveys before and after completing the First Face training,&#xD;
        across five time points over the course of two years. Half of the participants will be&#xD;
        randomized to receive the training initially, and half will receive it six months later.&#xD;
        Researchers will compare the two groups to examine whether the trainees demonstrate changes&#xD;
        in the outcomes of interest compared to the waitlist control group during the first six&#xD;
        months, and whether both groups demonstrate sustained changes after the first six months&#xD;
        (i.e., once both groups have received training).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For the First Face Training Evaluation study, the researchers will build upon our previous&#xD;
        work by evaluating a culturally grounded community mental health training curriculum, First&#xD;
        Face for Mental Health. The researchers developed First Face in collaboration with&#xD;
        stakeholders from seven Tribal nations to reflect these communities' cultural traditions and&#xD;
        values. First Face is a culturally-appropriate community-based mental health training for lay&#xD;
        persons and others living and working in Tribal communities that prepares learners to provide&#xD;
        assistance to someone having a mental health crisis. By training more individuals in a&#xD;
        community to identify, intervene, and connect struggling individuals with the support they&#xD;
        need, community culture can be transformed to recognize and address mental health crises.&#xD;
  &#xD;
        The overall goal for this First Face Training Evaluation Study (the Research Core component&#xD;
        of the Assessing Cultures of Recovery in Tribal Communities Native American Research Centers&#xD;
        for Health [NARCH] Center grant issued by NIH) is to evaluate the impact of First Face&#xD;
        training both on the trainees and within the Tribal communities as a whole. This Registration&#xD;
        covers the evaluation of trainee effects.&#xD;
  &#xD;
        The Training Evaluation study will evaluate First Face training using a randomized waitlist&#xD;
        control design, implemented in seven tribes, which includes five assessment time points for&#xD;
        both initial trainees (n=350) and waitlist controls (n=350). These assessments will measure&#xD;
        knowledge about mental health and addiction, as well as the ability and confidence of&#xD;
        individuals to respond appropriately to mental health crises.&#xD;
  &#xD;
        The researchers will recruit participants from the seven tribes via community-wide&#xD;
        announcements and information provided through multiple departments and organizations within&#xD;
        each tribe. The Healing Lodge research team and Working Group members will work directly and&#xD;
        in person with the tribes to facilitate this recruitment. The researchers will recruit the&#xD;
        sample proportional to the size of each tribe (e.g., 30 from the smallest tribe; 280 from the&#xD;
        largest). They will block randomize participants within each tribe as they sign up for the&#xD;
        study to either the initial training group or the waitlist control group, using a block size&#xD;
        of 4. To ensure a final recruitment of 700 who are able to attend the trainings, the&#xD;
        researchers will attempt to recruit 1,000 initially, allowing a 30% attrition rate for&#xD;
        individuals who cannot attend any of the offered training dates.&#xD;
  &#xD;
        Multiple trainings of 15-30 individuals will occur separately within each tribe. As shown int&#xD;
        he timeline, 350 individuals in the initial training group will receive training and complete&#xD;
        a baseline and post-training survey at the time of training. At that same time, the 350&#xD;
        individuals in the waitlist control group will complete an online pre-baseline survey. Six&#xD;
        months later, the waitlist control group will undergo training (again, multiple trainings of&#xD;
        15-30 individuals will occur separately within each tribe) and complete baseline and&#xD;
        post-training surveys. At the same time, the 350 individuals in the initial training group&#xD;
        will complete an online 6 month follow-up survey. Six months later, both groups will complete&#xD;
        online surveys - the initial training group will complete their 12-month follow-up and the&#xD;
        waitlist control group will complete their 6-month follow-up. Twelve months later, both&#xD;
        groups will again complete online surveys -- the initial training group will complete a&#xD;
        24-month follow-up and the waitlist control group will complete an 18-month follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">June 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <intervention_model_description>Waitlist-control design</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mental Health Knowledge</measure>
      <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</time_frame>
      <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).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Ability to Respond Measured via Situational Judgement Tasks</measure>
      <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</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Perceived Competence to Respond</measure>
      <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</time_frame>
      <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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Responsive Actions</measure>
      <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</time_frame>
      <description>Novel measures including 2 items to assess interventions in potential mental health crisis situations in the past 30 days. The first asks &quot;In what ways did you intervene (select all that apply)?&quot;, with 4 possible options and an &quot;Other (please specify):&quot; option, and the second asks &quot;What happened after you intervened (select all that apply)?&quot; with 5 possible options and an &quot;Other (please specify):&quot; 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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mental Health Stigma Measure 1</measure>
      <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</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mental Health Stigma Measure 2</measure>
      <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</time_frame>
      <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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cultural Identity</measure>
      <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</time_frame>
      <description>A 6-item scale to measure strength of respondents' cultural identity (i.e., adapted from the Multigroup Ethnic Identity Measure - Revised; Phinney &amp; 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.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Mental Health</condition>
    <condition>Substance-Related Disorders</condition>
    <arm_group>
      <arm_group_label>Initial training group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants who are initially trained in the First Face training program</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist-control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants who are trained in the First Face training program 6 months after the initial training group</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>First Face Training Program</intervention_name>
      <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.</description>
      <arm_group_label>Initial training group</arm_group_label>
      <arm_group_label>Waitlist-control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 14 or older&#xD;
  &#xD;
            -  Living or working in one of the seven Tribal Nations affiliated with the Healing Lodge&#xD;
               of the Seven Nations, including Northwestern United States, including the Coeur&#xD;
               d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated&#xD;
               Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai&#xD;
               Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age 13 or younger&#xD;
  &#xD;
            -  Not living or working in one of the seven Tribal Nations affiliated with the Healing&#xD;
               Lodge of the Seven Nations, including Northwestern United States, including the Coeur&#xD;
               d'Alene Tribe, the Confederated Tribes of the Colville Reservation, the Confederated&#xD;
               Tribes of the Umatilla Indian Reservation, the Kalispel Tribe of Indians, the Kootenai&#xD;
               Tribe of Idaho, the Nez Perce Tribe, and the Spokane Tribe of Indians&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah E. Nelson, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cambridge Health Alliance</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Martina Whelshula, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Healing Lodge of the Seven Nations</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah E. Nelson, Ph.D.</last_name>
      <phone>617-575-5616</phone>
      <email>sarah_nelson@hms.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hannah Tomeo</last_name>
      <phone>509-795-8344</phone>
      <email>info@firstface.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kootenai Tribe of Idaho</name>
        <address>
          <city>Bonners Ferry</city>
          <state>Idaho</state>
          <zip>83805</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nez Perce Tribe</name>
        <address>
          <city>Lapwai</city>
          <state>Idaho</state>
          <zip>83540</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Coeur d'Alene Tribe</name>
        <address>
          <city>Plummer</city>
          <state>Idaho</state>
          <zip>83851</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Division on Addiction, Cambridge Health Alliance</name>
        <address>
          <city>Malden</city>
          <state>Massachusetts</state>
          <zip>02148</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sarah E Nelson, PhD</last_name>
        <phone>617-575-5616</phone>
        <email>sarah_nelson@hms.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Sarah E Nelson, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Eric R Louderback, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Confederated Tribes of the Umatilla Indian Reservation</name>
        <address>
          <city>Pendleton</city>
          <state>Oregon</state>
          <zip>97801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Kalispel Tribe of Indians</name>
        <address>
          <city>Cusick</city>
          <state>Washington</state>
          <zip>99119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Confederated Tribes of the Colville Reservation</name>
        <address>
          <city>Nespelem</city>
          <state>Washington</state>
          <zip>99155</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Healing Lodge of the Seven Nations</name>
        <address>
          <city>Spokane Valley</city>
          <state>Washington</state>
          <zip>99212</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <phone>509-795-8344</phone>
        <email>info@firstface.org</email>
      </contact>
      <investigator>
        <last_name>Martina Whelshula, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Spokane Tribe of Indians</name>
        <address>
          <city>Wellpinit</city>
          <state>Washington</state>
          <zip>99040</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hannah Tomeo</last_name>
        <email>info@firstface.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://reporter.nih.gov/search/Fm725t7UakSYoX28Fmgljg/project-details/10437495</url>
      <description>Project Details on NIH RePORT for this funded grant (Assessing Cultures of Recovery in Tribal Communities - Research Core)</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>addiction</keyword>
    <keyword>mental health</keyword>
    <keyword>AI/AN</keyword>
    <keyword>native american</keyword>
    <keyword>american indian</keyword>
    <keyword>mental health training program</keyword>
    <keyword>training evaluation</keyword>
    <keyword>NARCH</keyword>
    <keyword>native american research centers for health</keyword>
    <keyword>addictive behaviors</keyword>
    <keyword>tribal participatory research</keyword>
    <keyword>TPR</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Substance-Related Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_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.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form: Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 21, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05998005/ICF_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form: Parental Permission Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 21, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05998005/ICF_001.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form: Assent Form Age 14-17</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>July 21, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT05998005/ICF_002.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998005
  org study id: 1S06GM146095-01-8249
  secondary id: 1S06GM146095
  nct id: NCT05998005
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Waitlist-control design
  primary purpose: Prevention
  masking: None (Open Label)
  measure: 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
  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).
  measure: 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
  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.
  measure: 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
  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.
  measure: 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
  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.
  measure: 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
  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.
  measure: 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
  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.
  measure: 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
  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.
  arm group label: Initial training group
  arm group type: Experimental
  description: Participants who are initially trained in the First Face training program
  arm group label: Waitlist-control group
  arm group type: Other
  description: Participants who are trained in the First Face training program 6 months after the initial training group
  intervention type: Behavioral
  intervention name: First Face Training Program
  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.
  arm group label: Initial training group
  arm group label: Waitlist-control group
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah E. Nelson, Ph.D.
  role: Principal Investigator
  affiliation: Cambridge Health Alliance
  last name: Martina Whelshula, Ph.D.
  role: Principal Investigator
  affiliation: Healing Lodge of the Seven Nations
  last name: Sarah E. Nelson, Ph.D.
  phone: 617-575-5616
  email: sarah_nelson@hms.harvard.edu
  last name: Hannah Tomeo
  phone: 509-795-8344
  email: info@firstface.org
  facility: 
  status: Recruiting
  contact: 
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  status: Recruiting
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  status: Not yet recruiting
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  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
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  investigator: 
  facility: 
  status: Recruiting
  contact: 
  country: United States
  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)
  responsible party type: Sponsor
  mesh term: Substance-Related Disorders
  sharing ipd: No
  ipd 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.
  provided document: 
  provided document: 
  provided document: 