A Native Path to Courage (NPC)

Montana State University (Other)
Overall Status
CT.gov ID

Study Details

Study Description

Brief Summary

Native Americans (NA) are at greater risk for anxiety and depression early in life with 10-39% of NA youth reporting clinical levels of anxiety or depression. This is concerning given potential negative effects of these conditions across the lifespan (substance use, suicide). Available culturally adapted prevention and early interventions (PEIs) for anxiety and depression in NA youth are limited. Two are indicated for at-risk youth (e.g., trauma), one universal PEI was not efficacious, community stakeholders served as consultants with no youth or parents involved, and evaluation used minimal mixed methods. Thus, there is a critical need for the development and evaluation of a culturally consonant, brief prevention and early intervention (PEI) for anxiety and depression in NA youth using a CBPR approach that include youth and parents and mixed method evaluation. The investigators' short-term goal is to provide the community with a potentially successful PEI to mitigate Rocky Boy youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research are to 1) culturally adapt COMPASS for Courage for NA youth (chosen by the CAB), 2) evaluate the feasibility and acceptability of the culturally-adapted COMPASS with NA Rocky Boy youth, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted COMPASS with NA youth. The investigators propose to build upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators will partner with the CAB to culturally adapt COMPASS for NA youth in year 1 within a CBPR framework, including Rocky Boy youth and parents. In year 2, The investigators will train three NA Rocky Boy providers and pilot test the adapted PEI among 30 Rocky Boy 8-12-year-olds in two schools serving youth from the reservation in Years 2 and 3. The investigators will evaluate feasibility and acceptability using mixed methods including focus groups of key stakeholders (youth, parents, and teachers) and estimate effect sizes of changes in anxiety and depressive symptoms using a pre-post, single group design. The investigators hypothesize Rocky Boy youth will find the adapted COMPASS intervention to be acceptable, enjoyable, and culturally appropriate and there will be pre- to post-intervention reductions in anxiety and depressive symptoms. The long-term goal is to continue refining and tailoring the adapted COMPASS intervention and evaluate its efficacy and sustainability. The investigators plan to submit an R01 (Clinical Trial) in response to the FOA, Intervention Research to Improve Native American Health (PAR-20-238), in Year 3 for a full-scale clinical trial that will be informed by the study's findings.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Culturally Adapted Compass for Courage

Detailed Description

This study will build upon a community-based participatory research partnership with the Chippewa Cree Tribe of the Rocky Boy Reservation to culturally adapt a brief and evidence-based prevention and early intervention program (COMPASS for Courage) addressing anxiety and depression in Native American (NA) Rocky Boy 8-12-year-olds. The investigators will evaluate how feasible it will be for NA providers from Rocky Boy to deliver the adapted intervention to Rocky Boy youth attending two schools serving the tribe. The investigators also will test the hypotheses that Rocky Boy youth will find it acceptable, enjoyable, and culturally appropriate, and it will reduce anxiety and depressive symptoms from pre- to post-intervention.

The investigators will use an iterative adaptation process within a CBPR framework to culturally adapt COMPASS (Aim 1). It will involve collaborating with the Cultural Advisory Board (CAB) and conducting adult work groups and youth focus groups with keys community stakeholders, including Rocky Boy youth and parents, to determine cultural adaptations and adapt COMPASS from September 2021 to October 2021. The investigators will first collaborate with the Cultural Advisory Board in reviewing prior literature on anxiety and depression, as well as the non-adapted intervention. The CAB will develop an initial conceptual model of what factors may cause or put NA Rocky Boy youth at risk for anxiety and depression and what outcomes would the investigators expect from a prevention and early intervention program targeting these causal or risk factors. Next, they will use NA cultural and tribal specific knowledge to modify the model integrate the understanding and meaning of anxiety and depression and behavioral determinants and outcomes from a Chippewa Cree perspective. This may involve adding, removing, or modifying/replacing certain constructs from the initial model to better align with the Chippewa Cree's worldview of mental health and healing. Moreover, the CAB will identify cultural or tribal behavioral determinants (e.g., Chippewa Cree identity) of anxiety and depression not described in the literature and add them to the model.

Next, the investigators will recruit 48 community stakeholders (Elders, parents/legal guardians, and mental health specialists who serve the community) and 20 NA Rocky Boy 8-12 year-olds to review the non-adapted intervention and suggest cultural adaptions and improvements to the content, strategies, and materials. In addition, Elders will be asked specific questions about explaining anxiety and depression in a cultural way, what does anxiety and depression mean coming from a cultural context, and what words the participants would use for anxiety and depression (this will add about 60 minutes to their group discussion). There will be eight adult focus groups (4-6 adults per group; ~45 adults) and four youth groups with two from each school (3-5 youth per group; ~ 16 youth). Focus groups will be audio recorded. Youth will also complete a pre-adaptation usability survey for each module (they will review only 3 of the 6 modules) of the non-adapted intervention that assesses acceptability, enjoyableness, and cultural appropriateness.

The investigators will analyze the focus group discussions to identify common themes and group suggestions together. The CAB will use this information and integrate with their own suggestions to modify a conceptual framework of anxiety and depression prevention and early intervention in Rocky Boy youth and determine the cultural adaptions that are most warranted given possible logistical barriers (e.g., time/funding). Identified themes will be reviewed and validated with the CAB and Laurie Sunchild (Project Manager). The CAB will work with the research team to culturally adapt the intervention and Laurie Sunchild (Project Manager) will begin training CAB-identified NA tribal members to provide it in the schools.

The investigators will use a mixed method design to evaluate the feasibility and acceptability of NA providers from Rocky Boy delivering the adapted COMPASS to 30 8-12-year-old Rocky youth in two schools that serve the Rocky Boy Reservation (Aim 2). The adapted intervention will be delivered once a week for six weeks and each session will last 30 minutes in January 2022 until October 2022. The investigators will obtain focus group data from six groups of five youth per group (3 groups per school). In addition, youth will complete a post-adaption usability survey at the end of each session to compare to the pre-adaption usability survey completed prior to adaptation. The investigators will implement a pre-post, single group to collect survey data 2 weeks before the intervention (pre) and 1 week following the intervention (post) to estimate effect sizes of pre-to-post intervention changes in anxiety and depressive symptoms. Survey data will be collected electronically using a tablet or computer and will be brief. Surveys previously used in the investigators' pilot work with Rocky Boy youth will assess youth demographics, the primary outcomes of youth anxiety and depressive symptoms (from youth and teachers), and secondary outcomes that include youth resilience, youth's beliefs whether they can control their anxiety symptoms, and youth's use of rumination when sad. The CAB will work with the research using the conceptual model in the adaptation process to decide on the addition, removal, or further revision of the assessments. The investigators will invite 30 youth who participated in the intervention to participate in one of six focus groups (4-5 youth per group; ~27 youth) to further discuss their experiences with adapted intervention and suggest improvements. Focus groups will be audio recorded.

The investigators will then recruit 32 parents/legal guardians and teachers of youth who participated in the adapted intervention to participate in a focus group about their experiences with the intervention and how the youth responded at home and in school. There will be two parent/legal guardian groups (5-8 parents per group; ~14 parents) and two groups of teachers (5-8 teachers per group ~14 teachers). The investigators will ask them to suggest how to improve the program and other strengths and barriers they noticed. The investigators also will ask them about the possibility of video or audio recording sessions in the future studies to test the fidelity and youth responsiveness while participating in the program. Focus groups will be audio recorded.

Data Analysis and Sample Size Considerations The primary goal of this study is to culturally adapt an existing and evidence-based prevention and early intervention that may have the potential to reduce anxiety and depressive symptoms in NA Rocky Boy youth. The paucity of these types of interventions that are available to Native American youth warrants careful consideration and preliminary community engagement into the adaption process to ensure the youth buy-in to the potential usefulness of the program lessons and that it is culturally appropriate. Hence, most of the participants (n = 80) will be recruited for focus groups to provide rich data for cultural adaptation decisions by the CAB and engage youth and parents in adaptation process.

The investigators will transcribe group suggestions in cultural adaptation phase of study and group suggestions that go together, as well as tally suggestions that are mentioned multiple times with specific phrasing and examples being noted. In the evaluation phase of the study with youth who participated in the intervention and their parents and teachers, The investigators will use line-by-line open coding of focus group responses and suggestions within a grounded theory framework to identify emerging themes and then continue coding to identity associations between themes that may represent broader theoretical concepts, such as potential barriers to youth response to the adapted intervention or acceptability. Identified themes will be reviewed and validated with the CAB and Laurie Sunchild (Project Manager). The investigators also will use post-adaptation usability ratings to test the hypothesis that at least 80% of youth will rate acceptability, enjoyability, and cultural appropriateness as a 4 or 5 on a Likert-type scale and examine whether ratings remained the same or improved after adaptation, another indication of success of the cultural adaptation.

The investigators will compute the change in the anxiety and depressive symptoms composite score from pre- to post-intervention (post - pre) and compute unadjusted averages and standard deviations. A one-sample t-test of the changes in any response scale will have 80% power to detect an standardized effect size (Cohen's d) of at least 0.53, and 90% power to detect an effect size of at least 0.61. The investigators will also obtain adjusted estimates using mixed effects linear regression models of post-test score on pre-test score with demographic factors and random effects for school and intervention group nested within school. This will allow us to estimate intra-class correlations for intervention group and school, which will be required for sample size estimation in a full efficacy trial. The investigators will triangulate all qualitative and quantitative data of feasibility and acceptability with the primary outcome (anxiety and depression) and the post-adaptation survey results. The investigators will review the integrative findings with the CAB to better understand the value and effectiveness of the culturally adapted components of COMPASS and utilize them to inform further refining and tailoring of the adapted COMPASS, revise the investigators' current assessments and/or develop new outcome assessments (e.g., video-record sessions for fidelity), and recruitment procedures for a full-scale clinical trial.

Study Design

Study Type:
Anticipated Enrollment :
130 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
A Native Path to Courage
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Aug 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Culturally Adapted Compass for Courage

All youth will receive the culturally adapted Compass for Courage from Native American providers in the school setting.

Behavioral: Culturally Adapted Compass for Courage
COMPASS is an indicated prevention and early intervention program for 8-13-year-old youth with higher anxiety. Our CAB has decided to adapt it as a universal prevention and early intervention for all NA Rocky Boy youth. It is delivered across six weeks with 30 min weekly sessions. Youth engage in games (e.g., WorryHeads Board Game) and role-play reducing anxiety and stress in mildly challenging situations to provide in-vivo exposure. Session 1 involves introductions, relaxation training, and discussing emotions. Session 2 teaches youth about worries and how to handle them. Session 3 focuses on having conversations with others. Session 4 teaches youth how to be assertive (CAB identified this as an area of adaption in initial meetings). Session 5 teaches youth how to face their fears. Session 6 is a review session. Parents and teachers are sent notes of what youth learned in each session and asked to encourage youth to practice their learned skills.

Outcome Measures

Primary Outcome Measures

  1. Revised Child Anxiety and Depression Scale - Short Version [5 minutes]

    The RCADS-25-S is a 25-item instrument used to assess DSM-IV symptoms for child anxiety (15 items) and depressive disorders (10 items). We will ask youth and teachers to rate how often each anxiety and depressive disorder symptom is true of them or youth on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Higher composite scores for each scale indicate greater frequency of anxiety and depressive disorder symptoms. Studies have shown good construct validity for the anxiety and depressive disorder scales, and was acceptable at discriminating between youth with and without an anxiety or depressive disorder. The internal consistency estimates for our pilot work with Native American 8-13 year-olds in a tribal school showed good to excellent reliability for the anxiety (youth - α = .83; teacher - α = .84) and depression (youth - α = .81; teacher - α = .90) scales.

Secondary Outcome Measures

  1. Anxiety Control Questionnaire for Children [5 minutes]

    The ACQ-C short form is a 10-item developmentally modified version of the ACQ and assesses children's control beliefs over anxiety-related "external" threats (e.g., fear-producing objects, events, and situations) and/or "internal" emotional or bodily reactions (e.g., flushed face).29 We will ask youth to rate how much each statement was true of them on a 5-point Likert-type scale consisting of: 0 (None), 1 (A Little), 2 (Some), 3 (A Lot), or 4 (Very Very Much). The ACQ-C has demonstrated excellent internal consistency for anxiety control beliefs (α = .94) and good convergent validity with established, validated child anxiety measures (r = -.47 for total control belief score). Higher composite scale score indicates greater anxiety control beliefs. The internal consistency estimate for our pilot work with Native American 8-13 year-olds in a tribal school showed good reliability for the total anxiety control belief scale (α = .80).

  2. Child Response Style Questionnaire - Rumination Scale [5 minutes]

    The CRSQ is a 26 item self-report instrument used to assess children's regulation of sadness using three types of strategies: rumination, problem-solving, and distraction. We will ask youth to rate how often they engage in each strategy when feeling sad (e.g., "When I am sad, I think about how alone I feel.") on a 4-point scale consisting of "Almost Never," "Sometimes," "Often," and "Almost Always." The CRSQ has demonstrated acceptable to good internal consistency for all three strategy scales (α's ranging from .65-.76) and good convergent validity with established, validated measures of depression (r = .26 for rumination). We will only use the rumination scale in the proposed study. Higher composite scale scores indicates greater rumination. The internal consistency estimate for our pilot work with Native American 8-13 year-olds in a tribal school showed excellent reliability for the rumination scale(α = .90).

  3. The Child and Youth Resilience Measure [5-10 minutes]

    The CYRM is a 36-item measure (10 of the items are community specific items were constructed with the Rocky Boy Cultural Advisory Board) that assesses resiliency across a number of areas including: personal skills, peer support, social skills, physical and psychological caregiving, spiritual, educational, and cultural. We will ask youth to indicate to what extent each statement describes them (e.g., "Getting an education is important to me," "I try to finish activities that I start," and "I feel supported by my friends") on a three-point scale of "No," "Sometimes," and "Yes." Higher composite scale scores reflect greater resiliency for each of the sub-domains (e.g., peer support, spiritual).

Other Outcome Measures

  1. Post-Intervention Usability Survey [5-10 minutes]

    Youth will complete a 15-item usability survey previously adapted for Alaskan Native youth participating in an computer-based intervention. The survey assesses likability, acceptability, enjoyable, ease of learning and using learned skills, credibility, motivational appeal, perceived impact, and cultural appropriateness. The CAB will assist in adapting the items and rating scale to improve fit for use with NA 8-12-year-old youth and intervention. Each question will be a five-point Likert scale.

Eligibility Criteria


Ages Eligible for Study:
8 Years to 90 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Elder residing on the reservation

  • Parent of 8-12 year-old youth residing on the reservation

  • 3rd-6th grade teacher at tribe-serving school

  • Mental health specialist serving the reservation or tribal-serving school

  • 8-12 year-old youth who attends either tribe-serving school and resides on the reservation with their parent/legal guardian.

  • Parent of 8-12 year-old youth who participated in the adapted intervention

  • Teacher of 8-12 year-old youth who participated in the adapted intervention

Exclusion Criteria:

• Does not meet inclusion criteria.

Contacts and Locations


Site City State Country Postal Code
1 Rocky Boy Reservation Box Elder Montana United States 59521

Sponsors and Collaborators

  • Montana State University


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Montana State University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • bscott
First Posted:
May 12, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022