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A Native Path to Courage (NPC) (NPC)

Primary Purpose

Anxiety Disorder, Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Culturally Adapted Compass for Courage
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anxiety Disorder

Eligibility Criteria

8 Years - 90 Years (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Montana State UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Culturally Adapted Compass for Courage

Arm Description

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

Outcomes

Primary Outcome Measures

Revised Child Anxiety and Depression Scale - Short Version
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

Anxiety Control Questionnaire for Children
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).
Child Response Style Questionnaire - Rumination Scale
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).
The Child and Youth Resilience Measure
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).

Full Information

First Posted
April 12, 2022
Last Updated
June 13, 2023
Sponsor
Montana State University
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT05371665
Brief Title
A Native Path to Courage (NPC)
Acronym
NPC
Official Title
A Native Path to Courage
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

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

5. 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 NA 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 living on a Northern Plains tribal reservation (chosen by the Cultural Advisory Board; CAB), 2) evaluate the feasibility and acceptability of the culturally-adapted COMPASS with NA youth living on the reservation, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted COMPASS with the 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 NA youth and parents. In year 2, the investigators will train three NA providers from the tribal community and pilot test the adapted PEI among 30 NA 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 NA 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.
Detailed Description
This study will build upon a community-based participatory research partnership with a Northern Plains tribal community to culturally adapt a brief and evidence-based prevention and early intervention program (COMPASS for Courage) addressing anxiety and depression in Native American (NA) 8-12-year-olds. The investigators will evaluate how feasible it will be for NA providers from the tribal community to deliver the adapted intervention to NA youth attending two schools serving the tribe. The investigators also will test the hypotheses that NA 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 NA youth and parents, to determine cultural adaptations and adapt COMPASS. The investigators will first collaborate with the CAB 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 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 their tribal and cultural perspective. This may involve adding, removing, or modifying/replacing certain constructs from the initial model to better align with the their worldview of mental health and healing. Moreover, the CAB will identify cultural or tribal behavioral determinants (e.g., cultural 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 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 NA 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 Project Manager. The CAB will work with the research team to culturally adapt the intervention and 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 the tribal community delivering the adapted COMPASS to 30 NA 8-12-year-olds in two schools that serve the tribal community (Aim 2). The adapted intervention will be delivered once a week for six weeks and each session will last 30 minutes. 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 include: 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culturally Adapted Compass for Courage
Arm Type
Experimental
Arm Description
All youth will receive the culturally adapted Compass for Courage from Native American providers in the school setting.
Intervention Type
Behavioral
Intervention Name(s)
Culturally Adapted Compass for Courage
Intervention Description
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 youth in the tribal community. 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.
Primary Outcome Measure Information:
Title
Revised Child Anxiety and Depression Scale - Short Version
Description
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.
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
Anxiety Control Questionnaire for Children
Description
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).
Time Frame
5 minutes
Title
Child Response Style Questionnaire - Rumination Scale
Description
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).
Time Frame
5 minutes
Title
The Child and Youth Resilience Measure
Description
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).
Time Frame
5-10 minutes
Other Pre-specified Outcome Measures:
Title
Post-Intervention Usability Survey
Description
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.
Time Frame
5-10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon G Scott, PhD
Phone
406-994-5218
Email
brandon.scott2@montana.edu
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Scott, Ph.D.
Phone
406-994-5218
Email
brandon.scott2@montana.edu

12. IPD Sharing Statement

Learn more about this trial

A Native Path to Courage (NPC)

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