Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children

Depressive Disorder Clinical Trial

Official title:

A Native Path to Courage: Feasibility Study of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371665
• Other study ID #: bscott
• Secondary ID: 5P20GM104417
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Montana State University
• Contact: Brandon G Scott, PhD
• Phone: 406-994-5218
• Email: brandon.scott2[@]montana.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Native Americans (NA) are at greater risk for anxiety and depression early in life. 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. Thus, there is a critical need for the development and evaluation of a culturally consonant, brief PEI for anxiety and depression in NA youth. 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 in the tribal community.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Depressive Disorder

Intervention

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 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.

Locations

Country	Name	City	State
United States	Montana State University	Bozeman	Montana

Sponsors (2)

Lead Sponsor	Collaborator
Montana State University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Post-Intervention Usability Survey	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.	5-10 minutes
Primary	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 - a = .83; teacher - a = .84) and depression (youth - a = .81; teacher - a = .90) scales.	5 minutes
Secondary	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 (a = .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 (a = .80).	5 minutes
Secondary	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 (a'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(a = .90).	5 minutes
Secondary	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).	5-10 minutes