Anxiety DisorderNCT05371665
Feasibility of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children
A study testing Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program in people with Anxiety Disorder and Depressive Disorder, run by Montana State University at 1 site in United States.
Trial summary
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the potential negative effects of these conditions across the lifespan (substance use, suicide). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Depressive Disorder
- What is being tested?
- Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 14 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 8-12 year-old youth who attends either tribe-serving school and resides on the reservation with their parent/legal guardian.
Who cannot join
- Does not meet inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Native Path to Courage: Feasibility Study of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the 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 AI 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 AI youth. The investigators' goal is to provide the community with a potentially successful PEI to mitigate AI youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research were to 1) culturally adapt a PEI program for AI 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 program with AI youth living on the reservation, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted program with the AI youth. The investigators built upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators partnered with the CAB to culturally adapt the PEI program for AI youth in year 1 and 2 using a CBPR framework, including AI youth and parents. In year 2, the investigators trained an AI school counselor from the tribal community and a white school counselor from the two tribal serving schools on the reservation to implement the adapted PEI program. We pilot tested the 6-week program (one 20-30 minute session per week) with 28 AI 3rd-6th graders in two schools serving youth from the reservation in year 3. The investigators will partner with the tribal community to further refine and tailor the adapted PEI program using the results of this study. Moreover, further testing of the refined program's efficacy and sustainability will be conducted using a larger sample and randomized, two-group design.
Read the detailed description
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the 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 AI youth are limited. Thus, there is a critical need for the development and evaluation of a culturally appropriate, brief PEI for anxiety and depression in AI youth. These were the three main goals of this study: 1) Partner with a Northern Plains tribal community to culturally adapt the PEI program for AI youth living on the reservation. 2) evaluate whether they were able to successfully provide the program to AI youth in two tribal schools and whether youth would accept/enjoy the program, and 3) test whether there were changes in anxiety and depressive symptoms, as well as resilience, among the AI youth from pre- to post-intervention. The investigators partnered with the tribal community, including AI youth and parents, to culturally adapt the PEI program in years 1 and 2. In year 3, the investigators trained an AI school counselor from the tribal community and a white school counselor to provide the adapted PEI program in the two tribal-serving schools. Twenty-eight AI 3rd-6th graders (8-12 years-old) participated in the program. The investigators will continue to partner with the tribal community to further refine and tailor the culturally adapted program using the results from this study. Moreover, further testing of the refined program's efficacy and sustainability will be conducted using a larger sample and control group.
This study built 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 (PEI) program addressing anxiety and depression in American Indian (AI) 8-12-year-olds. The investigators evaluated how feasible it would be for AI providers from the tribal community to deliver the adapted intervention to AI youth attending two schools serving the tribe. The investigators also tested the hypotheses that AI youth will find the program acceptable and enjoyable, and it will reduce anxiety and depressive symptoms from pre- to post-intervention.
The investigators used an iterative adaptation process within a CBPR framework to culturally adapt the evidence-based PEI program. It involved collaborating with the Cultural Advisory Board (CAB) and conducting adult work groups and youth focus groups with keys community stakeholders, including AI youth and parents, to determine cultural adaptations and adapt the program. The investigators first collaborated with the CAB in reviewing prior literature on anxiety and depression, as well as the non-adapted PEI program. The CAB developed an initial conceptual model of what factors may cause or put AI youth at risk for anxiety and depression. In addition the model included what outcomes were expected from a prevention and early intervention program targeting these causal or risk factors. Next, they used AI 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 involved adding, removing, or modifying/replacing certain parts of the initial model to better align with the tribe's worldview of mental health and healing. Moreover, the CAB identified 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 recruited 20 community stakeholders (Elders, parents/legal guardians, and mental health specialists who serve the community) and 14 AI 8-12 year-olds to review the non-adapted intervention and suggest cultural adaptions and improvements to the content, strategies, and materials. Focus groups were audio recorded. Youth also completed a pre-adaptation usability survey (they reviewed only 3 of the 6 program modules) of the non-adapted PEI program that assessed acceptability, enjoyableness, and cultural appropriateness.
The investigators analyzed focus and work group discussions to identify common themes and group suggestions together. The CAB used this information and integrate with their own suggestions to: 1) modify a conceptual framework of anxiety and depression prevention and early intervention in AI youth, and 2) determine the cultural adaptations that are most warranted given possible logistical barriers (e.g., time/funding). Identified themes were reviewed and validated with the CAB and Project Manager. The CAB worked with the research team to culturally adapt the intervention and identified two school counselors (i.e., an American Indian tribal member and a white non-tribal member) to provide it in the schools.
The two school counselors provided the program to 28 AI youth in the 3rd to 6th grade (8-12 years-old) in the two schools that serve the tribal community. The adapted intervention was delivered once a week for six weeks and each session lasted 20-30 minutes. Youth completed a post-adaption usability survey at the end of each session to assess acceptability and likeability of the adapted program. The investigators also collected survey data on the primary and secondary measures 1 week before the intervention (pre) and 1 week following the intervention (post). Survey data was collected electronically using a tablet or computer and included: 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 worked with the research team using the conceptual model in the adaptation process to decide on the addition, removal, or further revision of the assessments. The youth who completed the intervention and were present for session 6 participated in a post-intervention focus (3-4 youth per group) to further discuss their experiences with adapted intervention and suggest improvements. The focus groups were audio recorded. The two intervention providers also recorded youth attendance and provided additional information about following the program guidelines and steps as trained, what material was covered or not covered, and their judgements on implementing the program.
- Conditions
- Anxiety Disorder, Depressive Disorder
- Being tested
- Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) ProgramBehavioural
The prevention and early intervention is originally an indicated cognitive-behavioral program for 8-13-year-old youth with higher anxiety. Our CAB adapted it as a universal prevention and early intervention for all American Indian youth in the tribal community. It was delivered across six weeks with 20-30 min weekly sessions. Youth engaged in games and role-play reducing anxiety and stress in mildly challenging situations to provide in-vivo exposure. Session 1 involved introductions, relaxation training, and discussing emotions. Session 2 taught youth about worries and how to handle them. Session 3 focused on having conversations with others. Session 4 taught youth how to be assertive (CAB identified this as an area of adaption in initial meetings). Session 5 taught youth how to face their fears. Session 6 was a review session. Parents and teachers were sent notes of what youth learned in each session and asked to encourage youth to practice their learned skills.
| Study group | Role | What they receive |
|---|---|---|
| Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program | Experimental | All youth received the culturally adapted prevention and early intervention program from trained providers in the school setting. Receives: Behavioral: Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention
The Revised Child Anxiety and Depression Scale - Short Version Child Report (RCADS-25-S) is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Youth rated how often each anxiety and depressive disorder symptom is true of them on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' anxiety disorder symptoms at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Depressive Disorder Symptoms
The Revised Child Anxiety and Depression Scale - Short Version Child Report (RCADS-25-S) is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Youth rated how often each anxiety and depressive disorder symptom is true of them on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Teacher-reported Anxiety Disorder Symptoms
The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' anxiety disorder symptoms at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Teacher-reported Depressive Disorder Symptoms
The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Secondary outcomes (11)
Post-Intervention Youth-reported Anxiety Control Beliefs
The Anxiety Control Questionnaire for Children 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). Youth rated 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). Mean scores range from 0 to 4 with higher mean scores indicate greater perceived control over their anxiety symptoms and external anxiety-related events at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Rumination
The Child Response Style Questionnaire - Rumination Scale is 13 item rumination subscale of the 26 item measure. Youth rated 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" (coded 0), "Sometimes" (coded 1), "Often" (coded 2), and "Almost Always" (coded 3). Mean rumination scale scores ranged from 0 to 3 with higher mean scale scores indicating greater rumination at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Personal Skills Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' personal skills at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Peer Support Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' peer support at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Social Skills Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' social skills at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Physical Caregiving Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' physical caregiving at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Psychological Caregiving Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' psychological caregiving.
Measured: Post-Intervention
Post-Intervention Youth-reported Spiritual Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' spiritual experiences at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Educational Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' educational experiences at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Cultural Resilience
The Child and Youth Resilience Measure is a 26-item measure that assesses resiliency across a number of domains. Youth indicated 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 0 ("No"), 1 ("Sometimes") and 2 ("Yes"). Mean scale scores range from 0 to 2 with higher mean scale scores reflecting greater resilience as it pertains to youths' cultural experiences at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Post-Intervention Youth-reported Tribal Specific Resilience
The Child and Youth Resilience Measure - Tribal Resilience Scale is a 10-item measure that assesses tribal specific resilience based on exposure or using Native language, exposure or knowing Native/tribal history, and exposure or experiencing tribal or cultural practices. Youth indicated to what extent each statement describes them or their experiences on a three-point scale of 0 ("Not at All"), 1 ("Somewhat") and 2 ("A Lot"). Mean scale scores range from 0 to 2 with higher scores reflecting greater tribal specific resilience as it pertains to youths' tribal and cultural experiences at post-intervention, 8 weeks post-baseline.
Measured: Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start28 Mar 2022
- Primary completion14 May 2024
- Study completion14 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Brandon Scott, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371665
- Sponsor's protocol ID
- bscott
- Other IDs
- 5P20GM104417
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2022
- Last updated
- 4 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data is owned by the tribal community and we would need their permission to share data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Native Path to Courage: Feasibility Study of a Culturally Adapted Emotional-Behavioral Prevention Program for American Indian Children
- ClinicalTrials.gov ID
- NCT05371665
- Acronym / sponsor ID
- bscott
- Conditions
- Anxiety Disorder, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 14 May 2024 (actual)
- Study completion
- 14 May 2024 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Posted 4 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the 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 AI 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 AI youth. The investigators' goal is to provide the community with a potentially successful PEI to mitigate AI youth's anxiety and depression that integrates culture and traditions for delivery in schools. The Specific Aims of the proposed research were to 1) culturally adapt a PEI program for AI 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 program with AI youth living on the reservation, and 3) estimate effect size changes in anxiety and depressive symptoms of the culturally adapted program with the AI youth. The investigators built upon the investigators' strong community relationships and CBPR methods to achieve these aims. The investigators partnered with the CAB to culturally adapt the PEI program for AI youth in year 1 and 2 using a CBPR framework, including AI youth and parents. In year 2, the investigators trained an AI school counselor from the tribal community and a white school counselor from the two tribal serving schools on the reservation to implement the adapted PEI program. We pilot tested the 6-week program (one 20-30 minute session per week) with 28 AI 3rd-6th graders in two schools serving youth from the reservation in year 3. The investigators will partner with the tribal community to further refine and tailor the adapted PEI program using the results of this study. Moreover, further testing of the refined program's efficacy and sustainability will be conducted using a larger sample and randomized, two-group design.
Detailed description
American Indians (AI) are at greater risk for anxiety and depression early in life. This is concerning given the 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 AI youth are limited. Thus, there is a critical need for the development and evaluation of a culturally appropriate, brief PEI for anxiety and depression in AI youth. These were the three main goals of this study: 1) Partner with a Northern Plains tribal community to culturally adapt the PEI program for AI youth living on the reservation. 2) evaluate whether they were able to successfully provide the program to AI youth in two tribal schools and whether youth would accept/enjoy the program, and 3) test whether there were changes in anxiety and depressive symptoms, as well as resilience, among the AI youth from pre- to post-intervention. The investigators partnered with the tribal community, including AI youth and parents, to culturally adapt the PEI program in years 1 and 2. In year 3, the investigators trained an AI school counselor from the tribal community and a white school counselor to provide the adapted PEI program in the two tribal-serving schools. Twenty-eight AI 3rd-6th graders (8-12 years-old) participated in the program. The investigators will continue to partner with the tribal community to further refine and tailor the culturally adapted program using the results from this study. Moreover, further testing of the refined program's efficacy and sustainability will be conducted using a larger sample and control group.
This study built 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 (PEI) program addressing anxiety and depression in American Indian (AI) 8-12-year-olds. The investigators evaluated how feasible it would be for AI providers from the tribal community to deliver the adapted intervention to AI youth attending two schools serving the tribe. The investigators also tested the hypotheses that AI youth will find the program acceptable and enjoyable, and it will reduce anxiety and depressive symptoms from pre- to post-intervention.
The investigators used an iterative adaptation process within a CBPR framework to culturally adapt the evidence-based PEI program. It involved collaborating with the Cultural Advisory Board (CAB) and conducting adult work groups and youth focus groups with keys community stakeholders, including AI youth and parents, to determine cultural adaptations and adapt the program. The investigators first collaborated with the CAB in reviewing prior literature on anxiety and depression, as well as the non-adapted PEI program. The CAB developed an initial conceptual model of what factors may cause or put AI youth at risk for anxiety and depression. In addition the model included what outcomes were expected from a prevention and early intervention program targeting these causal or risk factors. Next, they used AI 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 involved adding, removing, or modifying/replacing certain parts of the initial model to better align with the tribe's worldview of mental health and healing. Moreover, the CAB identified 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 recruited 20 community stakeholders (Elders, parents/legal guardians, and mental health specialists who serve the community) and 14 AI 8-12 year-olds to review the non-adapted intervention and suggest cultural adaptions and improvements to the content, strategies, and materials. Focus groups were audio recorded. Youth also completed a pre-adaptation usability survey (they reviewed only 3 of the 6 program modules) of the non-adapted PEI program that assessed acceptability, enjoyableness, and cultural appropriateness.
The investigators analyzed focus and work group discussions to identify common themes and group suggestions together. The CAB used this information and integrate with their own suggestions to: 1) modify a conceptual framework of anxiety and depression prevention and early intervention in AI youth, and 2) determine the cultural adaptations that are most warranted given possible logistical barriers (e.g., time/funding). Identified themes were reviewed and validated with the CAB and Project Manager. The CAB worked with the research team to culturally adapt the intervention and identified two school counselors (i.e., an American Indian tribal member and a white non-tribal member) to provide it in the schools.
The two school counselors provided the program to 28 AI youth in the 3rd to 6th grade (8-12 years-old) in the two schools that serve the tribal community. The adapted intervention was delivered once a week for six weeks and each session lasted 20-30 minutes. Youth completed a post-adaption usability survey at the end of each session to assess acceptability and likeability of the adapted program. The investigators also collected survey data on the primary and secondary measures 1 week before the intervention (pre) and 1 week following the intervention (post). Survey data was collected electronically using a tablet or computer and included: 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 worked with the research team using the conceptual model in the adaptation process to decide on the addition, removal, or further revision of the assessments. The youth who completed the intervention and were present for session 6 participated in a post-intervention focus (3-4 youth per group) to further discuss their experiences with adapted intervention and suggest improvements. The focus groups were audio recorded. The two intervention providers also recorded youth attendance and provided additional information about following the program guidelines and steps as trained, what material was covered or not covered, and their judgements on implementing the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program | Experimental | Behavioral: Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) ProgramAll youth received the culturally adapted prevention and early intervention program from trained providers in the school setting. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 8-12 year-old youth who attends either tribe-serving school and resides on the reservation with their parent/legal guardian.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) ProgramThe prevention and early intervention is originally an indicated cognitive-behavioral program for 8-13-year-old youth with higher anxiety. Our CAB adapted it as a universal prevention and early intervention for all American Indian youth in the tribal community. It was delivered across six weeks with 20-30 min weekly sessions. Youth engaged in games and role-play reducing anxiety and stress in mildly challenging situations to provide in-vivo exposure. Session 1 involved introductions, relaxation training, and discussing emotions. Session 2 taught youth about worries and how to handle them. Session 3 focused on having conversations with others. Session 4 taught youth how to be assertive (CAB identified this as an area of adaption in initial meetings). Session 5 taught youth how to face their fears. Session 6 was a review session. Parents and teachers were sent notes of what youth learned in each session and asked to encourage youth to practice their learned skills. | Behavioural | Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program |
Primary outcome
Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention
Time frame: Post-Intervention
The Revised Child Anxiety and Depression Scale - Short Version Child Report (RCADS-25-S) is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Youth rated how often each anxiety and depressive disorder symptom is true of them on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' anxiety disorder symptoms at post-intervention, 8 weeks post-baseline.
Post-Intervention Youth-reported Depressive Disorder Symptoms
Time frame: Post-Intervention
The Revised Child Anxiety and Depression Scale - Short Version Child Report (RCADS-25-S) is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Youth rated how often each anxiety and depressive disorder symptom is true of them on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.
Post-Intervention Teacher-reported Anxiety Disorder Symptoms
Time frame: Post-Intervention
The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' anxiety disorder symptoms at post-intervention, 8 weeks post-baseline.
Post-Intervention Teacher-reported Depressive Disorder Symptoms
Time frame: Post-Intervention
The Revised Child Anxiety and Depression Scale - Short Version Teacher Report is a 25-item instrument used to assess DSM-IV anxiety disorders symptoms (15 items) and depressive disorder symptoms (10 items). Teachers rated how often each anxiety and depressive disorder symptom is true of each youth on a rating scale consisting of: 0 (Never), 1 (Sometimes), 2 (Often), and 3 (Always). Mean scores range from 0 to 3 with higher mean scores indicating greater frequency of youths' depressive disorder symptoms at post-intervention, 8 weeks post-baseline.
11 secondary outcomes
Post-Intervention Youth-reported Anxiety Control Beliefs
Time frame: Post-Intervention
Post-Intervention Youth-reported Rumination
Time frame: Post-Intervention
Post-Intervention Youth-reported Personal Skills Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Peer Support Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Social Skills Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Physical Caregiving Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Psychological Caregiving Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Spiritual Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Educational Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Cultural Resilience
Time frame: Post-Intervention
Post-Intervention Youth-reported Tribal Specific Resilience
Time frame: Post-Intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study data is owned by the tribal community and we would need their permission to share data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Adapted Cognitive-Behavioral Prevention and Early Intervention (PEI) Program in people with Anxiety Disorder and Depressive Disorder, run by Montana State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Intervention Youth-reported Anxiety Disorder Symptoms From Pre- to Post-Intervention (time frame: Post-Intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.