AnxietyNCT07425366
Personalizing Mental Health Treatment for Youth and Families
A study testing Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT), Cultural Formulation Interview and Modular Approach to Therapy for Children in people with Anxiety and Traumatic Stress, run by University of Oregon.
Trial summary
Incompatibility between evidence-based treatments (EBTs) and the cultural values, practices, and minoritized experiences of Latine youth and families contributes to racial-ethnic disparities in mental health treatment engagement and consequently mental health outcomes. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Anxiety, Traumatic Stress, Disruptive Behavior
- What is being tested?
- Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT), Cultural Formulation Interview and Modular Approach to Therapy for Children
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Identify as Latino
- Fluent in English or Spanish
- 5-15 years old
- Referred to individual psychotherapy with a participating clinician for a primary clinical concern involving anxiety, depression, trauma, or disruptive behaviors
Who cannot join
- -
About this study
Official title: Development of a Decision Support Tool for Culturally Adapting Mental Health Treatment to Improve Outcomes for Latine Youths
Incompatibility between evidence-based treatments (EBTs) and the cultural values, practices, and minoritized experiences of Latine youth and families contributes to racial-ethnic disparities in mental health treatment engagement and consequently mental health outcomes. The proposed study aims to develop and pilot a novel tool - the Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT) - for helping clinicians decide whether, when, and how to culturally adapt EBTs for individual Latine youth clients and thereby improve the cultural compatibility of EBTs for this underserved population. Completion of this study will result in a functional decision support tool designed to improve the quality and effectiveness of mental health services for Latine youths and promote mental health equity.
Read the detailed description
In the United States, racial-ethnic disparities in mental health treatment engagement and consequently rates of unmet mental health needs have increased over the past two decades. Although drivers of these disparities are multifaceted, key contributors include the fallacy that evidence-based treatments (EBTs) are acultural as well as limited empirically supported guidance on culturally adapting EBTs. Developing a tool to help clinicians decide whether, when, and how to culturally adapt EBTs for individual Latine youth clients may enhance the cultural compatibility of EBTs and consequently improve treatment engagement and outcomes for this underserved population. The overall objective of this research is to develop and pilot a novel tool to help clinicians make personalized cultural adaptation decisions for their Latine youth clients. Our central hypothesis is that this decision support tool will help clinicians make appropriate cultural adaptations to EBTs, which will ultimately lead to improved mental health services and outcomes for Latine youths. In Aim 1, we will develop a novel tool - the Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT) - through four co-creation sessions with nine clinicians and researchers. These co-creation sessions will involve activities to: triangulate cultural factors that may influence treatment engagement or progress to inform whether/when to culturally adapt EBTs; triangulate cultural adaptations to inform how to culturally adapt EBTs; match cultural factors with corresponding cultural adaptations; and determine how to package this tool to facilitate effective and efficient clinician use. In Aim 2, we will refine CRAFTT through usability testing with eight clinicians. Lab-based user testing ("think aloud") observations and quantitative usability ratings will be merged to identify and prioritize usability problems to be addressed through CRAFTT refinements. In Aim 3, we will evaluate the feasibility of the approach intended to be used in a future large-scale randomized effectiveness trial. This pilot study will include clinicians (N = 16) working with Latine youths (N = 64) with anxiety, depression, trauma, and disruptive behaviors. Clinicians will be randomized to either: 1)assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using CRAFTT; or 2) assess for cultural factors using the CFI, treat psychopathology using MATCH, and make cultural adaptation decisions using their best clinical judgement. Completion of this project will result in the first decision support tool for helping clinicians personalize cultural adaptation of EBTs for Latine youths. This work will also lay the foundation for a NIH R01 grant proposing to conduct a large randomized effectiveness trial testing the effect of MATCH augmented with CRAFTT on Latine youth treatment engagement and outcomes. This proposal aligns with NIMH's priority to adapt EBTs to improve mental health services for underserved populations and promote mental health equity.
- Conditions
- Anxiety, Traumatic Stress, Disruptive Behavior, Depression
- Being tested
- Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT), Cultural Formulation Interview, Modular Approach to Therapy for Children
- Keywords
- child, anxiety, depression, traumatic stress, disruptive behavior, community mental health, National Institute of Mental Health, treatment adaptation, treatment fidelity, decision support tool
- Medical subject headings
- Anxiety Disorders, Problem Behavior, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT)Other
CRAFTT will help clinicians assess whether their client is engaged and progressing, diagnose cultural risk and resilience factors, plan to implement cultural adaptations, implement cultural adaptations, and (re)evaluate client engagement and progress.
Cultural Formulation InterviewDiagnostic test
The Cultural Formulation Interview is a 16-item semi-structured interview that is organized into four sections: (i) definition of the problem; (ii) perceptions of cause, context, and support; (iii) factors affecting self-coping and past help seeking; and (iv) factors affecting current help seeking.
Modular Approach to Therapy for ChildrenBehavioural
The Modular Approach to Therapy for Children is a modular evidence-based treatment for youths, aged 5-15, with anxiety, depression, trauma, and disruptive behaviors.
| Study group | Role | What they receive |
|---|---|---|
| CFI + MATCH + CRAFTT | Experimental | Clinicians in this arm will assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using CRAFTT Receives: Other: Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT); Diagnostic Test: Cultural Formulation Interview; Behavioral: Modular Approach to Therapy for Children |
| CFI + MATCH | Active comparator | Clinicians in this arm will assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using their best clinical judgement Receives: Diagnostic Test: Cultural Formulation Interview; Behavioral: Modular Approach to Therapy for Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
DSM-5 Cross-Cutting Symptom Measure
24-item self-report questionnaire that assesses symptoms across psychiatric diagnoses
Measured: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Secondary outcomes (4)
Revised Anxiety and Depression Scale
25-item self-report questionnaire that assesses symptoms of anxiety
Measured: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Strengths and Difficulties Questionnaire
25-item self-report questionnaire that assesses psychopathology
Measured: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
UCLA PTSD Reaction Index
22-item self-repot questionnaire that assesses symptoms of traumatic stress
Measured: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Columbia Impairment Scale
13-item self-report questionnaire that assesses impairment
Measured: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oregon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425366
- Sponsor's protocol ID
- 1R34MH140927
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Decision Support Tool for Culturally Adapting Mental Health Treatment to Improve Outcomes for Latine Youths
- ClinicalTrials.gov ID
- NCT07425366
- Acronym / sponsor ID
- 1R34MH140927
- Conditions
- Anxiety, Traumatic Stress, Disruptive Behavior, Depression
- Keywords
- child, anxiety, depression, traumatic stress, disruptive behavior, community mental health, National Institute of Mental Health, treatment adaptation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of OregonUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incompatibility between evidence-based treatments (EBTs) and the cultural values, practices, and minoritized experiences of Latine youth and families contributes to racial-ethnic disparities in mental health treatment engagement and consequently mental health outcomes. The proposed study aims to develop and pilot a novel tool - the Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT) - for helping clinicians decide whether, when, and how to culturally adapt EBTs for individual Latine youth clients and thereby improve the cultural compatibility of EBTs for this underserved population. Completion of this study will result in a functional decision support tool designed to improve the quality and effectiveness of mental health services for Latine youths and promote mental health equity.
Detailed description
In the United States, racial-ethnic disparities in mental health treatment engagement and consequently rates of unmet mental health needs have increased over the past two decades. Although drivers of these disparities are multifaceted, key contributors include the fallacy that evidence-based treatments (EBTs) are acultural as well as limited empirically supported guidance on culturally adapting EBTs. Developing a tool to help clinicians decide whether, when, and how to culturally adapt EBTs for individual Latine youth clients may enhance the cultural compatibility of EBTs and consequently improve treatment engagement and outcomes for this underserved population. The overall objective of this research is to develop and pilot a novel tool to help clinicians make personalized cultural adaptation decisions for their Latine youth clients. Our central hypothesis is that this decision support tool will help clinicians make appropriate cultural adaptations to EBTs, which will ultimately lead to improved mental health services and outcomes for Latine youths. In Aim 1, we will develop a novel tool - the Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT) - through four co-creation sessions with nine clinicians and researchers. These co-creation sessions will involve activities to: triangulate cultural factors that may influence treatment engagement or progress to inform whether/when to culturally adapt EBTs; triangulate cultural adaptations to inform how to culturally adapt EBTs; match cultural factors with corresponding cultural adaptations; and determine how to package this tool to facilitate effective and efficient clinician use. In Aim 2, we will refine CRAFTT through usability testing with eight clinicians. Lab-based user testing ("think aloud") observations and quantitative usability ratings will be merged to identify and prioritize usability problems to be addressed through CRAFTT refinements. In Aim 3, we will evaluate the feasibility of the approach intended to be used in a future large-scale randomized effectiveness trial. This pilot study will include clinicians (N = 16) working with Latine youths (N = 64) with anxiety, depression, trauma, and disruptive behaviors. Clinicians will be randomized to either: 1)assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using CRAFTT; or 2) assess for cultural factors using the CFI, treat psychopathology using MATCH, and make cultural adaptation decisions using their best clinical judgement. Completion of this project will result in the first decision support tool for helping clinicians personalize cultural adaptation of EBTs for Latine youths. This work will also lay the foundation for a NIH R01 grant proposing to conduct a large randomized effectiveness trial testing the effect of MATCH augmented with CRAFTT on Latine youth treatment engagement and outcomes. This proposal aligns with NIMH's priority to adapt EBTs to improve mental health services for underserved populations and promote mental health equity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CFI + MATCH + CRAFTT | Experimental | Other: Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT), Diagnostic Test: Cultural Formulation Interview, Behavioral: Modular Approach to Therapy for ChildrenClinicians in this arm will assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using CRAFTT |
| CFI + MATCH | Active comparator | Diagnostic Test: Cultural Formulation Interview, Behavioral: Modular Approach to Therapy for ChildrenClinicians in this arm will assess for cultural factors that may influence treatment engagement or progress using the Cultural Formulation Interview (CFI), treat psychopathology using the Modular Approach to Treatment for Children (MATCH), and make cultural adaptation decisions using their best clinical judgement |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Identify as Latino
- Fluent in English or Spanish
- 5-15 years old
- Referred to individual psychotherapy with a participating clinician for a primary clinical concern involving anxiety, depression, trauma, or disruptive behaviors
Key exclusion criteria (1 listed)
- -
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 Responsive Assessment, Formulation, and Treatment Tool (CRAFTT)CRAFTT will help clinicians assess whether their client is engaged and progressing, diagnose cultural risk and resilience factors, plan to implement cultural adaptations, implement cultural adaptations, and (re)evaluate client engagement and progress. | Other | CFI + MATCH + CRAFTT |
| Cultural Formulation InterviewThe Cultural Formulation Interview is a 16-item semi-structured interview that is organized into four sections: (i) definition of the problem; (ii) perceptions of cause, context, and support; (iii) factors affecting self-coping and past help seeking; and (iv) factors affecting current help seeking. | Diagnostic test | CFI + MATCH, CFI + MATCH + CRAFTT |
| Modular Approach to Therapy for ChildrenThe Modular Approach to Therapy for Children is a modular evidence-based treatment for youths, aged 5-15, with anxiety, depression, trauma, and disruptive behaviors. | Behavioural | CFI + MATCH, CFI + MATCH + CRAFTT |
Primary outcome
DSM-5 Cross-Cutting Symptom Measure
Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
24-item self-report questionnaire that assesses symptoms across psychiatric diagnoses
4 secondary outcomes
Revised Anxiety and Depression Scale
Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Strengths and Difficulties Questionnaire
Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
UCLA PTSD Reaction Index
Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Columbia Impairment Scale
Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT), Cultural Formulation Interview and Modular Approach to Therapy for Children in people with Anxiety and Traumatic Stress, run by University of Oregon.
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 4 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
DSM-5 Cross-Cutting Symptom Measure (time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)). 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 20 Feb 2026.