- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07425366
Personalizing Mental Health Treatment for Youth and Families
February 18, 2026 updated by: University of Oregon
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.
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CFI + MATCH + CRAFTT
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
|
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.
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.
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.
|
|
Active Comparator: CFI + MATCH
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Anxiety and Depression Scale
Time Frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
|
25-item self-report questionnaire that assesses symptoms of anxiety
|
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)
|
25-item self-report questionnaire that assesses psychopathology
|
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)
|
22-item self-repot questionnaire that assesses symptoms of traumatic stress
|
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)
|
13-item self-report questionnaire that assesses impairment
|
Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
September 1, 2028
Study Registration Dates
First Submitted
February 9, 2026
First Submitted That Met QC Criteria
February 18, 2026
First Posted (Actual)
February 20, 2026
Study Record Updates
Last Update Posted (Actual)
February 20, 2026
Last Update Submitted That Met QC Criteria
February 18, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R34MH140927 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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