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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: 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.
Diagnostic test: Cultural Formulation Interview
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.
Behavioral: Modular Approach to Therapy for Children
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
Diagnostic test: Cultural Formulation Interview
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.
Behavioral: Modular Approach to Therapy for Children
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oregon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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