CClinicalTrials.gg
Not yet recruitingNCT07425366Updated Feb 20, 2026

Personalizing Mental Health Treatment for Youth and Families

An interventional study of Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT) and Cultural Formulation Interview in Anxiety, Traumatic Stress and Disruptive Behavior, sponsored by University of Oregon. Not yet recruiting. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-02-20.

Sponsored by University of Oregon · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Anxiety
  • Traumatic Stress
  • Disruptive Behavior
  • Depression

Keywords

  • child
  • anxiety
  • depression
  • traumatic stress
  • disruptive behavior
  • community mental health
  • National Institute of Mental Health
  • treatment adaptation
  • treatment fidelity
  • decision support tool
03

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
64 participants (estimated)

Study arms

  • 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) · Diagnostic Test: Cultural Formulation Interview · Behavioral: Modular Approach to Therapy for Children

  • 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 · Behavioral: Modular Approach to Therapy for Children

Interventions

  • OtherCulturally 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 testCultural 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.

  • BehavioralModular 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.

05

What researchers measure

Primary outcomes

  1. DSM-5 Cross-Cutting Symptom Measure

    24-item self-report questionnaire that assesses symptoms across psychiatric diagnoses

    Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)

Secondary outcomes

  1. Revised Anxiety and Depression Scale

    25-item self-report questionnaire that assesses symptoms of anxiety

    Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)

  2. Strengths and Difficulties Questionnaire

    25-item self-report questionnaire that assesses psychopathology

    Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)

  3. UCLA PTSD Reaction Index

    22-item self-repot questionnaire that assesses symptoms of traumatic stress

    Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)

  4. Columbia Impairment Scale

    13-item self-report questionnaire that assesses impairment

    Time frame: Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07425366
Lead sponsor
University of Oregon
Responsible party
Sponsor
First posted
Feb 20, 2026
Start date
Jan 2027 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Sep 2028 (estimated)
Last update
Feb 20, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion