NCT07425366

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
20mo left

Started Jan 2027

Typical duration for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.5 years

First QC Date

February 9, 2026

Last Update Submit

February 18, 2026

Conditions

Keywords

childanxietydepressiontraumatic stressdisruptive behaviorcommunity mental healthNational Institute of Mental Healthtreatment adaptationtreatment fidelitydecision support tool

Outcome Measures

Primary Outcomes (1)

  • DSM-5 Cross-Cutting Symptom Measure

    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 Outcomes (4)

  • Revised Anxiety and Depression Scale

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

  • Strengths and Difficulties Questionnaire

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

  • UCLA PTSD Reaction Index

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

  • Columbia Impairment Scale

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

Study Arms (2)

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

Other: Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT)Diagnostic Test: Cultural Formulation InterviewBehavioral: 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

Diagnostic Test: Cultural Formulation InterviewBehavioral: Modular Approach to Therapy for Children

Interventions

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.

CFI + MATCH + CRAFTT

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.

CFI + MATCHCFI + MATCH + CRAFTT

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.

CFI + MATCHCFI + MATCH + CRAFTT

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Identify as Latino
  • Fluent in English or Spanish
  • years old
  • Referred to individual psychotherapy with a participating clinician for a primary clinical concern involving anxiety, depression, trauma, or disruptive behaviors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersProblem BehaviorDepression

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorChild Behavior

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 20, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02