Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07425366
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalizing Mental Health Treatment for Youth and Families
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DSM-5 Cross-Cutting Symptom Measure', 'timeFrame': 'Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)', 'description': '24-item self-report questionnaire that assesses symptoms across psychiatric diagnoses'}], 'secondaryOutcomes': [{'measure': 'Revised Anxiety and Depression Scale', 'timeFrame': 'Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)', 'description': '25-item self-report questionnaire that assesses symptoms of anxiety'}, {'measure': 'Strengths and Difficulties Questionnaire', 'timeFrame': 'Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)', 'description': '25-item self-report questionnaire that assesses psychopathology'}, {'measure': 'UCLA PTSD Reaction Index', 'timeFrame': 'Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)', 'description': '22-item self-repot questionnaire that assesses symptoms of traumatic stress'}, {'measure': 'Columbia Impairment Scale', 'timeFrame': 'Baseline, and then quarterly until the end of treatment (approximately 1 year after baseline)', 'description': '13-item self-report questionnaire that assesses impairment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child', 'anxiety', 'depression', 'traumatic stress', 'disruptive behavior', 'community mental health', 'National Institute of Mental Health', 'treatment adaptation', 'treatment fidelity', 'decision support tool'], 'conditions': ['Anxiety', 'Traumatic Stress', 'Disruptive Behavior', 'Depression']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Latino\n* Fluent in English or Spanish\n* 5-15 years old\n* Referred to individual psychotherapy with a participating clinician for a primary clinical concern involving anxiety, depression, trauma, or disruptive behaviors\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07425366', 'briefTitle': 'Personalizing Mental Health Treatment for Youth and Families', 'organization': {'class': 'OTHER', 'fullName': 'University of Oregon'}, 'officialTitle': 'Development of a Decision Support Tool for Culturally Adapting Mental Health Treatment to Improve Outcomes for Latine Youths', 'orgStudyIdInfo': {'id': '1R34MH140927', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH140927', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CFI + MATCH + CRAFTT', 'description': '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', 'interventionNames': ['Other: Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT)', 'Diagnostic Test: Cultural Formulation Interview', 'Behavioral: Modular Approach to Therapy for Children']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CFI + MATCH', 'description': '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', 'interventionNames': ['Diagnostic Test: Cultural Formulation Interview', 'Behavioral: Modular Approach to Therapy for Children']}], 'interventions': [{'name': 'Culturally Responsive Assessment, Formulation, and Treatment Tool (CRAFTT)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['CFI + MATCH + CRAFTT']}, {'name': 'Cultural Formulation Interview', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['CFI + MATCH', 'CFI + MATCH + CRAFTT']}, {'name': 'Modular Approach to Therapy for Children', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['CFI + MATCH', 'CFI + MATCH + CRAFTT']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oregon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}