Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT06457256
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-21
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'School Services as Usual (SAU) waitlist design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 872}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Parents will assess ADHD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.'}, {'measure': 'Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Teachers will assess ADHD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 18 symptoms for ADHD, Combined type (ADHD:C; 18 items). Each symptom is rated on a 4-point scale (0= never to 3= very often). The average of ADHD:C scores range from zero to four, with higher scores indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Parents will assess ODD symptoms using the CSI-4. The CSI-4: Parent Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.'}, {'measure': 'Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Teachers will assess ODD symptoms using the CSI-4. The CSI-4: Teacher Checklist contains 9 symptoms of ODD. Each symptom is rated on a 4-point scale (0= never to 3= very often). The average ODD scores range from zero to four, with higher scores indicating more severe symptoms.'}, {'measure': 'Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Parents will assess impairment using the IRS. The IRS Parent Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.'}, {'measure': 'Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score', 'timeFrame': 'Baseline and post treatment (8 weeks) and follow-up (3 months)', 'description': 'Teachers will assess impairment using the IRS. The IRS Teacher Questionnaire contains 8 items of functional impairment (i.e., academic and peer relations). Each item is rated on a 7-point scale (1= no problem; does not need treatment/services to 7= extreme impairment; definitely needs treatment/services). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD']}, 'descriptionModule': {'briefSummary': "Neurodevelopmental disorders of Attention-Deficit/ Hyperactivity Disorder (ADHD) and Oppositional Defiant Disorder (ODD) are extremely common but underserved with Evidence- Based Treatments (EBT) worldwide. Thus, a school clinician training and ADHD/ODD intervention (i.e., the Collaborative Life Skills \\[CLS\\] program) was developed, implemented and evaluated for Mexico: a setting with high unmet need. Technology was integrated into the in-person program (CLS-FUERTE) to create a digitally enhanced version (CLS-R-FUERTE). Given findings demonstrating feasibility, acceptability, and efficacy of both program versions, a Type 2 Hybrid Effectiveness-Implementation Design will be applied to evaluate the program effectiveness, mechanisms of intervention change, and maintenance barriers/facilitators in a scaled-up cluster randomized controlled trial across two Mexican states -while simultaneously exploring an implementation strategy in which the program is adapted to enhance maintenance given each school's needs/resources (i.e., CLS-A-FUERTE). The implementation process is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model with evaluation following the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) Framework.", 'detailedDescription': 'Aim 1) Test the effectiveness and implementation of the CLS-A-FUERTE school clinician training and ADHD/ODD intervention program adapted for schools across Mexico. It is predicted:\n\nH1) School clinicians will engage in training and implement chosen intervention components with fidelity H2) Teachers and/or families will engage in chosen intervention components and adhere to the strategies H3) Students receiving the CLS-A-FUERTE intervention will show greater improvements in ADHD/ODD symptoms and associated impairment compared to students receiving school services as usual\n\nAim 2) Evaluate mechanisms of sustained intervention change. It is predicted:\n\nH4) Improvements in parenting behaviors will mediate sustained intervention effects H5) Improvements in teacher and/or school clinician competency will mediate intervention effects\n\nAim 3) Identify CLS-A-FUERTE maintenance barriers and facilitators. It is predicted that sustained intervention effects and continuation of program activities at follow-up will relate to:\n\nH6) Program feasibility (i.e., cost estimates) and acceptability (i.e., participant satisfaction) H7) Characteristics of participating schools and school context factors\n\nAim 4) Expand research capacity to a novel university setting. It is predicted that emerging investigators will:\n\nH8) Complete clinical research coursework and produce deliverables (i.e., presentations, papers, grants) H9) Show improved EBT skills, research capacity and culture ratings, and competency as program trainers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* must demonstrate at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often, AND at least one area of impairment rated as concerning by both parent and teacher, AND have a parent and teacher agreeing to participate (for student participants)\n* Must be a parents, teacher, or school clinicians of participating students (for parent, teacher, and school clinician participants)\n* Must be a university student in psychology or education at UAS or BUAP (for emerging investigator/university student participants)\n\nExclusion Criteria:\n\n* inability to speak and read Spanish\n* unstable medication regimen (for student participants)\n* severe visual or hearing impairment (for student participants)\n* severe language delay (for student participants)\n* psychosis (for student participants)\n* Placement in an all-day special education classroom (for student participants)'}, 'identificationModule': {'nctId': 'NCT06457256', 'acronym': '(CLS-A-FUERTE)', 'briefTitle': 'Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico (CLS-A-FUERTE)', 'orgStudyIdInfo': {'id': 'CLS-A-FUERTE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CLS-A-FUERTE', 'description': 'Receiving the CLS-A-FUERTE program immediately', 'interventionNames': ['Behavioral: CLS-A-FUERTE']}, {'type': 'NO_INTERVENTION', 'label': 'School Services as Usual (SA)', 'description': 'Receiving School Services as Usual while waiting to receive the CLS-A-FUERTE program in the subsequent schoolyear'}], 'interventions': [{'name': 'CLS-A-FUERTE', 'type': 'BEHAVIORAL', 'description': 'CLS-A-FUERTE Intervention Description: The CLS-A-FUERTE program is a school clinician training and psychosocial intervention program designed to improve attention and behavior in Mexican school-aged youth (grades 1-5). Participating school clinicians are supported by a clinical research team of trainers who co-leads weekly training/consultation meetings and observes each intervention component (i.e., 6 weekly parent and student skills groups, as well as classroom management in the form of a Daily Report Card) in-vivo via videoconferencing.', 'armGroupLabels': ['CLS-A-FUERTE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94104', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '72000', 'city': 'Puebla City', 'state': 'Puebla', 'country': 'Mexico', 'facility': 'Benemérita Universidad Autónoma de Puebla', 'geoPoint': {'lat': 19.04778, 'lon': -98.20723}}, {'zip': '80050', 'city': 'Culiacán', 'state': 'Sinaloa', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Sinaloa', 'geoPoint': {'lat': 24.80209, 'lon': -107.39421}}], 'overallOfficials': [{'name': 'Lauren Haack, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}