[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06457256":3,"trial-entities:NCT06457256":108,"trial-summary:NCT06457256":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":41,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":70,"locations":74,"central_contacts":101,"overall_officials":102,"references":106,"see_also_links":107},"NCT06457256","CLS-A-FUERTE","Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD\u002FODD Intervention Program Adapted for Schools Across Mexico","Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD\u002FODD Intervention Program Adapted for Schools Across Mexico (CLS-A-FUERTE)","ENROLLING_BY_INVITATION","2029-06-30","2025-08","2025-08-21","2024-10-16","University of California, San Francisco","OTHER",false,"Neurodevelopmental disorders of Attention-Deficit\u002F 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\u002FODD 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\u002Ffacilitators 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\u002Fresources (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.","Aim 1) Test the effectiveness and implementation of the CLS-A-FUERTE school clinician training and ADHD\u002FODD 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\u002For 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\u002FODD 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\u002For 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",[19],"ADHD",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},872,"ESTIMATED",[29],{"type":30,"name":5,"description":31,"armGroupLabels":32},"BEHAVIORAL","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\u002Fconsultation 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.",[5],[34,38],{"measure":35,"description":36,"timeFrame":37},"Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist ADHD Combined type Symptom Severity Score","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.","Baseline and post treatment (8 weeks) and follow-up (3 months)",{"measure":39,"description":40,"timeFrame":37},"Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist ADHD Combined type Symptom Severity Score","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.",[42,45,48,51],{"measure":43,"description":44,"timeFrame":37},"Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score","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":46,"description":47,"timeFrame":37},"Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score","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":49,"description":50,"timeFrame":37},"Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score","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\u002Fservices to 7= extreme impairment; definitely needs treatment\u002Fservices). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.",{"measure":52,"description":53,"timeFrame":37},"Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score","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\u002Fservices to 7= extreme impairment; definitely needs treatment\u002Fservices). The average of all IRS scores range from one to seven, with higher scores indicating more severe impairment.","ALL","5 Years",null,{"inclusion":58,"exclusion":62,"raw_text":69},[59,60,61],"must demonstrate at least six inattention symptoms and\u002For six hyperactive\u002Fimpulsive 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)","Must be a parents, teacher, or school clinicians of participating students (for parent, teacher, and school clinician participants)","Must be a university student in psychology or education at UAS or BUAP (for emerging investigator\u002Funiversity student participants)",[63,64,65,66,67,68],"inability to speak and read Spanish","unstable medication regimen (for student participants)","severe visual or hearing impairment (for student participants)","severe language delay (for student participants)","psychosis (for student participants)","Placement in an all-day special education classroom (for student participants)","Inclusion Criteria:\n\n* must demonstrate at least six inattention symptoms and\u002For six hyperactive\u002Fimpulsive 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\u002Funiversity 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)",[71,72,73],"CHILD","ADULT","OLDER_ADULT",[75,84,93],{"facility":76,"city":77,"state":78,"zip":79,"country":80,"geoPoint":81},"UCSF","San Francisco","California","94104","United States",{"lat":82,"lon":83},37.77493,-122.41942,{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Benemérita Universidad Autónoma de Puebla","Puebla City","Puebla","72000","Mexico",{"lat":91,"lon":92},19.04778,-98.20723,{"facility":94,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"Universidad Autonoma de Sinaloa","Culiacán","Sinaloa","80050",{"lat":99,"lon":100},24.80209,-107.39421,[],[103],{"name":104,"affiliation":13,"role":105},"Lauren Haack, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[110,111],"Attention Deficit Hyperactivity Disorder","Oppositional Defiant Disorder",[],{"nct_id":4,"found":15,"summary":56,"prompt_version":56}]