Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico
Enrolling by invitation · Not applicable
Conditions studied: ADHD
In brief
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.
Key facts
- Study ID
- NCT06457256
- Run by
- University of California, San Francisco
- People needed
- 872
- Starts
- 2024-10-16
- Expected to finish
- 2029-06-30
- Last updated by the study team
- 2025-08-21
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- 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/university student participants)
You may not qualify if…
- 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)
Where it is running
- UCSF — San Francisco, California, United States
- Benemérita Universidad Autónoma de Puebla — Puebla City, Puebla, Mexico
- Universidad Autonoma de Sinaloa — Culiacán, Sinaloa, Mexico
Full record on ClinicalTrials.gov
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