NCT06457256

Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico

Hybrid Effectiveness-Implementation Trial of a School Clinician Training and Psychosocial ADHD/ODD Intervention Program Adapted for Schools Across Mexico (CLS-A-FUERTE)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 872 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: H1) 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 Aim 2) Evaluate mechanisms of sustained intervention change. It is predicted: H4) Improvements in parenting behaviors will mediate sustained intervention effects H5) Improvements in teacher and/or school clinician competency will mediate intervention effects Aim 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: H6) Program feasibility (i.e., cost estimates) and acceptability (i.e., participant satisfaction) H7) Characteristics of participating schools and school context factors Aim 4) Expand research capacity to a novel university setting. It is predicted that emerging investigators will: H8) 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

Conditions

• ADHD

Interventions

Type	Name	Description
BEHAVIORAL	CLS-A-FUERTE	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.

Timeline

• Start date: 2024-10-16
• Primary completion: 2029-06-30
• Completion: 2029-06-30
• First posted: 2024-06-13
• Last updated: 2025-08-21

Locations

3 sites across 2 countries: United States, Mexico