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

NCT06457256 | Enrolling By Invitation

• 1 other identifier: CLS-A-FUERTE
• Study Type: interventional
• Target: 872
• Locations: 2 countries
• Sites: 3

Brief 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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• 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)

• 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.

  Baseline and post treatment (8 weeks) and follow-up (3 months)

Secondary Outcomes (4)

• Change in Child Symptom Inventory-4 (CSI-4) Parent Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score

  Baseline and post treatment (8 weeks) and follow-up (3 months)

• Change in Child Symptom Inventory-4 (CSI-4) Teacher Checklist (Oppositional Defiant Disorder) ODD Symptom Severity Score

  Baseline and post treatment (8 weeks) and follow-up (3 months)

• Change Impairment Rating Scale (IRS) Parent Questionnaire Overall Severity Score

  Baseline and post treatment (8 weeks) and follow-up (3 months)

• Change Impairment Rating Scale (IRS) Teacher Questionnaire Overall Severity Score

  Baseline and post treatment (8 weeks) and follow-up (3 months)

Study Arms (2)

CLS-A-FUERTE

EXPERIMENTAL

Receiving the CLS-A-FUERTE program immediately

Behavioral: CLS-A-FUERTE

School Services as Usual (SA)

NO INTERVENTION

Receiving School Services as Usual while waiting to receive the CLS-A-FUERTE program in the subsequent schoolyear

Interventions

CLS-A-FUERTE 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/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.

CLS-A-FUERTE

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of California, San Francisco: lead
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (3)

UCSF

San Francisco, California, 94104, United States

Location

Benemérita Universidad Autónoma de Puebla

Puebla City, Puebla, 72000, Mexico

Location

Universidad Autonoma de Sinaloa

Culiacán, Sinaloa, 80050, Mexico

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Lauren Haack, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: School Services as Usual (SAU) waitlist design

Study Record Dates

• First Submitted: June 7, 2024
• First Posted: June 13, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2); US (1)