School Clinician Training Program for ADHD

((CLS-A-FUERTE) Trial)

Recruiting at 2 trial locations

Overseen by Lauren Haack, PhD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lauren Haack, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for students with ADHD/ODD in Mexico. School clinicians will be trained to implement the CLS-A-FUERTE program, which includes digital enhancements and adaptations based on school resources. Students must attend participating schools where this new approach will be compared to usual school services.

Inclusion Criteria

My medication has been the same for a while.

Students meeting the following criteria are eligible: at least six inattention symptoms and/or six hyperactive/impulsive symptoms endorsed by parent or teacher as occurring often or very often, at least one area of impairment rated as concerning by both parent and teacher, and a parent and teacher agreeing to participate

Parents and teachers and school clinicians of participating are eligible to participate

Exclusion Criteria

Child Participants: Children taking medication will be eligible for screening after the child has been on a stable medication regimen for at least one month (to minimize chance that treatment effects are due to medication and not the proposed program), Presence of conditions that are incompatible with this study's treatment: severe visual or hearing impairment, severe language delay, psychosis, Child does not read or speak Spanish (inability to complete assessment measures or participate in group treatments), Child is in an all-day special education classroom. Children in these classrooms are frequently receiving intensive behavior modification programs and assistance such that the teacher consultation component would be expected to require modification for use in these settings.

I speak and read Spanish fluently.

Treatment Details

Interventions

• CLS-A-FUERTE (Behavioural Intervention)

Trial Overview The effectiveness of the CLS-A-FUERTE training and intervention program for ADHD/ODD is being tested across Mexican schools. The study aims to see if students improve more with this program than with standard care, and how well teachers and families can engage with it.

Participant Groups

Group I: CLS-A-FUERTE Experimental Treatment 1 Intervention

Receiving the CLS-A-FUERTE program immediately

Group II: School Services as Usual (SA) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Fogarty International Center of the National Institute of Health

Collaborator

Trials

157

Recruited

172,000+