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

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Unstable medication, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

872 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that students with an unstable medication regimen are excluded. This might mean that if your medication is stable, you can continue taking it.

What data supports the effectiveness of the treatment CLS-A-FUERTE for ADHD?

The research highlights the effectiveness of training school clinicians in evidence-based practices for ADHD, which can improve the implementation of treatments like CLS-A-FUERTE. The web-based training platform for clinicians showed promising results in usability and student outcomes, similar to in-person training, suggesting that well-trained clinicians can effectively deliver treatments for ADHD. ^{1 2 3 4 5}

Is the School Clinician Training Program for ADHD treatment safe for humans?

The safety of ADHD medications, including those similar to CLS-A-FUERTE, is not fully known, and there are concerns about possible serious side effects like heart issues and mental health risks. However, many studies have been conducted to understand and manage these risks, and more research is needed to better understand them. ^{6 7 8 9 10}

How is the CLS-A-FUERTE treatment for ADHD different from other treatments?

The CLS-A-FUERTE treatment is unique because it is a school-home intervention that involves collaboration between schools, parents, and students, with booster sessions to maintain its effects. It is delivered by school-based mental health providers, making it distinct from other treatments that may not integrate these elements or focus on the school environment. ^{11 12 13 14 15}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training and Implementation

School clinicians engage in training and implement chosen intervention components with fidelity

8 weeks

Weekly sessions

Follow-up

Participants are monitored for sustained intervention effects and continuation of program activities

3 months

Treatment Details

Interventions

• CLS-A-FUERTE

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+

Findings from Research

A new web-based training platform for school clinicians was developed to enhance their skills in evidence-based practices for treating youth with ADHD, showing high usability and clinician satisfaction.

The outcomes for students trained by clinicians using this remote platform were comparable to those achieved through traditional in-person training, indicating that online training can effectively disseminate evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Web-Based Training Platform for School Clinicians in Evidence-Based Practices for ADHD. Pfiffner, LJ., Dvorsky, MR., Friedman, LM., et al.[2023]

In a 12-week study involving 55 adolescents treated with osmotic-release oral system methylphenidate (MPH) for ADHD, both patients and parents reported similar adverse events (AEs), but clinicians identified more AEs, especially at week 6, suggesting the need for comprehensive reporting methods.

The study highlights the importance of using a drug-specific checklist for clinicians to better capture AEs, as differences in reported AEs between patients and parents indicate that gathering information from both sources can provide a fuller picture of the treatment's safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. Lee, MS., Lee, SI., Hong, SD., et al.[2015]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

ADHD medications, particularly stimulants, are effective treatments but can lead to various side effects, making it crucial to understand their prevalence and management strategies.

The review highlights the importance of recognizing and managing adverse events associated with ADHD medications to ensure safe and effective treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the risks of ADHD treatments. Schneider, BN., Enenbach, M.[2021]

In a 5-year study involving 2103 children with ADHD, those treated with methylphenidate experienced significantly fewer adverse events (AEs) compared to those treated with atomoxetine, indicating a better safety profile for methylphenidate.

Overall, 26.8% of participants reported mild AEs and 3.9% reported severe AEs, with atomoxetine associated with higher rates of both mild and severe AEs, including gastrointestinal and neuropsychiatric issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry. Cortese, S., Panei, P., Arcieri, R., et al.[2018]

The Collaborative Life Skills (CLS) program, which integrates treatments for students with ADHD, showed significant improvements in parent-reported symptoms and functional impairment even after a maintenance period into the next school year, based on a study involving 135 students across 23 schools.

While parents reported sustained benefits in ADHD and oppositional defiant disorder symptoms, the lack of significant improvements in teacher-reported outcomes suggests a need for additional strategies to enhance effectiveness with new teachers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. Pfiffner, LJ., Rooney, ME., Jiang, Y., et al.[2019]

Schools have a crucial but underutilized role in the treatment of ADHD, as children spend significant time there and interact with trained professionals who can support their needs.

A multi-modal treatment model is proposed, emphasizing a functional approach that tailors assessments and interventions to individual children's specific challenges and environmental factors affecting their behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of attention deficit hyperactivity disorder: a multi-modal model for schools. Maag, JW., Reid, R.[2005]

The Child Life and Attention Skills (CLAS) program significantly improved inattention, organizational skills, and social skills in children with ADHD-I compared to both parent-focused treatment and treatment as usual, based on a study involving 199 children aged 7-11.

Improvements from the CLAS program were maintained at follow-up for most parent-reported measures, highlighting the effectiveness of integrating treatment components across home and school settings for better outcomes in managing ADHD-I.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A two-site randomized clinical trial of integrated psychosocial treatment for ADHD-inattentive type. Pfiffner, LJ., Hinshaw, SP., Owens, E., et al.[2021]

References

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Two different solicitation methods for obtaining information on adverse events associated with methylphenidate in adolescents: a 12-week multicenter, open-label study. [2015]

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European guidelines on managing adverse effects of medication for ADHD. [2022]

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Gastrointestinal adverse events during methylphenidate treatment of children and adolescents with attention deficit hyperactivity disorder: A systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials. [2019]

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Managing the risks of ADHD treatments. [2021]

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Safety of Methylphenidate and Atomoxetine in Children with Attention-Deficit/Hyperactivity Disorder (ADHD): Data from the Italian National ADHD Registry. [2018]

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Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. [2019]

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Treatment of attention deficit hyperactivity disorder: a multi-modal model for schools. [2005]

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A two-site randomized clinical trial of integrated psychosocial treatment for ADHD-inattentive type. [2021]

15. Germany pubmed.ncbi.nlm.nih.gov

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