HELM for Childhood Behavior

(HELM 2 Trial)

Overseen By Marissa Thirion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Previous HELM exposure

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

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

What is the purpose of this trial?

Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS).

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications.

Is the HELM treatment generally safe for children?

The available research highlights the importance of monitoring adverse events (unintended, potentially harmful events) in pediatric treatments, especially when multiple medications or high-risk interventions are involved. While specific safety data for HELM is not provided, general safety practices in pediatric care emphasize careful monitoring to prevent harm. ^{1 2 3 4 5}

Research Team

Jill Locke, PhD

Principal Investigator

University of Washington

Aaron Lyon, PhD

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for school districts in Washington State committed to implementing PBIS in elementary schools, and educators working at these public elementary schools. It aims to address student social, emotional, and behavioral problems.

Inclusion Criteria

School districts in Washington State committed to implementing PBIS in its elementary schools

Educators working in a public elementary school within an enrolled school district

Exclusion Criteria

Schools with previous HELM exposure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the HELM strategy and PBIS framework in schools to address SEB needs

9 months

Regular school-based activities and assessments

Follow-up

Participants are monitored for effectiveness of the implementation strategy and student outcomes

3 months

Ongoing assessments and data collection

Treatment Details

Interventions

• HELM
• PBIS

Trial Overview The trial tests the HELM strategy's effectiveness for school-wide implementation of Positive Behavioral Interventions and Supports (PBIS) to improve student outcomes and address SEB issues exacerbated by COVID-19.

Participant Groups

Group I: HELM Experimental Treatment 2 Interventions

Helping Educational Leaders Mobilize Evidence (HELM) is an implementation strategy for promoting building-level implementation leadership, implementation climate, and high-fidelity delivery of evidence-based practices

Group II: PBIS Active Control 1 Intervention

Positive Behavioral Interventions and Supports (PBIS) is an evidence-based, multi-tiered, problem-solving, and team-based framework designed to build a continuum of supports to promote all students' social emotional behavioral health.

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Findings from Research

In a study analyzing pediatric hospitalizations, 24 patients experienced 29 adverse events (AEs) related to medical care, with a rate of 3.61% across all pediatric hospitalizations, which is lower than the 6.4% rate seen in non-elderly adults.

A significant 65.5% of these adverse events were deemed preventable, highlighting the need for targeted prevention strategies, especially since medication-related events accounted for 37.9% of the incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. Requena, J., Miralles, JJ., Mollar, J., et al.[2012]

In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a significant gap in safety reporting.

Among the studies that did monitor adverse events, there was a lack of consistency in how these events were defined and assessed, with only 11% evaluating the causes of the events, which is crucial for understanding the risks associated with these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. Lodewyk, K., Bagnell, A., Courtney, DB., et al.[2023]

In a study of 193 pediatric patients with severe traumatic brain injury (sTBI), 53% experienced at least one adverse event (AE), highlighting the high risk of complications in this vulnerable population.

The most common AE was decubitus ulcers, and patients with AEs had longer hospital stays and higher costs, indicating that identifying and preventing AEs can improve patient safety and reduce healthcare expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. Charyk Stewart, T., Luong, K., Alharfi, I., et al.[2021]

The Brazilian Portuguese version of the Pediatric Trigger Toolkit was successfully translated and adapted for use in Brazilian hospitals, involving a thorough validation process that included expert consensus and cultural adaptation.

The toolkit demonstrated a positive predictive value of 13.51% for identifying adverse drug events in pediatric patients, with antihistamine triggers being the most effective, indicating its potential utility in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. Silva, LT., Modesto, ACF., Martins, RR., et al.[2020]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Clinical safety paediatric patients]. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Adverse drug events in Chinese pediatric inpatients and associated risk factors: a retrospective review using the Global Trigger Tool. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Review: Adverse event monitoring and reporting in studies of pediatric psychosocial interventions: a systematic review. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Identification of adverse events in pediatric severe traumatic brain injury patients to target evidence-based prevention for increased performance improvement and patient safety. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

The Brazilian Portuguese version of the Pediatric Trigger Toolkit is applicable to measure the occurrence of adverse drug events in Brazilian pediatric inpatients. [2020]