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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how effectively a program called HELM assists schools in implementing a behavioral support system known as PBIS. PBIS improves students' social, emotional, and behavioral health in elementary schools. The trial specifically examines whether HELM can enhance the effectiveness of PBIS by supporting school leaders and teachers. Schools in Washington State that wish to use PBIS and have not previously used HELM are well-suited for this trial. As an unphased trial, this study offers schools the opportunity to lead in educational innovation, enhancing student well-being.

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.

What prior data suggests that the HELM implementation strategy is safe for school-wide use?

Research has shown that Positive Behavioral Interventions and Supports (PBIS) is well-researched and generally safe. This proven approach improves students' social, emotional, and behavioral health. PBIS presents no major safety concerns because it focuses on creating supportive school environments.

For the HELM strategy, direct safety data is limited. However, it aids school leaders in effectively using proven practices like PBIS, rather than serving as a direct intervention with students. Since HELM enhances the implementation of existing programs, it does not directly pose safety risks to students.

Overall, both PBIS and HELM aim to enhance students' well-being without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HELM approach because it focuses on building leadership and fostering a supportive environment for implementing evidence-based practices in schools. Unlike traditional behavior interventions that directly target student conduct, HELM aims to empower educational leaders to create a positive climate and ensure high-quality delivery of proven strategies. This innovative focus on leadership and implementation climate is expected to enhance the effectiveness and sustainability of behavioral interventions, potentially leading to better outcomes for students' social-emotional health.

What evidence suggests that the HELM implementation strategy is effective for improving school-wide implementation of PBIS?

This trial will compare the Positive Behavioral Interventions and Supports (PBIS) framework with the Helping Educational Leaders Mobilize Evidence (HELM) strategy. Studies have shown that PBIS effectively improves students' social, emotional, and behavioral outcomes. This well-known program helps create a supportive school environment, reducing problem behaviors and boosting academic performance. Meanwhile, HELM is designed to help schools better implement programs like PBIS. Early research suggests that HELM can enhance how schools use evidence-based practices, ensuring consistent and high-quality delivery. Although researchers are still thoroughly testing HELM, its focus on improving leadership and implementation processes shows promise for enhancing student outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Aaron Lyon, PhD

Principal Investigator

University of Washington

Jill Locke, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10989038/

Helping Educational Leaders Mobilize Evidence (HELM) This paper describes two studies that reflect the initial iterative redesign phases of an effective leadership-focused implementation strategy.

2. ies.ed.gov ies.ed.gov/use-work/awards/helping-educational-leadership-mobilize-evidence-helm-organizational-intervention-promote-strategic

Helping Educational Leadership Mobilize Evidence (HELM) The purpose of this project is to develop and test an organization-focused implementation intervention, called Helping Educational Leaders Mobilize Evidence ...

3. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01429-4

Study protocol for testing the efficacy of the Helping ... This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06586723?intr=helm

Impact Trial of Helping Educational Leaders Mobilize ... Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been ...

5. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/26334895241242523

Helping Educational Leaders Mobilize Evidence (HELM) This paper describes two studies that reflect the initial iterative redesign phases of an effective leadership-focused implementation strategy.

6. withpower.com withpower.com/trial/phase-development-child-1-2025-5ce06

HELM for Childhood Behavior (HELM 2 Trial) In a systematic review of 117 studies on psychosocial interventions for childhood mental disorders, only 31% monitored adverse events, highlighting a ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9844479/

Improving Functioning of Children Birth to Five with ... Comprehensive mental health services and supports were associated with improved emotional and behavioral functioning outcomes for children over time.

8. learningpolicyinstitute.org learningpolicyinstitute.org/product/evidence-social-emotional-learning-schools-brief

Evidence for Social and Emotional Learning in Schools Evidence from hundreds of studies indicates a consistent, reliable effect of SEL programs on students' social, emotional, behavioral, and academic outcomes.