Impact Trial of Helping Educational Leaders Mobilize Evidence

NCT06586723 | Recruiting

• 1 other identifier: STUDY00020559
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Child Development; Child Behavior

Outcome Measures

Primary Outcomes (1)

• PBIS Fidelity (Tiered Fidelity Inventory)

  The Tiered Fidelity Inventory (TFI) is a 45-item tool used to provide a valid, reliable, and efficient measure of the extent to which school personnel are applying the core features of PBIS. The TFI is a group-assessment completed by a schoolwide system planning team with external facilitation with strong internal consistency. The scoring criteria for each individual item ranges from 0-3 (0=Not Implemented, 1=Partially Implemented, 3=Fully Implemented); higher scores indicate better outcome.

  Baseline, 9 months, 12 months

Secondary Outcomes (8)

• Implementation Leadership: School Implementation Leadership Scale (SILS)

  Baseline, 9 months, 12 months

• Implementation Climate: School Implementation Climate Scale (SICS)

  Baseline, 9 months, 12 months

• Implementation Cost

  Baseline, 9 months, 12 months

• Academic Engagement, Prosocial Behavior, and Problem Behavior: Modified Direct Behavior Rating (DBR)

  Baseline, 9 months, 12 months

• Student Academic Outcomes

  Baseline, 9 months, 12 months

Study Arms (2)

PBIS

ACTIVE COMPARATOR

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.

Behavioral: PBIS

HELM

EXPERIMENTAL

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

Behavioral: PBIS; Other: HELM

Interventions

PBIS BEHAVIORAL

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.

HELM; PBIS

HELM OTHER

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

HELM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• School Districts: School districts in Washington State committed to implementing PBIS in its elementary schools
• Educators: Educators working in a public elementary school within an enrolled school district.

You may not qualify if:

• Schools with previous HELM exposure will be excluded

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

RECRUITING

Related Publications (1)

• Locke J, Williams NJ, Sridhar A, Ehrhart MG, Dopp A, Thirion M, Espeland C, Riddle B, Schmitz K, Hatch K, Buehler L, Lyon AR. Study protocol for testing the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in elementary schools: a hybrid type 3 effectiveness-implementation randomized controlled trial. Implement Sci. 2025 Apr 24;20(1):17. doi: 10.1186/s13012-025-01429-4.

  PMID: 40275358 DERIVED

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Jill Locke, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Aaron Lyon, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Locke, PhD

CONTACT

206-616-6703; jjlocke@uw.edu

Marissa Thirion

CONTACT

mthirion@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: PBIS coaches will be masked to HELM randomization
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor: School of Medicine, Psychiatry

Model Details: All schools that participate in the study will receive PBIS. Additionally, half of the schools will be randomized to receive HELM, an additional implementation support intervention.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: March 30, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)