Impact Trial of Helping Educational Leaders Mobilize Evidence (HELM 2)

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).

Study Overview

• Status: Recruiting
• Conditions: Child Behavior; Child Development
• Intervention / Treatment: Behavioral: PBIS; Other: HELM

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Locke, PhD; Phone Number: 206-616-6703; Email: jjlocke@uw.edu
• Study Contact Backup: Name: Marissa Thirion; Email: mthirion@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • University of Washington
      • Contact: Jill Locke, PhD; Phone Number: 206-616-6703; Email: jjlocke@uw.edu
      • Contact: Aaron Lyon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Schools with previous HELM exposure will be excluded

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PBIS; 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; 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.
Experimental: HELM; 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; 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.; Other: HELM; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation Leadership: School Implementation Leadership Scale (SILS)	The SILS has 24 items loading onto 8 subscales: Proactive, Knowledgeable, Supportive, Perseverant, Communication, Vision, Available, and Distributed Leadership. The scoring criteria for each individual item ranges from 0-4; higher scores indicate better outcome.	Baseline, 9 months, 12 months
Implementation Climate: School Implementation Climate Scale (SICS)	The SICS includes 21 items loading onto 7 subscales: Focus on EBP, Educational Support for EBP, Recognition for EBP, Rewards for EBP, Use of Data to Support EBP, Existing Supports for EBP, and EBP Integration. The scoring criteria for each individual item ranges from 0-4; higher scores indicate better outcome.	Baseline, 9 months, 12 months
Implementation Cost	This survey asks educators how much time they spent on study-related procedures each week. Inputs will include time, supplies, travel, overhead, and costs associated with HELM training/coaching meetings, including pre-work, scheduling, and attending meetings; as well as costs associated with PBIS training and delivery.	Baseline, 9 months, 12 months
Academic Engagement, Prosocial Behavior, and Problem Behavior: Modified Direct Behavior Rating (DBR)	The DBR will be used in which teachers observe and rate their classroom's overall academic engagement (i.e., actively or passively participating in the classroom activity, 0-100%), disruptive behavior (i.e., interrupting activities, 0-100%), and prosocial behavior (i.e., following directions, 0-100%; Chafouleas et al., 2012).	Baseline, 9 months, 12 months
Student Academic Outcomes	Standardized academic test scores will be derived from administrative records.	Baseline, 9 months, 12 months
Student Disciplinary Incidents	Number of office discipline referrals, suspensions, and expulsions will be derived from administrative records.	Baseline, 9 months, 12 months
Student Attendance Rates	Student attendance rates will be derived from administrative records.	Baseline, 9 months, 12 months
HELM Fidelity	As a manipulation check to document HELM intervention delivery, we will assess HELM fidelity using the HELM fidelity checklist (based on observations of recorded HELM trainings). HELM coaches will complete a standardized measure of dates specific steps were completed. Schools that achieve 80% or higher of the maximum possible score on all HELM fidelity criteria will be considered having received a full dose of HELM training and coaching.	Baseline, 9 months, 12 months

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Aaron Lyon, PhD, University of Washington; Principal Investigator: Jill Locke, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00020559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No