Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06586723

Conditions

Child Development

Child Behavior

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PBIS

HELM

Study Details

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

Study ID

NCT06586723

Start date

Apr 1, 2025

Status verified date

Sep, 2024

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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

Interventions

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.

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

Primary outcome measure

  • PBIS Fidelity (Tiered Fidelity Inventory) [ Time Frame: Baseline, 9 months, 12 months ]

Central Contacts and Locations

Central contacts

Marissa Thirion

mthirion@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98105

Contacts

Principal Investigator:

Aaron Lyon, PhD

More Information

Sponsor

University of Washington

Last update posted

Mar 30, 2025

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2025-03-30.