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

Background: Schools need to implement universal student supports that prevent social, emotional, and behavioral difficulties; minimize associated risks; and promote social, emotional, and behavioral competencies. The purpose of this study is to examine the efficacy of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy for promoting school-level implementation leadership, implementation climate, and high-fidelity delivery of an evidence-based practice. We will test HELM with an exemplar EBP, Positive Behavioral Interventions and Supports (PBIS). The specific aims of the study are to: 1) experimentally evaluate the effects of HELM versus PBIS training and technical assistance only (control condition); and 2) explore for whom, under what conditions, how equitably, and through which processes HELM works to improve outcomes, as well as its cost-effectiveness. Methods: This study will use a hybrid type 3 effectiveness-implementation trial to provide a rigorous test of the effects of HELM in elementary schools. Schools will be randomly assigned to HELM + PBIS training and technical assistance (n = 21 schools; n = 210 educators) or PBIS training and technical assistance only (n = 21 schools; n = 210 educators) in a 1:1 ratio within cohorts using covariate constrained randomization that accounts for degree of prior PBIS exposure (measured using the Tiered Fidelity Inventory at baseline) and school size. A series of mixed effects models (time within educator, educator within school) will test within-subject/between-subject interactions across three timepoints (12 months total) to examine whether HELM will show steeper gains than the control on implementation leadership (primary outcome), implementation climate, PBIS fidelity, and student outcomes. Mediational analyses will test hypothesized mechanisms of change (i.e., implementation leadership and climate) of HELM on PBIS fidelity. Sequential mixed-methods data collection and analyses will further explore how organizational mechanisms are linked to implementation outcomes. Cost-effectiveness analyses will compare costs and outcomes of PBIS training and technical assistance only versus PBIS implementation with HELM. Discussion: The nature of leadership support in schools can make the difference between successful and unsuccessful EBP implementation. Testing HELM within the context of PBIS implementation will provide rigorous evidence about whether and how HELM can equitably address important EBP and student outcomes. Name of the registry: clinicaltrials.gov. Trial Registration: Clinical Trials ID: NCT06586723. Date of Registration: August 27, 2024. Prospectively registered. URL of Trial Registry Record: https://clinicaltrials.gov/study/NCT06586723?intr=helm&rank=1