NCT06340074

Brief Summary

Many universal, evidence-based prevention practices (EBPPs) have been developed to prevent SEB problems, typically in elementary schools, but progress toward widespread implementation has been slow and few efforts have been made to develop and test interventions to enhance EBPP implementation in schools. Schools leaders (e.g., principals) are key to decision making and implementation of EBPPs, and their leadership has been shown to be consistently linked to student outcomes through their intentional efforts to support teacher adoption and use of innovative programs. Helping Educational Leaders Mobilize (HELM) Evidence is a pragmatic, multifaceted, organizationally-focused implementation strategy targeting the implementation leadership and implementation climate of school buildings (through principals) to enhance the adoption and delivery of EBPPs in elementary schools. This pilot study, part of the larger HELM project to adapt and test the strategy based on an existing leadership intervention, Leadership and Organizational Change for Implementation (LOCI), will be implemented in the context of Positive Greetings at the Door (PGD), a universal school-based EBPP previously demonstrated to reduce disruptive behavior and increase academic engagement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
333

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

March 21, 2024

Last Update Submit

March 29, 2024

Conditions

Outcome Measures

Primary Outcomes (9)

  • Proximal Outcome: Strategic Implementation Leadership

    The School Implementation Leadership Scale (SILS) is an 25-item scale that assesses the degree to which a school's leader is perceived to engage in eight specific behaviors that are supportive of EBP implementation which both principals and educators complete. The eight subscales include: 1) supportive; 2) perseverant; 3) communication; 4) proactive; 5) availability; 6) knowledgeable; 7) vision/mission; and 8) distributed leadership.

    Baseline, 4-months, 8-months

  • Proximal Outcome: Strategic Implementation Climate

    The School Implementation Climate Scale (SICS) is an 21-item scale for principals' and educators' shared perceptions of the policies, practices, and procedures that are expected, rewarded, and supported. The six subscales include: 1) focus on EBPs; 2) educational support for EBPs; 3) recognition for EBPs; 4) use of data to support EBPs; 5) existing supports to deliver EBPs; and 6) integration of EBPs.

    Baseline, 4-months, 8-months

  • Proximal Outcome: Implementation Citizenship Behavior

    The School Implementation Citizenship Behavior Scale (SICBS) is a 12-item rating scale that measures principals' and educators' perceptions regarding how educators engage with EBPs within their specific school context. The four subscales include: 1) helping others; 2) keeping informed; 3) taking Initiative; and 4) advocacy.

    Baseline, 4-months, 8-months

  • Proximal Outcome: Implementation Initiative Stability

    A modified version of the 8-item Commitment to Organizational Change Scale (COCS) will measure principals' and educators' perceptions of implementation initiative stability. Subscales include: Affective Commitment and Normative Commitment.

    Baseline, 4-months, 8-months

  • Implementation Outcome: Fidelity and Sustainment - Observed

    Assitant principals will be trained to conduct PGD fidelity observations and complete three PGD observations biweekly (October - December) and monthly (January - May) over the course of the school year. Minimum Score 0, Maximum Score 6. Higher Scores mean better outcome.

    2-months, 2.5-months, 3-months, 3.5-months, 4-months, 4.5-months, 5-months, 6-months, 7-months, 8-months

  • Implementation Outcome: Fidelity and Sustainment - Self Report

    A self-report fidelity rating scale will be used to capture adherence to delivering core PGD practices as planned. Educators will complete the rating scale at the mid-year and end-of-year assessments. Minimum Score 0, Maximum Score 4. Higher Scores mean better outcome.

    4-months, 8-months

  • Implementation Outcome: Reach

    Reach will be computed using the fidelity data to determine the proportion of students who are receiving PGD practices. The number of general education teachers who are implementing PGD divided by the total number of teachers who have received PGD training.

    9-months

  • Implementation Outcome: Facilitators and Barriers to Implementation

    A qualitative interview for HELM participants will explore: (1) potential changes to HELM (e.g., "What parts of HELM could be improved to increase its appropriateness to schools?"); (2) opportunity costs of participating (e.g., "Were there any activities you wanted to do but could not because of participation in HELM?"); and (3) unintended consequences.

    9-months

  • Implementation Outcome: Implementation Cost

    Costs of (1) delivering the HELM intervention to augment PGD implementation, as well as (2) implementation as usual, will be calculated using standard average weighted cost metrics. Inputs will include time, supplies, travel, overhead, and costs associated with HELM training/coaching meetings, including pre-work, scheduling, and attending meetings.

    9-months

Secondary Outcomes (2)

  • Student Educational Outcomes

    9-months

  • Student Behavioral Outcomes

    4-months, 8-months

Study Arms (2)

HELM

EXPERIMENTAL

Behavioral: HELM HELM is a 9-month, data-driven organizational and leadership implementation strategy.

Behavioral: HELM

Implementation Attention Control (IAC)

PLACEBO COMPARATOR

Behavioral: Implementation Attention Control (IAC) Schools assigned to the IAC condition received an online, self-paced, independent studies program broadly focused on leadership and management.

Behavioral: Implementation Attention Control (IAC)

Interventions

HELMBEHAVIORAL

HELM is a 9-month, data-driven organizational and leadership implementation strategy that entails eight core components: 1) Assessment and Feedback. 2) Initial Training. 3) Leadership Development Plan. 4) Individual Coaching. 5) Group Coaching. 6) Organizational Strategy Development. 7) Professional Learning Collaboratives. 8) Graduation.

HELM

Schools assigned to the IAC condition received an online, self-paced, independent studies program broadly focused on leadership and management. The program did not specifically discuss implementation leadership or climate. The program included four content modules hosted on a web-based learning portal: 1) Motivating and Engaging Employees, 2) Authentic Leadership, 3) Managing Diverse Teams, and 4) Fostering an Idea Culture. Each module consisted of one content-specific 60-minute webinar.

Implementation Attention Control (IAC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being a K-5th elementary school
  • Being a K-5th principal or assistant principal at an elementary school
  • Being a K-5th grade teacher, paraeducator, or specialist (e.g., reading) at an elementary school, and not a teacher in a special education-only classroom

You may not qualify if:

  • School building or teacher that is currently implementing PGD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington School Mental Health Assessment, Research, and Training (SMART) Center

Seattle, Washington, 98115-8160, United States

Location

Related Publications (1)

  • Locke J, Corbin CM, Goosey R, Collins VK, Ehrhart MG, Hatch K, Espeland C, Lyon AR. Not getting better but not getting worse: A cluster randomized controlled pilot trial of a leadership implementation strategy. Implement Res Pract. 2025 Jan 29;6:26334895241312405. doi: 10.1177/26334895241312405. eCollection 2025 Jan-Dec.

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Aaron Lyon, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2024

First Posted

April 1, 2024

Study Start

August 28, 2022

Primary Completion

June 1, 2023

Study Completion

June 7, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Data obtained during the HELM study will be provided to researchers who have demonstrated an academic interest in educational services, in-school mental health services, or in implementation sciences. Outside investigators who wish to use the data set to answer new research questions may also submit data analysis concept proposals for consideration by the PI on a case-by-case basis. The PI will review the proposal and will provide those who submit scientifically rigorous and promising proposals access to the data repository to address their research questions. This will ensure that the data resources of the proposed study will provide the greatest possible benefit to the scientific community. Data samples that may be shared will be coded based on study design, and all personal health and identifying will be removed. Prerequisite to data sharing, the PI will require applicable agreements (i.e., data transfer agreements) with the requesting entity.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data requests can be submitted to the PI starting 6 months after initial publication of the primary findings. The PI will continue to accept requests for those findings for 24 months following the end-date of the awarded grant.
Access Criteria
Access to study data can be requested by any qualified researchers who are engaging in independent scientific research, with approval dictated by the PI. Acceptance of data sharing will only be done following review of a sharing agreement.

Locations