Helping Educational Leadership Mobilize Evidence (HELM)

March 29, 2024 updated by: Aaron Lyon, University of Washington

Helping Educational Leadership Mobilize Evidence (HELM): An Organizational Intervention to Promote Strategic Implementation in Schools

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
333

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98115-8160
        • University of Washington School Mental Health Assessment, Research, and Training (SMART) Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • School building or teacher that is currently implementing PGD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HELM

Behavioral: HELM

HELM is a 9-month, data-driven organizational and leadership implementation strategy.
Behavioral: HELM
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.
Placebo Comparator: Implementation Attention Control (IAC)

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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proximal Outcome: Strategic Implementation Leadership
Time Frame: Baseline, 4-months, 8-months
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
Time Frame: Baseline, 4-months, 8-months
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
Time Frame: Baseline, 4-months, 8-months
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
Time Frame: Baseline, 4-months, 8-months
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
Time Frame: 2-months, 2.5-months, 3-months, 3.5-months, 4-months, 4.5-months, 5-months, 6-months, 7-months, 8-months
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
Time Frame: 4-months, 8-months
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
Time Frame: 9-months
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
Time Frame: 9-months
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
Time Frame: 9-months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Student Educational Outcomes
Time Frame: 9-months
Schools will complete a survey on student educational outcomes for the year, including questions related to grades (GPA) and standardized test scores. There is no reporting on a scale.
9-months
Student Behavioral Outcomes
Time Frame: 4-months, 8-months
Modified Direct Behavior Rating Scale - A modified version of the Direct Behavior Rating Scale will be given to educators to assess their classroom's on-task behavior, prosocial behavior, ability to follow directions the first time, and disruptive behavior. These questions all are part of the same scale that ask the proportion of time their students spent doing each in the first five minute of class (0-100%) and proportion of time their students spent doing each the whole day (0-100%).
4-months, 8-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aaron Lyon, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 28, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00010282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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