- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06340074
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
333
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: HELM
Behavioral: HELM HELM is a 9-month, data-driven organizational and leadership implementation strategy. |
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. |
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
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
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
Investigators
- 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)
August 28, 2022
Primary Completion (Actual)
June 1, 2023
Study Completion (Actual)
June 7, 2023
Study Registration Dates
First Submitted
March 21, 2024
First Submitted That Met QC Criteria
March 29, 2024
First Posted (Actual)
April 1, 2024
Study Record Updates
Last Update Posted (Actual)
April 1, 2024
Last Update Submitted That Met QC Criteria
March 29, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID 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.
Clinical Trials on Behavior, Child
-
Marmara UniversityCompleted
-
University of New MexicoActive, not recruitingChild Abuse | Parenting | Child Behavior | Child Development | Delinquency | Criminal Behavior | Child NeglectUnited States
-
Boston Medical CenterValhalla Foundation; Centering Healthcare Institute; Overdeck Family foundationRecruitingParent-Child Relations | Parenting | Child Behavior | Child DevelopmentUnited States
-
University of WashingtonEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingParent-Child Relations | Parenting | Child Behavior | Child MaltreatmentUnited States
-
Nigde Omer Halisdemir UniversityRecruitingInfant Behavior | Father - Child RelationsTurkey (Türkiye)
-
University of OregonCompleted
-
Children's Hospital of PhiladelphiaPNC FoundationTerminatedChild Behavior | Child Development | Child Behavior ProblemUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Active, not recruiting
-
Rutgers, The State University of New JerseyEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedParenting | Language Development | Behavior, Child | LiteracyUnited States
-
University of Southern CaliforniaSafe Water and AIDS Project; Early Childhood Development Network for Kenya...Active, not recruitingChild Behavior | Child Development | Language, ChildKenya
Clinical Trials on HELM
-
University of WashingtonRecruitingChild Behavior | Child DevelopmentUnited States
-
Rigshospitalet, DenmarkUnknown
-
University of California, Los AngelesUniversity of WashingtonRecruitingAutism Spectrum Disorder (ASD)United States