Behavior, ChildHELMNCT06340074
Helping Educational Leadership Mobilize Evidence
A study testing HELM in people with Behavior, Child, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child
- What is being tested?
- HELM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2022to 7 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- School building or teacher that is currently implementing PGD
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School Mental Health Assessment, Research, and Training (SMART) Center
Seattle, Washington, 98115-8160
About this study
Official title: 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.
- Conditions
- Behavior, Child
- Being tested
- HELM, Implementation Attention Control (IAC)
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HELMBehavioural
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.
Implementation Attention Control (IAC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| HELM | Experimental | Behavioral: HELM
HELM is a 9-month, data-driven organizational and leadership implementation strategy. Receives: 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. Receives: Behavioral: Implementation Attention Control (IAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 9-months
Secondary outcomes (2)
Student Educational Outcomes
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.
Measured: 9-months
Student Behavioral Outcomes
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%).
Measured: 4-months, 8-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start28 Aug 2022
- Primary completion1 Jun 2023
- Study completion7 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Lyon, University of Washington
- Investigators
- Aaron Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340074
- Sponsor's protocol ID
- STUDY00010282
- Acronym
- HELM
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39881952
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Educational Leadership Mobilize Evidence (HELM): An Organizational Intervention to Promote Strategic Implementation in Schools
- ClinicalTrials.gov ID
- NCT06340074
- Acronym / sponsor ID
- HELM / STUDY00010282
- Conditions
- Behavior, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 28 Aug 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 7 Jun 2023 (actual)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HELM | Experimental | Behavioral: HELMBehavioral: HELM HELM is a 9-month, data-driven organizational and leadership implementation strategy. |
| Implementation Attention Control (IAC) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- School building or teacher that is currently implementing PGD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HELMHELM 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. | Behavioural | HELM |
| 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. | Behavioural | Implementation Attention Control (IAC) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Student Educational Outcomes
Time frame: 9-months
Student Behavioral Outcomes
Time frame: 4-months, 8-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 39881952Locke 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron Lyon, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HELM in people with Behavior, Child, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Outcome: Strategic Implementation Leadership (time frame: Baseline, 4-months, 8-months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06340074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024; AzTrials last refreshed its copy on 3 Nov 2026.