Child DevelopmentHELM 2NCT06586723
Impact Trial of Helping Educational Leaders Mobilize Evidence
A study testing PBIS and HELM in people with Child Development and Child Behavior, run by University of Washington at 1 site in United States.
Trial summary
Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Behavior
- What is being tested?
- PBIS and HELM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- School Districts: School districts in Washington State committed to implementing PBIS in its elementary schools
- Educators: Educators working in a public elementary school within an enrolled school district.
Who cannot join
- Schools with previous HELM exposure will be excluded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marissa Thirion contact
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98105
Jill Locke, PhD, 206-616-6703, jjlocke@uw.edu
Aaron Lyon, PhD
About this study
Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS).
- Conditions
- Child Development, Child Behavior
- Being tested
- PBIS, HELM
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBISBehavioural
Positive Behavioral Interventions and Supports (PBIS) is an evidence-based, multi-tiered, problem-solving, and team-based framework designed to build a continuum of supports to promote all students' social emotional behavioral health.
HELMOther
Helping Educational Leaders Mobilize Evidence (HELM) is an implementation strategy for promoting building-level implementation leadership, implementation climate, and high-fidelity delivery of evidence-based practices
| Study group | Role | What they receive |
|---|---|---|
| PBIS | Active comparator | Positive Behavioral Interventions and Supports (PBIS) is an evidence-based, multi-tiered, problem-solving, and team-based framework designed to build a continuum of supports to promote all students' social emotional behavioral health. Receives: Behavioral: PBIS |
| HELM | Experimental | Helping Educational Leaders Mobilize Evidence (HELM) is an implementation strategy for promoting building-level implementation leadership, implementation climate, and high-fidelity delivery of evidence-based practices Receives: Behavioral: PBIS; Other: HELM |
What is being measured
The primary outcome is the main question the study is designed to answer.
PBIS Fidelity (Tiered Fidelity Inventory)
The Tiered Fidelity Inventory (TFI) is a 45-item tool used to provide a valid, reliable, and efficient measure of the extent to which school personnel are applying the core features of PBIS. The TFI is a group-assessment completed by a schoolwide system planning team with external facilitation with strong internal consistency. The scoring criteria for each individual item ranges from 0-3 (0=Not Implemented, 1=Partially Implemented, 3=Fully Implemented); higher scores indicate better outcome.
Measured: Baseline, 9 months, 12 months
Secondary outcomes (8)
Implementation Leadership: School Implementation Leadership Scale (SILS)
The SILS has 24 items loading onto 8 subscales: Proactive, Knowledgeable, Supportive, Perseverant, Communication, Vision, Available, and Distributed Leadership. The scoring criteria for each individual item ranges from 0-4; higher scores indicate better outcome.
Measured: Baseline, 9 months, 12 months
Implementation Climate: School Implementation Climate Scale (SICS)
The SICS includes 21 items loading onto 7 subscales: Focus on EBP, Educational Support for EBP, Recognition for EBP, Rewards for EBP, Use of Data to Support EBP, Existing Supports for EBP, and EBP Integration. The scoring criteria for each individual item ranges from 0-4; higher scores indicate better outcome.
Measured: Baseline, 9 months, 12 months
Implementation Cost
This survey asks educators how much time they spent on study-related procedures each week. Inputs will include time, supplies, travel, overhead, and costs associated with HELM training/coaching meetings, including pre-work, scheduling, and attending meetings; as well as costs associated with PBIS training and delivery.
Measured: Baseline, 9 months, 12 months
Academic Engagement, Prosocial Behavior, and Problem Behavior: Modified Direct Behavior Rating (DBR)
The DBR will be used in which teachers observe and rate their classroom's overall academic engagement (i.e., actively or passively participating in the classroom activity, 0-100%), disruptive behavior (i.e., interrupting activities, 0-100%), and prosocial behavior (i.e., following directions, 0-100%; Chafouleas et al., 2012).
Measured: Baseline, 9 months, 12 months
Student Academic Outcomes
Standardized academic test scores will be derived from administrative records.
Measured: Baseline, 9 months, 12 months
Student Disciplinary Incidents
Number of office discipline referrals, suspensions, and expulsions will be derived from administrative records.
Measured: Baseline, 9 months, 12 months
Student Attendance Rates
Student attendance rates will be derived from administrative records.
Measured: Baseline, 9 months, 12 months
HELM Fidelity
As a manipulation check to document HELM intervention delivery, we will assess HELM fidelity using the HELM fidelity checklist (based on observations of recorded HELM trainings). HELM coaches will complete a standardized measure of dates specific steps were completed. Schools that achieve 80% or higher of the maximum possible score on all HELM fidelity criteria will be considered having received a full dose of HELM training and coaching.
Measured: Baseline, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
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 Child DevelopmentStudies 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
- Factorial
- Model description
- All schools that participate in the study will receive PBIS. Additionally, half of the schools will be randomized to receive HELM, an additional implementation support intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jill Locke, University of Washington
- Investigators
- Jill Locke, PhD, Principal investigator, University of WashingtonAaron Lyon, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586723
- Sponsor's protocol ID
- STUDY00020559
- Acronym
- HELM 2
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Locke J, Williams NJ, Sridhar A, Ehrhart MG, Dopp A, Thirion M, Espeland C, Riddle B, Schmitz K, Hatch K, Buehler L, Lyon AR. 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. Implement Sci. 2025 Apr 24;20(1):17. doi: 10.1186/s13012-025-01429-4.
PubMed 40275358
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Trial of Helping Educational Leaders Mobilize Evidence
- ClinicalTrials.gov ID
- NCT06586723
- Acronym / sponsor ID
- HELM 2 / STUDY00020559
- Conditions
- Child Development, Child Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 19 Sep 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.
Social, emotional, and behavioral (SEB) problems occur frequently among elementary school students, dramatically impede student outcomes, and have been exacerbated by the COVID-19 pandemic. Evidence based practices exist to address student SEB needs, prevent problems, and ensure academic success. However, the implementation of these programs in schools is frequently incomplete, uneven, and occurs with insufficient fidelity to ensure positive effects for students due to significant implementation barriers across multiple levels. The purpose of this Impact Trial is to test the effectiveness of the Helping Educational Leaders Mobilize Evidence (HELM) implementation strategy in school-wide implementation of a Tier 1 evidence-based practice (EBP) - Positive Behavioral Interventions and Supports (PBIS).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All schools that participate in the study will receive PBIS. Additionally, half of the schools will be randomized to receive HELM, an additional implementation support intervention.
| Arm | Type | Receives |
|---|---|---|
| PBIS | Active comparator | Behavioral: PBISPositive Behavioral Interventions and Supports (PBIS) is an evidence-based, multi-tiered, problem-solving, and team-based framework designed to build a continuum of supports to promote all students' social emotional behavioral health. |
| HELM | Experimental | Behavioral: PBIS, Other: HELMHelping Educational Leaders Mobilize Evidence (HELM) is an implementation strategy for promoting building-level implementation leadership, implementation climate, and high-fidelity delivery of evidence-based practices |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- School Districts: School districts in Washington State committed to implementing PBIS in its elementary schools
- Educators: Educators working in a public elementary school within an enrolled school district.
Key exclusion criteria (1 listed)
- Schools with previous HELM exposure will be excluded
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 |
|---|---|---|
| PBISPositive Behavioral Interventions and Supports (PBIS) is an evidence-based, multi-tiered, problem-solving, and team-based framework designed to build a continuum of supports to promote all students' social emotional behavioral health. | Behavioural | HELM, PBIS |
| HELMHelping Educational Leaders Mobilize Evidence (HELM) is an implementation strategy for promoting building-level implementation leadership, implementation climate, and high-fidelity delivery of evidence-based practices | Other | HELM |
Primary outcome
PBIS Fidelity (Tiered Fidelity Inventory)
Time frame: Baseline, 9 months, 12 months
The Tiered Fidelity Inventory (TFI) is a 45-item tool used to provide a valid, reliable, and efficient measure of the extent to which school personnel are applying the core features of PBIS. The TFI is a group-assessment completed by a schoolwide system planning team with external facilitation with strong internal consistency. The scoring criteria for each individual item ranges from 0-3 (0=Not Implemented, 1=Partially Implemented, 3=Fully Implemented); higher scores indicate better outcome.
8 secondary outcomes
Implementation Leadership: School Implementation Leadership Scale (SILS)
Time frame: Baseline, 9 months, 12 months
Implementation Climate: School Implementation Climate Scale (SICS)
Time frame: Baseline, 9 months, 12 months
Implementation Cost
Time frame: Baseline, 9 months, 12 months
Academic Engagement, Prosocial Behavior, and Problem Behavior: Modified Direct Behavior Rating (DBR)
Time frame: Baseline, 9 months, 12 months
Student Academic Outcomes
Time frame: Baseline, 9 months, 12 months
Student Disciplinary Incidents
Time frame: Baseline, 9 months, 12 months
Student Attendance Rates
Time frame: Baseline, 9 months, 12 months
HELM Fidelity
Time frame: Baseline, 9 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40275358Locke J, Williams NJ, Sridhar A, Ehrhart MG, Dopp A, Thirion M, Espeland C, Riddle B, Schmitz K, Hatch K, Buehler L, Lyon AR. 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. Implement Sci. 2025 Apr 24;20(1):17. doi: 10.1186/s13012-025-01429-4.
- Individual participant dataSharing planned: No
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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.
Marissa Thirion contact
Jill Locke, PhD principal investigator
University of Washington
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 PBIS and HELM in people with Child Development and Child Behavior, 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 2 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: looking for participants now, as of the sponsor's last update on 30 Mar 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jill Locke, PhD (206-616-6703, jjlocke@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PBIS Fidelity (Tiered Fidelity Inventory) (time frame: Baseline, 9 months, 12 months). 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 NCT06586723, 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 30 Mar 2025.