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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06340074
Other study ID # STUDY00010282
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 28, 2022
Est. completion date June 7, 2023

Study information

Verified date March 2024
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date June 7, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Washington School Mental Health Assessment, Research, and Training (SMART) Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. 9-months
Secondary 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%). 4-months, 8-months
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