Behavior, Child Clinical Trial
— HELMOfficial title:
Helping Educational Leadership Mobilize Evidence (HELM): An Organizational Intervention to Promote Strategic Implementation in Schools
Verified date | March 2024 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington School Mental Health Assessment, Research, and Training (SMART) Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05525962 -
Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
|
||
Recruiting |
NCT05987761 -
PRT for Adolescents With High Functioning Autism
|
N/A | |
Active, not recruiting |
NCT05264415 -
Intergenerational Transmission of Traumatic Stress
|
N/A | |
Recruiting |
NCT05858593 -
Positive Youth Development in the Metaverse
|
N/A | |
Recruiting |
NCT04565210 -
Effects of Oriental Music on Preterm Infants
|
N/A | |
Completed |
NCT03728894 -
Oral Sedation With and Without Nitrous Oxide
|
Phase 3 | |
Active, not recruiting |
NCT04609553 -
Literacy Promotion for Latinos Study
|
N/A | |
Active, not recruiting |
NCT05403996 -
Effects of an Active Break Program at Primary School
|
N/A | |
Completed |
NCT05681832 -
Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency
|
N/A | |
Recruiting |
NCT05201534 -
Interventions in Mathematics and Cognitive Skills
|
N/A | |
Completed |
NCT03980067 -
Impact of Pre-Sedation Virtual Reality Game on Post-Discharge Negative Behaviors in the Pediatric Emergency Department
|
N/A | |
Enrolling by invitation |
NCT05189769 -
Reducing Racism and Discrimination in Schools: Comprehensive Prevention Services
|
N/A | |
Recruiting |
NCT06447909 -
Randomized Controlled Trial of a Behavioral Training App
|
N/A | |
Recruiting |
NCT04824989 -
Parents Advancing Toddler Health
|
N/A | |
Recruiting |
NCT05585905 -
Virtual Reality in Pediatric Dentistry
|
N/A | |
Completed |
NCT05302154 -
Effect of Virtual Reality on Dental Anxiety in Children
|
N/A | |
Completed |
NCT05592587 -
Pain and Anxiety Reduction Using a Vibrating Eye Massage Device With Relaxing Nature Sounds
|
N/A | |
Not yet recruiting |
NCT05839548 -
Articaine Efficacy and Safety for 3 Years Old Children
|
Phase 3 | |
Completed |
NCT04927754 -
Effect of Cartoon-assisted Visual/Auditory Distraction Method in Paediatric Dental Patients
|
N/A | |
Completed |
NCT04000230 -
Teacher Child Interaction Training (TCIT): Randomized Control Trial
|
N/A |