NCT05621603

Brief Summary

School leaders, staff, and teachers are tasked with keeping children safe from acts of violence, natural hazards and other emergencies while encouraging learning. Disaster plans are often developed without teacher involvement, resulting in limited knowledge of emergency preparedness, undermining buy-in and limited motivation to comply with safety protocols, including disaster drills. The lack of initial consultation and limited decision-making authority can also be sources of stress for teachers. Teachers and staff may experience anxiety about their roles and responsibilities in a crisis. This research project proposes that the key to enhancing emergency preparedness in this population is to incorporate 'psychological preparedness' within a disaster management framework. In other words, to provide the school workforce with awareness of their likely psychological response to threat and coping skills/strategies for management of that response. Importantly, workforce-focused mental health integrated approaches to emergency preparedness are likely to work best if implemented via peer support and shared leadership frameworks. This project involves adaptation and implementation of an integrated workforce mental health intervention into Pre-K-12 school emergency preparedness via shared leadership and peer support. This includes co-creating training curriculum with Pre-K-12 schools, labor organizations, and district officials, implementing and evaluating the impact of the intervention. A matched waitlist control comparison research design will be used with six Pre-K-12 schools. The hypothesized outcomes of the intervention are increases in H1: emergency preparedness climate; emergency preparedness specific H2: shared leadership; H3: peer support and social cohesion; H4: confidence (in emergency preparedness); and H5: psychological preparedness. The project also anticipates H6: increases in overall mental health and well-being, and H7: a reduction in emergency preparedness-specific burnout.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
519

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 4, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

November 4, 2022

Last Update Submit

February 5, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Psychological Preparedness (measuring change from pre to post intervention)

    This section has been adapted from existing sources. Examples of specific Psychological Preparedness Items are detailed below - * I am confident that I can perform the necessary actions in an emergency/high stress situation. * I am knowledgeable about the impact that emergencies/high stress situations can have on a person's ability to respond as they would like. All items are associated with a 5 point response scale from Strongly Disagree to Strongly Agree (higher scores = greater agreement). Individual items will be examined. A composite scale may be produced based on measures of internal consistency.

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Emergency Preparedness Climate (measuring change from pre to post intervention)

    This section has been adapted from existing sources. Examples of specific Emergency Preparedness Climate Items are below - * My school provides a clear vision for emergency preparedness at work * My school tries to continually improve emergency preparedness All items are associated with a 5 point response scale from Strongly Disagree to Strongly Agree (higher scores = greater agreement). Individual items will be examined. A composite scale may be produced based on measures of internal consistency.

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Shared leadership for Emergency Preparedness (measuring change from pre to post intervention)

    This section has been adapted from existing sources. Examples of specific Shared Leadership for Emergency Preparedness Items are below - School employees - * behave in a way that displays a commitment to emergency preparedness * provide a clear vision for emergency preparedness All items are associated with a 5 point response scale from Strongly Disagree to Strongly Agree (higher scores = greater agreement). Individual items will be examined. A composite scale may be produced based on measures of internal consistency.

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Peer Support and Social Cohesion associated with Emergency Preparedness (measuring change from pre to post intervention)

    This section has been adapted from existing sources. Examples of specific Peer Support and Social Cohesion Items associated with Emergency Preparedness Items below - School employees - * help each other to prepare for emergencies in concrete ways * help each other to prepare for emergencies in emotionally supportive ways All items are associated with a 5 point response scale from Strongly Disagree to Strongly Agree (higher scores = greater agreement). Individual items will be examined. A composite scale may be produced based on measures of internal consistency.

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Confidence in Emergency Preparedness (measuring change from pre to post intervention)

    All items related to 'confidence in district and school-level emergency preparedness' are below - * I am confident that my school district has prepared me to respond to a real emergency at my school. * I am confident that I can respond to a real emergency at my school. All items are associated with a response scale of not at all confident to very confident, 5 point scale (higher scores = greater confidence). Individual items will be examined. A composite scale may be produced based on measures of internal consistency.

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

Secondary Outcomes (6)

  • Stress/Work Stress (measuring change from pre to post intervention)

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Depression (measuring change from pre to post intervention)

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Anxiety (measuring change from pre to post intervention)

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Post-traumatic stress disorder (measuring change from pre to post intervention)

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • Mental well-being (measuring change from pre to post intervention)

    Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented

  • +1 more secondary outcomes

Study Arms (2)

Training

EXPERIMENTAL

Participants receive the intervention, which is a training program.

Behavioral: Training

Control

NO INTERVENTION

Participants do NOT receive the intervention, which is a training program. This is a waitlist control comparison model.

Interventions

TrainingBEHAVIORAL

The proposed intervention for the school workforce draws on a mental health integrated disaster preparedness model, emphasizing peer support, developed and used successfully by our team working with communities experiencing multiple disasters. The 3 hour training is comprised of 4 modules - Module 1: Emergency Preparedness Module 2: Psychological Preparedness Module 3: Peer Support Module 4: Shared Leadership and Feedback Session

Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-K-12 schools, including school leadership, teacher, and staff

You may not qualify if:

  • Schools other than Pre-K-12
  • Only adults are enrolled in this workforce-focused study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Psychological Well-BeingBurnout, Psychological

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorStress, PsychologicalBehavioral Symptoms

Study Officials

  • Courtney Welton-Mitchell, PhD

    Colorado School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: We will employ a matched waitlist control comparison design. Schools (6) will be randomly assigned to either the training arm or the control arm. Schools assigned to the control arm will eventually receive the training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

November 4, 2022

First Posted

November 18, 2022

Study Start

November 2, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

All participant survey data collected by the researchers will be made available in a timely manner upon written request.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available upon study completion in August 2023 and will be stored in the longer term for three years after the study concludes, per federal regulations.
Access Criteria
Files with de-identified data will be transferred via electronic format using a secure electronic file transfer along with a statement of data use standards. Documentation of data use standards will be included. To protect our participants we will make the data and its associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Locations