Mental Health Clinical Trial
Official title:
Adapting and Testing an Intervention to Integrate Workforce Mental Health Into Pre-K-8 School Emergency Preparedness Via Shared Leadership and Peer Support
NCT number | NCT05621603 |
Other study ID # | 21-4190 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2, 2022 |
Est. completion date | June 1, 2023 |
Verified date | February 2024 |
Source | Colorado School of Public Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 519 |
Est. completion date | June 1, 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: - Pre-K-12 schools, including school leadership, teacher, and staff Exclusion Criteria: - Schools other than Pre-K-12 Only adults are enrolled in this workforce-focused study |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Anschutz Medical Campus | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado School of Public Health | National Institute for Occupational Safety and Health (NIOSH/CDC) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Stress/Work Stress (measuring change from pre to post intervention) | All items related to 'perceived stress at work' are below - -Please check the number that describes how much stress/distress you have been experiencing in the past week, including today.
Scale is 0-10 with 10 = greater stress/distress -Please share how much job-related stress you have been feeling in the past two weeks. Response scale is 5 point, from none to very much (higher scores = more stress). Individual items will be examined. |
Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented | |
Secondary | Depression (measuring change from pre to post intervention) | All items related to 'depression' are below -
I have felt little interest or pleasure in doing things. I have felt down, depressed, or hopeless. 4-point scale: 1-not at all, 2-several, 3-more than half, 4-nearly every day (higher scores = greater symptoms). 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 | Anxiety (measuring change from pre to post intervention) | All items related to 'anxiety' are below -
I have felt nervous, anxious or on edge. I have not been able to stop or control worrying. I have been worrying too much about different things. I have had trouble relaxing. I have been so restless that it is hard to sit still. I have become easily annoyed or irritable. I have been feeling anxious about the potential for an emergency to happen at my job. I have felt afraid, as if something awful might happen. 4-point scale: 1-not at all, 2-several, 3-more than half, 4-nearly every day (higher scores = greater symptoms). 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 | Post-traumatic stress disorder (measuring change from pre to post intervention) | All items related to 'PTSD' are below -
I have been feeling jumpy or easily startled I have been having repeated, disturbing and unwanted memories of a stressful or traumatic event. I have been avoiding external reminders of a stressful or traumatic event (for example, people, places, activities, conversations, activities, objects or situations). I have been having strong negative beliefs about myself, other people or the world. 4-point scale: 1-not at all, 2-several, 3-more than half, 4-nearly every day (higher scores = greater symptoms). 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 | Mental well-being (measuring change from pre to post intervention) | Single item measure - How would you rate your overall mental health and wellbeing? Excellent, Very Good, Good, Fair, Poor, with higher scores indicating worse mental health | Immediately prior to intervention with follow-up approximately 2-4 weeks after the intervention is implemented | |
Secondary | Burnout (measuring change from pre to post intervention) | All items related to 'burnout' are below, adapted from existing measures. Considering this definition (definition provided), please share how much burnout you are feeling related to your job in the past two weeks.
I have been thinking about quitting my job. I've been feeling optimistic about the future related to my job. I've been dealing with problems well at my job. I've been thinking clearly at my job. I've been feeling good about myself at my job. 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT04108689 -
Internet-based Acceptance and Commitment Training for Elite Ice Hockey Players
|
N/A | |
Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
Recruiting |
NCT05227352 -
Bio-Experiential Spaces for Mental Health in Healthworkers
|
N/A | |
Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
Completed |
NCT02157766 -
Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
|
N/A | |
Completed |
NCT02480907 -
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
|
N/A | |
Completed |
NCT01155687 -
Psychosocial Counseling in Afghanistan
|
N/A | |
Unknown status |
NCT01177696 -
Intervention in Groups of Family Caregivers in Primary Health Care
|
N/A | |
Completed |
NCT01037946 -
Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
|
N/A | |
Completed |
NCT00700349 -
Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa
|
N/A | |
Recruiting |
NCT03885401 -
Enhanced Care Planning for Patients With Multiple Chronic Conditions
|
N/A | |
Completed |
NCT03118388 -
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
|
Phase 2 | |
Completed |
NCT05061966 -
The Digital Wellbeing Project
|
N/A | |
Completed |
NCT04026308 -
Written vs Electronic Safety Planning Study
|
N/A | |
Completed |
NCT04546061 -
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
|
N/A | |
Completed |
NCT05738109 -
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
|
N/A | |
Completed |
NCT03901274 -
Partnering for Student Wellness
|
N/A | |
Not yet recruiting |
NCT05910580 -
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
|
N/A |