- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05574764
ABC Mental Health: A Behavioral Study of K-12 Teachers and School Staff
This study looks at school employees' mental health, well-being, and effectiveness before and after completing a professional development workshop. The participants' schools are offering the Cultivating Awareness and Resilience in Education (CARE) professional development workshop to all teachers, staff, and administrators. CARE will be presented in three in-person training sessions over two to three months during the school year.
People who participate in CARE are asked to answer questions about their demographic information, mental health, well-being, and effectiveness before the workshop and two times after completing the workshop. This consent form provides the necessary information for people interested in answering these questions to make an informed decision. This consent form is not for the professional development workshop. Taking part in the workshop and questionnaires is optional.
This study is being conducted because teachers, school staff, and children's mental health has declined since the beginning of the COVID-19 pandemic. The investigators hope to use information collected in this study to tell schools, local public health officials, and state leaders how best to support teachers' mental health and well-being.
There are minimal risks associated with this study. The greatest risk of this study is loss of confidentiality.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Lenoir, North Carolina, United States, 28645
- Caldwell County Schools
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult participant, defined as an adult (18 years or older) employed by a school working with youth in kindergarten through 12th grade.
- Fluent in the English language
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Teachers
This cohort includes K-12 teachers.
Schools will offer all teachers the professional development program called Cultivating Awareness and Resilience in Education (CARE) .
CARE will be presented in three in-person training sessions over two to three months during the school year.
Tools include mindful awareness practices and caring and emotion skills training.
Each intervention workshop includes 30 to 35 participants and a facilitator, who is part of the CARE team.
The workshops will be held at a location selected by the school, likely on their campus.
|
CARE provides teachers and staff with tools and resources to reduce stress, prevent burnout, enliven teaching, and help students thrive socially, emotionally, and academically.
CARE blends instruction with experiential activities, reflection, and discussion.
|
|
Active Comparator: Staff, Non-Administrative
This cohort includes non-administrative staff.
Schools will offer all non-administrative staff the professional development program called Cultivating Awareness and Resilience in Education (CARE) .
CARE will be presented in three in-person training sessions over two to three months during the school year.
Tools include mindful awareness practices and caring and emotion skills training.
Each intervention workshop includes 30 to 35 participants and a facilitator, who is part of the CARE team.
The workshops will be held at a location selected by the school, likely on their campus.
|
CARE provides teachers and staff with tools and resources to reduce stress, prevent burnout, enliven teaching, and help students thrive socially, emotionally, and academically.
CARE blends instruction with experiential activities, reflection, and discussion.
|
|
Active Comparator: Staff, Administrative
This cohort includes administrative staff.
Schools will offer all administrative staff the professional development program called Cultivating Awareness and Resilience in Education (CARE) .
CARE will be presented in three in-person training sessions over two to three months during the school year.
Tools include mindful awareness practices and caring and emotion skills training.
Each intervention workshop includes 30 to 35 participants and a facilitator, who is part of the CARE team.
The workshops will be held at a location selected by the school, likely on their campus.
|
CARE provides teachers and staff with tools and resources to reduce stress, prevent burnout, enliven teaching, and help students thrive socially, emotionally, and academically.
CARE blends instruction with experiential activities, reflection, and discussion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the change in the self-effectiveness of teachers after completion of the CARE workshop using the Teachers' Sense of Efficacy Scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Teachers' Sense of Efficacy Scale is used for rating teachers' efficacy in engaging students, providing instructional strategies, and managing classrooms.
Total scores range from 1 to 9, with higher scores indicating a greater sense of efficacy.
Scores are also calculated for three subscales measuring engagement, instruction and management.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of burnout syndrome in teachers after completion of the CARE workshop using the Maslach Burnout Inventory.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Maslach Burnout Inventory - Educator Survey is used for assessing burnout by identifying how educators view their jobs and the individuals with who they work.
Scores are calculated for the three subscales measuring emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA).
The EE subscale has a minimum score of 0 and maximum score of 54.
A higher score on the EE subscale reflects a worse outcome, because it indicates that the participant is experiencing emotional exhaustion more frequently.
The DP subscale has a minimum score of 0 and maximum score of 30.
A higher score on the DP subscale reflects a worse outcome, because it indicates that the participant depersonalizes others more frequently.
The PA subscale has a minimum score of 0 and maximum score of 48.
A higher score on the PA subscale reflects a better outcome, because it indicates that the participant recognizes personal accomplishments more frequently.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of burnout syndrome in non-administrative staff after completion of the CARE workshop using the Maslach Burnout Inventory.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Maslach Burnout Inventory - Educator Survey is used for assessing burnout by identifying how educators view their jobs and the individuals with who they work.
Scores are calculated for the three subscales measuring emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA).
The EE subscale has a minimum score of 0 and maximum score of 54.
A higher score on the EE subscale reflects a worse outcome, because it indicates that the participant is experiencing emotional exhaustion more frequently.
The DP subscale has a minimum score of 0 and maximum score of 30.
A higher score on the DP subscale reflects a worse outcome, because it indicates that the participant depersonalizes others more frequently.
The PA subscale has a minimum score of 0 and maximum score of 48.
A higher score on the PA subscale reflects a better outcome, because it indicates that the participant recognizes personal accomplishments more frequently.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of burnout syndrome in administrative staff after completion of the CARE workshop using the Maslach Burnout Inventory.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Maslach Burnout Inventory - Educator Survey is used for assessing burnout by identifying how educators view their jobs and the individuals with who they work.
Scores are calculated for the three subscales measuring emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA).
The EE subscale has a minimum score of 0 and maximum score of 54.
A higher score on the EE subscale reflects a worse outcome, because it indicates that the participant is experiencing emotional exhaustion more frequently.
The DP subscale has a minimum score of 0 and maximum score of 30.
A higher score on the DP subscale reflects a worse outcome, because it indicates that the participant depersonalizes others more frequently.
The PA subscale has a minimum score of 0 and maximum score of 48.
A higher score on the PA subscale reflects a better outcome, because it indicates that the participant recognizes personal accomplishments more frequently.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of anxiety in teachers after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Generalized Anxiety Disorder 7 (GAD7) measures generalized anxiety traits and is primarily used with the Patient Health Questionnaire 8 (PHQ8) as a screening in health settings.
Scores range from 0 to 21, with higher scores indicating the respondent experienced increased frequency in anxiety-related symptoms.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of anxiety in non-administrative staff after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Generalized Anxiety Disorder 7 (GAD7) measures generalized anxiety traits and is primarily used with the Patient Health Questionnaire 8 (PHQ8) as a screening in health settings.
Scores range from 0 to 21, with higher scores indicating the respondent experienced increased frequency in anxiety-related symptoms.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of anxiety in administrative staff after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Generalized Anxiety Disorder 7 (GAD7) measures generalized anxiety traits and is primarily used with the Patient Health Questionnaire 8 (PHQ8) as a screening in health settings.
Scores range from 0 to 21, with higher scores indicating the respondent experienced increased frequency in anxiety-related symptoms.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of depression in teachers after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms.
Scores range from 0 to 24, with higher scores indicating that the respondent experiences depression related symptoms at a higher frequency.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of depression in non-administrative staff after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms.
Scores range from 0 to 24, with higher scores indicating that the respondent experiences depression related symptoms at a higher frequency.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of depression in administrative staff after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms.
Scores range from 0 to 24, with higher scores indicating that the respondent experiences depression related symptoms at a higher frequency.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of stress in teachers after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Perceived Stress Scale (PSS) scale measures the perception of stress by examining the degree to which situations in one's life are assessed as stressful.
The PSS scale has a minimum score of 0 and maximum score of 16.
A higher score on the PSS scale reflects a worse outcome, because it indicates that the participant perceives stress more frequently in their life.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of stress in non-administrative staff after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Perceived Stress Scale (PSS) scale measures the perception of stress by examining the degree to which situations in one's life are assessed as stressful.
The PSS scale has a minimum score of 0 and maximum score of 16.
A higher score on the PSS scale reflects a worse outcome, because it indicates that the participant perceives stress more frequently in their life.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
|
Evaluate the change of stress in administrative staff after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale.
Time Frame: Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
The Perceived Stress Scale (PSS) scale measures the perception of stress by examining the degree to which situations in one's life are assessed as stressful.
The PSS scale has a minimum score of 0 and maximum score of 16.
A higher score on the PSS scale reflects a worse outcome, because it indicates that the participant perceives stress more frequently in their life.
|
Prior to intervention (up to 1 month), 1 week post intervention, 2 months post intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the change in teachers' perceptions of self-resiliency and classroom management after completing the CARE workshop using the Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The CARE PD scale measures the participants' perceived changes in self-resiliency and classroom management after completing CARE.
The CARE Professional Development Program scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in resiliency skills and classroom management; a score of 3 indicates no change in resiliency skills and classroom management; a score of 1 or 2 indicates a decline in resiliency skills and classroom management.
|
1 week post intervention, 2 months post intervention
|
|
Evaluate the change in non-administrative staff's perceptions of self-resiliency and classroom management after completing the CARE workshop using the Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The CARE PD scale measures the participants' perceived changes in self-resiliency and classroom management after completing CARE.
The CARE Professional Development Program scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in resiliency skills and classroom management; a score of 3 indicates no change in resiliency skills and classroom management; a score of 1 or 2 indicates a decline in resiliency skills and classroom management.
|
1 week post intervention, 2 months post intervention
|
|
Evaluate the change in administrative staff's perceptions of self-resiliency and classroom management after completing the CARE workshop using the Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The CARE PD scale measures the participants' perceived changes in self-resiliency and classroom management after completing CARE.
The CARE Professional Development Program scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in resiliency skills and classroom management; a score of 3 indicates no change in resiliency skills and classroom management; a score of 1 or 2 indicates a decline in resiliency skills and classroom management.
|
1 week post intervention, 2 months post intervention
|
|
Evaluate the change in teachers' perceptions of students' behavior and academic performance after completing the CARE workshop using the Result of Cultivating Awareness and Resilience in Education (CARE) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The Result of CARE scale measures participants' perceived changes in students' behavior and academic performance after completing CARE.
The Result of CARE scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in student behavior and academic performance; a score of 3 indicates no change in student behavior and academic performance; a score of 1 or 2 indicates a decline in student behavior and academic performance.
|
1 week post intervention, 2 months post intervention
|
|
Evaluate the change in non-administrative staff's perceptions of students' behavior and academic performance after completing the CARE workshop using the Result of Cultivating Awareness and Resilience in Education (CARE) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The Result of CARE scale measures participants' perceived changes in students' behavior and academic performance after completing CARE.
The Result of CARE scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in student behavior and academic performance; a score of 3 indicates no change in student behavior and academic performance; a score of 1 or 2 indicates a decline in student behavior and academic performance.
|
1 week post intervention, 2 months post intervention
|
|
Evaluate the change in administrative staff's perceptions of students' behavior and academic performance after completing the CARE workshop using the Result of Cultivating Awareness and Resilience in Education (CARE) scale.
Time Frame: 1 week post intervention, 2 months post intervention
|
The Result of CARE scale measures participants' perceived changes in students' behavior and academic performance after completing CARE.
The Result of CARE scale has a min score of 1 and max score of 5: A score of 4 or 5 indicates an improvement in student behavior and academic performance; a score of 3 indicates no change in student behavior and academic performance; a score of 1 or 2 indicates a decline in student behavior and academic performance.
|
1 week post intervention, 2 months post intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emily D'Agostino, DPH, MS, MEd, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00111936
- OT2HD107559 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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