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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05574764
Other study ID # PRO00111936
Secondary ID OT2HD107559
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2022
Est. completion date October 3, 2023

Study information

Verified date November 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date October 3, 2023
Est. primary completion date October 3, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Cultivating Awareness and Resilience in Education (CARE)
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.

Locations

Country Name City State
United States Caldwell County Schools Lenoir North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluate the change in teachers' perceptions of student instruction and behavior management after completing the CARE workshop using the CARE for Teachers and Staff Professional Development Program scale. The Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale measures change in participants' resiliency and their perception of children's behavior/performance and program after completing CARE. Scores are calculated for four subscales. All subscales have a min score of 1 and max score of 5. Resiliency subscale: A higher score is a better outcome (resiliency skills improved). A lower score is a worse outcome (resiliency skills declined). Recommend subscale: A higher score is a better outcome (CARE is recommended). A lower score reflects a worse outcome (CARE is not recommended). The Behavior subscale: A higher score is a better outcome (positive change in children's behavior). A lower score is a worse outcome (negative change in children's behavior). The Academic subscale: A higher score is a better outcome (positive change in children's academic performance). A lower score is a worse outcome (negative change in children's academic performance). 1 week post intervention, 2 months post intervention
Other Evaluate the change in non-administrative staff's perceptions of student instruction and behavior management after completing the CARE workshop using the CARE for Teachers and Staff Professional Development Program scale. The Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale measures change in participants' resiliency and their perception of children's behavior/performance and program after completing CARE. Scores are calculated for four subscales. All subscales have a min score of 1 and max score of 5. Resiliency subscale: A higher score is a better outcome (resiliency skills improved). A lower score is a worse outcome (resiliency skills declined). Recommend subscale: A higher score is a better outcome (CARE is recommended). A lower score reflects a worse outcome (CARE is not recommended). The Behavior subscale: A higher score is a better outcome (positive change in children's behavior). A lower score is a worse outcome (negative change in children's behavior). The Academic subscale: A higher score is a better outcome (positive change in children's academic performance). A lower score is a worse outcome (negative change in children's academic performance). 1 week post intervention, 2 months post intervention
Other Evaluate the change in administrative staff's perceptions of student instruction and behavior management after completing the CARE workshop using the CARE for Teachers and Staff Professional Development Program scale. The Cultivating Awareness and Resilience in Education (CARE) Professional Development (PD) scale measures change in participants' resiliency and their perception of children's behavior/performance and program after completing CARE. Scores are calculated for four subscales. All subscales have a min score of 1 and max score of 5. Resiliency subscale: A higher score is a better outcome (resiliency skills improved). A lower score is a worse outcome (resiliency skills declined). Recommend subscale: A higher score is a better outcome (CARE is recommended). A lower score reflects a worse outcome (CARE is not recommended). The Behavior subscale: A higher score is a better outcome (positive change in children's behavior). A lower score is a worse outcome (negative change in children's behavior). The Academic subscale: A higher score is a better outcome (positive change in children's academic performance). A lower score is a worse outcome (negative change in children's academic performance). 1 week post intervention, 2 months post intervention
Primary Evaluate the change in the self-effectiveness of teachers after completion of the CARE workshop using the Teachers' Sense of Efficacy Scale. 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 12 to 108, 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
Primary Evaluate the change of burnout syndrome in teachers after completion of the CARE workshop using the Maslach Burnout Inventory. 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 (P), and personal accomplishment (PA). The EE subscale has a minimum score of 0 and maximum score of 6. 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 6. 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 6. 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
Primary Evaluate the change of burnout syndrome in non-administrative staff after completion of the CARE workshop using the Maslach Burnout Inventory. 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 (P), and personal accomplishment (PA). The EE subscale has a minimum score of 0 and maximum score of 6. 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 6. 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 6. 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
Primary Evaluate the change of burnout syndrome in administrative staff after completion of the CARE workshop using the Maslach Burnout Inventory. 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 (P), and personal accomplishment (PA). The EE subscale has a minimum score of 0 and maximum score of 6. 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 6. 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 6. 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
Primary Evaluate the change of anxiety in teachers after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale. 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 7 to 28, 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
Primary Evaluate the change of anxiety in non-administrative staff after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale. 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 7 to 28, 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
Primary Evaluate the change of anxiety in administrative staff after completion of the CARE workshop using the Generalized Anxiety Disorder 7 (GAD7) scale. 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 7 to 28, 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
Primary Evaluate the change of depression in teachers after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale. The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms. Scores range from 8 to 32, 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
Primary Evaluate the change of depression in non-administrative staff after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale. The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms. Scores range from 8 to 32, 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
Primary Evaluate the change of depression in administrative staff after completion of the CARE workshop using the Patient Health Questionnaire 8 (PHQ-8) scale. The Patient Health Questionnaire 8 (PHQ-8) scale is used to provide a brief report on depression symptoms. Scores range from 8 to 32, 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
Primary Evaluate the change of stress in teachers after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale. 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 1 and maximum score of 5. 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
Primary Evaluate the change of stress in non-administrative staff after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale. 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 1 and maximum score of 5. 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
Primary Evaluate the change of stress in administrative staff after completion of the CARE workshop using the Perceived Stress Scale (PSS) scale. 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 1 and maximum score of 5. 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
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