Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers
Primary Purpose
Occupational Stress, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Community of Support
Mentorship Incubator
Sponsored by
About this trial
This is an interventional prevention trial for Occupational Stress
Eligibility Criteria
Inclusion Criteria:
- classified as a beginning farmer by the USDA criteria
- has the ability to read and speak English;
- access to wi-fi or smartphone technology.
- primary residence or farm in Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford or Owen County, Kentucky
Exclusion Criteria:
- less than 18 years of age.
Sites / Locations
- University of Kentucky
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Interventional
Attention Control
Arm Description
The intervention group will participate in a round table educational session with a study facilitator/mentor farmer and occupational health nurse plus receive an invitation to participate in an interactive virtual community providing ongoing resources and support from community farmers and agriculture experts.
The second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction.
Outcomes
Primary Outcome Measures
Occupational Stress
Psychological stress as result of farming measured with the Farm Stressors Inventory, a 37 item self-report survey measuring potentially prevalent farm stressors. Items from the following categories of stressors are addressed in the assessment tool: personal finances, weather, regulatory climate, workload and other job demands, physical environment, control and ambiguity, interpersonal issues, and job and retirement security. The tool is comprised of a 1-5 likert scale of 37 items, higher scores indicating higher occupational stress related to farming.
Depressive symptoms
Depressive symptoms as measured with the 10-item short Beck Depression Inventory to detect moderate and severe depressive episodes. High sensitivity and negative predictive value (NPV) were obtained with a cut-off score of 9/10 (sensitivity = 100%, specificity = 83.1%, NPV = 100%). High sensitivity and positive predictive value (PPV) were obtained with a cut-off score of 13/14 (sensitivity = 93.5%, specificity = 96%, PPV = 85.3%). The area under the ROC curve was 98.4% (95% Confidence Interval = 0.97-1.00). This tool includes 10 items, each including four alternative statements ranging in order of severity from zero to three. For the short form ,higher scores indicate higher depression.
Secondary Outcome Measures
Self-Efficacy
Self-efficacy will be measured with the John Henry Active Coping Scale, a 12 item self-report survey measuring coping strategies associated with sustained cognitive and emotional stressors. The scale includes twelve items answered on a Likert Scale with responses ranging from 1 "completely false" to 5 "completely true." Sample items include, "hard work has really helped me to get ahead"; "it's not always easy, but I manage to find a way to do the things I really need to get done"; and "once I make up my mind to do something, I stay with it until the job is completely done." The items were summed, with higher scores indicating a higher degree of high-effort coping
Adherence to Intervention
Intervention fidelity will be monitored by the PI, who will ensure all research assistants and study facilitators follow the study protocol. Study participants assigned to the intervention will have adherence monitored by participation in the virtual community and at the face to face meeting.
Full Information
NCT ID
NCT04932018
First Posted
June 10, 2021
Last Updated
November 15, 2022
Sponsor
Martha Biddle
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
1. Study Identification
Unique Protocol Identification Number
NCT04932018
Brief Title
Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers
Official Title
Exploring the Feasibility of a Start-up Incubator to Decrease Occupational Stress and Depression in Beginning Kentucky Farmers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martha Biddle
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this 6- month study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. The objectives are to: #1) test the feasibility of a mentorship and start-up incubator intervention on depression in beginning Kentucky farmers using questionnaires administered prestudy, mid-study, and post-study; #2) explore associations between mentorship, occupational stress and depression in beginning Kentucky farmers using specific survey questionnaires to guide future research. This study's results will provide valuable data to agriculture and occupational health researchers. The data will illustrate the impact of mentorship and community support on improving depression and occupational stress of beginning Kentucky farmers.
Detailed Description
A suicide rate in farmers which is higher than the general population (rate 17.3/100,000) should remind occupational health professionals that the important work of agriculture is creating an emotional burden resulting in preventable death. Given the high incidence of suicide in the farming population, it is imperative that we explore the agrarian culture to guide the development of interventions to reduce occupational stress and depression in beginning Kentucky farmers. The isolating nature of rural farming, a leading risk factor for depression, creates an urgency to develop interventions to protect our Kentucky farmers from occupational stress and depression, which are leading risk factors for suicide. Interventions developed to reduce occupational stress and depression are an essential strategy to improve mental health before the devastating outcome of suicide. To address a gap in the management of occupational stress and depression in beginning farmers in Kentucky, novel interventions must address the unique agrarian culture, rural isolation, peer influence and social stigma of depression. Interventions must be available at little to no expense and without extensive time commitment; must be accessible in rural areas and provide mentorship and community support. The concept of a start-up incubator for beginning farmers is one type of intervention that combines the accessibility of a virtual program with mentorship by farming experts, peer and community support, with a mental health curriculum provided by occupational health nurses is our proposed intervention to address occupational stress and depression in the beginning Kentucky farmer. The curriculums of several existing programs related to occupational stress and depression guide the development of this incubator intervention. Incubator curriculums are designed to address failures and mitigate conditions to support future success. Rural Resilience, Farm Aid, and Farm Stress are training programs that address stress, depression, and suicide in farmers, these programs use components of an incubator model to fit the constructs of agrarian business and culture. The start-up incubator model in this proposal utilizes mentorship and community support to form a strategic alliance between mentors and beginner farmers.
Mentorship and community support are social capital that can be utilized through networking opportunities which may eliminate the structural barriers identified by beginning farmers. The impact of mentorship and community support in the context of healthcare, business, and farming has consistently been supported in research. Uncomfortable topics of occupational stressors and depression have only recently been included in initiatives to help farmers, however available mentorship programs in Kentucky are currently focused on farm management knowledge deficits. Results from this proposed study have the potential to guide future research related to the effectiveness for occupational stress, depression and suicide reduction in beginning Kentucky farmers. This proposal will address a major mental health objective of Healthy People 2020: Reducing the rising national suicide rate, specifically by addressing the vulnerable population of farmworkers considered to be at high risk (https://www.healthypeople.gov/node/4804/data_details). The The purpose of this study is to determine the feasibility of a start-up incubator intervention designed to decrease occupational stress and depression for beginning Kentucky farmers. The central hypothesis is: A start-up incubator intervention will be feasible and acceptable to the beginning farmer population. Specific Aim #1: To test the feasibility of a start-up incubator intervention on occupational stress and depression in beginning Kentucky farmers. Hypothesis #1: Compared to an attention control group, individuals assigned to the incubator intervention (6 month curriculum) group will have a lower incidence of occupational stress and depression at three and six months from baseline.
Specific Aim #2: To explore associations between mentorship, occupational stress and depression in beginning Kentucky farmers to guide future research. Hypothesis #2: Associations exist between mentorship, occupational stress and depression that will guide future research focused on prioritizing efforts to advance farmer health and well-being.
Study Design. The design is that of a two-group intervention study. Subjects (N=48) will be assigned to 1 of 2 groups (intervention group or attention control group based on county of residence; randomization will occur at the county level). Subjects will be recruited from eight central Kentucky counties: Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford and Owen. The intervention group will participate in a round table educational session with a study facilitator/mentor farmer and occupational health nurse plus receive an invitation to participate in an interactive virtual community providing ongoing resources and support from community farmers and agriculture experts. The second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction. Data collection for both groups will occur at baseline, 3 months, and 6-months.
Sample and Setting. Subjects will be referred by county extension agents located in Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford and Owen counties in Kentucky that have contact with "beginning farmers", as defined by the United States Department of Agriculture (USDA). Subjects will be contacted via email or personal contact by County Extension agents, or via CCTS recruitment services, potential interested parties will be given the PI's email, name and phone to contact for pre-screening of eligibility into the study. A total of 48 subjects meeting inclusion criteria will be assigned to one of two groups. Based on USDA estimates of beginning farmer characteristics, the planned enrollment in this study is 60% men, 95% Caucasian, and 5% Black or African American (demographic survey will include a question regarding Hispanic ethnicity).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Stress, Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
The intervention group will participate in a round table educational session with a study facilitator/mentor farmer and occupational health nurse plus receive an invitation to participate in an interactive virtual community providing ongoing resources and support from community farmers and agriculture experts.
Arm Title
Attention Control
Arm Type
Sham Comparator
Arm Description
The second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Community of Support
Intervention Description
The 6-month virtual community will consist of self-directed learning modules that will vary in content from worker and family relationships, collaboration and skill acquisition to self-care habits; problem-solving; monthly sessions will include a positive psychology exercise.
Intervention Type
Behavioral
Intervention Name(s)
Mentorship Incubator
Intervention Description
The 6-month incubator intervention will consist of monthly interactive time with an assigned study facilitator/farmer mentor.
Primary Outcome Measure Information:
Title
Occupational Stress
Description
Psychological stress as result of farming measured with the Farm Stressors Inventory, a 37 item self-report survey measuring potentially prevalent farm stressors. Items from the following categories of stressors are addressed in the assessment tool: personal finances, weather, regulatory climate, workload and other job demands, physical environment, control and ambiguity, interpersonal issues, and job and retirement security. The tool is comprised of a 1-5 likert scale of 37 items, higher scores indicating higher occupational stress related to farming.
Time Frame
Change from baseline occupational stress at 6 months
Title
Depressive symptoms
Description
Depressive symptoms as measured with the 10-item short Beck Depression Inventory to detect moderate and severe depressive episodes. High sensitivity and negative predictive value (NPV) were obtained with a cut-off score of 9/10 (sensitivity = 100%, specificity = 83.1%, NPV = 100%). High sensitivity and positive predictive value (PPV) were obtained with a cut-off score of 13/14 (sensitivity = 93.5%, specificity = 96%, PPV = 85.3%). The area under the ROC curve was 98.4% (95% Confidence Interval = 0.97-1.00). This tool includes 10 items, each including four alternative statements ranging in order of severity from zero to three. For the short form ,higher scores indicate higher depression.
Time Frame
Change from baseline depressive symptoms at 6 months
Secondary Outcome Measure Information:
Title
Self-Efficacy
Description
Self-efficacy will be measured with the John Henry Active Coping Scale, a 12 item self-report survey measuring coping strategies associated with sustained cognitive and emotional stressors. The scale includes twelve items answered on a Likert Scale with responses ranging from 1 "completely false" to 5 "completely true." Sample items include, "hard work has really helped me to get ahead"; "it's not always easy, but I manage to find a way to do the things I really need to get done"; and "once I make up my mind to do something, I stay with it until the job is completely done." The items were summed, with higher scores indicating a higher degree of high-effort coping
Time Frame
Change from baseline self-efficacy at 6 months
Title
Adherence to Intervention
Description
Intervention fidelity will be monitored by the PI, who will ensure all research assistants and study facilitators follow the study protocol. Study participants assigned to the intervention will have adherence monitored by participation in the virtual community and at the face to face meeting.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
classified as a beginning farmer by the USDA criteria
has the ability to read and speak English;
access to wi-fi or smartphone technology.
primary residence or farm in Washington, Anderson, Franklin, Henry, Scott, Harrison, Woodford or Owen County, Kentucky
Exclusion Criteria:
- less than 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Biddle, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40507
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers
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