Clinical trial NCT04932018: 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
Overall status: COMPLETED
Phase: NA
Conditions: Occupational Stress
Depression
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
First posted: 2021-06-18
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: Occupational Stress
timeFrame: Change from baseline occupational stress at 6 months
measure: Depressive symptoms
timeFrame: Change from baseline depressive symptoms at 6 months
Secondary outcomes:
measure: Self-Efficacy
timeFrame: Change from baseline self-efficacy at 6 months
measure: Adherence to Intervention
timeFrame: 6 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Martha Biddle, PhD
role: PRINCIPAL_INVESTIGATOR
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