Exploring an Incubator to Decrease Stress in Farmers Occupational Stress and Depression in Beginning Kentucky Farmers

NCT ID: NCT04932018

Last Updated: 2022-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Occupational Stress Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

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.

Group Type EXPERIMENTAL

Virtual Community of Support

Intervention Type BEHAVIORAL

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.

Mentorship Incubator

Intervention Type BEHAVIORAL

The 6-month incubator intervention will consist of monthly interactive time with an assigned study facilitator/farmer mentor.

Attention Control

The second group (attention control) will receive an invitation to participate in the virtual community without mentor interaction.

Group Type SHAM_COMPARATOR

Virtual Community of Support

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Virtual Community of Support

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

Mentorship Incubator

The 6-month incubator intervention will consist of monthly interactive time with an assigned study facilitator/farmer mentor.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute for Occupational Safety and Health (NIOSH/CDC)

FED

Sponsor Role collaborator

Martha Biddle

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Martha Biddle

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martha Biddle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Olson KR, Schellenberg RP. Farm stressors. Am J Community Psychol. 1986 Oct;14(5):555-69. doi: 10.1007/BF00935358.

Reference Type BACKGROUND
PMID: 3799552 (View on PubMed)

Cuthbertson C, Brennan A, Shutske J, Zierl L, Bjornestad A, Macy K, Schallhorn P, Shelle G, Dellifield J, Leatherman J, Lin E, Skidmore M. Developing and Implementing Farm Stress Training to Address Agricultural Producer Mental Health. Health Promot Pract. 2022 Jan;23(1):8-10. doi: 10.1177/1524839920931849. Epub 2020 Jun 9.

Reference Type BACKGROUND
PMID: 32517517 (View on PubMed)

Gerrard N. An application of a community psychology approach to dealing with farm stress. Can J Commun Ment Health. 2000 Fall;19(2):89-100. doi: 10.7870/cjcmh-2000-0017.

Reference Type BACKGROUND
PMID: 11381740 (View on PubMed)

Hoyt DR, Conger RD, Valde JG, Weihs K. Psychological distress and help seeking in rural America. Am J Community Psychol. 1997 Aug;25(4):449-70. doi: 10.1023/a:1024655521619.

Reference Type BACKGROUND
PMID: 9338954 (View on PubMed)

Peterson C, Stone DM, Marsh SM, Schumacher PK, Tiesman HM, McIntosh WL, Lokey CN, Trudeau AT, Bartholow B, Luo F. Suicide Rates by Major Occupational Group - 17 States, 2012 and 2015. MMWR Morb Mortal Wkly Rep. 2018 Nov 16;67(45):1253-1260. doi: 10.15585/mmwr.mm6745a1.

Reference Type BACKGROUND
PMID: 30439869 (View on PubMed)

Cassitto MG, Gilioli R. [Emerging aspects of occupational stress]. Med Lav. 2003 Jan-Feb;94(1):108-13. Italian.

Reference Type BACKGROUND
PMID: 12768962 (View on PubMed)

Oatley K, Bolton W. A social-cognitive theory of depression in reaction to life events. Psychol Rev. 1985 Jul;92(3):372-88. No abstract available.

Reference Type BACKGROUND
PMID: 4023147 (View on PubMed)

Rudolphi JM, Berg RL, Parsaik A. Depression, Anxiety and Stress Among Young Farmers and Ranchers: A Pilot Study. Community Ment Health J. 2020 Jan;56(1):126-134. doi: 10.1007/s10597-019-00480-y. Epub 2019 Oct 3.

Reference Type BACKGROUND
PMID: 31583619 (View on PubMed)

Frey LM, Hans JD, Cerel J. Perceptions of Suicide Stigma. Crisis. 2016 Mar;37(2):95-103. doi: 10.1027/0227-5910/a000358. Epub 2015 Dec 23.

Reference Type BACKGROUND
PMID: 26695868 (View on PubMed)

Kris-Etherton PM, Petersen KS, Hibbeln JR, Hurley D, Kolick V, Peoples S, Rodriguez N, Woodward-Lopez G. Nutrition and behavioral health disorders: depression and anxiety. Nutr Rev. 2021 Feb 11;79(3):247-260. doi: 10.1093/nutrit/nuaa025.

Reference Type BACKGROUND
PMID: 32447382 (View on PubMed)

Logstein B. Farm-Related Concerns and Mental Health Status Among Norwegian Farmers. J Agromedicine. 2016;21(4):316-26. doi: 10.1080/1059924X.2016.1211055.

Reference Type BACKGROUND
PMID: 27420178 (View on PubMed)

Hammen C. Stress and depression. Annu Rev Clin Psychol. 2005;1:293-319. doi: 10.1146/annurev.clinpsy.1.102803.143938.

Reference Type BACKGROUND
PMID: 17716090 (View on PubMed)

Truchot D, Andela M. Burnout and hopelessness among farmers: The Farmers Stressors Inventory. Soc Psychiatry Psychiatr Epidemiol. 2018 Aug;53(8):859-867. doi: 10.1007/s00127-018-1528-8. Epub 2018 May 3.

Reference Type BACKGROUND
PMID: 29725701 (View on PubMed)

Fernander AF, Duran RE, Saab PG, Llabre MM, Schneiderman N. Assessing the reliability and validity of the John Henry Active Coping Scale in an urban sample of African Americans and white Americans. Ethn Health. 2003 May;8(2):147-61. doi: 10.1080/13557850303563.

Reference Type BACKGROUND
PMID: 14671768 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

61320

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effectiveness of the Educator Well-being Program
NCT05641987 ENROLLING_BY_INVITATION NA
Active Workplace Study
NCT03556670 UNKNOWN NA
Brief Mood Enhancement Intervention
NCT02954965 COMPLETED NA
Promo@Work Entrepreneurs
NCT03648593 UNKNOWN NA
Working Toward Wellness
NCT00694681 COMPLETED NA
Implementation of DWM in Dutch SMEs
NCT06979089 RECRUITING NA