NCT04932018

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

1.5 years

First QC Date

June 10, 2021

Last Update Submit

November 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    Change from baseline occupational stress at 6 months

  • 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.

    Change from baseline depressive symptoms at 6 months

Secondary Outcomes (2)

  • Self-Efficacy

    Change from baseline self-efficacy at 6 months

  • Adherence to Intervention

    6 months

Study Arms (2)

Interventional

EXPERIMENTAL

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.

Behavioral: Virtual Community of SupportBehavioral: Mentorship Incubator

Attention Control

SHAM COMPARATOR

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

Behavioral: Virtual Community of Support

Interventions

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.

Attention ControlInterventional

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

Interventional

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40507, United States

Location

Related Publications (14)

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

    PMID: 3799552BACKGROUND
  • 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.

    PMID: 32517517BACKGROUND
  • 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.

    PMID: 11381740BACKGROUND
  • 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.

    PMID: 9338954BACKGROUND
  • 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.

    PMID: 30439869BACKGROUND
  • Cassitto MG, Gilioli R. [Emerging aspects of occupational stress]. Med Lav. 2003 Jan-Feb;94(1):108-13. Italian.

    PMID: 12768962BACKGROUND
  • 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.

    PMID: 4023147BACKGROUND
  • 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.

    PMID: 31583619BACKGROUND
  • 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.

    PMID: 26695868BACKGROUND
  • 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.

    PMID: 32447382BACKGROUND
  • 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.

    PMID: 27420178BACKGROUND
  • Hammen C. Stress and depression. Annu Rev Clin Psychol. 2005;1:293-319. doi: 10.1146/annurev.clinpsy.1.102803.143938.

    PMID: 17716090BACKGROUND
  • 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.

    PMID: 29725701BACKGROUND
  • 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.

    PMID: 14671768BACKGROUND

MeSH Terms

Conditions

Occupational StressDepression

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Martha Biddle, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2021

First Posted

June 18, 2021

Study Start

April 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations