Test of Hearing Health Education Programs for Farm and Rural Youth (FARMYOUTHEAR)

February 23, 2017 updated by: Marjorie McCullagh, University of Michigan
Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss (NIHL). There is a lack of programs to prepare this high-risk population to use hearing conservation strategies. This randomly-controlled trial of innovative community-based interventions is designed to compare effectiveness and sustainability of approaches to increase youths' use of hearing conservation strategies. Consistent use of hearing conservation strategies is expected to reduce rates of NIHL and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Farm and rural youth have frequent exposure to hazardous noise on the farm and recreationally, and have an increased prevalence of noise-induced hearing loss. An estimated 2 million children and adolescents younger than 20 years of age are exposed to farm noise hazards as farm residents, farm family workers, hired workers, children of migrant or seasonal workers, or farm visitors. This noise exposure begins from an early age, and is compounded by frequent exposure to recreational noise (e.g., all-terrain vehicles and firearms). Farm youth also have an increased prevalence of noise-induced hearing loss, a permanent and irreversible condition negatively impacting quality of life of the affected person, as well as their family members.

Although primary prevention offers the best opportunity for success, farm and rural youth are rarely served by an Occupational Safety and Health Administration-mandated or other hearing conservation program. Although previous tests of limited educational programs to promote hearing conservation among small groups of farm youth have demonstrated short-term increases in hearing protector use (or intent to use), their impact on this population has been limited by program reach and sustainability.

The purpose of this project is to test innovative hearing health education programs delivered to a large target group and to determine the effectiveness and sustainability of these programs in promoting hearing health among farm and rural youth. Specifically, this project includes: a) an interactive Safety Days program alone, b) an interactive Safety Days program followed by an Internet-based booster, and c) a no-intervention control. This test is designed to determine the most effective and sustainable approach to hearing health education among farm and rural youth. Only with effective and sustainable hearing health education programs can use of hearing conservation strategies be increased to prevent noise-induced hearing loss and other negative effects of high noise exposure, and improve quality of life in this high-risk and under-served group.

This project will involve a partnership between the University of Michigan School of Nursing and a major farm and rural youth safety education organization to accomplish project aims.

This randomized-controlled trial of innovative community- based interventions is designed to determine the most effective and sustainable approach to increase youths' use of hearing protection strategies. Results of this study will be used to inform future research-to-practice studies to protect the health and safety of farm and rural youth. Consistent use of hearing conservation strategies is expected to reduce rates of noise-induced hearing loss and other negative effects of high noise exposure, and improve quality of life in this high-risk and underserved group.

Study Type

Interventional

Enrollment (Actual)

2093

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • enrollment in grade 4
  • parental consent
  • English speaking
  • attending a Safety Days event included in the cluster sampling

Exclusion Criteria:

  • (none)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Interactive Lesson
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health
Behavioral: Interactive youth educational program
Participation in a community-based face-to-face interactive youth educational program focusing on hearing health (i.e., noise hazards, risk of noise-induced hearing loss, mechanism of injury to the internal ear, and preventive measures)
Other Names:
  • Progressive Agriculture Foundation Safety Days
Active Comparator: Interactive lesson + Web-based booster
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health followed by an Internet-based educational booster
Behavioral: Interactive youth educational program
Participation in a community-based face-to-face interactive youth educational program focusing on hearing health (i.e., noise hazards, risk of noise-induced hearing loss, mechanism of injury to the internal ear, and preventive measures)
Other Names:
  • Progressive Agriculture Foundation Safety Days
Behavioral: Internet-based educational booster
Visit to an educational Web site focused on hearing health
Other Names:
  • Dangerous Decibels Virtual Exhibit
No Intervention: No-intervention control
No interventions; pre- and post- measures only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported use of hearing conservation strategies (i.e., using hearing protection devices, walking away from hazardous noise, or turning down sources of hazardous noise) when in high noise
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost effectiveness
Time Frame: 12 months
Costs association with program delivery (i.e., instruction time, travel time)
12 months
Sustainability
Time Frame: 12 months
Key stakeholders' ratings of program capacity to maintain program and its benefits over time using scale prepared for this purpose
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)
Progressive Agriculture Foundation

Investigators

  • Principal Investigator: Marjorie C McCullagh, PhD, University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 17, 2015

Primary Completion (Actual)

December 19, 2016

Study Completion (Actual)

December 19, 2016

Study Registration Dates

First Submitted

June 9, 2015

First Submitted That Met QC Criteria

June 11, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2017

Last Update Submitted That Met QC Criteria

February 23, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F037851-00
  • R01DC013885 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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