Test of Hearing Health Education Programs for Farm and Rural Youth

NCT ID: NCT02472821

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2093 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-17
• Study Completion Date: 2016-12-19

Brief Summary

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.

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.

Conditions

Noise-induced Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Interactive Lesson

Subjects will receive a community-based face-to-face interactive youth educational program on hearing health

Group Type: ACTIVE_COMPARATOR

Interactive youth educational program

Intervention Type: BEHAVIORAL

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)

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

Group Type: ACTIVE_COMPARATOR

Interactive youth educational program

Intervention Type: BEHAVIORAL

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)

Internet-based educational booster

Intervention Type: BEHAVIORAL

Visit to an educational Web site focused on hearing health

No-intervention control

No interventions; pre- and post- measures only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: BEHAVIORAL

Internet-based educational booster

Visit to an educational Web site focused on hearing health

Intervention Type: BEHAVIORAL

Other Intervention Names

Progressive Agriculture Foundation Safety Days; Dangerous Decibels Virtual Exhibit

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• (none)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Progressive Agriculture Foundation

UNKNOWN

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Marjorie McCullagh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marjorie C McCullagh, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

McCullagh MC, Banerjee T, Yang J. Protocol of a test of hearing health education programs for farm and rural youth. BMC Public Health. 2015 Oct 16;15:1061. doi: 10.1186/s12889-015-2393-y.

Reference Type: DERIVED

PMID: 26475373 (View on PubMed)

Other Identifiers

R01DC013885

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F037851-00

Identifier Type: -

Identifier Source: org_study_id