Overview

This trial is active, not recruiting.

Condition noise-induced hearing loss
Treatments interactive youth educational program, internet-based educational booster
Sponsor University of Michigan
Collaborator National Institute on Deafness and Other Communication Disorders (NIDCD)
Start date April 2015
End date March 2017
Trial size 2093 participants
Trial identifier NCT02472821, F037851-00, R01DC013885

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health
interactive youth educational program Progressive Agriculture Foundation Safety Days
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)
(Active Comparator)
Subjects will receive a community-based face-to-face interactive youth educational program on hearing health followed by an Internet-based educational booster
interactive youth educational program Progressive Agriculture Foundation Safety Days
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 Dangerous Decibels Virtual Exhibit
Visit to an educational Web site focused on hearing health
(No Intervention)
No interventions; pre- and post- measures only.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
Cost effectiveness
time frame: 12 months
Sustainability
time frame: 12 months

Eligibility Criteria

Male or female participants from 8 years up to 12 years old.

Inclusion Criteria: - enrollment in grade 4 - parental consent - English speaking - attending a Safety Days event included in the cluster sampling Exclusion Criteria: - (none)

Additional Information

Official title Test of Hearing Health Education Programs for Farm and Rural Youth
Principal investigator Marjorie C McCullagh, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by University of Michigan.