Behavior Change Interventions, Effectiveness of Application Education Intervention, Noise Induced Hearing Loss, Primary School Children
Conditions
Keywords
Noise-induced hearing loss, Prevention, Primary school, Randomized controlled trial, Effectiveness
Brief summary
The goal of this randomized controlled trial is to evaluate the effectiveness of the educational program the HoorToren in promoting recreational safe listening behavior among Dutch primary school children in group 7 (aged 10-11 years) and thereby contribute to preventing noise-induced hearing loss. The main objectives are: * To evaluate the HoorToren's effects on promoting the child's safe listening behavior when using headphones or earbuds. Both safe listening and its psychological determinants will be measured. * To evaluate the HoorToren's effects on parents' perception of their child's safe listening behaviors. The effects on parental behavior promoting or facilitating their child's safe listening behavior, including its psychological determinants, will also be evaluated. Researchers will compare children who receive lessons from the HoorToren educational program, and their parents (intervention group) with children and their parents who do not receive the lessons (control group) to evaluate the effectiveness of the HoorToren. Outcomes will be assessed using newly developed and validated self-report questionnaires for both children and their parents. Additionally, the child's listening behavior will be measured via a smartphone application installed on the child's phone. Measurements will take place at four time points during the school year.
Detailed description
Results of the currently pending validation study will decide how the primary outcome (the child´s listening behavior) will eventually be defined, i.e. based on the child's versus the parent's report. The child's listening behavior as measured via the smartphone app is an important secondary outcome.
Interventions
OTHERHoorToren educational package
Educational program, consisting of 7 classroom lessons for group 7. Each lesson has an average duration of 30-45 minutes. Parents are targeted in 4 home assignments for the children.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
For schools: None. For children: * Dutch primary school children in group 7 (corresponding to Year 6 in the UK). * Informed consent from legally authorized parent(s) or guardian(s). Parents: • Child is participating.
Exclusion criteria
For schools: • HoorToren package has been taught at group 6 in the previous school year. For children: * Children without informed consent from legally authorized parent(s) or guardian(s). * Children who cannot read and write Dutch. For parents: • Parents who cannot read and write Dutch
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the child's recreational listening behavior when using earbuds or headphones, as reported by either the child or a parent (pending the validation study). | The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention. | The primary outcome measure will be assessed using newly developed and validated self-report questionnaires for children and parents. The final primary outcome (i.e. either child or parent-reported) will be chosen based on the pending validation study. The outcome will include a composite variable based on the self-reported listening duration and volume. The exact definition will depend on the validation study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The child's recreational safe listening behavior when using earbuds or headphones with their own smartphone. | The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention. | This outcome will be objectively measured with a newly developed smartphone application. The composite variable that will be included will be based on the registered listening duration and volume. The exact definition will depend on the validation study. |
| The child's psychological determinants of safe listening behavior. | The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention. | These outcomes will be measured using newly developed and validated self-report questionnaires, and are pending the validation study. Examples of determinants are risk perception (susceptibility to, severity of noise-induced hearing loss (NIHL)) and capacity to apply the safe listening behavior. |
| Parents' psychological determinants related to promoting or facilitating safe listening behavior in their child. | The measurements will take place at the start of the study (baseline, i.e., pre-intervention), immediately post-intervention (2 months after baseline), 3 months post-intervention, and 7 months post-intervention. | These outcomes will be measured using newly developed and validated self-report questionnaires, and are pending the validation study. Examples of determinants are risk perception (child susceptibility to, severity of NIHL) and capacity to facilitate the child's safe listening behavior. |
Countries
Netherlands
Contacts
CONTACTWillemijn van Diemen, Master of science.
CONTACTMarc van der Schroeff, dr.
Outcome results
None listed