AChild - Austrian Children With Hearing Impairment - Longitudinal Database

There is high variability in outcomes in children with hearing impairment. Existing literature focus mainly on subpopulations (children with hearing aids, children with CI) and is usually not epidemiological. Often children with additional needs (intellectual disability, visual impairment, autism spectrum disorder, complex syndromes) are excluded from the studies. This subgroup of children makes up around 1/3 of the population of children with hearing impairment.

What factors contribute to the unexplained variance in language development in children with hearing loss? (including children with additional needs, multilingual) There is a lack of European epidemiological studies that evaluate the effects of Newborn Hearing Screening and early intervention.

Study Overview

• Status: Recruiting
• Conditions: Hearing Impaired Children
• Intervention / Treatment: Device: Hearing Aids and Hearing Implants; Behavioral: Family Centred Early Intervention

Detailed Description

Aims:

• to collect population based data on children born in Upper Austria with a significant hearing impairment and to describe this population in detail regarding audiological, etiological (including geno- and phenotypical correlations), neurodevelopmentally, psychological, psychiatrically and linguistically with a special interest is in children with additional needs
• collecting child development outcomes (language, communication, psychosocial) and family outcomes (quality of life, stress)
• to investigate possible effects of the Newborn Hearing Screening, early intervention and specific parent behaviors targeted in early intervention
• collecting developmental trajectories of the total sample and subgroups of the sample (particularly audiological, etiological and cognitive). This data should help identify red flags
• investigating predictors of developmental trajectories regarding the child and the intervention (e.g. time and

Hypothesis:

• It is expected that .2% of the total population of preschool children have a sensorineural hearing loss (bilateral and unilateral)
• a significantly higher prevalence of intellectual disabilities (up to 20%), visual impairment, autism spectrum disorder and motor impairment
• it is expected that for at least 50% of the children, there is a genetic explanation for the hearing impairment and 30% out of them are expected to be syndromal
• it is expected that there is a higher proportion of children with psycho-social problems (especially peer problems and behavioral-/emotional problems)
• Due to a change in the environmental conditions over the past two decades, better child outcomes, compared to previous ones are expected. Nevertheless around 30-50% of the children are expected to not be reaching their nonverbal cognitive potential.
• expected intervention effects, particularly for provision with and use of hearing technology family-child interaction self-efficacy and wellbeing of the family regulated media use

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Daniel Holzinger, PhD; Phone Number: 13720 00437327897; Email: daniel.holzinger@bblinz.at
• Study Contact Backup: Name: Magdalena Dall, MSc; Phone Number: 0043664602468641; Email: magdalena.dall@jku.at

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Johannes Kepler University
    • Contact: Daniel Holzinger, PhD; Phone Number: 13720 00437327897; Email: daniel.holzinger@bblinz.at
    • Sub-Investigator: Magdalena Dall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All children in Upper Austria with a significant sensorineural hearing impairment or permanent congential conductive deafness who were diagnosed before the age of 6 years are included in the study.

Description

Inclusion Criteria:

• with significant sensorineural hearing impairment or permanent congenital conductive deafness; profound hearing impairment above frequency of 0.5, 1, 2 and 4 kHz of ≥ 25 dB
• unilateral or bilateral
• diagnosed before the age of 6 years
• including children with multiple disabilities
• including children with another language than German (including sign language)
• including children with auditory neuropathy spectrum disorder (ANS)
• including children with behavioral problems and psychiatric disorders

Exclusion Criteria:

• children who were older than 6 years when they were diagnosed
• who's families do not agree to participate in the study
• with temporary conductive deafness

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vocabulary Expressive of the Child	Questionnaire used for this Outcome is: SET 3-5	5 years
Vocabulary Receptive of the Child	Questionnaire used for this Outcome is: PPVT-4	5 years
Grammar Expressive of the Child	Questionnaire used for this Outcome is: LOGIK_S Expressive Grammatik	5 years
Language Receptive of the Child	Questionnaire used for this Outcome is: TROG-D	5 years
Language Receptive of the Child (ÖGS)	Questionnaire used for this Outcome is: RDLS ÖGS	5 years
Social Communication of the Child	Questionnaire used for this Outcome is: CCC-2	5 years
Symbolic Behaviour of the Child	Questionnaire used for this Outcomes is: CSBS	5 years
Psychosocial Development of the Child	Questionnaire used for this Outcome is: SDQ	5 years
Emotional and Behaviour Problems of the Child	Questionnaire used for this Outcome is: CBCL	5 years
Quality of Life of the Child	Questionnaire used for this Outcome is: AUQUEI	5 years
Family Stress	Questionnaire used for this Outcome is: EBI (Elternbelastungsinventar)	5 years
Parental Self-Efficacy	Questionnaire used for this Outcome is: SPISE-R	5 years
Non-Verbal Development	Questionnaire used for this Outcome is: SON	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Executive Functioning of the Child	The questionnaire used for this Outcome is: VIEF (Verhaltens - Inventar Exekutiver Funktionen)	5 years
Adaptive Skills of the Child	The questionnaire used for this Outcome is: Vineland-2	5 years
Visual successive memory and attention	The questionnaire used for this Outcome is: KNOX cube test	5 years
Phonological working memory	The questionnaire used for this Outcome is: Mottier test	5 years
Mental Health	The questionnaire used for this Outcome is: SDQ 4-16 (Strength and Difficulties Questionnaire)	5 years
Media use	The questionnaire used for this Outcome is: Kinder und Medien Fragebogen	5 years

Collaborators and Investigators

• Sponsor: Johannes Kepler University of Linz

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Longitudinal Database
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: AChild

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No