Hearing Impaired ChildrenNCT04317456
AChild - Austrian Children With Hearing Impairment - Longitudinal Database
An observational study of Hearing Impaired Children, run by Johannes Kepler University of Linz at 1 site in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 72 months
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Hearing Aids and Hearing Implants and Family Centred Early Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2019to Aug 2025
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 72 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Johannes Kepler University
Linz, 4020
Daniel Holzinger, PhD, 00437327897 ext. 13720, daniel.holzinger@bblinz.at
Magdalena Dall
About this study
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.
Read the 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
- Conditions
- Hearing Impaired Children
- Being tested
- Hearing Aids and Hearing Implants, Family Centred Early Intervention
- Keywords
- Longitudinal Database
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aids and Hearing ImplantsDevice
Hearing Aids and Hearing Implants (age at first fitting and implantation and aided audibility)
Family Centred Early InterventionBehavioural
Family Centred Early Intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Vocabulary Expressive of the Child
Questionnaire used for this Outcome is:
SET 3-5
Measured: 5 years
Vocabulary Receptive of the Child
Questionnaire used for this Outcome is:
PPVT-4
Measured: 5 years
Grammar Expressive of the Child
Questionnaire used for this Outcome is:
LOGIK_S Expressive Grammatik
Measured: 5 years
Language Receptive of the Child
Questionnaire used for this Outcome is:
TROG-D
Measured: 5 years
Language Receptive of the Child (ÖGS)
Questionnaire used for this Outcome is:
RDLS ÖGS
Measured: 5 years
Social Communication of the Child
Questionnaire used for this Outcome is:
CCC-2
Measured: 5 years
Symbolic Behaviour of the Child
Questionnaire used for this Outcomes is:
CSBS
Measured: 5 years
Psychosocial Development of the Child
Questionnaire used for this Outcome is:
SDQ
Measured: 5 years
Emotional and Behaviour Problems of the Child
Questionnaire used for this Outcome is:
CBCL
Measured: 5 years
Quality of Life of the Child
Questionnaire used for this Outcome is:
AUQUEI
Measured: 5 years
Family Stress
Questionnaire used for this Outcome is:
EBI (Elternbelastungsinventar)
Measured: 5 years
Parental Self-Efficacy
Questionnaire used for this Outcome is:
SPISE-R
Measured: 5 years
Non-Verbal Development
Questionnaire used for this Outcome is:
SON
Measured: 5 years
Secondary outcomes (6)
Executive Functioning of the Child
The questionnaire used for this Outcome is:
VIEF (Verhaltens - Inventar Exekutiver Funktionen)
Measured: 5 years
Adaptive Skills of the Child
The questionnaire used for this Outcome is:
Vineland-2
Measured: 5 years
Visual successive memory and attention
The questionnaire used for this Outcome is:
KNOX cube test
Measured: 5 years
Phonological working memory
The questionnaire used for this Outcome is:
Mottier test
Measured: 5 years
Mental Health
The questionnaire used for this Outcome is:
SDQ 4-16 (Strength and Difficulties Questionnaire)
Measured: 5 years
Media use
The questionnaire used for this Outcome is:
Kinder und Medien Fragebogen
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Sep 2019
- Primary completionJun 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Impaired ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johannes Kepler University of Linz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317456
- Sponsor's protocol ID
- AChild
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AChild - Austrian Children With Hearing Impairment - Longitudinal Database
- ClinicalTrials.gov ID
- NCT04317456
- Acronym / sponsor ID
- AChild
- Conditions
- Hearing Impaired Children
- Keywords
- Longitudinal Database
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Johannes Kepler University of LinzUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- Up to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Aids and Hearing ImplantsHearing Aids and Hearing Implants (age at first fitting and implantation and aided audibility) | Device | – |
| Family Centred Early InterventionFamily Centred Early Intervention | Behavioural | – |
Primary outcome
Vocabulary Expressive of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: SET 3-5
Vocabulary Receptive of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: PPVT-4
Grammar Expressive of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: LOGIK_S Expressive Grammatik
Language Receptive of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: TROG-D
Language Receptive of the Child (ÖGS)
Time frame: 5 years
Questionnaire used for this Outcome is: RDLS ÖGS
Social Communication of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: CCC-2
Symbolic Behaviour of the Child
Time frame: 5 years
Questionnaire used for this Outcomes is: CSBS
Psychosocial Development of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: SDQ
Emotional and Behaviour Problems of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: CBCL
Quality of Life of the Child
Time frame: 5 years
Questionnaire used for this Outcome is: AUQUEI
Family Stress
Time frame: 5 years
Questionnaire used for this Outcome is: EBI (Elternbelastungsinventar)
Parental Self-Efficacy
Time frame: 5 years
Questionnaire used for this Outcome is: SPISE-R
Non-Verbal Development
Time frame: 5 years
Questionnaire used for this Outcome is: SON
6 secondary outcomes
Executive Functioning of the Child
Time frame: 5 years
Adaptive Skills of the Child
Time frame: 5 years
Visual successive memory and attention
Time frame: 5 years
Phonological working memory
Time frame: 5 years
Mental Health
Time frame: 5 years
Media use
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Outcomes of Cartilage Tympanoplasty in Children
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RecruitingObservational study
Alpha-Tectorin, Interleukin-10 and Thiol-Disulfide Homeostasis in Children With Congenital Hearing Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Impaired Children, run by Johannes Kepler University of Linz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Holzinger, PhD (00437327897 ext. 13720, daniel.holzinger@bblinz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vocabulary Expressive of the Child (time frame: 5 years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.