NCT04317456

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

5.8 years

First QC Date

February 27, 2020

Last Update Submit

March 29, 2022

Conditions

Hearing Impaired Children

Keywords

Longitudinal Database

Outcome Measures

Primary Outcomes (13)

  • 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 Outcomes (6)

  • Executive Functioning of the Child

    5 years

  • Adaptive Skills of the Child

    5 years

  • Visual successive memory and attention

    5 years

  • Phonological working memory

    5 years

  • Mental Health

    5 years

  • +1 more secondary outcomes

Interventions

Hearing Aids and Hearing ImplantsDEVICE

Hearing Aids and Hearing Implants (age at first fitting and implantation and aided audibility)

Family Centred Early InterventionBEHAVIORAL

Family Centred Early Intervention

Eligibility Criteria

AgeUp to 72 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johannes Kepler University

Linz, 4020, Austria

RECRUITING

MeSH Terms

Interventions

Hearing Aids

Intervention Hierarchy (Ancestors)

Wearable Electronic DevicesElectrical Equipment and SuppliesEquipment and SuppliesSensory Aids

Central Study Contacts

Daniel Holzinger, PhD

CONTACT

00437327897daniel.holzinger@bblinz.at

Magdalena Dall, MSc

CONTACT

0043664602468641magdalena.dall@jku.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2020

First Posted

March 23, 2020

Study Start

September 1, 2019

Primary Completion

June 1, 2025

Study Completion

August 1, 2025

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

AU(1)