Effect of early intervention for permanent childhood hearing impairment on outcome at secondary school age

ISRCTN ISRCTN03307358
DOI https://doi.org/10.1186/ISRCTN03307358
Secondary identifying numbers 9804
Submission date
22/03/2011
Registration date
24/03/2011
Last edited
12/04/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Hannah Pimperton
Scientific

Mailpoint 806
Division of Clinical Neurosciences
Tremona Road
Southampton
SO16 6YD
United Kingdom

Email h.pimperton@soton.ac.uk

Study information

Study designNon-randomised observational study
Primary study designObservational
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleEffect of early intervention for permanent childhood hearing impairment on outcome at secondary school age: a non-randomised observational study
Study acronymHearing Outcomes in Teenagers
Study objectivesA follow up study of teenagers with hearing impairment and a comparison group of normally hearing teenagers, who participated in the first phase of this research in 2002-2004. This study will explore the impact of screening for hearing impairment at birth, and early confirmation of hearing impairment, on speech, language, behavioural, social and educational outcomes in the teenagers with hearing impairment.
Ethics approval(s)Southampton and South West Hampshire REC (A),14th September, ref: 201010/H0502/71
Health condition(s) or problem(s) studiedPermanent childhood hearing impairment
InterventionThe participants will complete questionnaires and standardised tests assessing their receptive and expressive language, reading comprehension and accuracy, non-verbal intelligence, quality of life, health, everyday behaviour, and theory of mind. This will be supplemented by information from their parents regarding their adaptive behaviour, quality of life, health, everyday behaviour, speech, economic costs and demographic factors. A subset of participants will also provide information on their social functioning through a semi-structured interview. Outcomes on these measures for early- and late-identified deaf teenagers will be compared, and data from the previous phase of this research will be used to look at speech, language and literacy outcomes longitudinally.
Intervention typeOther
Primary outcome measureReading comprehension- Single testing session
Secondary outcome measuresQuestionnaires and standardised tests to assess:
1. Receptive and expressive language
2. Quality of life, health, everyday behaviour and theory of mind
Overall study start date01/02/2011
Completion date01/08/2012

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit13 Years
Upper age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 144; UK Sample Size: 144
Key inclusion criteria1. Male & Female, upper age limit 18 years, lower age limit 13 years
2. One of the children with bilateral permanent childhood hearing impairment (PCHI) > 40 dB in the 1992-1997, Wessex and Greater London birth cohort of 157,000 that was previously invited to take part in the Hearing Outcomes Project
3. One of the comparison group of children with normal hearing from the same birth cohort who were previously invited to take part in the Hearing Outcomes Project
Key exclusion criteria1. Severe, active illness precluding participation in this project
2. A known post-natal cause of the PCHI (e.g. meningitis)
Date of first enrolment01/02/2011
Date of final enrolment01/08/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Mailpoint 806
Southampton
SO16 6YD
United Kingdom

Sponsor information

Southampton University Hospitals NHS Trust (UK)
Hospital/treatment centre

Tremona Road
Southampton
SO16 6YD
England
United Kingdom

ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Research council

Wellcome Trust (UK) (grant ref:no:089251/Z/09/Z)
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2016 Yes No
Results article results 24/02/2018 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

12/04/2018: Publication reference added.
12/04/2016: Publication reference added.