Condition category
Ear, Nose and Throat
Date applied
22/03/2011
Date assigned
24/03/2011
Last edited
27/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hannah Pimperton

ORCID ID

Contact details

Mailpoint 806
Division of Clinical Neurosciences
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
h.pimperton@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9804

Study information

Scientific title

Effect of early intervention for permanent childhood hearing impairment on outcome at secondary school age: a non-randomised observational study

Acronym

Hearing Outcomes in Teenagers

Study hypothesis

A 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

Southampton and South West Hampshire REC (A),14th September, ref: 201010/H0502/71

Study design

Non-randomised observational study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Permanent childhood hearing impairment

Intervention

The 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reading comprehension- Single testing session

Secondary outcome measures

Questionnaires and standardised tests to assess:
1. Receptive and expressive language
2. Quality of life, health, everyday behaviour and theory of mind

Overall trial start date

01/02/2011

Overall trial end date

01/08/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 144; UK Sample Size: 144

Participant exclusion criteria

1. Severe, active illness precluding participation in this project
2. A known post-natal cause of the PCHI (e.g. meningitis)

Recruitment start date

01/02/2011

Recruitment end date

01/08/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mailpoint 806
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Tremona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research council

Funder name

Wellcome Trust (UK) (grant ref:no:089251/Z/09/Z)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/25425604

Publication citations

Additional files

Editorial Notes

27/04/2016: Internal review 12/04/2016: Publication reference added.