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
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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
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