Effect of early intervention for permanent childhood hearing impairment on outcome at secondary school age
| ISRCTN | ISRCTN03307358 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN03307358 |
| Protocol serial number | 9804 |
| Sponsor | Southampton University Hospitals NHS Trust (UK) |
| Funder | Wellcome Trust (UK) (grant ref:no:089251/Z/09/Z) |
- 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
Scientific
Mailpoint 806
Division of Clinical Neurosciences
Tremona Road
Southampton
SO16 6YD
United Kingdom
| h.pimperton@soton.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Non-randomised observational study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of early intervention for permanent childhood hearing impairment on outcome at secondary school age: a non-randomised observational study |
| Study acronym | Hearing Outcomes in Teenagers |
| Study objectives | 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(s) | Southampton and South West Hampshire REC (A),14th September, ref: 201010/H0502/71 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Reading comprehension- Single testing session |
| Key secondary outcome measure(s) |
Questionnaires and standardised tests to assess: |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 144 |
| Key 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 |
| Key exclusion criteria | 1. Severe, active illness precluding participation in this project 2. A known post-natal cause of the PCHI (e.g. meningitis) |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 01/08/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Mailpoint 806
Southampton
SO16 6YD
United Kingdom
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2018: Publication reference added.
12/04/2016: Publication reference added.
