Hearing LossDIADSNCT01932515
Diagnostic Instruments for Autism in Deaf Children Study
A study testing A revised screening instrument for use in Deaf children in people with Hearing Loss and ASD, run by Leeds and York Partnership NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children. The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for use with deaf children. Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, ASD
- What is being tested?
- A revised screening instrument for use in Deaf children
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2013to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For the purposes of this study, children and young people will be recruited if they have a chronological age of ≥18 months old, up to 18 years.
- Deaf children will have a hearing loss of at least 40dB
Who cannot join
- This is a pragmatic trial which recognises the frequency and complexity of co-morbidities in children with Autistic Spectrum Disorders (ASD) and deafness. We will therefore not exclude on the basis of co-morbidity in the groups where a diagnosis of ASD already exists, since these tools would be used with this population if adopted more widely in the NHS.
- We will not exclude children or young people with language delay as children with ASD may have severe language delay. Families where the parents do not have either a signed language being studied here, or a language in which the ADI-R is available, will not be included.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds and York Partnership NHS Foundation Trust
York, North Yorkshire, YO30 5RE
About this study
The trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children.
The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for use with deaf children. This will involve choosing the most promising screening instrument (SRS-2) based on the systematic review and the expertise of a review panel, which contains experts and public and patient involvement (PPI). This phase of the study seeks a wide range of user (parents/ carers and young people) views and experiences about the symptomatology and presentation of deaf children with autism, comparing this to hearing children with autism, and deaf children without autism.
Read more
The second stage is to ensure that the newly modified instruments are accessible to deaf children and deaf parents by making any necessary translations from English into British Sign Language. This involves a strict translation and back translation methodology with reiterations until successful translation is achieved.
For stage three in order to ensure that the new questionnaires are successfully identifying children and young people with Autism Spectrum Disorder, the modified instrument will be validated using a 'gold standard'. The current 'gold standard' for the mental health screening of Deaf children is a clinical interview administered by experienced senior multidisciplinary deaf child mental health clinicians.
- Conditions
- Hearing Loss, ASD
- Being tested
- A revised screening instrument for use in Deaf children
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A revised screening instrument for use in Deaf childrenBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Screening | No intervention | Not described Receives: Behavioral: A revised screening instrument for use in Deaf children |
What is being measured
The primary outcome is the main question the study is designed to answer.
A validated Autism Spectrum Disorder screening instrument to identify those in need of further assessment from deaf children suspected of ASD, with both English and BSL versions (for deaf parents).
Measured: 42 months
Secondary outcomes (1)
A modified version of the Autism Diagnostic Interview Revised (ADIR) validated for use in the assessment of deaf young people; accessible in English and BSL (for hearing and deaf parents to fully participate in assessment).
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds and York Partnership NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- University of Manchester, Newcastle University
- Responsible party
- Sponsor
- Investigators
- Barry Wright, Principal investigator, Leeds and York Partnership NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932515
- Sponsor's protocol ID
- BH120870
- Acronym
- DIADS
- Status last verified
- Jun 2014
- First submitted
- 27 Aug 2013
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Instruments for Autism in Deaf Children Study
- ClinicalTrials.gov ID
- NCT01932515
- Acronym / sponsor ID
- DIADS / BH120870
- Conditions
- Hearing Loss, ASD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- Leeds and York Partnership NHS Foundation TrustOther government
- Collaborators
- University of Manchester, Newcastle University
- Study start
- Nov 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial is in three stages and will translate and validate screening and assessment instruments for use with deaf children.
The first stage is modifying the screening and assessment instruments (ADI-R and ADOS-2) for use with deaf children. This will involve choosing the most promising screening instrument (SRS-2) based on the systematic review and the expertise of a review panel, which contains experts and public and patient involvement (PPI). This phase of the study seeks a wide range of user (parents/ carers and young people) views and experiences about the symptomatology and presentation of deaf children with autism, comparing this to hearing children with autism, and deaf children without autism.
The second stage is to ensure that the newly modified instruments are accessible to deaf children and deaf parents by making any necessary translations from English into British Sign Language. This involves a strict translation and back translation methodology with reiterations until successful translation is achieved.
For stage three in order to ensure that the new questionnaires are successfully identifying children and young people with Autism Spectrum Disorder, the modified instrument will be validated using a 'gold standard'. The current 'gold standard' for the mental health screening of Deaf children is a clinical interview administered by experienced senior multidisciplinary deaf child mental health clinicians.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | No intervention | Behavioral: A revised screening instrument for use in Deaf children |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- For the purposes of this study, children and young people will be recruited if they have a chronological age of ≥18 months old, up to 18 years.
- Deaf children will have a hearing loss of at least 40dB
Key exclusion criteria (2 listed)
- This is a pragmatic trial which recognises the frequency and complexity of co-morbidities in children with Autistic Spectrum Disorders (ASD) and deafness. We will therefore not exclude on the basis of co-morbidity in the groups where a diagnosis of ASD already exists, since these tools would be used with this population if adopted more widely in the NHS.
- We will not exclude children or young people with language delay as children with ASD may have severe language delay. Families where the parents do not have either a signed language being studied here, or a language in which the ADI-R is available, will not be included.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A revised screening instrument for use in Deaf children | Behavioural | Screening |
Primary outcome
A validated Autism Spectrum Disorder screening instrument to identify those in need of further assessment from deaf children suspected of ASD, with both English and BSL versions (for deaf parents).
Time frame: 42 months
1 secondary outcome
A modified version of the Autism Diagnostic Interview Revised (ADIR) validated for use in the assessment of deaf young people; accessible in English and BSL (for hearing and deaf parents to fully participate in assessment).
Time frame: 42 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry Wright principal investigator
Leeds and York Partnership NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A revised screening instrument for use in Deaf children in people with Hearing Loss and ASD, run by Leeds and York Partnership NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A validated Autism Spectrum Disorder screening instrument to identify those in need of further assessment from deaf children suspected of ASD, with both English and BSL versions (for deaf parents). (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2014.