Diagnostic Instruments for Autism in Deaf Children Study

Hearing Loss Clinical Trial

— DIADS  

Official title:

Diagnostic Instruments for Autism in Deaf Children Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01932515
• Other study ID #: BH120870
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2013
• Last updated: June 25, 2014
• Start date: November 2013
• Est. completion date: April 2017

Study information

• Verified date: June 2014
• Source: Leeds and York Partnership NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 325
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• ASD
• Hearing Loss

Intervention

Behavioral:
• A revised screening instrument for use in Deaf children

Locations

Country	Name	City	State
United Kingdom	Leeds and York Partnership NHS Foundation Trust	York	North Yorkshire

Sponsors (3)

Lead Sponsor	Collaborator
Leeds and York Partnership NHS Foundation Trust	Newcastle University, University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	A modified version of the Autism Diagnostic Observation Schedule (ADOS 2) validated for use with deaf young people in both BSL or English.		42 months	No
Primary	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).		42 months	No
Secondary	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).		42 months	No