Overview

This trial is active, not recruiting.

Conditions hearing loss, asd
Treatment a revised screening instrument for use in deaf children
Sponsor Leeds and York Partnership NHS Foundation Trust
Collaborator University of Manchester
Start date November 2013
End date April 2017
Trial size 325 participants
Trial identifier NCT01932515, BH120870

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(No Intervention)
a revised screening instrument for use in deaf children

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 2 years up to 18 years old.

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.

Additional Information

Official title Diagnostic Instruments for Autism in Deaf Children Study
Principal investigator Barry Wright
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Leeds and York Partnership NHS Foundation Trust.