Diagnostic Instruments for Autism in Deaf Children Study

NCT ID: NCT01932515

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2017-04-30

Brief 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.

Conditions

Hearing Loss; ASD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Screening

Group Type: NO_INTERVENTION

A revised screening instrument for use in Deaf children

Intervention Type: BEHAVIORAL

Interventions

A revised screening instrument for use in Deaf children

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manchester

OTHER

Sponsor Role: collaborator

Newcastle University

OTHER

Sponsor Role: collaborator

Leeds and York Partnership NHS Foundation Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barry Wright

Role: PRINCIPAL_INVESTIGATOR

Leeds and York Partnership NHS Foundation Trust

Locations

Leeds and York Partnership NHS Foundation Trust

York, North Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

BH120870

Identifier Type: -

Identifier Source: org_study_id