Diagnostic Instruments for Autism in Deaf Children Study (DIADS)

June 25, 2014 updated by: Leeds and York Partnership NHS Foundation Trust

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • North Yorkshire
      • York, North Yorkshire, United Kingdom, YO30 5RE
        • Leeds and York Partnership NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Screening
Behavioral: A revised screening instrument for use in Deaf children

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
42 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
42 months

Other Outcome Measures

Outcome Measure
Time Frame
A modified version of the Autism Diagnostic Observation Schedule (ADOS 2) validated for use with deaf young people in both BSL or English.
Time Frame: 42 months
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leeds and York Partnership NHS Foundation Trust

Collaborators

Newcastle University
University of Manchester

Investigators

  • Principal Investigator: Barry Wright, Leeds and York Partnership NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (ESTIMATE)

August 30, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH120870

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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