Diagnostic Instruments for Autism in Deaf Children Study (DIADS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Manchester
Newcastle University
Information provided by (Responsible Party):
Leeds and York Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01932515
First received: August 27, 2013
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Hearing Loss
ASD
Behavioral: A revised screening instrument for use in Deaf children

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Diagnostic Instruments for Autism in Deaf Children Study

Resource links provided by NLM:


Further study details as provided by Leeds and York Partnership NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 325
Study Start Date: November 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Screening Behavioral: A revised screening instrument for use in Deaf children

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01932515

Locations
United Kingdom
Leeds and York Partnership NHS Foundation Trust
York, North Yorkshire, United Kingdom, YO30 5RE
Sponsors and Collaborators
Leeds and York Partnership NHS Foundation Trust
University of Manchester
Newcastle University
Investigators
Principal Investigator: Barry Wright Leeds and York Partnership NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Leeds and York Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01932515     History of Changes
Other Study ID Numbers: BH120870
Study First Received: August 27, 2013
Last Updated: June 25, 2014
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2014