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Diagnostic Instruments for Autism in Deaf Children Study (DIADS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2014 by Leeds and York Partnership NHS Foundation Trust.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01932515
First Posted: August 30, 2013
Last Update Posted: June 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Manchester
Newcastle University
Information provided by (Responsible Party):
Leeds and York Partnership NHS Foundation Trust
  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: None (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 ]

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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Leeds and York Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01932515     History of Changes
Other Study ID Numbers: BH120870
First Submitted: August 27, 2013
First Posted: August 30, 2013
Last Update Posted: June 26, 2014
Last Verified: June 2014

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