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A Clinical Trial of a New Computer Based Intervention for Children With Autism. (Click-East)

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ClinicalTrials.gov Identifier: NCT01493609
Recruitment Status : Completed
First Posted : December 16, 2011
Last Update Posted : November 25, 2013
Sponsor:
Collaborators:
NHS Lothian
Newcastle University
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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Brief Summary:
The CLICK-EAST research project is an investigation of the efficacy of a computer based learning programme which aims to teach the fundamental components of social attention to young children with autism spectrum disorder (ASD). "Social attention" describes the process of choosing to look at or listen to social information in the world, normally in preference to any other available information. Social information normally refers to people: for example, we notice human voices more than birdsong or traffic noise, even if the latter is louder. As a rule, children with ASD are less likely to prioritise this kind of social information. This is thought to have a significant effect on their development and behaviour. For example, a child who doesn't listen to what his parents say may be very slow to learn language, and may also fail to follow important instructions. Our goal is to create a new learning programme, in the form of an enjoyable computer game, which encourages children to practise the skills of looking at and listening to people, despite the presence of distracting information. The investigators will develop the game with the input of an advisory group of parents and teachers of children with ASD as well as some young adults with an ASD diagnosis. Then they will perform a trial of the game with a group of preschoolers with ASD and their families, in order to determine whether the game is having a positive effect on the children's abilities.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Click-East app Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer Learning in Children - the Edinburgh Autism Social-attention Trial.
Study Start Date : February 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Waitlist Control
Experimental: Click-East app
Participants will receive a copy of the game immediately following recruitment and assessment.
 Behavioral: Click-East app
Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.


Outcome Measures
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Primary Outcome Measures :
  1. Autism Diagnostic Observation Schedule - Change (ADOS-C) [ Time Frame: approx 6 months ]
    The primary outcome measure is the ADOS-C. The primary outcome will be: Is there a difference in ADOS-C composite score for children receiving the intervention compared to a treatment as usual control group? The ADOS-C is a detailed observation of social behaviours coded from the videoed interaction that takes place during the Autism Diagnostic Observation Schedule assessment.


Eligibility Criteria
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Ages Eligible for Study:   15 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of core autism
  • aged between 15 months and 5 years, 11 months.
  • minimum nonverbal age equivalent of 15 months.

Exclusion Criteria:

  • Children with epilepsy whose developmental progress may be impeded
  • families with little knowledge of the English language such that their understanding of the information sheets and instructions accompanying the trial is limited. Unfortunately funding is not available for the provision of translators or translated materials.
Contacts and Locations
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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): NCT01493609


Locations
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United Kingdom
University of Edinburgh
Edinburgh, Midlothian, United Kingdom, EH8 8AQ
Clinical Research Facility, Royal Hospital for Sick Children
Edinburgh, Midlothian, United Kingdom, EH9 1LF
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Newcastle University
Investigators
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Principal Investigator: Sue Fletcher-Watson, PhD University of Edinburgh
More Information
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Additional Information:

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01493609    
Other Study ID Numbers: 2010/C/PMLD/03
NCF/36343 ( Other Grant/Funding Number: Nuffield Foundation )
First Posted: December 16, 2011    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders