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

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• Principal Investigator: Sue Fletcher-Watson, PhD; University of Edinburgh

More Information

Additional Information:

Study website 

• 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
• Last Update Posted: November 25, 2013
• Last Verified: November 2013

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders