A Clinical Trial of a New Computer Based Intervention for Children With Autism. (Click-East)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Computer Learning in Children - the Edinburgh Autism Social-attention Trial.|
- Autism Diagnostic Observation Schedule - Change (ADOS-C) [ Time Frame: approx 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2012|
|Study Completion Date:||June 2013|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493609
|University of Edinburgh|
|Edinburgh, Midlothian, United Kingdom, EH8 8AQ|
|Clinical Research Facility, Royal Hospital for Sick Children|
|Edinburgh, Midlothian, United Kingdom, EH9 1LF|
|Principal Investigator:||Sue Fletcher-Watson, PhD||University of Edinburgh|