A Clinical Trial of a New Computer Based Intervention for Children With Autism.

Early Phase 1

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Click-East app

• Registration Number: NCT01493609
• Lead Sponsor: University of Edinburgh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-15
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-02
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Click-East app	Click-East app	Participants will receive a copy of the game immediately following recruitment and assessment.

Primary Outcome Measures

Name	Time	Method
Autism Diagnostic Observation Schedule - Change (ADOS-C)	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.

Trial Locations

Locations (2)

Clinical Research Facility, Royal Hospital for Sick Children; 🇬🇧 Edinburgh, Midlothian, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, Midlothian, United Kingdom