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

Autism Spectrum Disorder Clinical Trial

— Click-East  

Official title:

Computer Learning in Children - the Edinburgh Autism Social-attention Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493609
• Other study ID #: 2010/C/PMLD/03
• Secondary ID: NCF/36343
• Status: Completed
• Phase: Phase 0
• First received: December 15, 2011
• Last updated: November 21, 2013
• Start date: February 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Months to 6 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• Click-East app
Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.

Locations

Country	Name	City	State
United Kingdom	Clinical Research Facility, Royal Hospital for Sick Children	Edinburgh	Midlothian
United Kingdom	University of Edinburgh	Edinburgh	Midlothian

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Newcastle University, NHS Lothian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism Diagnostic Observation Schedule - Change (ADOS-C)	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.	approx 6 months	No

External Links

•   Study website