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

NCT ID: NCT01493609

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Click-East app

Participants will receive a copy of the game immediately following recruitment and assessment.

Group Type EXPERIMENTAL

Click-East app

Intervention Type BEHAVIORAL

Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.

Interventions

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Click-East app

Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

15 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NHS Lothian

OTHER_GOV

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role collaborator

University of Edinburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sue Fletcher-Watson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Edinburgh

Locations

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University of Edinburgh

Edinburgh, Midlothian, United Kingdom

Site Status

Clinical Research Facility, Royal Hospital for Sick Children

Edinburgh, Midlothian, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.dart.ed.ac.uk/click-east

Study website

Other Identifiers

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NCF/36343

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2010/C/PMLD/03

Identifier Type: -

Identifier Source: org_study_id