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

Study Overview
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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.

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

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Click-East app


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist Control<br> | |
| Experimental: Click-East app<br>Participants will receive a copy of the game immediately following recruitment and assessment. | Behavioral: Click-East app<br>* Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |