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A Clinical Trial of a New Computer Based Intervention for Children With Autism. (Click-East)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Click-East app
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

15 Months - 6 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Edinburgh
  • Clinical Research Facility, Royal Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist Control

Click-East app

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2011
Last Updated
November 21, 2013
Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Newcastle University
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1. Study Identification

Unique Protocol Identification Number
NCT01493609
Brief Title
A Clinical Trial of a New Computer Based Intervention for Children With Autism.
Acronym
Click-East
Official Title
Computer Learning in Children - the Edinburgh Autism Social-attention Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
NHS Lothian, Newcastle University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Title
Click-East app
Arm Type
Experimental
Arm Description
Participants will receive a copy of the game immediately following recruitment and assessment.
Intervention Type
Behavioral
Intervention Name(s)
Click-East app
Intervention Description
Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.
Primary Outcome Measure Information:
Title
Autism Diagnostic Observation Schedule - Change (ADOS-C)
Description
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.
Time Frame
approx 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Fletcher-Watson, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Edinburgh
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH8 8AQ
Country
United Kingdom
Facility Name
Clinical Research Facility, Royal Hospital for Sick Children
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH9 1LF
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.dart.ed.ac.uk/click-east
Description
Study website

Learn more about this trial

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

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