A Clinical Trial of a New Computer Based Intervention for Children With Autism. (Click-East)
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ClinicalTrials.gov Identifier: NCT01493609 |
Recruitment Status :
Completed
First Posted : December 16, 2011
Last Update Posted : November 25, 2013
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder | Behavioral: Click-East app | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 54 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Computer Learning in Children - the Edinburgh Autism Social-attention Trial. |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
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No Intervention: Waitlist Control | |
Experimental: Click-East app
Participants will receive a copy of the game immediately following recruitment and assessment.
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Behavioral: Click-East app
Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills. |
- Autism Diagnostic Observation Schedule - Change (ADOS-C) [ Time Frame: 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.

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Ages Eligible for Study: | 15 Months to 6 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493609
United Kingdom | |
University of Edinburgh | |
Edinburgh, Midlothian, United Kingdom, EH8 8AQ | |
Clinical Research Facility, Royal Hospital for Sick Children | |
Edinburgh, Midlothian, United Kingdom, EH9 1LF |
Principal Investigator: | Sue Fletcher-Watson, PhD | University of Edinburgh |
Responsible Party: | University of Edinburgh |
ClinicalTrials.gov Identifier: | NCT01493609 |
Other Study ID Numbers: |
2010/C/PMLD/03 NCF/36343 ( Other Grant/Funding Number: Nuffield Foundation ) |
First Posted: | December 16, 2011 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | November 2013 |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |