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

This study has been completed.
Sponsor:
Collaborators:
NHS Lothian
Newcastle University
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT01493609
First received: December 15, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Autism Spectrum Disorder
Behavioral: Click-East app
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer Learning in Children - the Edinburgh Autism Social-attention Trial.

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • Autism Diagnostic Observation Schedule - Change (ADOS-C) [ Time Frame: approx 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 54
Study Start Date: February 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Waitlist Control
Experimental: Click-East app
Participants will receive a copy of the game immediately following recruitment and assessment.
Behavioral: Click-East app
Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.

  Eligibility

Ages Eligible for Study:   15 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493609

Locations
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
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Newcastle University
Investigators
Principal Investigator: Sue Fletcher-Watson, PhD University of Edinburgh
  More Information

Additional Information:
No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT01493609     History of Changes
Other Study ID Numbers: 2010/C/PMLD/03, NCF/36343
Study First Received: December 15, 2011
Last Updated: November 21, 2013
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014