NCT01493609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.3 years

First QC Date

December 15, 2011

Last Update Submit

November 21, 2013

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Waitlist Control

NO INTERVENTION

Click-East app

EXPERIMENTAL

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

Behavioral: Click-East app

Interventions

Click-East appBEHAVIORAL

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

Click-East app

Eligibility Criteria

Age15 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • confirmed diagnosis of core autism
  • aged between 15 months and 5 years, 11 months.
  • minimum nonverbal age equivalent of 15 months.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Edinburgh

Edinburgh, Midlothian, EH8 8AQ, United Kingdom

Location

Clinical Research Facility, Royal Hospital for Sick Children

Edinburgh, Midlothian, EH9 1LF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sue Fletcher-Watson, PhD

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 16, 2011

Study Start

February 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

GB(2)