Plain English Summary
Background and study aims
Attentional control can be described as an individual's ability to choose what they pay attention to and what they ignore. We are conducting a study to see whether it is possible to deliver a five-week-long training programme that uses eye-tracking technology to improve attention control during infancy. This is a key ability that is thought to be required for learning language and in academic settings. The primary aim is to find out whether it is possible to conduct such a targeted short-term intervention in Children’s Centres.
Who can participate?
11-month-old typically developing healthy infants
What does the study involve?
Before the first visit we send caregivers two questionnaires that assess their infant’s temperament and communication (word learning and other early gestures). The five visits then take place over five weeks. At each visit the infant watches things happening on the screen while sitting on their caregiver’s lap. Infants are randomly assigned to one of two groups - training or control - that watch different kinds of presentations during the visits. Infants in the training group are required to exercise control over what they pay attention to, as the cartoons displayed on the screen change/move depending on where the infant is looking. The control group infants view a variety of infant-appropriate TV clips and animations in front of the eye-tracker for a matched amount of time. These TV clips and animations include short clips from infant-directed television programmes such as In the Night Garden and Sesame Street, clips from appropriate adult-directed television programmes such as the BBC News and clips of tennis matches, as well as camcorder shots of urban and rural scenes. After the study is completed, parents are debriefed to explain which group their infant was allocated to and what effects we are hoping to find.
What are the possible benefits and risks of participating?
The successful completion of this study will allow the development of a new programme for infants and will provide a good basis for conducting a larger study of its effectiveness. There is no evidence of any risks from this sort of training early in development. Related forms of training are in widespread use with older (pre-school age) children, including children with ADHD.
Where is the study run from?
Birkbeck College, University of London (UK)
When is the study starting and how long is it expected to run for?
March 2012 to June 2012
Who is funding the study?
Nuffield Foundation (UK)
Who is the main contact?
Dr Haiko Ballieux
haiko@uel.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Derek Moore
ORCID ID
Contact details
Institute for Research in Child Development (IRCD)
School of Psychology
University of East London
Water Lane
London
E15 4LZ
United Kingdom
+44 (0)20 8223 4433
d.g.moore@uel.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Training 11-month-old infants' visual attention control in a community setting: a pilot study using eye tracking technology to deliver gaze-contingency training in children's centres in East London
Acronym
iSTARS
Study hypothesis
Determine whether it is possible to conduct a targeted short-term training of visual attention of 11-month-old infants in Children's Centres in two areas in East London with significant socio-economic deprivation.
Establish whether infants from areas with significant socio-economic deprivation can improve their attention control in the same way as infants with middle-to-high income parents trained in a lab context.
Ethics approval
University of East London Research Ethics Committee, 15/02/2012
Study design
Randomised double-blind multicentre interventional design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Visual attention control in infants
Intervention
Using eye-tracking technology to train visual attention control in infants based on their own eye movements. The study structure is a close replication of a previously approved and published pilot study (Wass et al., 2011). Before the first visit caregivers will be sent two questionnaires that assess the infant's temperament (IBQ-VeryShort) and communication (Oxford CDI, word learning and other early gestures).
Visit 1 and 5 - Visit 1 entails a pre-assessment and the first training session. The infant will view a number of cartoons and eye-tracking 'games' on the eye-tracker screen, examining aspects of attention skills. Each visit will last about 1.5 hours in total. Visit 5 includes the final training session and a post-test.
Visits 2 to 4 - These visits entail training sessions only, and will last 30 minutes to 1 hour. The infant will be watching things happen on the screen, while sitting on the caregiver's lap. Infants are randomly assigned to one of two groups - training or control - that will be watching different kinds of presentations during training visits.
Pre- and post-assessment
The pre-post measures are a gap-overlap task, cognitive control task, habituation task, and a free-viewing task. Infants' behaviour will also be video recorded during administration of the tests and coded/analyzed post hoc.
Training
The attention control training is based on cognitive training techniques that are in widespread use throughout the cognitive neuroscience community (Klingberg et al., 2005; Rueda et al., 2005; Holmes et al., 2009). Infants in the training group will be presented with paradigms in which they are required to exercise volitional control over what they attend to. In this group cartoons displayed on the screen will change/move depending on where the infant is looking. This programme is aimed at training the following cognitive skills: interference resolution, inhibition, and focused attention. We will administer about 75 minutes of training per infant in sessions 1-5 together.
The control participants will view a variety of infant-appropriate TV clips and animations in front the eye-tracker for a matched amount of time. These TV clips and animations will include short (<2 minute) clips from commercially available infant-directed television programmes, clips from appropriate adult-directed television programmes, clips of tennis matches, and naturalistic camcorder shots of urban and rural scenes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Visual attention control (specifically interference resolution, inhibition, and focused attention), measured once a week for a 5-week period (same day of the week every time) through administration of a gap-overlap task, cognitive control task, habituation task, and free-viewing task.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/03/2012
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
11-month-old typically developing healthy infants (both boys and girls)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
40
Total final enrolment
33
Participant exclusion criteria
1. Major medical condition in the first 6 months of life
2. Extreme prematurity (<36 weeks)
3. Major delivery complications (e.g. asphyxia, low Apgar score, gestational diabetes)
4. First degree relative with any diagnosed psychiatric disorder
Recruitment start date
01/03/2012
Recruitment end date
30/06/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of East London
London
E15 4LZ
United Kingdom
Sponsor information
Organisation
University of East London (UK)
Sponsor details
Quality Assurance and Assessment
Docklands Campus
University Way
London
E16 2RD
United Kingdom
+44 (0)20 8223 2009 / 3322
researchethics@uel.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Nuffield Foundation (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
2018 results in https://www.nuffieldfoundation.org/sites/default/files/files/Main%20Public%20Report%20Dec18%20copyfinal2%20(1).pdf
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list