Status
Conditions
Treatments
About
Infants' attention control, defined as the ability to select what to pay attention to, is a fundamental building block for developing learning abilities and behaviour self-regulation. Infants born before term (<37 weeks gestation) display delays in attention control, and these delays cause cascade effects that include learning difficulties and behaviour problems. Infants born before 32 weeks of gestation, known as very preterm (VP), are particularly at risk of persistent difficulties in attention.
A ground-breaking early intervention, the Attention Control Training (ACT), targets infants' attention control. The novelty of the ACT lies in engaging young infants in "brain-training" using a computer interface, which tracks infants' gaze direction and presents training visual stimuli appropriate to the infants' ability level. Results demonstrate ACT improves attention of typically developing infants, contributing to improvements in other cognitive abilities (e.g. memory), but ACT has not been tested in clinical populations such as VP infants.
The investigators are running a feasibility study of the ACT intervention amongst VP infants aged 1 year (corrected age for prematurity). This feasibility study is necessary in order to adapt the ACT material and presentation to VP infants, and in particular to investigate the acceptability of a Randomised Trial and its training schedule by parents of VP infants.
The proposed study will allow the investigators to identify solutions to problems, ensuring the ACT material and delivery are customised for VP infants.
Full description
The aims of this project are to:
To allow for a fair test of the ACT, infants will be randomly assigned to receive the ACT programme or to watch age appropriate non-interactive cartoons (control procedure). By randomly assigning infants to the ACT or the control procedure, the investigators can be sure that infants in the treatment group do not differ systematically from those in the control group: the two groups will therefore differ only for effect of chance, and the only systematic difference between them will lie in the experimental treatment.
All the assessments will take place in a dedicated room. The use of a dedicated room will ensure that infants are assessed in controlled conditions whereby interference from noise, changes in light, or other sources of distraction, are minimised.
The first session will take place by the time the infant is aged 12 months (age corrected for prematurity). This session will include a baseline assessment followed by a first training/control procedure (depending on the child's random assignment in one group or the other). During the baseline assessment parents will be asked to answer questions about the family and infants' behaviour.
The investigators will also assess infants' attention using computer-based tasks whereby infants have to watch some images on a screen (e.g. pictures of babies, cartoon characters, etc.), as well as using tasks whereby infants are asked to play with novel toys or interact with the researcher. The investigators will also collect a general assessment of the infants' cognitive skills using the Mullen scales, a validated and age-appropriate battery. Finally, the investigators will record mother and infant playing together for some minutes in order to assess infants' abilities to pay attention and focus on other people and objects in a naturalistic situation, similar to familiar play routines at home.
After the assessment, the researcher tasked with running the ACT or control procedure will open a sealed envelope and will find out to which group (ACT or control) the child has been assigned. If the infant is still in an alert and attentive state, the experimenter will proceed with the delivery of the ACT or control procedure accordingly to the infant's assignment.
Parents will not be told what type of videos (ACT or control) their child will be watching. This is to ensure that parents do not change their behaviour when they know to which procedure their child is taking part. The cartoons displayed to the control group will be identical to those shown to the treated: the only (pivotal) difference will lie in that the cartoons will be interactive (i.e. activated contingently on infant's gaze behaviour) for the treated, while they will not be interactive for infants in the control group. Since the cartoons will be identical across groups, and, furthermore, parents will not be able to detect the direction of gaze of the infant during training while infants are held on the parent's lap, the investigators believe that it will be difficult for parents to recognise their infant's group allocation. However, the research team will investigate this by asking a series of follow-up questions to parents at the end of the study.
Infants will be allocated to one of two groups :
Weekly session 2, 3, and 4 will involve further administration of training/control procedures.
The final session in week 5 will involve collection of outcome measures. The same questionnaires and tasks described in the baseline assessment will be used. The researcher that will assess the infant in the 5th session will be a blind assessor (who will not know in which group, ACT or Control, the infant has been allocated).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
12 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Oliver Perra, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal