Attention Control Training (ACT) and Very Preterm Infants
Condition: Very Premature Baby
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      The aims of this project are to:

        1. Investigate VP infants' engagement with the ACT procedure;

        2. Assess the quality of data collected during the training and assessments used, and
           compare them to similar data obtained from typically developing infants who completed
           studies conducted by collaborators.

        3. Investigate retention into the programme.

        4. Investigate infants' performance in outcome measures and assess trends indicating
           differences in performance between treated and controls.

      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 :

        1. the ACT training programme delivered across 4 consecutive weekly sessions for a month
           (n=10);

        2. Control (n=10), whereby infants will be shown cartoons over the same number of weekly
           sessions and for a corresponding amount of time as infants in the ACT intervention.

      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).
    

Intervention name(s): Attention Control Training; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Infants watch interactive cartoons that respond to infants' direction of gaze. An eye-tracker records the infant's eye movements in real time, relaying this information to the computer. These presentations trigger motivating stimuli (cartoon animations with child-friendly sounds) every time the infant fulfills the demands of a task (e.g. when the infant looks at a character on the screen avoiding to be distracted by other objects moving across the screen). The length of training sessions varies depending on infants' engagement with stimuli and time criteria.; The control procedure involves presentation of cartoons on a screen, while infants' gaze direction is recorded using the same eye-tracker and camera. The crucial difference is that the cartoons in this case are not interactive, thus do not change depending on infants' gaze direction. To ensure presentations in the control procedure are similar in length to those of the intervention group, infants in the control group are matched infant-by-infant and visit-by-visit with participants in the ACT treatment group: Infants in the control group see a replay of the session of the matched treated infant. Therefore, while the presentation is exactly the same (i.e. same length and same stimuli) for the treated and the control child, in the latter case the presentation is not interactive (i.e. not generated contingently on the infants' visual behaviour).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Learning; Memory; Memory Training; Attention; Computerized Cognitive Training