A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
Phase: NA
Conditions: Very Premature Baby
Sponsor: Queen's University, Belfast

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A feasibility study of the Attention Control Training (ACT) intervention 
amongst very preterm (VP) infants. 
 
Introduction 
The incidence of premature births in high income countries has increased in recent 
decades(1,2), and more infants born preterm survive.  In England and Wales(3) and Northern 
Ireland(4) approximately 7% of all live births take place prematurely (less than 37 weeks’ gestation). 
Premature birth is associated with increased risk for intellectual problems and lower educational 
achievement(5,6). Risk for these unfavourable outcomes increases amongst infants of lower 
gestational age. Children born between 28 and 31 weeks are defined as very preterm (henceforth: 
VP) and are at risk of persistent learning difficulties(6,7) and problem behaviour such as attention 
deficit disorder(8) even in absence of major health complications.  
Several studies(9-13) indicate that the basis of learning and behavioural problems of VP 
children lies in impaired ability to regulate the acquisition and retention of information during 
infancy.  One of the key processes that are disrupted in VP infants is attention control, which 
indicates infants’ ability to select actively what to pay attention to and what to ignore(14): active 
control over the flow of information attended enables infants to focus on task-relevant information. 
In typically developing infants, attention control starts to emerge around 1 year of age and develops 
throughout early childhood(15). Attention control may be impaired in VP infants because 
prematurity is associated with disruptions of brain development, which may ultimately affect neural 
plasticity(16). 
VP infants display problems in attention control from an early age(10,17), and these 
problems persist over time(11,18,19). Longitudinal studies show that problems in attention abilities 
mediate the association between prematurity and cognitive difficulties(10, 20, 21). Attention control 
problems in infancy may thus cause a cascade of effects that disrupts the development of other 
abilities(12), such as Executive Functions (EFs), and these in turn may affect children’s learning(22) 
and behaviour regulation(23). These links from prematurity to early attention difficulties, poorer 
EFs(24,25), learning and self-regulation problems(26,27), emphasise the importance of intervening 
at an early age, providing infants with remedial processes at a time of greater plasticity of  brain 
networks and before deficits are entrenched. Early interventions targeted at key early skills can help 
infants attain the necessary building blocks for later attainments.  
A new intervention to target infants’ attention control has been developed(28,29), the 
Attention Control Training (ACT). This intervention uses computer interfaces that monitor infants’ 
direction of gaze through eye-tracking: this allows the computer to provide interactive presentations 
whereby visual stimuli on the screen change and vary in response to infants’ gaze direction. Using 
interactive presentations, infants are presented with adaptive challenges, i.e. challenges appropriate 
for the initial skill-set of each individual child. The use of computer interfaces also facilitates the ACT 
delivery with fidelity across centres and with reduced personnel costs.  
The ACT has been trialled with normally-developing children and has provided evidence of 
transfer of effects to attention and memory skills (28, 29), thus demonstrating generalizability. 
Adapting this intervention for VP infants meets the need for targeted early interventions(30-32). 
Furthermore, the coherent theoretical background of this intervention and its specific focus meet 
the need for research on the key mechanisms of early intervention amongst preterm infants, a need 
highlighted by a recent Cochrane review(33). However, before the intervention can be tested with 

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VP infants, a series of processes need to be investigated to underpin its implementation in a full-
scale randomised trial. These processes are the subject of this project.   
Aims and Objectives 
We will conduct a feasibility study to test processes we plan to use in a full-scale randomised 
trial of the effectiveness of the ACT intervention with VP infants.  These processes will include 
adapting the ACT procedure to the VP population, testing the quality of the information collected 
during training and assessments with the VP population, investigating acceptability of a RCT 
procedure and the ACT schedule by parents of VP infants.  
The aims of this project are to: 
(a) Investigate VP infants’ engagement with the ACT procedure;  
(b) 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. 
(c) Investigate retention into the programme. 
(d) Investigate infants’ performance in outcome measures and assess trends indicating 
differences in performance between treated and controls.  
 
This protocol presents the procedures and methods we will use to fulfil these aims. These 
will involve the running of a feasibility RCT whereby 20 infants will be recruited and randomly 
allocated to the intervention (the ACT training) or control procedure (regular visits to watch 
standard cartoons). This feasibility study, its aims and its procedures, have been developed in 
collaboration and consultation with the charity TinyLife, which is a co-applicant in the grant.  
 
Methods 
Trial design 
The study involves testing the feasibility of a randomised trial in which eligible infants are 
allocated to one of two groups when they are aged 12 months (age corrected for gestational age, 
corresponding to approximately 14 months of age from the actual date of birth): 
 (1) The ACT training programme delivered across consecutive weekly sessions for a month 
(n=10); 
 (2) Control (n=10), whereby infants will be shown age-appropriate cartoons over the same 
number of weekly sessions and for a corresponding amount of time as infants in the ACT 
intervention.  
The sample size has been determined using power calculations based on a confidence 
interval approach (34).  While the effect size reported in a previous study conducted with typically 
developing infants was 0.69 (29), we considered this effect may be substantially smaller amongst VP 
infants.  Using a Cochrane review of interventions involving infancy outcomes of preterm infants 
(33), we estimated this could be close to 0.40. Using the formulae reported by Cocks and Torgerson 
(34), the sample size required  to run a pilot with 80% power to detect an effect size equal to  0.40, 
and considering alpha = .05, would be 18 participants. We will recruit 20 infants in order to allow 
10% drop out rate from the study.  
 
 
Participants 
 
Eligible participants are infants born very preterm (less than 32 weeks gestation age) 
residing in Northern Ireland. Approximately 0.7% of newborns in Northern Ireland are born between 

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28 to 31 weeks of gestation age(4), thus accounting for over 200 infants  every year. Participants will 
be approximately 1 year old at the start of the intervention, age corrected for prematurity.  We will 
exclude infants with: significant visual and/or hearing disabilities; congenital anomalies that may 
impact on their cognitive and sensory-motor development; a diagnosis of Cerebral Palsy; are taking 
part in a trial (or have recently  taken part in a trial) which may interfere with this study (e.g. by 
affecting concentration abilities) or represented a significant burden for the family. We will ask the 
child’s main caregiver to provide some information about the child and her behaviour. Furthermore, 
the caregiver that will be present during the sessions will be asked to involve the child in free-play 
during pre- and post-test assessments. We expect that in most of the cases the main caregiver that 
will provide information and take part in these free play sessions will be one of the child’s parents 
(either the mother or the father). However, we will not exclude infants that are being looked after 
by caregivers other than a parent (i.e. a grandparent).  
 
 
Recruitment  
The recruitment will take place with the involvement of Co-I David Sweet, consultant 
neonatologist at the Royal Maternity Hospital in Belfast, and is described in a schematic form in 
Figure 1. Dr Sweet will act as a co-ordinator of the study. He will contact paediatricians in the Belfast 
Trust to let them know about the study and inform them that we would like their collaboration in 
passing information about the study to families of potentially eligible babies who were born in 
Belfast.   
Paediatricians typically review ex-preterm babies for follow up at around the time infants 
are 8-9 months (corrected age). Using the admission book from Royal Maternity Hospital, Dr Sweet 
will be able to identify children that potentially would meet eligibility criteria for this study before 
they are due their follow-up visit with a paediatrician. We will then prompt the paediatrician 
providing follow up in advance of the infant’s visit to consider if there are any exclusion criteria. 
Together with this letter prompting the paediatrician about the study, we will send a study 
summary, as well as information about the study that the consultant can give to parents, if they are 
interested in taking part. The information provided will include contact details of the research team, 
and therefore interested parents will have a chance to contact the researchers to ask questions and 
receive more information about the study.  
We will also collaborate with the charity TinyLife. TinyLife has supported parents of children 
born preterm for nearly 30 years, and provides a range of support services to families, including 
baby-massage, counselling, parent groups, etc. Charity workers will identify eligible children, and will 
pass information to their families. Families will thus have the choice to contact the research team to 
ask more information about the study.  However, since the medical history of these children will not 
be known by staff at TinyLife, if parents are interested, they will be offered a consultation with Dr 
Sweet before meeting the research team and receive more information about the study. Dr Sweet 
will meet the family and, with their consent, check the medical records to ensure the child meets 
inclusion criteria for the study.  
The procedures described above will ensure that the research team will not approach 
parents directly: the paediatricians and TinyLife will act as gatekeepers, passing information to 
parents of children that may be eligible. Only when parents have expressed an interest in the study, 
will they have the opportunity to contact the research team and receive further information.  

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Figure 1: Diagram of recruiting phases 

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When parents contact the research team to express interest in the study, the RA will provide 
an overview of the study, allow parents to read the PIS, and also explain the randomisation 
procedure.  At this stage, if the parents are still interested, they will receive the consent form to sign. 
Parents will be told they will be contacted again when the child is 12 months corrected age. The 
period between consent and contact preceding scheduling of an appointment will act as a “cool-off” 
period. If parents are still happy to take part by the time they are contacted again, an appointment 
will be scheduled. Parents will be reminded that they and their child are expected to take part in five 
weekly consecutive sessions, but that they can withdraw from the study at any time. They will 
receive gift vouchers (£50) at the end of the study, as well as compensation for travel expenses 
incurred in each session attended.   
 
Randomisation  
Randomisation will be computer-generated using ALEA software, with allocation concealed 
to assessors and parents. The allocated group will be notified automatically to the research assistant 
responsible for the training.  
 
Procedure 
The first 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. 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 baseline and the final assessments will 
take place  in a dedicated room within the premises of TinyLife. The use of a dedicated room will 
ensure that infants are tested in controlled conditions whereby interference from noise, changes in 
light, or other sources of distraction, are minimised.  Parents will be offered the choice of whether 
they prefer to attend the training/control sessions (weekly sessions 2, 3, and 4) in the same 
dedicated TinyLife room, or in their own house. In case parents opt for the latter, a researcher will 
travel to the family’s house with the equipment (eye-tracker; web-camera; PC screen; laptop; 
photography light tent). The researcher will set the equipment in a room within the family’s house 
and deliver the training/control procedure. To minimise distractions and interferences due to 
changes in luminosity of the room, the eye-tracker and screen whereby the stimuli will be 
presented will be set inside the photography light tent: the infant will watch the screen inside the 
tent while sitting on the parent’s lap. The use of the tent will contribute in maintaining control 
over environmental factors that may affect infants’ attention and distractibility, as well as the 
recording by the eye-tracker. During the sessions, the experimenter will also emphasise the 
importance of avoiding other distractions (e.g. loud noises), thus encouraging parents to maintain 
these to a minimum while the sessions are running. Delivering the sessions in the families’ house 
will provide some challenges (e.g. less control on the setting). However, the feedback we have 
received from parents suggests that families found attending weekly sessions in a premise outside 
their home challenging. By offering the possibility of delivering the training/control sessions in the 
families’ home and by being more flexible in the timing of these sessions, more parents may be 
inclined to take part.  The researcher delivering the sessions in the families’ home will follow the 
lone-worker policies in order to minimise and prevent risks. These are outlined in an attached 
document.  
Infant’s parent or parents will be present during the whole of the session, whether they 
take place in the premises of TinyLife or in the families’ home. Parents will supervise the infant at 
all times. 

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Baseline assessment. 
We will ask the main caregiver of the child to complete a demographic questionnaire and 
the short form of the Infant Behaviour Questionnaire (IBQ) (35). These questionnaires will be sent in 
advance of the appointment, but will be available for parents that may not have had a chance to 
complete them in advance. Infants will be video-recorded during tasks to allow for further data 
analyses of behaviour. The researcher will be blind to group allocation of the child during the 
baseline assessment.  
The tasks administered will take approximately 60 minutes in total and are: 
 (1) Eye-tracker and computer-based cognitive and attention tasks: Using a laptop with an 
eye-tracker device, we will administer validated measures of sustained attention, attention 
disengagement,  and cognitive control described in more details in the Details of Protocol 
document.  
(2) Naturalistic attention and social attention tasks from the Lab-Tab assessment (Task 
orientation; Attractive toy placed in box) and from the Early Social Communication Scales  
(Gaze following task;  Book presentation task). 
(3) The Mullen scales, administered by the researcher.   
(4) A mother-infant “free-play” session: Mothers will be asked to play with their infant as 
they normally do, and will have a set of toys available. This free-play session will be used to 
investigate parenting behaviour and infants’ attention and communication skills in 
naturalistic conditions (e.g. ability to follow the parent’s direction of gaze).   
The tasks will be interspersed by pauses and breaks to allow infants and parents to rest 
whenever deemed necessary or requested by a parent, or because the infant is sleepy, hungry, etc.  
Intervention. 
 
Infants in the ACT intervention will watch interactive stimuli presentations that are 
contingent on infants’ direction of gaze. An eye-tracker will record the infant’s eye movements in 
real time, while a camera will also record the infant during the training. Collecting video-recording is 
important for monitoring the quality of data collected (e.g. lack of engagement with tasks by infants) 
and to potentially complement any loss of data (e.g. when the infant leans too close to the screen). 
Interactive presentations will provide animations in response to the infant’s gaze in ways that meet 
pre-specified criteria. We will use the training tasks described in Ballieux et al. (28):  (a) Butterfly;  (b) 
Stars; (c) Windows; (d) Suspects. The length of training sessions will vary depending on infants’ 
engagement with stimuli and time criteria, but are expected to last approximately 30 minutes. 
However, parents will be reminded that they can stop the sessions whenever they want. The 
researcher will also assess if the infant is still in calm and alert status before commencing any new 
task, and will stop the sessions if the infant becomes restless or drowsy.  
Control. 
The control procedure will involve presentation of cartoons on a screen, while infants’ gaze 
direction will also be recorded using the same eye–tracker and camera. The crucial difference will be 
that stimuli presented are not interactive, thus do not change contingently with 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 will be matched infant-by-infant and visit-by-visit 
with participants in the ACT control, thus ensuring exactly equivalent length of presentations. The 
cartoons displayed to a control child will follow the same schedule produced by the corresponding 
yoked child in the intervention group. In this way, the cartoons displayed to both groups will be the 
same, but the crucial difference will be that the display is generated contingently on infants’ gaze 

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behaviour during treatment, and it is instead generated according to a pre-set schedule for infants in 
the control group.  
Final  assessment. 
 
The final assessment after the intervention/control procedure will take place in week 5. The 
same questionnaires and tasks described in the baseline assessment will be used. Parents will be 
also asked to complete a feedback questionnaire on the study participation. The assessment will 
take approximately 70 minutes in total.  
Follow up interview with parents. 
 
Feedback from families of VP infants that take part in the study will be valuable in designing 
and planning a future larger trial of the ACT intervention. In this study we ask parents to answer a 
set of questions about their participation when parents attend the final post-test session. However, 
a further follow-up  semi-structured interview could provide more in-depth, rich information on the 
facilitators and obstacles to family participation. This information will be valuable in ensuring future 
trial design address issues that may curtail recruitment, participation, and retention.  At the end of 
the study, parents are asked to sign a consent form to be contacted again to take part in further 
follow up activities related to this study. We propose to contact all parents that have taken part and 
agreed to be contacted for follow ups, and ask them to take part in a short telephone interview 
regarding the study. The invitation to this follow up will be provided in an ad-hoc  PIS. Parents will 
then be invited to register their interest in taking part in this follow-up interview by informing a 
Research team member (e.g. the RA). Once parents have registered their interest, a Research Team 
member will contact them to agree a date and time for the interview. Parents will be reminded they 
can always change their mind. On the agreed date, before the interview is conducted by a Research 
Team member known to the parents, the researcher will first confirm the parent is happy to 
proceed. At this point, the researcher will inform the parent that we need to register their consent, 
and to do so the researcher will read a series of statements and ask the parent to confirm 
agreement with these statements. The researcher will also inform the parent that their consent will 
be recorded to ensure this is documented, but this recording will be kept separate from the rest of 
the interview. If the parent agrees to the interview, then the researcher will proceed with the 
interview following the interview-schedule. The interview will be audio recorded for further 
analyses. Any information and quotes we will report will be anonymised, reporting only a study 
number, and we will take care in ensuring that parents and children will be not identifiable from the 
information we will report.  
 
 
Measures  
The primary measures  are eye-tracking measures of attention and short-term memory. We 
will assess these skills using different tasks compared to those involved in the training, thus testing 
generalizability of results. We will use validated measures of sustained attention, attention 
disengagement, and cognitive control described in Wass et al. (36).  Infants will be assessed using 
these tasks before randomisation (pre-test) and at the end of the trial in week 5. Secondary 
outcomes will be naturalistic measures of attention (Lab Tab tasks), social communication and joint 
attention abilities (Early Social Communication Scales), general measures of cognitive functioning 
(Mullen scales), parental reports of infants’ temperament and behaviour (Infant Behavior 
Questionnaire). A secondary outcome of the study includes analyses of the quality of data recorded 

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during assessments and during training sessions. For this purpose, we will use procedures similar to 
those described by Bailleux et al. (28), which involve comparisons of eye-tracking data quality 
indexes such as the number of usable fragments and the degree of consistency in the reported 
position of gaze between recorded samples. We will compare data collected in this pilot trial with 
data collected from normative samples in previous studies.  
  
Blinding/Masking 
Participant’s group allocation will be known to the research assistant responsible for the 
training, but will be concealed to the assessor, who will have responsibility for carrying out infants’ 
assessments at  baseline and at end of the trial (week 5). The allocation will also be concealed from 
the parents by not revealing the nature of the cartoons being displayed to the infant. Parents will be 
present at all time during testing and training, which poses the risk they could identify the group 
allocation of their child when watching the cartoons displayed. However, we believe this risk is 
minimal for a series of reasons:  
(a) During training, the infant will be sitting on the parent’s lap, and therefore  the parent 
will not have a direct of view of the infant’s direction of gaze. This will make it difficult for the parent 
to assess whether the cartoons are interactive or not. 
(b) The presentations displayed to the control and intervention group will use the same 
stimuli, and will be identical. In fact, we will match each child in the control group to a child in the 
intervention, and the control child will be shown the same exact presentation produced during the 
trained child’s session.  
Indeed, our experience in running these studies is that parents are not aware of whether 
their child is in the training or control group. However, as part of this feasibility study, we will collect 
information on this from parents in a questionnaire to be provided at the conclusion of the study.  
Data storage 
All the paper data will be stored in a locked bag during transportation between TinyLife or 
the participants’ house and Queen’s University Belfast, and will be stored in a locked cabinet within 
QUB premises. The electronic and video data will be kept in the encrypted drive of the laptop, 
copied into a secure network drive within Queen’s, where they will be stored and backed-up, and 
then securely erased from the laptop drive. Only members of the research team will have access to 
the data and the video recordings, which will be only used for research purposes. Data and video-
recordings will be stored for five years following publication of findings in reports and/or scientific 
journals, and will successively be destroyed securely.  
Data Analyses 
 
Data analyses will involve comparisons in the outcome measures collected in week 5 
between treated and controls  using ANCOVA in order to control for baseline measures collected. 
The analyses will also provide information on the observed effect size, which will be useful in 
planning future studies.  
Other analyses will focus on sample retention across the trial, as well as completion and 
duration of completed training and assessment tasks by infants. In these analyses, we will also 
explore family and infant’s characteristics associated with differences in these outcomes, with the 
view of informing factors that may affect retention and intervention compliance in a larger trial.  
Further analyses will involve comparisons of indicators of quality of eye-tracker data in this study 
and data from normative typically developing samples collected across other studies. Indicators used 

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will include the number of usable fragments, or the degree of consistency in the reported position of 
gaze between recorded samples.  
Ethical Issues 
VP infants are potentially vulnerable.  The eligibility of babies will be ensured by asking 
paediatric consultants who are already reviewing these infants to consider if they meet the inclusion 
criteria, thus safeguarding children that may be more vulnerable or whose conditions may preclude 
their participation.  
It is possible the clinical condition of some infants taking part in the trial may worsen after 
the initial contact and during study participation e.g. hospitalisation for bronchiolitis: contact with 
parents after they consented may cause them distress in some circumstances. If such situations 
arise, we will provide families with information about further support that is available to them (e.g. 
counselling). We have developed a Distress Protocol that details a course of action in this and similar 
circumstances.  
The tests used in our trial are not designed to provide diagnostic information (e.g. on infants’ 
cognitive delay). Furthermore, the researchers working on the project are not trained to conduct 
and deliver diagnostic assessments. The Participant Information Sheets will clarify that the 
assessments in the study are not designed to provide diagnostic information. Therefore, the PIS will 
specify that we will not provide information on any individual child’s performance to parents, but we 
will only provide a report on the aggregate results of the study after its conclusion. However, should 
our researchers have any concern about the health and wellbeing of a child, we will discuss the 
concern with the consultant paediatrician involved in this study, and, if considered appropriate by 
the consultant, we will discuss these concerns with the family or with a relevant authority (e.g. in 
case of suspected maltreatment).  
The anonymity of the information collected from parents and infants will be safeguarded 
when publishing results by reporting summary statistics and avoiding reporting information that may 
identify participants. The database used for analyses will only include data on the assessment and 
outcomes and will not include sensitive information or information that can identify the child or the 
parents. To this purpose, each child will receive a unique identification code, and personal and 
sensitive information (e.g. date of birth) will be stored in a separate encrypted file, which will only be 
accessible by the researcher and the data custodian with credentials.  Video recording will also be 
stored securely in encrypted drives, and labelled only with the study ID of the child. We will ask 
parents’ consent to be contacted in the future regarding the study and possible follow-up.  

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Behavioural and emotional problems in very preterm and very low birthweight infants at age 5 
years. Archives of Disease in Childhood-Fetal and Neonatal Edition 2006 NOV 2006;91(6):F423-F428. 
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Applying gaze-contingent training within community settings to infants from diverse SES 
backgrounds. Journal of Applied Developmental Psychology 2016 0;43:8-17. 
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Current Biology 2011 SEP 27 2011;21(18):1543-1547. 
(30) Holmes J. Baby Brain: Training Executive Control in Infancy. Current Biology 2011 
9/27;21(18):R684-R685. 
(31) Wass SV. Applying cognitive training to target executive functions during early 
development. Child Neuropsychology 2015 MAR 4 2015;21(2):150-166. 
(32) Wass SV, Scerif G, Johnson MH. Training attentional control and working memory – Is 
younger, better? Developmental Review 2012 12;32(4):360-387. 
(33) Spittle A, Orton J, Anderson PJ, Boyd R, Doyle LW. Early developmental intervention 
programmes provided post hospital discharge to prevent motor and cognitive impairment in 
preterm infants. The Cochrane database of systematic reviews 2015 Nov 24;11:CD005495-
CD005495. 
(34)Cocks K, Torgerson  DJ. Sample size calculations for pilot randomized trials: a confidence 
interval approach. Journal of clinical epidemiology 2013; 66(2): 197-201. 

ACT ERA Protocol v14 - 16.11.2018 
 
12    IRAS Project ID: 237537 
 
(35) Gartstein MA, Rothbart MK. Studying infant temperament via the revised infant 
behavior questionnaire. Infant Behavior and Development 2003;26(1):64-86. 
(36) Wass, S. V., Cook, C., & Clackson, K. (2017). Changes in behavior and salivary cortisol 
after targeted cognitive training in typical 12-month-old infants. Developmental psychology, 53(5), 
815-825.