Clinical trial NCT03896490: Attention Control Training (ACT) and Very Preterm Infants
Official title: A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Very Premature Baby
Keywords: Learning
Memory
Memory Training
Attention
Computerized Cognitive Training
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Public Health Agency, Health and Social Care Research and Development
name: TinyLife
First posted: 2019-04-01
Enrollment: 12
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Infants born very preterm (gestational age 28 to less than 32 weeks);
* Infant's family residing in Northern Ireland;
* Infant's age 12 months (+/- 1 month) at the start of the study, corrected for prematurity

Exclusion Criteria:

* Significant visual and/or hearing disabilities;
* Congenital anomalies that may impact on their cognitive and sensory-motor development;
* A diagnosis of Cerebral Palsy;
* Infant 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 representing a significant burden for the family).

Primary outcomes:
measure: Recruitment and Retention
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of Training/Control Sessions Attended by Infants
timeFrame: 1 year
measure: Percentage of Training/Control Sessions Completed by Infants
timeFrame: 1 year
measure: Duration of Tasks Administered to Infants During Training/Control Sessions
timeFrame: 1 year
measure: Percentage of Tasks Completed at Post-test
timeFrame: 1 year
measure: Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments
timeFrame: 1 year
measure: Performance During Training
timeFrame: 1 year
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Queen's University Belfast
state: Northern Ireland
Study officials:
References:
citation: Perra O, Wass S, McNulty A, Sweet D, Papageorgiou K, Johnston M, Patterson A, Bilello D, Alderdice F. Training attention control of very preterm infants: protocol for a feasibility study of the Attention Control Training (ACT). Pilot Feasibility Stud. 2020 Feb 10;6:17. doi: 10.1186/s40814-020-0556-9. eCollection 2020.
citation: Perra O, Alderdice F, Sweet D, McNulty A, Johnston M, Bilello D, Papageorgiou K, Wass S. Attention and social communication skills of very preterm infants after training attention control: Bayesian analyses of a feasibility study. PLoS One. 2022 Sep 22;17(9):e0273767. doi: 10.1371/journal.pone.0273767. eCollection 2022.
citation: Perra O, Wass S, McNulty A, Sweet D, Papageorgiou KA, Johnston M, Bilello D, Patterson A, Alderdice F. Very preterm infants engage in an intervention to train their control of attention: results from the feasibility study of the Attention Control Training (ACT) randomised trial. Pilot Feasibility Stud. 2021 Mar 12;7(1):66. doi: 10.1186/s40814-021-00809-z.