Attention Control Training (ACT) and Very Preterm Infants (ACT)

• ClinicalTrials.gov Identifier: NCT03896490
• Recruitment Status: Unknown
• First Posted: April 1, 2019
• Last Update Posted: November 29, 2019
• Sponsor: Queen's University, Belfast
• Collaborators: Public Health Agency, Health and Social Care Research and Development; TinyLife
• Information provided by (Responsible Party): Oliver Perra, Queen's University, Belfast

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Very Premature Baby	Behavioral: ACT; Behavioral: Control	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
• Actual Study Start Date: March 11, 2018
• Actual Primary Completion Date: June 30, 2019
• Estimated Study Completion Date: March 11, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: ACT	Behavioral: ACT; 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 presentation trigger motivating stimulations (cartoon animations with child-friendly sounds) every time the infant fulfils 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.
Placebo Comparator: Control	Behavioral: 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 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 will be matched infant-by-infant and visit-by-visit with participants in the ACT treatment group: Infants in the control group will see a replay of the session of the matched treated infant. Therefore, while the presentation will be exactly the same (i.e. same length and same stimuli) for the treated and the control child, in the latter case the presentation will not be interactive (i.e. not generated contingently on the infants' visual behaviour).

Outcome Measures

Primary Outcome Measures :

1. Recruitment and Retention [ Time Frame: 1 year ]
   Recruitment as a percentage of the eligible families approached who agreed to take part in the study and were randomised, and retention, defined as the percentage of randomised participants for whom data are available at baseline and post-test.

Secondary Outcome Measures :

1. Percentage of training/control sessions attended by infants [ Time Frame: 1 year ]
   Sessions attended are defined as sessions to which parent and infant are present at the scheduled appointment
2. Percentage of training/control sessions completed by infants [ Time Frame: 1 year ]
   Sessions completed are defined as sessions whereby infants engaged without interruptions for at least 240 sec in at least two tasks.
3. Duration of tasks administered to infants during training/control sessions [ Time Frame: 1 year ]
   Duration is defined as the cumulative duration in seconds of the tasks delivered to infants during the training or control sessions.
4. Percentage of tasks completed at post-test [ Time Frame: 1 year ]
   Completion is defined according to time criteria specific for each of the four attention tasks. Specifically, a sustained attention stipulates an infant completes two consecutive looks at less than 50% of the longest look displayed, or 120 s of accumulated looking time, or 12 trials without showing consecutive looks at less than 50% of the longest look displayed (habituation criterion). A visual-paired comparison task stipulates that stimuli are displayed for 16,000 ms. A disengagement task stipulates administration of at least 52 trials. An information density preference task stipulates administration of 6 blocks of the task in total.
5. Quality of eye-tracker data collected during baseline and post-test attention assessments [ Time Frame: 1 year ]
   A random sample of the baseline and post-test attention assessments will be selected at random (20% of all the completed assessments). The quality of the eye-tracker data collected will be assessed by determining the number of usable fragments recorded during the task and the proportion of usable fragments recorded by the duration of the task in seconds.
6. Quality of eye-tracker data collected during training [ Time Frame: 1 year ]
   A random sample of the completed attention training tasks will be selected at random (20% of all the completed tasks). The quality of the eye-tracker data collected will be assessed by determining the number of usable fragments recorded during the task and the proportion of usable fragments recorded by the duration of the task in seconds.

Eligibility Criteria

• Ages Eligible for Study: 11 Months to 13 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Contacts

Contact: Oliver Perra, PhD; +44 (0)289097 ext 2313; o.perra@qub.ac.uk

Locations

United Kingdom

Queen's University Belfast; Recruiting

Belfast, Northern Ireland, United Kingdom, BT9 7BL

Principal Investigator: Oliver Perra, PhD

Sponsors and Collaborators

Queen's University, Belfast

Public Health Agency, Health and Social Care Research and Development

TinyLife

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Erratum in: Pilot Feasibility Stud. 2021 Nov 11;7(1):201.

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.

• Responsible Party: Oliver Perra, Principal Investigator, Queen's University, Belfast
• ClinicalTrials.gov Identifier: NCT03896490
• Other Study ID Numbers: R4798NUR
• First Posted: April 1, 2019
• Last Update Posted: November 29, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oliver Perra, Queen's University, Belfast:

Learning; Memory; Memory Training; Attention; Computerized Cognitive Training