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

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

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

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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

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).




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.



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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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896490


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

Locations
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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

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Responsible Party: Oliver Perra, Principal Investigator, Queen's University, Belfast
ClinicalTrials.gov Identifier: NCT03896490    
Other Study ID Numbers: R4798NUR
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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