Attention Control Training (ACT) and Very Preterm Infants

NCT03896490 | Completed Results

• 1 other identifier: R4798NUR
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Very Premature Baby

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recruitment and Retention

  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.

  1 year

Secondary Outcomes (6)

• Percentage of Training/Control Sessions Attended by Infants

  1 year

• Percentage of Training/Control Sessions Completed by Infants

  1 year

• Duration of Tasks Administered to Infants During Training/Control Sessions

  1 year

• Percentage of Tasks Completed at Post-test

  1 year

• Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments

  1 year

Study Arms (2)

ACT

EXPERIMENTAL

Behavioral: Attention Control Training

Control

PLACEBO COMPARATOR

Behavioral: Control

Interventions

Attention Control Training BEHAVIORAL

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.

ACT

Control BEHAVIORAL

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).

Control

Eligibility Criteria

• Age: 11 Months - 13 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Public Health Agency, Health and Social Care Research and Development: collaborator
• TinyLife: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, Northern Ireland, BT9 7BL, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 32055404 BACKGROUND

• 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.

  PMID: 36137090 DERIVED

• 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.

  PMID: 33712090 DERIVED

Related Links

• Paper describing the study protocol

Results Point of Contact

• Title: Dr Oliver Perra
• Organization: Queen's University Belfast

o.perra@qub.ac.uk

+44289097

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 1, 2019
• Study Start: March 11, 2018
• Primary Completion: June 28, 2019
• Study Completion: March 11, 2020
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)