Very Premature BabyACTNCT03896490
Attention Control Training (ACT) and Very Preterm Infants
A study of Very Premature Baby, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 13 monthsHealthy volunteers can take part
- Conditions the study is for
- Very Premature Baby
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Mar 2018to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen's University Belfast
Belfast, Northern Ireland, BT9 7BL
About this study
Official title: A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
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.
Read more
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.
Read the detailed description
The aims of this project are to:
- Investigate VP infants' engagement with the ACT procedure;
- 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.
- Investigate retention into the programme.
- 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 :
- the ACT training programme delivered across 4 consecutive weekly sessions for a month (n=10);
- 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).
- Conditions
- Very Premature Baby
- Being tested
- Attention Control Training, Control
- Keywords
- Learning, Memory, Memory Training, Attention, Computerized Cognitive Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Control TrainingBehavioural
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.
ControlBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Not described Receives: Behavioral: Attention Control Training |
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Percentage of Training/Control Sessions Attended by Infants
Sessions attended are defined as sessions to which parent and infant are present at the scheduled appointment
Measured: 1 year
Percentage of Training/Control Sessions Completed by Infants
Sessions completed are defined as sessions whereby infants engaged without interruptions for at least 240 sec in at least two tasks.
Measured: 1 year
Duration of Tasks Administered to Infants During Training/Control Sessions
Duration is defined as the cumulative duration in seconds of the tasks delivered to infants during the training or control sessions.
Measured: 1 year
Percentage of Tasks Completed at Post-test
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.
Measured: 1 year
Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments
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.
Measured: 1 year
Performance During Training
Performance indicators included reaction times or level of task difficulty achieved. These indicators were standardized (std.): higher scores indicated better performance and followed a normal distribution with ranges roughly between -3 and +3. Each infant contributed several performance scores during each visit. We used multilevel growth regression models to test if trained infants displayed linear changes in performance across visits: linear effects would indicate significant performance improvement across tasks. In these analyses, the units of observations were the std. scores registered across visits, which were considered nested within infants. The models allowed to estimate the initial status (average std. scores in the first visit) and the rate of change (the average change in performance std. scores from one visit to another), as well as residual variances around these parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start11 Mar 2018
- Primary completion28 Jun 2019
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Very Premature BabyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Agency, Health and Social Care Research and Development, TinyLife
- Responsible party
- Principal investigator, Oliver Perra, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896490
- Sponsor's protocol ID
- R4798NUR
- Acronym
- ACT
- Status last verified
- Sep 2022
- First submitted
- 27 Mar 2019
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32055404Perra 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.
PubMed 36137090Perra 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.
PubMed 33712090
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of the Attention Control Training (ACT) Intervention Among Very Preterm (VP) Infants
- ClinicalTrials.gov ID
- NCT03896490
- Acronym / sponsor ID
- ACT / R4798NUR
- Conditions
- Very Premature Baby
- Keywords
- Learning, Memory, Memory Training, Attention, Computerized Cognitive Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Public Health Agency, Health and Social Care Research and Development, TinyLife
- Study start
- 11 Mar 2018 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Posted 25 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Investigate VP infants' engagement with the ACT procedure;
- 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.
- Investigate retention into the programme.
- 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 :
- the ACT training programme delivered across 4 consecutive weekly sessions for a month (n=10);
- 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: Attention Control Training |
| Control | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 11 to 13 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attention Control TrainingInfants 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. | Behavioural | ACT |
| ControlThe 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). | Behavioural | Control |
Primary outcome
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.
6 secondary outcomes
Percentage of Training/Control Sessions Attended by Infants
Time frame: 1 year
Percentage of Training/Control Sessions Completed by Infants
Time frame: 1 year
Duration of Tasks Administered to Infants During Training/Control Sessions
Time frame: 1 year
Percentage of Tasks Completed at Post-test
Time frame: 1 year
Quality of Eye-tracker Data Collected During Baseline and Post-test Attention Assessments
Time frame: 1 year
Performance During Training
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32055404Perra 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.
- Derived from this study: PubMed 36137090Perra 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.
- Derived from this study: PubMed 33712090Perra 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.
- Paper describing the study protocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Very Premature Baby, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and Retention (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03896490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.