Attention Concentration DifficultyNCT04698577

Evaluation of a School-Based Attention Training Programme for Improving Concentration

A study testing Attention Training in people with Attention Concentration Difficulty, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates a school-based attention training programme for improving sustained attention in children. Read more about this study

Who is it for?: Ages 9 to 11 years
Conditions the study is for: Attention Concentration Difficulty
What is being tested?: Attention Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteIreland
Study dates: 26 Nov 2018to 30 May 2019
Phase: Interventional
Are there results?: None posted in the registry

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 9 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

4th and 5th class students
aged 9 to 11 years
parent consent and participant assent

Who cannot join

Trial locations and contacts

1 site in 1 country.

Ireland1 site

Department of Psychology, University of Limerick
Limerick

Other trials in Ireland

About this study

Official title: Evaluation of a School-Based Attention Training Programme for Improving Sustained Attention: A Cluster Randomised Pilot Study

This study evaluates a school-based attention training programme for improving sustained attention in children.

Read the detailed description

Sustained attention is an elementary attentional function that is essential for effective learning and functioning in school. Poor sustained attention is a relatively common problem in childhood with as many as 24% of children exhibiting frequent inattention. Children with attentional difficulties are at increased risk for a variety of negative educational outcomes, including lower standardised grades, dropping out of school and repeating a year. This evidence highlights the need to develop interventions aimed at enhancing students' sustained attention capacity. Current school-based interventions for student attention problems include intervention strategies targeting behavioural, academic and self-regulation. However, none of these interventions aim to enhance attentional capacity. Attention network training (or attention training) has been identified as a potentially promising intervention for enhancing attentional capacity. This pilot study aimed to evaluate the preliminary efficacy of a theory-driven attention training programme, Keeping Score!, in improving students' capacity to sustain attention in a school setting. Training was based on sustained updating. Children engaged this process by mentally keeping score during an interactive face-to-face game without external aids. The study used a cluster randomised design. Students (N = 36) were assigned based on their class group to either the 6-week attention training programme (n = 18) or an active control (n = 18). Outcome measures were assessed at baseline, immediately after training and an approximate 6-week follow up.

Conditions: Attention Concentration Difficulty
Being tested: Attention Training, Active Control
Keywords: Attention training, Cognitive training, Attention, Sustained attention, Working memory, School intervention, Children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Attention TrainingBehavioural
The training was delivered face-to-face in groups of three participants. Participants were involved in a game of table tennis with two players and one spectator. The roles were rotated every 5 minutes so that each participant experienced 10 minutes of play and 5 minutes of observation. The game was played as normal with one point awarded to the player for every score achieved. All 3 players were asked to keep the score of the game in their minds during each 5-minute round. Participants had two objectives 1) to play and win the game and 2) to silently keep the score of the game. The researcher watched the game and accurately kept score, using a notepad. At the end of every 5-minute round, the researcher paused play and asked each child to write down the score they were holding in their mind. The researcher then revealed the true score, asked participants to swap roles and commence another round.
Active ControlBehavioural
The control group was the same as the training group except for the core training mechanism; children were not required to mentally keep score. The researcher kept score by continually calling out the updated score as each point was won. The observing child was simply told to wait his/her turn.

Study groups in NCT04698577
Study group	Role	What they receive
Attention Training	Experimental	Engaged in sustained updating by mentally keeping score during an interactive game without written or verbal aids. Participants received 15-minute sessions, three times a week for six weeks (18 sessions in total). Receives: Behavioral: Attention Training
Active Control	Active comparator	Played the same interactive game as the attention training group without the requirement of mentally keeping score. Participants received 15-minute sessions, three times a week for six weeks (18 sessions in total). Receives: Behavioral: Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in scores on the Vigil subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
The Vigil subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to count slow, irregularly paced stimuli. Participants completed 10 trials. The outcome variable was the total number of correct trials. Higher scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Cerberus subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
The Cerberus subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to listen to short clips and respond (press the spacebar) to a target auditory stimulus while ignoring other sounds. Participants completed 15 trials. The outcome measure was mean reaction time in msecs weighted for accuracy. Lower scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Sustained Attention to Response Task (SART) subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
The SART subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to respond (press the spacebar) to every shape (go-trial) that appeared on screen but not to respond to a triangle (no-go trial). There were 20 no-go trials. The outcome measure was errors of commission (no-go trial responses). Lower scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Secondary outcomes (5)

Change in scores on the Digit Span Backwards subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
The Digit Span Backwards subtest is a measure of working memory. Participants were required to repeat a dictated string of numbers in the reverse order. The task was discontinued when the participant failed to answer both trials of a set correctly. The outcome measure was the total number of correctly recalled trials. The maximum total score is 18. Higher scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Operation Span subtest of the Adaptive Composite Complex Span (ACCES).
The Operation Span subtest is a measure of working memory. Participants were required to evaluate maths problems while memorising letters. Participants completed 6 trials. The number of stimulus-problem pairs within a trial varied between two and eight. The outcome measure was the total number of stimuli correctly recalled. Higher scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores using the Symmetry Span subtest of the Adaptive Composite Complex Span (ACCES).
The Symmetry Span subtest is a measure of working memory. Participants were required to evaluate whether geometric shapes were symmetrical while remembering spatial locations. Participants completed 6 trials. The number of stimulus-problem pairs within a trial varied between two and eight. The outcome measure was the total number of stimuli correctly recalled. Higher scores indicate a better outcome .
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Digit Span Forward subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
The Digit Span Forwards subtest is a measure of short-term memory. Participants were required to repeat a dictated string of numbers in the same order. The task was discontinued when the participant failed to answer both trials of a set correctly. The outcome measure was the total number of correctly recalled trials. The maximum total score is 18. Higher scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in parent ratings of executive function behaviour on the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF-2).
The BRIEF-2 assesses everyday behaviours associated with executive function in the home environment. Parents rated 63 items on a three-point Likert scale (0 = never, 1 = sometimes and 2 = often). The following indices were used: Behaviour Regulation Index (BRI), Emotion Regulation Index (ERI), Cognitive Regulation Index (CRI) and Global Executive Composite (GEC). Lower scores indicate a better outcome.
Measured: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 201830 May 2019

First posted7 Jan 2021
Study start26 Nov 2018
Primary completion30 May 2019
Study completion30 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Attention Concentration DifficultyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This is a two arm, single-blind, pilot cluster randomised study. Participants were randomly allocated to the attention training group or active control group based on class groups (three class groups of fourth-class students and one class group of fifth-class students).
Masking: Single blind
Who is masked: Participant
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04698577
Sponsor's protocol ID: 2018_10_10_EHS
Status last verified: Jan 2021
First submitted: 23 Dec 2020
Last updated: 7 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The anonymised dataset is available on the Open Science Framework (OSF).

Publications

Gonthier C, Aubry A, Bourdin B. Measuring working memory capacity in children using adaptive tasks: Example validation of an adaptive complex span. Behav Res Methods. 2018 Jun;50(3):910-921. doi: 10.3758/s13428-017-0916-4.
PubMed 28643158
Dopfner M, Breuer D, Wille N, Erhart M, Ravens-Sieberer U; BELLA study group. How often do children meet ICD-10/DSM-IV criteria of attention deficit-/hyperactivity disorder and hyperkinetic disorder? Parent-based prevalence rates in a national sample--results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:59-70. doi: 10.1007/s00787-008-1007-y.
PubMed 19132305
DuPaul GJ, Gormley MJ, Laracy SD. School-based interventions for elementary school students with ADHD. Child Adolesc Psychiatr Clin N Am. 2014 Oct;23(4):687-97. doi: 10.1016/j.chc.2014.05.003. Epub 2014 Aug 1.
PubMed 25220080
Tang YY, Posner MI. Attention training and attention state training. Trends Cogn Sci. 2009 May;13(5):222-7. doi: 10.1016/j.tics.2009.01.009. Epub 2009 Apr 16.
PubMed 19375975

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Attention Concentration Difficulty trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of a School-Based Attention Training Programme for Improving Sustained Attention: A Cluster Randomised Pilot Study
ClinicalTrials.gov ID: NCT04698577
Acronym / sponsor ID: 2018_10_10_EHS
Conditions: Attention Concentration Difficulty
Keywords: Attention training, Cognitive training, Attention, Sustained attention, Working memory, School intervention, Children
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: University of LimerickUniversity, hospital or other
Collaborators: Irish Research Council
Study start: 26 Nov 2018 (actual)
Primary completion: 30 May 2019 (actual)
Study completion: 30 May 2019 (actual)
First posted: 7 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates a school-based attention training programme for improving sustained attention in children.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This is a two arm, single-blind, pilot cluster randomised study. Participants were randomly allocated to the attention training group or active control group based on class groups (three class groups of fourth-class students and one class group of fifth-class students).

Arm	Type	Receives
Attention Training	Experimental	Behavioral: Attention TrainingEngaged in sustained updating by mentally keeping score during an interactive game without written or verbal aids. Participants received 15-minute sessions, three times a week for six weeks (18 sessions in total).
Active Control	Active comparator	Behavioral: Active ControlPlayed the same interactive game as the attention training group without the requirement of mentally keeping score. Participants received 15-minute sessions, three times a week for six weeks (18 sessions in total).

Who may qualify

Ages: 9 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

4th and 5th class students
aged 9 to 11 years
parent consent and participant assent

Key exclusion criteria (1 listed)

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 TrainingThe training was delivered face-to-face in groups of three participants. Participants were involved in a game of table tennis with two players and one spectator. The roles were rotated every 5 minutes so that each participant experienced 10 minutes of play and 5 minutes of observation. The game was played as normal with one point awarded to the player for every score achieved. All 3 players were asked to keep the score of the game in their minds during each 5-minute round. Participants had two objectives 1) to play and win the game and 2) to silently keep the score of the game. The researcher watched the game and accurately kept score, using a notepad. At the end of every 5-minute round, the researcher paused play and asked each child to write down the score they were holding in their mind. The researcher then revealed the true score, asked participants to swap roles and commence another round.	Behavioural	Attention Training
Active ControlThe control group was the same as the training group except for the core training mechanism; children were not required to mentally keep score. The researcher kept score by continually calling out the updated score as each point was won. The observing child was simply told to wait his/her turn.	Behavioural	Active Control

Primary outcome

Change in scores on the Vigil subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
The Vigil subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to count slow, irregularly paced stimuli. Participants completed 10 trials. The outcome variable was the total number of correct trials. Higher scores indicate a better outcome.
Change in scores on the Cerberus subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
The Cerberus subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to listen to short clips and respond (press the spacebar) to a target auditory stimulus while ignoring other sounds. Participants completed 15 trials. The outcome measure was mean reaction time in msecs weighted for accuracy. Lower scores indicate a better outcome.
Change in scores on the Sustained Attention to Response Task (SART) subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
The SART subtest of the TEA-Ch2 is a measure of sustained attention. Participants were required to respond (press the spacebar) to every shape (go-trial) that appeared on screen but not to respond to a triangle (no-go trial). There were 20 no-go trials. The outcome measure was errors of commission (no-go trial responses). Lower scores indicate a better outcome.

5 secondary outcomes

Change in scores on the Digit Span Backwards subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Operation Span subtest of the Adaptive Composite Complex Span (ACCES).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores using the Symmetry Span subtest of the Adaptive Composite Complex Span (ACCES).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in scores on the Digit Span Forward subtest of the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
Change in parent ratings of executive function behaviour on the Behaviour Rating Inventory of Executive Function - Second Edition (BRIEF-2).
Time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
Background: PubMed 28643158Gonthier C, Aubry A, Bourdin B. Measuring working memory capacity in children using adaptive tasks: Example validation of an adaptive complex span. Behav Res Methods. 2018 Jun;50(3):910-921. doi: 10.3758/s13428-017-0916-4.
Background: PubMed 19132305Dopfner M, Breuer D, Wille N, Erhart M, Ravens-Sieberer U; BELLA study group. How often do children meet ICD-10/DSM-IV criteria of attention deficit-/hyperactivity disorder and hyperkinetic disorder? Parent-based prevalence rates in a national sample--results of the BELLA study. Eur Child Adolesc Psychiatry. 2008 Dec;17 Suppl 1:59-70. doi: 10.1007/s00787-008-1007-y.
Background: PubMed 25220080DuPaul GJ, Gormley MJ, Laracy SD. School-based interventions for elementary school students with ADHD. Child Adolesc Psychiatr Clin N Am. 2014 Oct;23(4):687-97. doi: 10.1016/j.chc.2014.05.003. Epub 2014 Aug 1.
Background: PubMed 19375975Tang YY, Posner MI. Attention training and attention state training. Trends Cogn Sci. 2009 May;13(5):222-7. doi: 10.1016/j.tics.2009.01.009. Epub 2009 Apr 16.
Individual participant dataSharing planned: Yes. The anonymised dataset is available on the Open Science Framework (OSF).

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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.

Eadaoin J Slattery, M.Sc. principal investigator

University of Limerick

Laura P McAvinue, PhD study director

University College Dublin / University of Limerick

Patrick Ryan, D.Clin.Psych study director

University of Limerick

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Attention Training in people with Attention Concentration Difficulty, run by University of Limerick at 1 site in Ireland.

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 1 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 7 Jan 2021. 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 Ireland. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in scores on the Vigil subtest of the Test of Everyday Attention for Children - Second Edition (TEA-Ch2). (time frame: Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.). The study lists 3 primary outcomes in all. 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 NCT04698577, which also lists 4 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 7 Jan 2021.