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

January 4, 2021 updated by: Eadaoin Slattery, University of Limerick

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Limerick, Ireland
        • Department of Psychology, University of Limerick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

9 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Attention Training

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).
Behavioral: Attention Training
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 Comparator: Active Control

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).
Behavioral: Active Control
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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).
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.
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).
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.
Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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 .
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.
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.
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.
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.
Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Limerick

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Irish Research Council

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eadaoin J Slattery, M.Sc., University of Limerick
  • Study Director: Laura P McAvinue, PhD, University College Dublin / University of Limerick
  • Study Director: Patrick Ryan, D.Clin.Psych, University of Limerick
  • Study Director: Donal G Fortune, PhD, University of Limerick

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 26, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018_10_10_EHS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The anonymised dataset is available on the Open Science Framework (OSF).

IPD Sharing Time Frame

Available from 23/11/2020

IPD Sharing Access Criteria

Data is publicly available

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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