- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698577
Evaluation of a School-Based Attention Training Programme for Improving Concentration
Evaluation of a School-Based Attention Training Programme for Improving Sustained Attention: A Cluster Randomised Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Limerick, Ireland
- Department of Psychology, University of Limerick
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 4th and 5th class students
- aged 9 to 11 years
- parent consent and participant assent
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
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.
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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). |
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.
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What is the study measuring?
Primary Outcome Measures
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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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Secondary Outcome Measures
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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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 .
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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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.
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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.
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Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- 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
General 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018_10_10_EHS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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