NCT04698577

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

December 23, 2020

Last Update Submit

January 4, 2021

Conditions

Keywords

Attention trainingCognitive trainingAttentionSustained attentionWorking memorySchool interventionChildren

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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).

    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).

    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).

    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).

    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).

    Baseline (pre-training), post-training at approximately 6 weeks after baseline and study completion at approximately 12 weeks after baseline.

Study Arms (2)

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).

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).

Behavioral: Active Control

Interventions

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.

Attention Training
Active ControlBEHAVIORAL

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.

Active Control

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, University of Limerick

Limerick, Ireland

Location

Related Publications (4)

  • 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.

    PMID: 28643158BACKGROUND
  • 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.

    PMID: 19132305BACKGROUND
  • 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.

    PMID: 25220080BACKGROUND
  • 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.

    PMID: 19375975BACKGROUND

Study Officials

  • Eadaoin J Slattery, M.Sc.

    University of Limerick

    PRINCIPAL INVESTIGATOR
  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants and their parents were blind to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms.

Study Record Dates

First Submitted

December 23, 2020

First Posted

January 7, 2021

Study Start

November 26, 2018

Primary Completion

May 30, 2019

Study Completion

May 30, 2019

Last Updated

January 7, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
ANALYTIC CODE
Time Frame
Available from 23/11/2020
Access Criteria
Data is publicly available
More information

Locations