Plain English Summary
Background and study aims
If children with attention deficit hyperactivity disorder (ADHD) symptoms do not have effective interventions and prevention, they very often have other disorders, such as oppositional defiant disorder (ODD). Accurate evaluation combined with proper intervention allows for a smooth academic and social transition into the school environment. At first, working memory training generated great interest, with claims that the training interventions can have profound beneficial effects on children’s executive function, academic and intellectual attainment, and also reduce ADHD symptoms. Despite the promising results of working memory training studies, the current research of all of the available evidence of working memory training is less optimistic. Near transfer of working memory training to untrained memory tasks has been observed. However, not all studies have found positive far transfer of learning to other executive functions, and academic and intellectual attainment. The aim of this study is to find out whether computer working memory training improves memory function as well as cognitive performance, academic and intellectual attainment.
Who can participate?
Children aged 4 -7 either with diagnosed ADHD symptoms and children with typical development
What does the study involve?
Participants are randomly allocated to one of two groups. Group 1 receives the working memory training. Group 2 is put on a waiting list and then receives the working memory training for the last laboratory meeting. The computerized working memory training includes eight visuospatial memory tasks. The children in group 1 are asked to practice on the training three tasks for 15 minutes a day on their personal computers at home, 5 days a week for 8 weeks. Additionally, all children (groups 1 and 2) are assessed individually in the laboratory at three different times: before training, after training is completed and three months after completing training.
What are the possible benefits and risks of participating?
Benefits are expected in the working memory, intelligence and quality of educational and social life. No risks are expected.
Where is the study run from?
SWPS University of Social Sciences and Humanities, Interdisciplinary Center for Applied Cognitive Studies (ICACS), (Warsaw) (Poland)
When is the study starting and how long is it expected to run for?
September 2012 to March 2016
Who is funding the study?
National Science Centre (Poland)
Who is the main contact?
Dr Anna Orylska
Trial website
Contact information
Type
Scientific
Primary contact
Dr Anna Orylska
ORCID ID
http://orcid.org/0000-0002-3853-1806
Contact details
Chodakowska 19/31
Warsaw
03-815
Poland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
National Science Centre: UMO-2011/03/N/HS6/04849
Study information
Scientific title
Training, motivation and maturation influences on development of executive functions at early childhood
Acronym
Study hypothesis
The main hypotheses were:
1. Intervention – computer working memory training (WMT) improves trained (outcomes that are similar to those trained during WMT) memory function as well as untrained cognitive performance, academic and intellectual attainment of children
2. After intervention some participants achieve a greater benefits than others
Ethics approval
Research Ethics of Empirical Research with the Participation of People as Persons Researched; SWPS University of Social Sciences and Humanities, Warsaw, Poland, 11/07/2012, ref: 2/V/11-12
Study design
Randomised; Interventional; Design type: Treatment, Stimulation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Attention Deficit Hyperactivity Disorder (ADHD), typically developing children
Intervention
At study intake, parents and children were informed of randomization to one of two groups. Both groups, clinical (ADHD) and control (typical developing participants), had a known probability of being selected (probability sampling) for one of two groups. For each group (clinical and control) the trialists used simple random sampling and applied random number tables.
1. Intervention group - computerized working memory training
2. Waiting group - without intervention
During pretest (before intervention), following parent consent and child assent, posttest (8 weeks later after intervention) and follow up (3 months after posttest), a description of children’s behavior and cognitive function – questionnaire was completed by the parents. Also working memory, attention control measures, educational achievement, IQ measure was completed by the children. All training was conducted at home and was scheduled to be completed over a 8-week (5 times per week) period based on the family’s schedule.
The computerized WM training was developed by author Anna Orylska. It included eight visuospatial training tasks: five short-term (VSSTM) and three working memory (VSWM) tasks. Each task had six levels of difficulty, with each level having three sub-levels. The training interface provided children with feedback for correct and incorrect performance (a smiley or sad face). The task was continuously adapted across training so that the difficulty level reflected current performance (i.e. three correct trials were required in order to advance to the next level, and for each incorrect trial, difficulty decreased by three sublevels). Children were expected to complete three tasks per session. The training was scheduled so that children worked on each task equally across 40 training sessions. Training task performance was recorded as the highest score obtained in each session and where each level corresponded to the number of items that the child had to remembered (from 2 items at level 1 to 7 items at level 6, and every level consists of 3 sublevels, possible score range = 1-18, counted as the sum of all sublevels). Performance (training efficiency) was calculated across eight blocks each with five sessions (possible score range for each block was 1-18).
Intervention type
Other
Phase
Drug names
Primary outcome measures
Working memory capabilities, assessed using (1) a counting span task, (2) a set switching task and (3) a spatial location memory task at three different timepoints: pretest - prior to training (T1), post-test - no more than 1 week after training was completed (T2) and follow up - three months after completing training (T3)
Secondary outcome measures
Measured at three different timepoints: pretest - prior to training (T1), post-test - no more than 1 week after training was completed (T2) and follow up - three months after completing training (T3):
1. Executive attention, assessed using the Flanker task
2. Parent-reported executive abilities, assessed using the Behaviour Rating Inventory of Executive Function (BRIEF)
3. Educational achievement, assessed using the Test of Knowledge and Competences (1) the numeracy skills scale, (2) the writing skills scale measures, (3) the reading skills scale measures
4. IQ, assessed using Raven’s CPM to measure general intelligence
Overall trial start date
20/09/2012
Overall trial end date
19/03/2016
Reason abandoned
Eligibility
Participant inclusion criteria
Both groups:
1. IQ score of ≥ 85
2. An opinion about the child's educational and social functioning issued by a teacher
Control group:
1. Free of other disabilities and disorders
Clinical group:
1. Diagnosed with symptoms of ADHD by a psychologist or a psychiatrist
2. Experiencing clinically significant symptoms of inattention, hyperactivity and impulsivity (ADHD/C), inattention (ADHD/I), or hyperactivity and impulsivity (ADHD/H),observed in different settings (family and preschool/school)
Participant type
Mixed
Age group
Child
Gender
Both
Target number of participants
187 children: 94 children diagnosed with ADHD symptoms and 93 children were typically developing (control group)
Participant exclusion criteria
1. Under 4 and over 8 years old children
2. Participants had to be free of epilepsy, pervasive developmental disorder, central nervous system disease and pharmacological treatment
3. Children not meeting IQ score of ≥ 85
Recruitment start date
01/09/2012
Recruitment end date
30/06/2015
Locations
Countries of recruitment
Poland
Trial participating centre
SWPS University of Social Sciences and Humanities
ul. Chodakowska 19/31
Warsaw
03-815
Poland
Sponsor information
Organisation
SWPS University of Social Sciences and Humanities
Sponsor details
Chodakowska 19/31
Warsaw
03-815
Poland
+48 (0)22 517 96 00
swps@swps.edu.pl
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Narodowe Centrum Nauki
Alternative name(s)
National Science Centre, National Science Centre of Poland, Polish National Science Centre, National Science Centre, Poland, National Science Centre Poland, NCN
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Poland
Results and Publications
Publication and dissemination plan
The trialists have submitted an article and plan to publish one more article in a high-impact peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anna Orylska. Data that will be shared: individual participant data that underlie the results reported in published articles. Data will be available: beginning 9 months and ending 36 months following article publication. Data will be available for researchers who provide a methodologically sound proposal, for individual participant data meta-analysis.
Intention to publish date
31/12/2018
Participant level data
Available on request
Results - basic reporting
Publication summary