Plain English Summary
Background and study aims
An educational computer game (so called serious game) can possibly contribute to optimizing daily functioning of children with attention deficit hyperactivity disorder (ADHD). The main objective of this study is to examine the effectiveness of an online serious game for improving time management, planning and organisation and social behaviour skills of children with ADHD.
Who can participate?
Children with ADHD (all subtypes) randomly selected among registered mental health care institutions, private psychology practices and paediatric practices across The Netherlands and Belgium.
What does the study involve?
Children are randomized to one of two groups:
1. An immediate treatment group (the game is available from week 0 to week 10)
2. A delayed treatment group (the game is available from week 10 to week 20)
This study involves an online serious game that is offered as an additional intervention to treatment as usual. Children are encouraged to play the game three times a week for one hour. Assessments were carried out at baseline and at 10 and 20 weeks.
What are the possible benefits and risks of participating?
This study provides children with ADHD the opportunity to join a non-medical intervention to improve time management, planning and organising and social behaviour skills. The game is available in the home context as it is offered online. Risks of participation in this study are limited as children play the game within a restricted time frame. Possible side effects are the side effects that can be expected from using a computer (like Repetitive Strain Injury; RSI). Side effects of the game itself are not expected.
Where is the study run from?
This study has been set up by Stichting Yulius, Erasmus University Rotterdam and Catholic University of Leuven and conducted in collaboration with Mondriaan Care Group, Netherlands.
When is the study starting and how long is it expected to run for?
January 2013 to August 2013
Who is funding the study?
Janssen-Cilag (Netherlands) and Flanders' Care (Netherlands)
Who is the main contact?
K.C.M. Bul, MSc
k.bul@yulius.nl
Trial website
Contact information
Type
Scientific
Primary contact
Dr Athanasios Maras
ORCID ID
Contact details
Mathenesserlaan 202
Rotterdam
3014 HH
Netherlands
+31 (0)884056957
a.maras@yulius.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CONCERTAATT4110
Study information
Scientific title
The effectiveness of a serious game for children with attention deficit hyperactivity disorder: an open, randomized, controlled, multicenter trial
Acronym
Study hypothesis
Does the serious game improve skills in the area of time management, planning and organisation and social behaviour skills of children with attention deficit hyperactivity disorder (ADHD) from 8 to 12 years of age? The expectation is that playing the serious game will lead to significant improvements in skills in the areas of time management, planning and organisation and social behaviour skills compared to a control group condition.
Ethics approval
1. Medisch Ethische Toetsings Commissie Erasmus MC, 31/01/2013, ethics board reference number: MEC-2012-539, general reference number: NL40860.078.12
2. Commissie Medische Ethiek Universitaire Ziekenhuizen KU Leuven, 17/01/2013, ethics board reference number: S54837 - ML8901
Study design
20-week immediate versus delayed intervention open-label randomised controlled multicenter trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention deficit hyperactivity disorder (ADHD)
Intervention
The intervention in this study is a serious game called HealSeeker. HealSeeker is an online computer game with a futuristic and adventurous character. This game is offered as an additional intervention to treatment as usual.
Children are randomized to one of the following two groups:
1. An immediate treatment group (in which the game is available from week 0 to week 10)
2. A delayed treatment group (in which the game is available from week 10 to week 20)
In the first 10 weeks, children from the immediate treatment group will be asked to play the game, continuing their treatment as usual. The results from this group will be compared to the other group following treatment as usual. After 10 weeks, the game will be available for the delayed treatment group. Several missions and three minigames are embedded in the game. These minigames are related to three learning goals: time management, planning and organisation and social behaviour. A closed social community is included in which children can communicate with each other and ask each other for help through predefined messages. The game is web-based and the children can play this game at home during the study period. Children will be encouraged to play three times a week and each playing session will last a maximum of 45 minutes. Children can access the social community for a maximum of 20 minutes per session.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Time management, measured using a self-constructed questionnaire
2. Planning and organisation, measured using the subscale Plan/Organize from the Behaviour Rating Inventory of Executive Function (BRIEF)
3. Social behaviour skills, measured using the subscale Cooperation from the Social Skills Rating System (SSRS)
During the study period of 20 weeks, these outcomes will be measured at baseline and after 10 and 20 weeks.
Secondary outcome measures
1. Working memory
2. Self-efficacy
These outcome measures will be evaluated at baseline and after 10 and 20 weeks by different questionnaires filled out by parents, teachers and by tasks and a short questionnaire for the child. Socio-demographic information will be available through a parent-reported questionnaire at baseline.
Overall trial start date
28/01/2013
Overall trial end date
15/08/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All children included in the study will be from 8 to 12 years of age.
2. All children must have an official Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV ADHD diagnosis (all subtypes). The diagnosis must have been previously set by a child and adolescent psychiatrist, healthcare psychologist, clinical psychologist or paediatrician specialised in social paediatrics. Children with common diagnosed comorbid disorders (i.e., dyslexia, oppositional defiant disorder) can participate in the study.
3. All participants need to be stable on ADHD treatment, both pharmacological and psychological, for at least two months prior to start of the intervention. All types of treatments, both pharmacological and psychological, are accepted. Stable treatment can also include no pharmacological and psychological treatment. Whether subject receives stable ADHD treatment will be collected through self-constructed questionnaire filled out by patents/legal guardians.
4. Minimum total intelligence quotient (TIQ) score must greater than or equal to 80. If the total intelligence score is not known, has been established by a non-COTAN approved test or has been performed more than two years previous to the start of the intervention, total intelligence score will be established using two subtests of the Wechsler Intelligence Scale for Children third version (WISC-III-NL; Wechsler, 2005).
5. Children can only be included after a written informed consent has been signed by both parents or legal guardians, indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Twelve year olds must give their own written informed assent in addition to their parents/legal guardians.
6. The child and at least one of the parents/legal guardians must have a reasonable understanding of the Dutch language in order to understand the messages in the game, and have clear communication with the investigators.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
170
Participant exclusion criteria
1. Children with a severe physical (i.e., developmental coordination disorder), auditory (i.e., deafness), visual (i.e., blindness), neurological (i.e., epilepsy), speech and language (i.e., expressive receptive language disorder) or cognitive (i.e., mental handicap) disability will encounter great difficulties in playing the game, as will children with severe dyslexia (if they are not able to read texts), and are problematic for standardised measurements.
2. Furthermore, children who are addicted to drugs, alcohol and/or gaming, have conduct disorder (CD) or have severe acute psychiatric disorders, psychotic disorder, major depressive disorder and mania will be excluded.
3. Children with an autism spectrum disorder and pervasive developmental disorder not otherwise specified.
4. Children that have previous played the serious game.
Recruitment start date
28/01/2013
Recruitment end date
15/08/2013
Locations
Countries of recruitment
Belgium, Netherlands
Trial participating centre
Mathenesserlaan 202
Rotterdam
3014 HH
Netherlands
Sponsor information
Organisation
Janssen-Cilag (Netherlands)
Sponsor details
Dr. Paul Janssenweg 150
Tilburg
5026 RH
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Janssen-Cilag (Netherlands), ref: CONCERTAATT4110
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Flanders' Care (Netherlands), ref: DEM2012-02-07
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26883052