The primary objective of this study is to examine the effectiveness of the serious game called HealSeeker for improving time management, planning and organisation and social behaviour skills of children with ADHD. The secondary objective of this…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome variables are the time management skills, planning and
organisation skills and social behaviour skills of the child.
Secondary outcome
Secondary outcome variables are working memory and self-efficacy. The outcome
variables will be evaluated by different questionnaires to be filled out by the
child*s parent/ legal guardian, the child*s teacher and by tasks and a short
questionnaire for the child.
Background summary
Rationale: Psycho stimulants are recognized as the most effective treatment to
reduce the core symptoms of Attention Deficit Hyperactivity Disorder (ADHD ).
Reducing the core symptoms of ADHD offers the possibility to stimulate and
teach new behaviour. Additional interventions appear to be particularly
valuable for this purpose. It is therefore important that a multimodal
treatment also aims to reduce associated and co morbid problems, next to
reducing the core symptoms of ADHD. It appears that these problems strongly
predict the prognosis of ADHD and largely impact the daily functioning of the
ADHD child and his/her family. Serious Gaming can possibly contribute to
optimizing daily functioning of children with ADHD. The first results from the
pilot study are promising.
Study objective
The primary objective of this study is to examine the effectiveness of the
serious game called HealSeeker for improving time management, planning and
organisation and social behaviour skills of children with ADHD. The secondary
objective of this research is to examine the mediating role of working memory
and self-efficacy. In addition, it is examined whether intervention effects
vary as a function of gender, age, ethnicity, socio-economic status (SES ),
intelligence level, comorbidity, game experience, severity of psychopathology
and satisfaction regarding HealSeeker.
Study design
The design for this study consists of an open randomised, controlled,
multicenter trial. Onehundred and fifty participants are randomly assigned to
one of the two groups: an immediate and delayed treatment group. Three
measurement moments will take place. Furthermore, performances within the game
will continuously be registred by a computer database.
Intervention
The intervention in this study is a Serious Game called Healseeker. HealSeeker
is an online computer game with a futuristic and adventurous character. 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, the children can play this game at home during
the 10 weeks of the study. Children will be encouraged to play 3 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.
Study burden and risks
The extent of the burden and risks associated with participation in this study
is limited. Children and parents/legal guardians have to invest time in filling
out the questionnaires. It takes children approximately 215 minutes to fill out
the questionnaires and perform neuropsychological tasks. For parents this takes
approximately 245 - 275 minutes, for teachers this is 90 minutes. HealSeeker is
played 3 times a week for 10 weeks at the child*s home, therefore
parents/legal guardians do not have to travel, which limits the extent of
burden. The children spend a maximum of 135 minutes per week on the game. Apart
from playing the game, the children in the intervention condtion can play in
the social community for a maximum of 60 minutes per week. Children diagnosed
with ADHD are usually very motivated to play a computer game. The parents/legal
guardians are not expected to be involved in this activity. Side effects to be
expected are the site effects that can be expected from using computer (like
Repetitive Strain Injury (RSI)). Side effects of the game itself are not
expected.
This study provides children with ADHD the opportunity to join a non-medicinal
intervention aimed at abating associated problems and elevating daily
functioning. The game is web-based and can be played at the child*s home during
the study, therefore the intervention is accessible for a lot of children and
parents/legal guardians.
Dr. Paul Janssenweg 150
Tilburg 5014 KD
NL
Dr. Paul Janssenweg 150
Tilburg 5014 KD
NL
Listed location countries
Age
Inclusion criteria
1. All children included in the study will be from 8 up to 12 years of age.
2. All children must have an official DSM-IV ADHD diagnose (all subtypes). The diagnosis must have been previously set by a child and adolescent psychiatrist, a health care psychologist, clinical psychologist or a paediatrician specialised in social paediatrics. Children with common diagnosed co morbid 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.
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 HealSeeker, 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 HealSeeker.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40860.078.12 |