The purpose of this study is to evaluate the preliminary effects of the prototype Serious Game on children with ADHD, in preparation of a randomized controlled trial (RCT). The goal of the intervention is to improve skills as: planning, time…
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome variables in this research are: background characteristics of
the child, behavioral characteristics and planning skills, time management,
frustration tolerance, social and risk behavior.
Secondary outcome
Secondary outcome variables are parental expectations of the prototype Serious
Game, (signs of) resistence and the satisfaction of parents and child after the
intervention.
Background summary
Psycho stimulants are recognized as most effective treatment to reduce the
core symptoms of ADHD. Reducing the core symptoms of ADHD offers the
possibility to stimulate and teach new behavior. 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. Next it is important to
improve the self management of children with ADHD. This means that children
understand that making certain choices influences a certain situation and
they learn to trust their own capacities to achieve goals and, as a
consequence, develop a positive identity (empowerment). Serious Gaming can
possibly contribute to this process and increase self management and treatment
compliance of children with ADHD.
Study objective
The purpose of this study is to evaluate the preliminary effects of the
prototype Serious Game on children with ADHD, in preparation of a randomized
controlled trial (RCT). The goal of the intervention is to improve skills as:
planning, time management, frustration tolerance, social functioning and
decrease risk behavior. Furthermore the effect of the intervention on
children*s self efficiency and behaviour is examined. A secondary goal of this
study is to examine the usabilty and whether the research design is applicable
on a larger research population.
Study design
The design of this pilot study is a randomized pre-post test design. Children
play the prototype of Serious Game during two months. Children are randomly
allocated to one of the two conditions: (1) children playing the prototype
Serious Game for a minimum of eight times per two weeks; (2) children playing
the prototype Serious Game for a maximum of three times per two weeks. This
last group of children functions as a control group in this study. A first
measurement is conducted before starting the intervention, a second measurement
takes place after two months.
Intervention
The intervention in this research is a prototype Serious game, which is
developed for children with ADHD. The theme of this innovative and interactive
game environment is *Sience Fiction*. The prototype is web-based and therefore
can be played at the child*s home for two months. The prototype includes three
mini games. Each minigame has to be played for two weeks and are offered
seperately. After six weeks there is an open phase (two weeks) where the
children can play their favorite mini game. The mini games are accessible for a
maximum of 45 minutes per play session.
Study burden and risks
The extent of the burden and risks associated with participation in this pilot
study is limited. Children and parents have to invest time in filling out the
questionnaires. It takes children approximately 55 minutes to fill out the
questionnaires. For parent this takes approximately 45 minutes. The prototype
Serious Game is played for two months at the child*s home. A child who plays
the prototype Serious Game for a minimum of eight times per two weeks, spends
at least 1440 minutes (= 24 hours) on the game. A child who plays the prototype
Serious Game for a maximum of three times per two weeks, spends a maximum of
540 minutes (=9 hours) on the game. This intervention can be played at the
child*s home and therefore parents do not have to travel, which limits the
extent of burden. Children diagnosed with ADHD are usually very motivated to
play a computer game. The parents are not expected to be involved in this
activity. There are no (medical) risks related to the intervention and side
effects are not expected.
Mathenesserlaan 202
3014 HH Rotterdam
NL
Mathenesserlaan 202
3014 HH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1. Aged 8-11 years
2. Total IQ above 70
3. Signed informed consent by the parents and the child
4. Sufficient understanding of the Dutch language by parents and child
5. The child has a current ADHD diagnosis that is diagnosed by a child psychiatrist, GZ-psychologist, clinical psychologist or a pediatrician (specialized in social pediatrics). Children with ADHD and co morbid disorders (as Dyslexia or Oppositional Defiant Disorder) are also allowed to participate in this pilot study.
6. Children must be at a stable dose of medication and/or receive other forms of psychological treatment (e.g. behavior therapy) for their ADHD for at least two months. They are supposed to continue their treatment during the 2 months of the pilot study. All kinds of medication for ADHD are allowed in this research.
7. Acces to a PC with a sound system and internet acces.
Exclusion criteria
As severe physical or cognitive impairments (as blindness, deafness, motor or mental handicap) may interfere with filling out standardized measures and playing the prototype Serious Game, children with these impairments are not able to participate in this research.
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 | NL37983.097.11 |