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The effectiveness of a serious game for children with ADHD: A randomized, controlled, multicenter trial.

The effectiveness of a serious game for children with ADHD: A randomized, controlled, multicenter trial. - Serious gaming & ADHD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39279
Enrollment
120
Registered
2013-01-31
Start date
2012-11-28
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Interventions

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 embedd

Sponsors

Janssen-Cilag
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The main outcome variables are the time management skills, planning and organisation skills and social behaviour skills of the child.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)