The effectiveness of a serious game for children with attention deficit hyperactivity disorder: an open, randomized, controlled, multicenter trial

Janssen-Cilag (Netherlands)0 sites170 target enrollmentDecember 23, 2013

ConditionsMental and Behavioural Disorders Disturbance of activity and attention Attention deficit hyperactivity disorder (ADHD)

Overview

Phase: 未知
Intervention: Not specified
Conditions: Mental and Behavioural Disorders
Sponsor: Janssen-Cilag (Netherlands)
Enrollment: 170
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 23, 2013

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Janssen-Cilag (Netherlands)

Eligibility Criteria

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.

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.