Clinical trial NCT04337905: Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)
Official title: A New Development Diagnostic Tool for ADHD: A VR Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Executive Dysfunction
Keywords: ADHD
virtual reality,
diagnostic tool
neuropsychological test
Indonesia
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
name: Dr Cipto Mangunkusumo General Hospital
name: Binus University International
First posted: 2020-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There is two group of children:

1. Group 1: Children with ADHD
2. Group 2: Children without ADHD as a control group

Both group will running the ADHD-VR diagnostic test and goes to diagnosis by child psychiatrist. The outcomes that were analyzed:

1. The sensitivity, specificity and Likelihood ratio of the ADHD-VR diagnostic test in detecting the ADHD clinical symptoms and executive function
2. Content validity of the ADHD-VR diagnostic test
Primary purpose: DIAGNOSTIC

Brief summary: Attention deficit/ hyperactivity disorder (ADHD) is a common neurodevelopmental disorder. The common diagnostic of ADHD is based on psychiatric examination and interview. So far, there is not any other diagnostic tool for ADHD nowadays. Therefore, virtual reality (VR) technology can be used as a stimulus, replacing real stimuli, recreating experiences, which are in the real world would be impossible. Consequently, ADHD-VR diagnostic tool development should be started to justify the ADHD diagnosis in psychiatric out-patient clinical services.

Detailed description: Diagnostic test is a very essential in modern medical practices, especially in child and adolescent psychiatry field because the main diagnostic tool is only based on psychiatry interview and observation. Using Diagnostic tool can help a confirmation towards specific clinical diagnosis, provide more evidence for eliminating one diagnosis versus another, provide more evidence for parents, or to rule out the differential diagnosis. Even though psychiatric examination is the main approach on ADHD diagnostic procedure, however the laboratory testing or imaging examination is also used especially to rule out the general medical condition or to find out any medical conditions that mimic ADHD but not to facilitate the ADHD diagnosis per se. Nowadays, the expand study in biological psychiatry has found a lot of biological markers in ADHD as well; but none is really sensitive and specific for ADHD diagnostic test. Therefore, there should be another approach for developing diagnostic tool in ADHD. VR is one of the best approach bacasue these days, because VR as an ADHD diagnostic tool could create and replace real stimuli, recreating experiences, which could not be observed by the clinician at the out-patient clinic.

Eligibility criteria: Inclusion Criteria for ADHD group:

* Children with ADHD drug naive
* Parent willing to participate in the study by signing informed consent
* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes

Exclusion Criteria:

* Having untreated chronic physical illnesses
* Having other mental disorders except ADHD

Inclusion Criteria for healthy children group:

* Do not have any mental disorder
* Do not have untreated chronic physical illnesses
* Parent willing to participate in the study by signing informed consent
* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes

Primary outcomes:
measure: The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms
timeFrame: up to 30 minutes
measure: The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function
timeFrame: up to 30 minues
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: dr. Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
affiliation: Dr Cipto Mangunkusumo General Hospital
name: Tjhin Wiguna, PhD
role: PRINCIPAL_INVESTIGATOR
References: