Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)

Not Applicable

• Conditions: Executive Dysfunction; ADHD
• Interventions: Device: ADHD-VR diagnosis tool

• Registration Number: NCT04337905
• Lead Sponsor: Tjhin Wiguna

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.

Study Timeline

• Study Start: 2019-05-25
• Status Verified: 2020-04
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-06
• Last Update Submitted: 2020-04-06
• Study First Posted: 2020-04-08
• Last Update Posted: 2020-04-08
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Children with ADHD	ADHD-VR diagnosis tool	Children with ADHD that running the ADHD-VR diagnostic test and also did the psychiatric examination to determine the ADHD diagnosis and to rule out other mental disorders
Children without ADHD	ADHD-VR diagnosis tool	Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms	up to 30 minutes	The comparing between the ADHD-VR diagnostic test results and expert judgement on ADHD diagnosis
The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function	up to 30 minues	Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.

Trial Locations

Locations (1)

dr. Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia