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

Primary Purpose

ADHD, Executive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
ADHD-VR diagnosis tool
Sponsored by
Tjhin Wiguna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ADHD focused on measuring ADHD, virtual reality,, diagnostic tool, neuropsychological test, Indonesia

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • dr. Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Children with ADHD

Children without ADHD

Arm Description

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

Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders

Outcomes

Primary Outcome Measures

The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms
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
Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2020
Last Updated
April 6, 2020
Sponsor
Tjhin Wiguna
Collaborators
Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Binus University International
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1. Study Identification

Unique Protocol Identification Number
NCT04337905
Brief Title
Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)
Acronym
New
Official Title
A New Development Diagnostic Tool for ADHD: A VR Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 25, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tjhin Wiguna
Collaborators
Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Binus University International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Executive Dysfunction
Keywords
ADHD, virtual reality,, diagnostic tool, neuropsychological test, Indonesia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There is two group of children: Group 1: Children with ADHD 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: The sensitivity, specificity and Likelihood ratio of the ADHD-VR diagnostic test in detecting the ADHD clinical symptoms and executive function Content validity of the ADHD-VR diagnostic test
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator blind to the ADHD-VR diagnostic test results The care provider blind to the ADHD-VR diagnostic test results The ADHD-VR assessor blind to the ADHD diagnosis
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Children with ADHD
Arm Type
Experimental
Arm Description
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
Arm Title
Children without ADHD
Arm Type
Active Comparator
Arm Description
Healthy children that also running the ADHD-VR diagnostic test and also psyhchiatric examination to rule out the ADHD diagnosis and other mental disorders
Intervention Type
Device
Intervention Name(s)
ADHD-VR diagnosis tool
Intervention Description
Since that time and in accordance with the application area, several definitions have been formulated: for example, Fuchs and Bishop (1992) defined VR as "real-time interactive graphics with 3D models, combined with a display technology that gives the user the immersion in the model world and direct manipulation"; Gigante (1993) described VR as "The illusion of participation in a synthetic environment rather than external observation of such an environment. VR relies on a 3D, stereoscopic head-tracker displays, hand/body tracking and binaural sound. VR is an immersive, multi-sensory experience"; and "Virtual reality refers to immersive, interactive, multi-sensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments".
Primary Outcome Measure Information:
Title
The sensitivity and specificity of ADHD-VR diagnostic tool towards ADHD clinical symptoms
Description
The comparing between the ADHD-VR diagnostic test results and expert judgement on ADHD diagnosis
Time Frame
up to 30 minutes
Title
The sensitivity and specificity of ADHD-VR diagnostic tool towards executive function
Description
Comparing between the ADHD-VR diagnostic test results and Behavior Rating Inventory for Executive Function Rating Scale.
Time Frame
up to 30 minues

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjhin Wiguna, PhD
Organizational Affiliation
Dr Cipto Mangunkusumo General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
dr. Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No decided yet

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

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