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

NCT04337905 | Unknown

• 1 other identifier: ADHD-VR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; Executive Dysfunction

Keywords

ADHD; virtual reality,; diagnostic tool; neuropsychological test; Indonesia

Outcome Measures

Primary Outcomes (2)

• 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

  up to 30 minutes

• 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.

  up to 30 minues

Study Arms (2)

Children with ADHD

EXPERIMENTAL

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

Device: ADHD-VR diagnosis tool

Children without ADHD

ACTIVE COMPARATOR

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

Device: ADHD-VR diagnosis tool

Interventions

ADHD-VR diagnosis tool DEVICE

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".

Children with ADHD; Children without ADHD

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tjhin Wiguna: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Binus University International: collaborator

Study Sites (1)

dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Tjhin Wiguna, PhD

  Dr Cipto Mangunkusumo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. dr.

Model Details: 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

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: May 25, 2019
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: April 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)