Therapeutic Gaming for the Treatment of Attention Deficit Hyperactivity Disorder

NCT05067322 | Terminated

• 1 other identifier: TVG001
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children with ADHD play a videogame to test symptom control

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Score on NICHQ Vanderbilt assessment

  Score on NICHQ Vanderbilt assessment

  One month

Study Arms (2)

Minecraft

EXPERIMENTAL

This group played the video game under development in Minecraft

Device: Minecraft

Control

PLACEBO COMPARATOR

This group played another game.

Device: Minecraft

Interventions

Minecraft DEVICE

A game played within the videogame Minecraft

Control; Minecraft

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. Primary diagnosis of ADHD in accordance with DSM-5. 2. On a current regimen of a stimulant type ADHD medication, such as Vyvanse. 3. Sex: males and females. 4. Age: between 10 and 15 years of age. 5. Stated willingness to comply with all study procedures and availability for the duration of the study, including adherence to medication and play regimen. 6. Are capable, as determined by the investigator, to perform the following:
• complete the study log.
• are able to comply with the required study visits. 7. Have given written informed assent along with parents/legal guardians to participate in this study in accordance to local regulations before any trial related activities (other than initial screening) are carried out. 8. Are Minecraft players and have access to a full version of PC/Mac (Java) Minecraft, Xbox Minecraft, or pocket Minecraft version (Android, Kindle) that supports play on Realms. 9. Subjects' parents and subjects both currently have Google accounts and electronic devices to access Google accounts online. 10.Must have an NICHQ Vanderbilt Assessment scored by parents and teacher(s) within the last month, or get an assessment scored by parents and teacher(s) within one week of enrollment and before beginning to play the video game if the subject is in the video game arm). 11.At least one parent and the subject must be proficient in spoken and written English.

You may not qualify if:

• \- 1. Current or past history of substance abuse. 2. Patients who for whatever reason are deemed by the investigator inadequate for participation in this trial (e.g., patients with incapacitating mental illness).
• \. Have previously completed or withdrawn from this study after having signed the informed consent/assent document. 4. Lack of proficiency in spoken and written English

Sponsors & Collaborators

• Spherix Incorporated: lead
• BioSpherix: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Test group and a control group

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 5, 2021
• Study Start: January 9, 2017
• Primary Completion: September 23, 2021
• Study Completion: September 23, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-09