Therapeutic Gaming for the Treatment of Attention Deficit Hyperactivity Disorder (THERAGAME)

September 23, 2021 updated by: Robert A Lodder, PhD, Spherix Incorporated
Children with ADHD play a videogame to test symptom control

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Minecraft is an online video game containing a "virtual land where users can create their own worlds and experiences, using building blocks, resources discovered on the site and their own creativity" that requires its users to apply problem solving, planning, and organizational skills for creative building and exploration.1

It is being studied as an adjunctive treatment in combination with stimulant medications in children with attention deficit hyperactivity disorder (ADHD) to improve executive function and ADHD symptoms, as well as to allow for the use of lower doses of stimulant drugs. Although there is little research on the effect of Minecraft in humans, there is considerable research on the effects of other video games. Like pharmaceuticals, the effect seen seems to be often related to the amount and style of video games to which humans are exposed. First-person shooter games with violence have been associated with anxiety and fear (Strasburger et al. 2010). The negative outcomes of video play include obesity, aggressiveness, antisocial behavior, and addiction (Strasburger et al 2010).2 Video and computer games come in many different genres, some violent, some nonviolent, some with lots of action, some without any action, etc. Chess and checkers were among the earliest computer games and they still remain popular. Cognitive training interventions administered in a game format have been studied in children with ADHD. Taken together, the results of studies show that these cognitive training interventions are generally effective in improving the specific executive functions they target, as well as parent-reported ADHD symptoms. The majority of the interventions studied have targeted training of working memory, although some interventions have also targeted attention, response inhibition, and cognitive flexibility in the training. A recent meta-analysis found that interventions targeting multiple executive function domains had a stronger effect on parent-reported ADHD symptoms than studies targeting working memory alone (which showed minimal benefits), but it is possible that the greater benefits seen were due to a more intensive intervention schedule.3

The improvements in cognitive assessments and parent-rated ADHD symptoms have been shown to persist for up to 6 months after completion of training.4 However, it should be noted that the improvements in cognitive function could be due to practice effects arising from repetition of the cognitive tasks, rather than a true alteration in cognitive function.5 In contrast to the effects on "near-transfer" functions and parent-rated ADHD symptoms, evidence of "far-transfer" effects to untrained functions and non-clinical environments has been limited, and improvements in teacher-rated ADHD symptoms have not been observed. The latter observation is particularly important as teacher ratings of ADHD symptoms can be a more objective measure of efficacy than parent ratings, and the most significant limitations for a majority of the studies have been effective blinding procedures and an appropriate control condition. These results are further limited by overrepresentation of males subjects in study populations, the exclusion of patients with comorbidities in most of the studies, and small sample sizes (for review, see Rutledge, et al. (2012), Chacko, et al. (2013) , and Rivero, et al. (2015)).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

10 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. 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:

    1. complete the study log.
    2. 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.

Exclusion Criteria:

- 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).

3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Minecraft
This group played the video game under development in Minecraft
Device: Minecraft
A game played within the videogame Minecraft
Placebo Comparator: Control
This group played another game.
Device: Minecraft
A game played within the videogame Minecraft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Score on NICHQ Vanderbilt assessment
Time Frame: One month
Score on NICHQ Vanderbilt assessment
One month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spherix Incorporated

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioSpherix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 23, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TVG001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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