Attention Deficit Hyperactivity DisorderTHERAGAMENCT05067322
Therapeutic Gaming for the Treatment of Attention Deficit Hyperactivity Disorder
A study testing Minecraft in people with Attention Deficit Hyperactivity Disorder, run by Spherix Incorporated.
Trial summary
Children with ADHD play a videogame to test symptom control Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Minecraft
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2017to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- 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.
Who cannot join
- 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
About this study
Children with ADHD play a videogame to test symptom control
Read the 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)).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Minecraft
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinecraftDevice
A game played within the videogame Minecraft
| Study group | Role | What they receive |
|---|---|---|
| Minecraft | Experimental | This group played the video game under development in Minecraft Receives: Device: Minecraft |
| Control | Placebo comparator | This group played another game. Receives: Device: Minecraft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on NICHQ Vanderbilt assessment
Score on NICHQ Vanderbilt assessment
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start9 Jan 2017
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Why it stopped: Low enrollment at the site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test group and a control group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spherix Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioSpherix
- Responsible party
- Principal investigator, Robert A Lodder, PhD, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067322
- Sponsor's protocol ID
- TVG001
- Acronym
- THERAGAME
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Gaming for the Treatment of Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT05067322
- Acronym / sponsor ID
- THERAGAME / TVG001
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment at the site.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Spherix IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- BioSpherix
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with ADHD play a videogame to test symptom control
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 design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test group and a control group
| Arm | Type | Receives |
|---|---|---|
| Minecraft | Experimental | Device: MinecraftThis group played the video game under development in Minecraft |
| Control | Placebo comparator | Device: MinecraftThis group played another game. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinecraftA game played within the videogame Minecraft | Device | Control, Minecraft |
Primary outcome
Score on NICHQ Vanderbilt assessment
Time frame: One month
Score on NICHQ Vanderbilt assessment
Results and safety
The study was stopped early (reason given: Low enrollment at the site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Minecraft in people with Attention Deficit Hyperactivity Disorder, run by Spherix Incorporated.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment at the site.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on NICHQ Vanderbilt assessment (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.