Attention Deficit Hyperactivity DisorderNCT01808066
GroundsKeeper: A Qualitative Study of Applied Game-based Interactives in Special Education Programs
A study testing Groundskeeper in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by CogCubed, Corp at 1 site in United States.
Trial summary
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Pervasive Developmental Disorder
- What is being tested?
- Groundskeeper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Attention Deficit Hyperactivity Disorder
- Autism Spectrum Disorder
- Pervasive Developmental Disorder
- Asperger's Disorder
- Cognitive Disabilities
Who cannot join
- Subject does not have cognitive disabilities, Attention Deficit Hyperactivity Disorder or Autism Spectrum Disorders
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The hypothesis is that the use of these devices will increase engagement, motivation, interest, and have perceived benefits to users with unique attention-limiting cognitive disabilities. How does the observation of and user feedback from gameplay reveal areas of improvement for the game, strengths, and perceptions of value among the players and adults?
Read the detailed description
Primarily the investigators seek to observe and interview participants over a three-week period of time to assess their ongoing interest and the perceived effects of regular play segments each day (10-20 minutes each). Data will be collected in pre/post interviews, teacher journals, and observation of pre/post play sessions.
These new hands-on digitized cubes are motion sensitive blocks that are capable of interactively reacting to each other and motion applied to them. The game GroundKeeper makes use of these cubes to use auditory and visual stimuli to provide distractors during play apart from the goal of the game. The investigators expect that play will encourage attention in players and are interested to see what players and their teachers/parents perceive the effects to be.
The investigator's goal is not to measure actual attention rates and times of the students, but the subjective observations of players' engagement with the devices, motivation to play the game, interest initially and over time, and perceived effect of the game on attention. This type study is commonly known as 'play-testing' a software product with the target audience; a process refined as "design-based research" in academia (Laurel, 2003) and used for assessing the quality of digital designs for learning (Barab \& Squire, 2004) and using data to improve them. This study will be a qualitative counter-balance to the quantitative work being done separately by the University of Minnesota (Under Dr. Srivastava), using clinical and computer based diagnostics and data mining respectively on the same product.
Digital tools are facilitating both traditional and '21st century skills' via new information and communication technologies for knowledge work, thinking, learning, and leading digital lifestyles (p. 23) (Trilling \& Fadel, 2009). Further there is growing evidence these skills, along with traditional literacies are being learned by using digital applications (Gee, 2007; Squire \& Barab, 2004; Steinkuehler \& Duncan, 2008). Early evidence that digital tools can 'amplify' learning activity shows potential for digital technology to beneficial even if 'played' or used 'in the wild' (Squire \& Dikkers, 2012). This study seeks to further explore learning attributes of a digitally mediated learning experience designed for a particular learning goal.
Additionally, current diagnostic aids, used in treating attention capacity for Attention Deficit Hyperactivity Disorder (ADHD) and Autism, are currently expensive, time intensive, and provide little information about accessory movements in response to a stimulus. One in ten children, ages 5 to 17, has been diagnosed with ADHD; and the number of kids with autism has increased 78% in the last ten years http://www.cnn.com/2012/03/29/ health/autism/index.html). This study will seek to assess the accessibility and usability of software that seeks to help shape attention strategies through play and 'fun' learning for both ADHD and Autistic children that struggle with attention. If effective this could be a valuable and affordable option for educational institutions to serve these learners.
This study seeks to aid CogCubed in improved design for their game that will improve its' ability to engage, motivate, and retain player interest over time.
- Conditions
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Pervasive Developmental Disorder, Asperger's Disorder
- Being tested
- Groundskeeper
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder, Child Development Disorders, Pervasive, Asperger Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroundskeeperDevice
Also called Executive Function Training Game
Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task.
| Study group | Role | What they receive |
|---|---|---|
| Play Groundskeeper | Experimental | This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab \& Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time. We will assess the participants for their ability to stay engaged in play by observing their engagement in the game, time played, frequency of play, and the ability to complete a session over the course of three weeks while in school. Receives: Device: Groundskeeper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Increase/Improvement in Focusing
Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.
Measured: 3 weeks
Secondary outcomes (1)
Number of Participants Identified as Attentive, Interested and Motivated Via Pre Interview
Researchers will conduct interviews with players and collect all notes/journals recorded. Specific questions will be asked about their perception of their attention, interest and motivation to play the game. Example of questions included if they enjoyed playing the game, if they wanted to play the game and if they have trouble focusing during the game. Was it too long? Themes of the answers will be identified by researchers as a qualitative measure of interest.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CogCubed, Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ohio University
- Responsible party
- Sponsor
- Investigators
- Seann Dikkers, PhD, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808066
- Sponsor's protocol ID
- 12X226
- Other IDs
- 12X226
- Status last verified
- Oct 2019
- First submitted
- 6 Mar 2013
- Last updated
- 16 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Trilling, Bernie, & Fadel, Charles. (2009). 21 Century Skills: Learning for Life in our Times. San Francisco, CA: Jossey-Bass.
Steinkuehler, C., & Duncan, S. (2008). Scientific Habits of Mind in Virtual Worlds. Journal of Science Education and Technology, 17(6), 530-543. doi: Doi 10.1007/S10956-008-9120-8
Squire, K., & Dikkers, S. (2012). Amplifications of learning: Use of mobile media devices among youth. Convergence: The International Journal of Research into New Media Technologies, OnlineFirst. http://con.sagepub.com/content/early/2012/02/15/1354856511429646 doi:10.1177/1354856511429646.
Squire, K., & Barab, S. (2004). Replaying history: Engaging urban undeserved students in learning world history. Paper presented at the 6th international conference on Learning sciences, Los Angeles, CA.
Gee, J. P. (2007). What Video Games have to Teach us about Learning and Literacy. New York, NY: Palgrave Macmillan
Barab, S. and K. Squire (2004).
Laurel, B., Ed. (2003). Design Research: Methods and Perspectives. Cambridge, MA, The MIT Press.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GroundsKeeper: A Qualitative Study of Applied Game-based Interactives in Special Education Programs
- ClinicalTrials.gov ID
- NCT01808066
- Acronym / sponsor ID
- 12X226
- Conditions
- Attention Deficit Hyperactivity Disorder, Autism Spectrum Disorder, Pervasive Developmental Disorder, Asperger's Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CogCubed, CorpIndustry (pharma, biotech, devices)
- Collaborators
- Ohio University
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Mar 2013 (estimated)
- Results
- Posted 9 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the use of, and reaction to, one particular software application(GroundsKeeper) delivered on unique platform - Sifteo cubes (www.sifteo.com). The hypothesis is that the use of these devices will increase engagement, motivation, interest, and have perceived benefits to users with unique attention-limiting cognitive disabilities. How does the observation of and user feedback from gameplay reveal areas of improvement for the game, strengths, and perceptions of value among the players and adults?
Detailed description
Primarily the investigators seek to observe and interview participants over a three-week period of time to assess their ongoing interest and the perceived effects of regular play segments each day (10-20 minutes each). Data will be collected in pre/post interviews, teacher journals, and observation of pre/post play sessions.
These new hands-on digitized cubes are motion sensitive blocks that are capable of interactively reacting to each other and motion applied to them. The game GroundKeeper makes use of these cubes to use auditory and visual stimuli to provide distractors during play apart from the goal of the game. The investigators expect that play will encourage attention in players and are interested to see what players and their teachers/parents perceive the effects to be.
The investigator's goal is not to measure actual attention rates and times of the students, but the subjective observations of players' engagement with the devices, motivation to play the game, interest initially and over time, and perceived effect of the game on attention. This type study is commonly known as 'play-testing' a software product with the target audience; a process refined as "design-based research" in academia (Laurel, 2003) and used for assessing the quality of digital designs for learning (Barab \& Squire, 2004) and using data to improve them. This study will be a qualitative counter-balance to the quantitative work being done separately by the University of Minnesota (Under Dr. Srivastava), using clinical and computer based diagnostics and data mining respectively on the same product.
Digital tools are facilitating both traditional and '21st century skills' via new information and communication technologies for knowledge work, thinking, learning, and leading digital lifestyles (p. 23) (Trilling \& Fadel, 2009). Further there is growing evidence these skills, along with traditional literacies are being learned by using digital applications (Gee, 2007; Squire \& Barab, 2004; Steinkuehler \& Duncan, 2008). Early evidence that digital tools can 'amplify' learning activity shows potential for digital technology to beneficial even if 'played' or used 'in the wild' (Squire \& Dikkers, 2012). This study seeks to further explore learning attributes of a digitally mediated learning experience designed for a particular learning goal.
Additionally, current diagnostic aids, used in treating attention capacity for Attention Deficit Hyperactivity Disorder (ADHD) and Autism, are currently expensive, time intensive, and provide little information about accessory movements in response to a stimulus. One in ten children, ages 5 to 17, has been diagnosed with ADHD; and the number of kids with autism has increased 78% in the last ten years http://www.cnn.com/2012/03/29/ health/autism/index.html). This study will seek to assess the accessibility and usability of software that seeks to help shape attention strategies through play and 'fun' learning for both ADHD and Autistic children that struggle with attention. If effective this could be a valuable and affordable option for educational institutions to serve these learners.
This study seeks to aid CogCubed in improved design for their game that will improve its' ability to engage, motivate, and retain player interest over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Play Groundskeeper | Experimental | Device: GroundskeeperThis study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab \& Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time. We will assess the participants for their ability to stay engaged in play by observing their engagement in the game, time played, frequency of play, and the ability to complete a session over the course of three weeks while in school. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Attention Deficit Hyperactivity Disorder
- Autism Spectrum Disorder
- Pervasive Developmental Disorder
- Asperger's Disorder
- Cognitive Disabilities
Key exclusion criteria (1 listed)
- Subject does not have cognitive disabilities, Attention Deficit Hyperactivity Disorder or Autism Spectrum Disorders
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 |
|---|---|---|
| GroundskeeperAlso: Executive Function Training GameGroundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task. | Device | Play Groundskeeper |
Primary outcome
Number of Participants With an Increase/Improvement in Focusing
Time frame: 3 weeks
Researchers will observe and record data during the first play session. Over the three weeks, teachers/support staff will be asked to observe players each day and record their observations as needed in a journal. These observations will measure their improvement in their ability to focus by assessing their engagement, time played, frequency of play, ability to complete a session and ability to start and finish a session. At the end of three weeks, researchers will attend the final play session and record observations in writing.
1 secondary outcome
Number of Participants Identified as Attentive, Interested and Motivated Via Pre Interview
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTrilling, Bernie, & Fadel, Charles. (2009). 21 Century Skills: Learning for Life in our Times. San Francisco, CA: Jossey-Bass.
- BackgroundSteinkuehler, C., & Duncan, S. (2008). Scientific Habits of Mind in Virtual Worlds. Journal of Science Education and Technology, 17(6), 530-543. doi: Doi 10.1007/S10956-008-9120-8
- BackgroundSquire, K., & Dikkers, S. (2012). Amplifications of learning: Use of mobile media devices among youth. Convergence: The International Journal of Research into New Media Technologies, OnlineFirst. http://con.sagepub.com/content/early/2012/02/15/1354856511429646 doi:10.1177/1354856511429646.
- BackgroundSquire, K., & Barab, S. (2004). Replaying history: Engaging urban undeserved students in learning world history. Paper presented at the 6th international conference on Learning sciences, Los Angeles, CA.
- BackgroundGee, J. P. (2007). What Video Games have to Teach us about Learning and Literacy. New York, NY: Palgrave Macmillan
- BackgroundBarab, S. and K. Squire (2004).
- BackgroundLaurel, B., Ed. (2003). Design Research: Methods and Perspectives. Cambridge, MA, The MIT Press.
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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.
Seann Dikkers, PhD principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Groundskeeper in people with Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, run by CogCubed, Corp at 1 site in United States.
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 5 inclusion and 1 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: finished, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With an Increase/Improvement in Focusing (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01808066, which also lists 7 linked publications.
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 16 Oct 2019.