Cognitive ImpairmentNCT05522946
Circle Game Collaborative--Freddie the Frog
A study testing Gameplay between parent and child or adolescent with or without a disability in people with Cognitive Impairment and Physical Disability, run by Ohio State University at 1 site in United States.
Trial summary
Families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. This increased level of burden results in higher rates of emotional stress and hardship for those families. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Physical Disability
- What is being tested?
- Gameplay between parent and child or adolescent with or without a disability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to Dec 2023
- 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 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Group 1: Children without disabilities between the ages of 5-9 years. Any parent/caregiver to the child
- Group 2: Adolescents with mild to moderate physical or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child
- Group 3: Adolescents with moderate to severe physical and/or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child
Who cannot join
- All groups:
- Parents who do not understand and speak English
- Parents with a disability
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University College of Nursing
Columbus, Ohio, 43210
About this study
Families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. This increased level of burden results in higher rates of emotional stress and hardship for those families. Motivated by the idea of making deeper connections between children with disabilities and their parents, our gaming platform is designed around two key concepts - human touch and collaborative play. Using wearable sensors, conductive fabrics, microcontrollers, and wireless communication, our gaming platform will register and interpret "touch" as a way to interface with game apps and the devices they are installed on. In other words, touch is translated into player input. Thus, rather than interact with an iPad directly, children and their parents interact with each other instead. Our platform engages both parents and children with disabilities equally in order to better focus on their shared physical expression. As touch can be registered from any part of the body, our platform can be used with children with any type of disability and allows for both active and passive participation by children with a severe disability.
- Conditions
- Cognitive Impairment, Physical Disability
- Being tested
- Gameplay between parent and child or adolescent with or without a disability
- Keywords
- Children with disabilities, Parent, Family, Games, Technology, Collaborative game
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gameplay between parent and child or adolescent with or without a disabilityOther
Parent and child or adolescent will play the game using the provided sensors for 10-15 minutes total. Depending on the cognitive and/or physical ability of the child or adolescent, the two may take turns wearing the sensors or if the child or adolescent does not have the physical or cognitive ability to deliberately touch the sensor, then the child or adolescent will wear the sensors and the parent will touch the sensors in order to move the game forward.
| Study group | Role | What they receive |
|---|---|---|
| Parent and child without disability | Experimental | Parent and child will play the game on the iPad using the sensors provided. Receives: Other: Gameplay between parent and child or adolescent with or without a disability |
| Parent and adolescent with mild to moderate cognitive or physical disability | Experimental | Parent and adolescent will play the game on the iPad using the sensors provided. Receives: Other: Gameplay between parent and child or adolescent with or without a disability |
| Parent and adolescent with moderate to severe cognitive and/or physical disability | Experimental | Parent and adolescent will play the game on the iPad using the sensors provided. Receives: Other: Gameplay between parent and child or adolescent with or without a disability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish the feasibility of cooperative gameplay between parents and children without disabilities
Successful completion of gameplay session
Measured: 1 hour
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
Successful completion of gameplay session
Measured: 1 hour
Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
Successful completion of gameplay session
Measured: 1 hour
Secondary outcomes (16)
Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure
Using individual Patient-Reported Outcomes Measurement Information System (PROMIS) items from the global health, mental health, physical health, social health, and symptom item banks, explore the child and adolescent global health, mental health, physical health, social health, as well as pain and stress. The scores will range from 2-54 with higher scores indicating better outcomes.
Measured: Pre-gameplay
Semi-Structured interviews with open-ended questions to explore childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life
Using semi-structured interviews with open ended questions, we will ask parents and children/adolescents who are willing and able to answer questions related to playing the game together. We will ask children/adolescents who are willing and able questions immediately post gameplay. We will ask parents questions related to gameplay either immediately after the child/adolescent or up to 1 week later. To be qualitatively analyzed
Measured: Immediately Post-gameplay and up to one week post-gameplay
Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"
Explore parent feelings of bonding pre/post gameplay examine whether playing the game together increased their feelings of bonding with their child/adolescent. Bonding will be measured using a new investigator-developed measure named the Connection \& Bonding Questionnaire, a 5 item Likert-style questionnaire with responses ranging from Strongly Disagree (0) to Strongly Agree (5) and scores ranging from 0-25 with higher scores indicating a stronger connection and parent/child bond.
Measured: 1 hour post-game play
Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"
Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using an investigator-developed measure named the "Child Needs Survey", a 5 item survey with 4 questions with responses of Yes, No, Unsure/Decline to Answer, and Not able/Not applicable, one visual analog-type response ranging from "Little to none" to "Fully" and one open-ended question asking parents to describe any additional needs that may or may not have been met. More "yes" answers mean a better outcome.
Measured: Pre-gameplay
Explore whether the child had pain pre/post gameplay using visual analog scale
Using a visual analog scale, have the child and parent rate the child's pain pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Pre gameplay and immediately post gameplay
Explore whether the child had stress pre/post gameplay using visual analog scale
Using a visual analog scale, have the child and parent rate the child's stress pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Pre gameplay and immediately post gameplay
Explore whether the parent had pain pre/post gameplay using visual analog scale
Using a visual analog scale, have the parent rate their pain pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Pre gameplay and immediately post gameplay
Explore whether the parent had stress pre/post gameplay using visual analog scale
Using a visual analog scale, have the parent rate the their stress pre and immediately post gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Pre gameplay and immediately post gameplay
Compare childs' and adolescents' Global, Mental, Physical, and Social Health using the single measure "Patient-Reported Outcomes Measurement Information System (PROMIS)" from Group 1, Group 2, and Group 3
Examine and describe differences in Global, Mental, Physical, and Social Health between groups using the "Patient-Reported Outcomes Measurement Information System (PROMIS)" measure described in Outcome 4. All units of measure are the same across groups. The scores will range from 2-54 with higher scores indicating better outcomes.
Measured: 1 hour post-gameplay
Semi-structured interviews with open ended questions to compare childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life in Group 1, Group 2, and Group 3
Using semi-structured interviews with open ended questions, we will examine and describe differences in feelings about gameplay between groups using qualitative responses gathered using semi-structured interview from Outcome 5. To be qualitatively analyzed.
Measured: 1 hour post-gameplay
Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3
Examine and describe differences in feelings about parent bonding between groups using responses obtain from the "Connection \& Bonding Questionnaire", a 5 item Likert-style questionnaire with responses ranging from Strongly Disagree (0) to Strongly Agree (5) and scores ranging from 0-25 with higher scores indicating a stronger connection and parent/child bond.
Measured: 1 hour post-gameplay
Compare the parents' feelings of whether the child's physical and psychological needs were met before gameplay using the "Child Needs Survey" in Group 1, Group 2, and Group 3
Examine and describe differences in whether the child's physical and psychological needs were met before gameplay between groups using responses from the "Child Needs Survey." A 5 item survey with 4 questions with responses of Yes, No, Unsure/Decline to Answer, and Not able/Not applicable, one visual analog-type response ranging from "Little to none" to "Fully" and one open-ended question asking parents to describe any additional needs that may or may not have been met. More "yes" answers mean a better outcome.
Measured: 1 hour post-gameplay
Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Examine and describe differences in whether the child had pain pre/post gameplay between groups using the Visual Analog Scales. Using a visual analog scale, have the child rate their pain pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Examine and describe differences in whether the child had stress pre/post gameplay between groups using the Visual Analog Scale. Using a visual analog scale, have the child rate their stress pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Examine and describe differences in whether the parent had pain pre/post gameplay between groups using the Visual Analog Scale. Using a visual analog scale, have the parent rate their pain pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Examine and describe differences in whether the parent had stress pre/post gameplay between groups using the Visual Analog Scale.Using a visual analog scale, have the parent rate their stress pre- and immediately post-gameplay. Visual Analog Scales are a 100mm line with endpoints "none" at the 0 endpoint and "worst ever" at the 100mm endpoint. A higher score indicates a worse outcome.
Measured: Immediately pre-gameplay and 1 hour post-gameplay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start17 Feb 2021
- Primary completionMay 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Participants were not assigned to an intervention and as such this was not considered a clinical trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Group 1: Parents and children without disabilities Group 2: Parents and adolescents with mild to moderate cognitive or physical disability Group 3: Parents and adolescents with moderate to severe cognitive and/or physical disability
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan E Thrane, PhD, RN, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522946
- Sponsor's protocol ID
- 2020B0306
- Status last verified
- Aug 2022
- First submitted
- 1 Apr 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circle Game Collaborative--Freddie the Frog
- ClinicalTrials.gov ID
- NCT05522946
- Acronym / sponsor ID
- 2020B0306
- Conditions
- Cognitive Impairment, Physical Disability
- Keywords
- Children with disabilities, Parent, Family, Games, Technology, Collaborative game
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Participants were not assigned to an intervention and as such this was not considered a clinical trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 31 Aug 2022 (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.
Families who have children with disabilities experience more challenges in interacting with their children than families who have children without disabilities. This increased level of burden results in higher rates of emotional stress and hardship for those families. Motivated by the idea of making deeper connections between children with disabilities and their parents, our gaming platform is designed around two key concepts - human touch and collaborative play. Using wearable sensors, conductive fabrics, microcontrollers, and wireless communication, our gaming platform will register and interpret "touch" as a way to interface with game apps and the devices they are installed on. In other words, touch is translated into player input. Thus, rather than interact with an iPad directly, children and their parents interact with each other instead. Our platform engages both parents and children with disabilities equally in order to better focus on their shared physical expression. As touch can be registered from any part of the body, our platform can be used with children with any type of disability and allows for both active and passive participation by children with a severe disability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Group 1: Parents and children without disabilities Group 2: Parents and adolescents with mild to moderate cognitive or physical disability Group 3: Parents and adolescents with moderate to severe cognitive and/or physical disability
| Arm | Type | Receives |
|---|---|---|
| Parent and child without disability | Experimental | Other: Gameplay between parent and child or adolescent with or without a disabilityParent and child will play the game on the iPad using the sensors provided. |
| Parent and adolescent with mild to moderate cognitive or physical disability | Experimental | Other: Gameplay between parent and child or adolescent with or without a disabilityParent and adolescent will play the game on the iPad using the sensors provided. |
| Parent and adolescent with moderate to severe cognitive and/or physical disability | Experimental | Other: Gameplay between parent and child or adolescent with or without a disabilityParent and adolescent will play the game on the iPad using the sensors provided. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Group 1: Children without disabilities between the ages of 5-9 years. Any parent/caregiver to the child
- Group 2: Adolescents with mild to moderate physical or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child
- Group 3: Adolescents with moderate to severe physical and/or cognitive disability between the ages of 10-17 years. Any parent/caregiver to the child
Key exclusion criteria (3 listed)
- Parents who do not understand and speak English
- Parents with a disability
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 |
|---|---|---|
| Gameplay between parent and child or adolescent with or without a disabilityParent and child or adolescent will play the game using the provided sensors for 10-15 minutes total. Depending on the cognitive and/or physical ability of the child or adolescent, the two may take turns wearing the sensors or if the child or adolescent does not have the physical or cognitive ability to deliberately touch the sensor, then the child or adolescent will wear the sensors and the parent will touch the sensors in order to move the game forward. | Other | Parent and adolescent with mild to moderate cognitive or physical disability, Parent and adolescent with moderate to severe cognitive and/or physical disability, Parent and child without disability |
Primary outcome
Establish the feasibility of cooperative gameplay between parents and children without disabilities
Time frame: 1 hour
Successful completion of gameplay session
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
Time frame: 1 hour
Successful completion of gameplay session
Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
Time frame: 1 hour
Successful completion of gameplay session
16 secondary outcomes
Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure
Time frame: Pre-gameplay
Semi-Structured interviews with open-ended questions to explore childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life
Time frame: Immediately Post-gameplay and up to one week post-gameplay
Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"
Time frame: 1 hour post-game play
Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"
Time frame: Pre-gameplay
Explore whether the child had pain pre/post gameplay using visual analog scale
Time frame: Pre gameplay and immediately post gameplay
Explore whether the child had stress pre/post gameplay using visual analog scale
Time frame: Pre gameplay and immediately post gameplay
Explore whether the parent had pain pre/post gameplay using visual analog scale
Time frame: Pre gameplay and immediately post gameplay
Explore whether the parent had stress pre/post gameplay using visual analog scale
Time frame: Pre gameplay and immediately post gameplay
Compare childs' and adolescents' Global, Mental, Physical, and Social Health using the single measure "Patient-Reported Outcomes Measurement Information System (PROMIS)" from Group 1, Group 2, and Group 3
Time frame: 1 hour post-gameplay
Semi-structured interviews with open ended questions to compare childs' and adolescents' (where appropriate), and parents' feelings about gameplay for fun, well being, quality of life in Group 1, Group 2, and Group 3
Time frame: 1 hour post-gameplay
Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3
Time frame: 1 hour post-gameplay
Compare the parents' feelings of whether the child's physical and psychological needs were met before gameplay using the "Child Needs Survey" in Group 1, Group 2, and Group 3
Time frame: 1 hour post-gameplay
Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Time frame: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Time frame: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Time frame: Immediately pre-gameplay and 1 hour post-gameplay
Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Time frame: Immediately pre-gameplay and 1 hour post-gameplay
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No. No plan to share data.
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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.
Susan E Thrane, PhD, RN principal investigator
Ohio State 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 Gameplay between parent and child or adolescent with or without a disability in people with Cognitive Impairment and Physical Disability, run by Ohio State University 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Jun 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Establish the feasibility of cooperative gameplay between parents and children without disabilities (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 15 Jun 2023.