Circle Game Collaborative--Freddie the Frog

Cognitive Impairment Clinical Trial

Official title:

Circle Game Collaborative--Freddie the Frog

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05522946
• Other study ID #: 2020B0306
• Status: Withdrawn
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

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 Exclusion Criteria:

All groups:

• Parents who do not understand and speak English
• Parents with a disability

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Physical Disability

Intervention

Other:
• Gameplay between parent and child or adolescent with or without a disability
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.

Locations

Country	Name	City	State
United States	The Ohio State University College of Nursing	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the feasibility of cooperative gameplay between parents and children without disabilities	Successful completion of gameplay session	1 hour
Primary	Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities	Successful completion of gameplay session	1 hour
Primary	Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play	Successful completion of gameplay session	1 hour
Secondary	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.	Pre-gameplay
Secondary	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	Immediately Post-gameplay and up to one week post-gameplay
Secondary	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.	1 hour post-game play
Secondary	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.	Pre-gameplay
Secondary	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.	Pre gameplay and immediately post gameplay
Secondary	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.	Pre gameplay and immediately post gameplay
Secondary	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.	Pre gameplay and immediately post gameplay
Secondary	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.	Pre gameplay and immediately post gameplay
Secondary	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.	1 hour post-gameplay
Secondary	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.	1 hour post-gameplay
Secondary	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.	1 hour post-gameplay
Secondary	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.	1 hour post-gameplay
Secondary	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.	Immediately pre-gameplay and 1 hour post-gameplay
Secondary	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.	Immediately pre-gameplay and 1 hour post-gameplay
Secondary	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.	Immediately pre-gameplay and 1 hour post-gameplay
Secondary	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.	Immediately pre-gameplay and 1 hour post-gameplay