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Circle Game Collaborative--Freddie the Frog

Primary Purpose

Cognitive Impairment, Physical Disability

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gameplay between parent and child or adolescent with or without a disability
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cognitive Impairment focused on measuring Children with disabilities, Parent, Family, Games, Technology, Collaborative game

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State University College of Nursing

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Parent and child without disability

Parent and adolescent with mild to moderate cognitive or physical disability

Parent and adolescent with moderate to severe cognitive and/or physical disability

Arm Description

Parent and child will play the game on the iPad using the sensors provided.

Parent and adolescent will play the game on the iPad using the sensors provided.

Parent and adolescent will play the game on the iPad using the sensors provided.

Outcomes

Primary Outcome Measures

Establish the feasibility of cooperative gameplay between parents and children without disabilities
Successful completion of gameplay session
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
Successful completion of gameplay session
Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
Successful completion of gameplay session

Secondary Outcome Measures

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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 1, 2021
Last Updated
June 12, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT05522946
Brief Title
Circle Game Collaborative--Freddie the Frog
Official Title
Circle Game Collaborative--Freddie the Frog
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Participants were not assigned to an intervention and as such this was not considered a clinical trial.
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Physical Disability
Keywords
Children with disabilities, Parent, Family, Games, Technology, Collaborative game

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent and child without disability
Arm Type
Experimental
Arm Description
Parent and child will play the game on the iPad using the sensors provided.
Arm Title
Parent and adolescent with mild to moderate cognitive or physical disability
Arm Type
Experimental
Arm Description
Parent and adolescent will play the game on the iPad using the sensors provided.
Arm Title
Parent and adolescent with moderate to severe cognitive and/or physical disability
Arm Type
Experimental
Arm Description
Parent and adolescent will play the game on the iPad using the sensors provided.
Intervention Type
Other
Intervention Name(s)
Gameplay between parent and child or adolescent with or without a disability
Intervention Description
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.
Primary Outcome Measure Information:
Title
Establish the feasibility of cooperative gameplay between parents and children without disabilities
Description
Successful completion of gameplay session
Time Frame
1 hour
Title
Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
Description
Successful completion of gameplay session
Time Frame
1 hour
Title
Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
Description
Successful completion of gameplay session
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure
Description
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.
Time Frame
Pre-gameplay
Title
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
Description
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
Time Frame
Immediately Post-gameplay and up to one week post-gameplay
Title
Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"
Description
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.
Time Frame
1 hour post-game play
Title
Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"
Description
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.
Time Frame
Pre-gameplay
Title
Explore whether the child had pain pre/post gameplay using visual analog scale
Description
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.
Time Frame
Pre gameplay and immediately post gameplay
Title
Explore whether the child had stress pre/post gameplay using visual analog scale
Description
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.
Time Frame
Pre gameplay and immediately post gameplay
Title
Explore whether the parent had pain pre/post gameplay using visual analog scale
Description
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.
Time Frame
Pre gameplay and immediately post gameplay
Title
Explore whether the parent had stress pre/post gameplay using visual analog scale
Description
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.
Time Frame
Pre gameplay and immediately post gameplay
Title
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
Description
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.
Time Frame
1 hour post-gameplay
Title
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
Description
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.
Time Frame
1 hour post-gameplay
Title
Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3
Description
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.
Time Frame
1 hour post-gameplay
Title
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
Description
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.
Time Frame
1 hour post-gameplay
Title
Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Description
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.
Time Frame
Immediately pre-gameplay and 1 hour post-gameplay
Title
Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Description
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.
Time Frame
Immediately pre-gameplay and 1 hour post-gameplay
Title
Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
Description
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.
Time Frame
Immediately pre-gameplay and 1 hour post-gameplay
Title
Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
Description
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.
Time Frame
Immediately pre-gameplay and 1 hour post-gameplay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan E Thrane, PhD, RN
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University College of Nursing
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data.

Learn more about this trial

Circle Game Collaborative--Freddie the Frog

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