Clinical trial NCT05522946: Circle Game Collaborative--Freddie the Frog
Official title: Circle Game Collaborative--Freddie the Frog
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cognitive Impairment
Physical Disability
Keywords: Children with disabilities
Parent
Family
Games
Technology
Collaborative game
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Establish the feasibility of cooperative gameplay between parents and children without disabilities
timeFrame: 1 hour
measure: Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities
timeFrame: 1 hour
measure: Examine childs', adolescents', and parents ability to play the game through analysis of video recordings of game play
timeFrame: 1 hour
Secondary outcomes:
measure: Explore childs' and adolescents' Global, Mental, Physical, and Social Health using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure
timeFrame: Pre-gameplay
measure: 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
timeFrame: Immediately Post-gameplay and up to one week post-gameplay
measure: Explore the parents' feelings of bonding with their child/adolescent using the "Connection & Bonding Questionnaire"
timeFrame: 1 hour post-game play
measure: Explore whether the parent felt that their child's physical and psychological needs were met before gameplay using the "Child Needs Survey"
timeFrame: Pre-gameplay
measure: Explore whether the child had pain pre/post gameplay using visual analog scale
timeFrame: Pre gameplay and immediately post gameplay
measure: Explore whether the child had stress pre/post gameplay using visual analog scale
timeFrame: Pre gameplay and immediately post gameplay
measure: Explore whether the parent had pain pre/post gameplay using visual analog scale
timeFrame: Pre gameplay and immediately post gameplay
measure: Explore whether the parent had stress pre/post gameplay using visual analog scale
timeFrame: Pre gameplay and immediately post gameplay
measure: 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
timeFrame: 1 hour post-gameplay
measure: 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
timeFrame: 1 hour post-gameplay
measure: Compare the parents' feelings of bonding using the "Connection & Bonding Questionnaire" with their child/adolescent in Group 1, Group 2, and Group 3
timeFrame: 1 hour post-gameplay
measure: 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
timeFrame: 1 hour post-gameplay
measure: Compare whether the child had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
timeFrame: Immediately pre-gameplay and 1 hour post-gameplay
measure: Compare whether the child had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
timeFrame: Immediately pre-gameplay and 1 hour post-gameplay
measure: Compare whether the parent had pain using the Visual Analog Scale in Group 1, Group 2, and Group 3
timeFrame: Immediately pre-gameplay and 1 hour post-gameplay
measure: Compare whether the parent had stress using the Visual Analog Scale in Group 1, Group 2, and Group 3
timeFrame: Immediately pre-gameplay and 1 hour post-gameplay
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Nursing
state: Ohio
Study officials:
affiliation: Ohio State University
name: Susan E Thrane, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: