Circle Game Collaborative--Freddie the Frog

NCT05522946 | Withdrawn

• 1 other identifier: 2020B0306
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment; Physical Disability

Keywords

Children with disabilities; Parent; Family; Games; Technology; Collaborative game

Outcome Measures

Primary Outcomes (3)

• Establish the feasibility of cooperative gameplay between parents and children without disabilities

  Successful completion of gameplay session

  1 hour

• Establish the feasibility of cooperative gameplay between parents and adolescents with disabilities

  Successful completion of gameplay session

  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

  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

  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

  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"

  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"

  Pre-gameplay

• Explore whether the child had pain pre/post gameplay using visual analog scale

  Pre gameplay and immediately post gameplay

Study Arms (3)

Parent and child without disability

EXPERIMENTAL

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

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.

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.

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

Interventions

Gameplay between parent and child or adolescent with or without a disability OTHER

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.

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

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University College of Nursing

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Susan E Thrane, PhD, RN

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: August 31, 2022
• Study Start: February 17, 2021
• Primary Completion: May 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 15, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)