- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06319430
Technology in Play for Children With Physical Disabilities: the Dice Model of Play
The Role of Technology in Facilitating Play for Children With Physical Disabilities: Development of the Dice Model of Play
Play is an important activity for children. Almost all children play, but what is play? It is not easy to define play. In the past, people believed that children played to burn their energy. Now, it is known that play is important for children's growth. Some kids with disabilities cannot play. Many experts use play to teach children specific skills. People often forget that play is a child's right. It is important to help all children play. The first step is to define play and find what features are important in helping a child with a disability play.
There are some models of play. But they are not complete. They do not look at play as a whole. Some models are just about playfulness, and some are about playing with others. Having a model that defines play helps researchers and clinicians think about play and the different parts of it. Then, when a child cannot play, experts can fix the part that is not working. Investigators want to introduce a model of play in this project. Investigators want to edit and complete it in three steps. First, Investigators will ask parents and children with disabilities about things that help or do not help them play; then, investigators will give Lego robots to children that they will build with help and play with them for a few weeks. And at the end, investigators will ask therapists and other experts about our model of play. This model will be edited during the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Minoo Dabiri Golchin, Ph.D.
- Phone Number: 204-789-3897
- Email: Minoo.DabiriGolchin@umanitoba.ca
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3G1
- Recruiting
- Rehabilitation Centre for Children
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Contact:
- Liz Hammond
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having a disability or typically developed
- Between 3 to 9 years old
- Speaking and understanding English or Persian
- Living in Winnipeg
Exclusion Criteria:
- Not receiving play therapy within the last three months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: robots
Participants will be randomly allocated to groups A or B. Those in group A will co-design and build their LEGO™ robot, using the researcher's assistance, as led by the child.
A go-along interview will be conducted during the co-design with the child .
The co-design session will be video recorded to provide context, visual data, and to inform the qualitative analysis.
Videos will be deleted right after analysis.
A research assistant (RA) will visit the participant's home twice a week for 30 to 45 minutes (after school or on the weekend) to play with the child and their built LEGO™ robots for four weeks (4 sessions total).
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LEGO robots with adaptation according to child's age and developmental skills.
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Experimental: conventional toys
Group B will engage in the same process of 4 play intervention sessions over four weeks with the research assistant; however, they will receive conventional play tools.
The RA will carry a prepared play pack for the play intervention session.
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A pack of conventional play tools consists of dolls, teddy bears, miniature wild animals, and small cars.
All are available, and the child can choose to play with them.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test of Playfulness
Time Frame: before the session 1, after session 8, after session 16, each time 10 to 20 minutes.
|
The Test of playfulness (TOP) version 4 (Bundy, 1998) is an observational test that covers four main elements of playfulness: intrinsic motivation, internal control, freedom of reality, and framing within 29 Likert scale related to extent, intensity, and skillfulness and is used for children between 15 months and 18 years old.
Upper scores means better play skills, no cut-off score.
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before the session 1, after session 8, after session 16, each time 10 to 20 minutes.
|
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The Child Initiated Pretend Play Assessment (ChIPPA-2)
Time Frame: before the session 1, after session 8, after session 16, each time 18 minutes for 3 years old children and 30 minutes for 4-8 years old children.
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The Child Initiated Pretend Play Assessment (ChIPPA-2) provides a play tool pack consisting of two different sets: conventional and symbolic play tools.
Percentage of Elaborated Play Actions (PEPA), Number of Object Substitutions (NOS), and Number of Imitations (NIA) are reported for conventional, symbolic, and general pretend play.
Higher PEPA and NOS and lower NIA scores show better play skills.
There are Z-scores for each age range that child can be compared with typically developed children.
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before the session 1, after session 8, after session 16, each time 18 minutes for 3 years old children and 30 minutes for 4-8 years old children.
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The Pretend Play Enjoyment-Developmental Checklist (PPE-DC)
Time Frame: before the session 1, after session 8, after session 16, each time almost 10 minutes for parents and 10 minutes for researcher.
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The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) measures play enjoyment and covers some aspects of pretend play, such as sequences, storytelling, playing with dolls, object substitution, roleplay, and social interaction, from parents and experts prospectives within two different scoresheets, items are defined for different developmental ages and by choosing one item, the play developmental age in each subcategory can be estimated.
Play enjoyment score is better when is higher.
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before the session 1, after session 8, after session 16, each time almost 10 minutes for parents and 10 minutes for researcher.
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Immune System Diseases
- Neoplasms by Histologic Type
- Hematologic Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Hemic and Lymphatic Diseases
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Organizations
- Health Care Economics and Organizations
- Congresses as Topic
Other Study ID Numbers
- HS26236(H2023:343)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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