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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06319430
Other study ID # HS26236(H2023:343)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 1, 2024
Est. completion date May 28, 2025

Study information

Verified date April 2024
Source University of Manitoba
Contact Minoo Dabiri Golchin, Ph.D.
Phone 204-789-3897
Email Minoo.DabiriGolchin@umanitoba.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 kids 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.


Description:

The study is designed in three phases, employing a mixed-method approach that integrates qualitative and quantitative methods. Phase 1 involves exploring the alignment of the Dice Model of Play with the experiences of 10 children (aged 3-8, diagnosed with physical disabilities) and their guardians through semi-structured interviews and content analysis; Phase 2 examines the practical application of the model with a cross-over design. Ten children will build their Lego robots within a co-design and will play with that robot for eight sessions. The other group will play with conventional toys for eight sessions. They will switch after finishing those sessions. Sessions will be directed by a master of occupational therapy student supervised by Dr. Jacquie Ripat, a registered occupational therapist in Manitoba. Assessments will be Test of Playfulness (TOP), enjoyment (PPE_DC), and play skills (ChIPPA-2) three times at the start, switching point, and last session. A go-along interview will be conducted in the co-design. Lastly, Phase 3 seeks expert opinions on the revised Dice Model of Play's clarity, relevance, and applicability, using online focus groups with professionals in occupational therapy, psychology, and computer science. The study aims to modify and enhance the model based on the findings from these phases.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date May 28, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 3 Years to 8 Years
Eligibility Inclusion Criteria: - Having a physical disability - Between 3 to 8 years old - Speaking and understanding English - Living in Winnipeg Exclusion Criteria: - primarily neuro-cognitive symptoms such as Autism, and receiving play therapy within the last three months

Study Design


Related Conditions & MeSH terms


Intervention

Other:
robots
LEGO robots with adaptation according to child's age and developmental skills.
conventional
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Manitoba Rehabilitation Centre for Children, Canada

Outcome

Type Measure Description Time frame Safety issue
Primary Test of Playfulness 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. before the session 1, after session 8, after session 16, each time 10 to 20 minutes.
Primary The Child Initiated Pretend Play Assessment (ChIPPA-2) 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. 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.
Primary The Pretend Play Enjoyment-Developmental Checklist (PPE-DC) 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. 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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