NCT06319430

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Feb 2025May 2026

First Submitted

Initial submission to the registry

February 21, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

February 6, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2026

Expected
Last Updated

May 5, 2026

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

February 21, 2024

Last Update Submit

April 28, 2026

Conditions

Keywords

play and playthingsAssistive technologyPediatric ALL

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

robots

EXPERIMENTAL

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).

Other: robots

conventional toys

EXPERIMENTAL

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.

Other: conventional

Interventions

robotsOTHER

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

robots

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.

conventional toys

Eligibility Criteria

Age3 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Having a disability or typically developed
  • Between 3 to 9 years old
  • Speaking and understanding English or Persian
  • Living in Winnipeg

You may not qualify if:

  • Not receiving play therapy within the last three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Centre for Children

Winnipeg, Manitoba, R3E 3G1, Canada

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Central Study Contacts

Minoo Dabiri Golchin, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: The primary purpose is validation of..........
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 20, 2024

Study Start

February 6, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

May 28, 2026

Last Updated

May 5, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations