Clinical trial NCT02432443: Play and Pre-Literacy Among Young Children
Official title: Play and Pre-Literacy Among Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Motor Skills
Pre-literacy Skills
Early Intervention
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 53
Sex: ALL
Minimum age (years): 36
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Children begin to develop fundamental motor skills (FMS), such as running and kicking, and pre-literacy skills, such as rhyming, during early childhood. These skills are very important as they lay the foundation for more complex movements and literacy skill development later in life, support overall healthy development in several areas, and help contribute to the child's readiness for school. A child with strong motor skills is well equipped to lead a life with healthy levels of physical activity, positive social interactions, positive self-perceptions, and greater cognitive and language abilities. These skills will not develop optimally on their own so it is essential to teach, challenge, and reinforce them at an early age; often this learning takes place at home prior to entering school. Most research on this topic has primarily focused on school-aged children or children with specific developmental challenges and less is known about teaching motor and pre-literacy skills to young children and giving parents the tools to practice these skills at home with their children. The aim of the present study is to examine the effect of a motor and pre-literacy program, which emphasizes parental involvement, on motor, pre-literacy, social skills, cognitive abilities, and self-competence in 3 to 4 year old children with typical development.

Detailed description: The primary purpose of the intervention is to support the overall healthy development of children. Children will be recruited from families attending community agencies (e.g. Ontario Early Years Centres) in Hamilton. Interested parents will receive information flyers with the study team's contact information and instructions to contact the study team if they are interested in participating in the study. Interested parents will be screened for eligibility of their child. Information packages will be emailed or mailed to eligible families and will be followed-up with over the telephone in one week to obtain informed verbal consent. Baseline appointments will be booked for all eligible children. Informed written consent will be obtained at the baseline appointment before testing begins. Children will be randomized 1:1 to either the experimental or wait-list control group. Randomization will be completed using a computer algorithm. All children will be assessed pre- and post-program as well as at follow-up, 5 weeks after the completion of the program. Children in the wait-list control group will be assessed one additional time at baseline. The program will run for one hour per week for 10 consecutive weeks. Parents will be asked to complete a checklist each week indicating the number of times they practiced the activities at home. A sample size of 36 children is considered sufficient to provide 80% power to detect a medium effect size, with an alpha of 0.05. Eighteen children will be randomized to the experimental group and 18 children will be randomized to the wait-list control group.

Eligibility criteria: Inclusion Criteria:

* typical development

Exclusion Criteria:

* diagnosed with any developmental delay (e.g., autism, Developmental Coordination Disorder, etc.) or health conditions that may prohibit safe participation in the program (e.g., unstable heart condition).

Primary outcomes:
measure: Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
timeFrame: Baseline and 11-12 weeks
measure: Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 11-12 weeks
timeFrame: Baseline and 11-12 weeks
Secondary outcomes:
measure: Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Peabody Developmental Motor Scales-2 at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 11-12 weeks
timeFrame: Baseline and 11-12 weeks.
measure: Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 11-12 weeks
timeFrame: Baseline and 11-12 weeks.
measure: Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
timeFrame: Baseline and 15-16 weeks.
measure: Change from baseline in Social Skills Improvement System (parent version) scale at 11-12 weeks
timeFrame: Baseline and 11-12 weeks.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Boys and Girls Club of Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: McMaster Innovation Park
state: Ontario
Study officials:
affiliation: McMaster University
name: John Cairney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bedard C, Bremer E, Campbell W, Cairney J. Evaluation of a Direct-Instruction Intervention to Improve Movement and Preliteracy Skills among Young Children: A Within-Subject Repeated-Measures Design. Front Pediatr. 2018 Jan 17;5:298. doi: 10.3389/fped.2017.00298. eCollection 2017.
citation: Bedard C, Bremer E, Campbell W, Cairney J. A Quasi-Experimental Study of a Movement and Preliteracy Program for 3- and 4-Year-Old Children. Front Pediatr. 2017 May 1;5:94. doi: 10.3389/fped.2017.00094. eCollection 2017.