Play and Pre-Literacy Among Young Children (PLAY)

March 21, 2017 updated by: John Cairney, McMaster University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8H 4L8
        • Boys and Girls Club of Hamilton
      • Hamilton, Ontario, Canada, L8P 0A1
        • McMaster Innovation Park

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Motor and pre-literacy program
First group to receive the motor and pre-literacy program.
Behavioral: Motor and pre-literacy program
The program will run for 60 minutes once per week for 10 consecutive weeks and will consist of three components: direct FMS instruction, unstructured exploratory free-play, and an interactive storybook reading activity. The curriculum and teaching strategies to be used for the first two segments of our intervention have been successfully implemented in previous research to improve the motor skills of 4 year old children with autism (Bremer, Balogh, & Lloyd, 2014). Specific strategies and books were selected from an existing evidence-based curriculum (Justice & McGuinty, 2009). There will be active involvement of at least one parent in the direct instruction and reading components.
Active Comparator: Wait-list comparison
Second group to receive the motor and pre-literacy program after the experimental arm has completed the program.
Other: Wait-list Comparison
The participants will not participate in the motor and pre-literacy program for 10 weeks after enrollment and will continue with their normal daily life without any intervention. After the experimental arm completes the motor and pre-literacy program, the wait-list group will receive the exact same motor and pre-literacy intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
Time Frame: Baseline and 11-12 weeks
Baseline and 11-12 weeks
Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 11-12 weeks
Time Frame: Baseline and 11-12 weeks
Baseline and 11-12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Peabody Developmental Motor Scales-2 at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 11-12 weeks
Time Frame: Baseline and 11-12 weeks.
Baseline and 11-12 weeks.
Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Parent-reported measure of executive function
Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 11-12 weeks
Time Frame: Baseline and 11-12 weeks.
Parent-reported measure of executive function
Baseline and 11-12 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
Time Frame: Baseline and 15-16 weeks.
Parent-reported measure of social skills and behavioral problems
Baseline and 15-16 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 11-12 weeks
Time Frame: Baseline and 11-12 weeks.
Parent-reported measure of social skills and behavioral problems
Baseline and 11-12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 24, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • INCH-0415

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.

Clinical Trials on Child Development

Clinical Trials on Motor and pre-literacy program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe