Child DevelopmentPLAYNCT02432443
Play and Pre-Literacy Among Young Children
A study testing Motor and pre-literacy program and Wait-list Comparison in people with Child Development, run by McMaster University at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Motor and pre-literacy program and Wait-list Comparison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2015to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- typical development
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Boys and Girls Club of Hamilton
Hamilton, Ontario, L8H 4L8
McMaster Innovation Park
Hamilton, Ontario, L8P 0A1
About this study
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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Motor and pre-literacy program, Wait-list Comparison
- Keywords
- Motor Skills, Pre-literacy Skills, Early Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor and pre-literacy programBehavioural
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.
Wait-list ComparisonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Motor and pre-literacy program | Experimental | First group to receive the motor and pre-literacy program. Receives: Behavioral: Motor and pre-literacy program |
| Wait-list comparison | Active comparator | Second group to receive the motor and pre-literacy program after the experimental arm has completed the program. Receives: Other: Wait-list Comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
Measured: 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
Measured: Baseline and 11-12 weeks
Secondary outcomes (9)
Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
Measured: Baseline and 15-16 weeks.
Change from baseline in Peabody Developmental Motor Scales-2 at 15-16 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 15-16 weeks
Parent-reported measure of executive function
Measured: Baseline and 15-16 weeks.
Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 11-12 weeks
Parent-reported measure of executive function
Measured: Baseline and 11-12 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
Parent-reported measure of social skills and behavioral problems
Measured: Baseline and 15-16 weeks.
Change from baseline in Social Skills Improvement System (parent version) scale at 11-12 weeks
Parent-reported measure of social skills and behavioral problems
Measured: Baseline and 11-12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startJun 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Cairney, McMaster University
- Investigators
- John Cairney, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432443
- Sponsor's protocol ID
- INCH-0415
- Acronym
- PLAY
- Status last verified
- Mar 2017
- First submitted
- 24 Apr 2015
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Boethel M. Readiness: School, Family, & Community Connections. Annual Synthesis, 2004. Southwest Educational Development Laboratory [Internet]. 2004 [cited 2015 Feb2]. Available from: http://files.eric.ed.gov/fulltext/ED484507.pdf
Bremer E, Balogh R, Lloyd M. Effectiveness of a fundamental motor skill intervention for 4-year-old children with autism spectrum disorder: A pilot study. Autism. 2015 Nov;19(8):980-91. doi: 10.1177/1362361314557548. Epub 2014 Nov 28.
PubMed 25432505Clark JE From the beginning: a developmental perspective on movement and mobility. Quest [Internet]. 2005 [cited 2014 Dec 1]; 57(1):37-45. Available from: http://www.tandfonline.com/doi/pdf/10.1080/00336297.2005.10491841 DOI: 10.1080/00336297.2005.10491841
Diamond A. Close interrelation of motor development and cognitive development and of the cerebellum and prefrontal cortex. Child Dev. 2000 Jan-Feb;71(1):44-56. doi: 10.1111/1467-8624.00117.
PubMed 10836557Folio MR, Fewell RR. Peabody Developmental Motor Scales--2nd Edition. 1974
Gioia G, Espy KA, Isquith PK. Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P). Odessa, FL: Psychological Assessment Resources; 2005.
Gresham FM, Elliott SN. Social Skills Improvement System-Rating Scales. Minneapolis, MN: Pearson Assessments; 2008.
Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
PubMed 6525886Invernizzi MA, Sullivan A, Meier JD, Swank L. Phonological Awareness Literacy Screening: Preschool Charlottesville, VA: University of Virginia; 2004.
Isenberg JP, Quisenberry N. A position paper of the Association for Childhood Education International PLAY: Essential for all Children. Childhood Education [Internet] 2002 [cited 2015 Feb 22];79(1):33-39. Available from: http://www.tandfonline.com/doi/pdf/10.1080/00094056.2002.10522763
Iverson JM. Developing language in a developing body: the relationship between motor development and language development. J Child Lang. 2010 Mar;37(2):229-61. doi: 10.1017/S0305000909990432. Epub 2010 Jan 25.
PubMed 20096145Justice LM, Ezell HK. Word and print awareness in 4-year old children. Child Language Teaching and Therapy [Internet] 2001 October [cited 2015 Apr 2];17(3): 207-225. Available from: http://clt.sagepub.com/content/17/3/207.full.pdf+html
Justice LM, McGuinty AS. Read It Again-PreK!A Preschool Curriculum Supplement to Promote Language and Literacy Foundations. [Internet] 2009 [cited 2014 Oct 20]. Available from: http://arts-sciences.und.edu/communication-sciences-disorders/_files/docs/readitagain-prekmanual.pdf
Logan SW, Robinson LE, Wilson AE, Lucas WA. Getting the fundamentals of movement: a meta-analysis of the effectiveness of motor skill interventions in children. Child Care Health Dev. 2012 May;38(3):305-15. doi: 10.1111/j.1365-2214.2011.01307.x. Epub 2011 Sep 1.
PubMed 21880055National Research Council (US) and Institute of Medicine (US) Committee on Integrating the Science of Early Childhood Development; Shonkoff JP, Phillips DA, editors. From Neurons to Neighborhoods: The Science of Early Childhood Development. Washington (DC): National Academies Press (US); 2000. Available from http://www.ncbi.nlm.nih.gov/books/NBK225557/
PubMed 25077268
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Play and Pre-Literacy Among Young Children
- ClinicalTrials.gov ID
- NCT02432443
- Acronym / sponsor ID
- PLAY / INCH-0415
- Conditions
- Child Development
- Keywords
- Motor Skills, Pre-literacy Skills, Early Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor and pre-literacy program | Experimental | Behavioral: Motor and pre-literacy programFirst group to receive the motor and pre-literacy program. |
| Wait-list comparison | Active comparator | Other: Wait-list ComparisonSecond group to receive the motor and pre-literacy program after the experimental arm has completed the program. |
Who may qualify
- Ages
- 36 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- typical development
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor and pre-literacy programThe 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. | Behavioural | Motor and pre-literacy program |
| Wait-list ComparisonThe 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. | Other | Wait-list comparison |
Primary outcome
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
Time frame: 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
9 secondary outcomes
Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
Time frame: 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.
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.
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.
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.
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.
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.
Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- BackgroundBoethel M. Readiness: School, Family, & Community Connections. Annual Synthesis, 2004. Southwest Educational Development Laboratory [Internet]. 2004 [cited 2015 Feb2]. Available from: http://files.eric.ed.gov/fulltext/ED484507.pdf
- Background: PubMed 25432505Bremer E, Balogh R, Lloyd M. Effectiveness of a fundamental motor skill intervention for 4-year-old children with autism spectrum disorder: A pilot study. Autism. 2015 Nov;19(8):980-91. doi: 10.1177/1362361314557548. Epub 2014 Nov 28.
- BackgroundClark JE From the beginning: a developmental perspective on movement and mobility. Quest [Internet]. 2005 [cited 2014 Dec 1]; 57(1):37-45. Available from: http://www.tandfonline.com/doi/pdf/10.1080/00336297.2005.10491841 DOI: 10.1080/00336297.2005.10491841
- Background: PubMed 10836557Diamond A. Close interrelation of motor development and cognitive development and of the cerebellum and prefrontal cortex. Child Dev. 2000 Jan-Feb;71(1):44-56. doi: 10.1111/1467-8624.00117.
- BackgroundFolio MR, Fewell RR. Peabody Developmental Motor Scales--2nd Edition. 1974
- BackgroundGioia G, Espy KA, Isquith PK. Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P). Odessa, FL: Psychological Assessment Resources; 2005.
- BackgroundGresham FM, Elliott SN. Social Skills Improvement System-Rating Scales. Minneapolis, MN: Pearson Assessments; 2008.
- Background: PubMed 6525886Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
- BackgroundInvernizzi MA, Sullivan A, Meier JD, Swank L. Phonological Awareness Literacy Screening: Preschool Charlottesville, VA: University of Virginia; 2004.
- BackgroundIsenberg JP, Quisenberry N. A position paper of the Association for Childhood Education International PLAY: Essential for all Children. Childhood Education [Internet] 2002 [cited 2015 Feb 22];79(1):33-39. Available from: http://www.tandfonline.com/doi/pdf/10.1080/00094056.2002.10522763
- Background: PubMed 20096145Iverson JM. Developing language in a developing body: the relationship between motor development and language development. J Child Lang. 2010 Mar;37(2):229-61. doi: 10.1017/S0305000909990432. Epub 2010 Jan 25.
- BackgroundJustice LM, Ezell HK. Word and print awareness in 4-year old children. Child Language Teaching and Therapy [Internet] 2001 October [cited 2015 Apr 2];17(3): 207-225. Available from: http://clt.sagepub.com/content/17/3/207.full.pdf+html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Cairney, PhD principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor and pre-literacy program and Wait-list Comparison in people with Child Development, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks (time frame: Baseline and 11-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432443, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2017.