NCT02432443

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
28 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

April 24, 2015

Last Update Submit

March 21, 2017

Conditions

Keywords

Motor SkillsPre-literacy SkillsEarly Intervention

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Peabody Developmental Motor Scales-2 at 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

    Baseline and 11-12 weeks

Secondary Outcomes (9)

  • Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks

    Baseline and 15-16 weeks.

  • Change from baseline in Peabody Developmental Motor Scales-2 at 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

    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

    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

    Baseline and 15-16 weeks.

  • +4 more secondary outcomes

Study Arms (2)

Motor and pre-literacy program

EXPERIMENTAL

First group to receive the motor and pre-literacy program.

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.

Other: Wait-list Comparison

Interventions

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.

Motor and pre-literacy program

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.

Wait-list comparison

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • typical development

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Boys and Girls Club of Hamilton

Hamilton, Ontario, L8H 4L8, Canada

Location

McMaster Innovation Park

Hamilton, Ontario, L8P 0A1, Canada

Location

Related Publications (17)

  • 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

    BACKGROUND
  • 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.

    PMID: 25432505BACKGROUND
  • Clark 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
  • 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.

    PMID: 10836557BACKGROUND
  • Folio MR, Fewell RR. Peabody Developmental Motor Scales--2nd Edition. 1974

    BACKGROUND
  • Gioia G, Espy KA, Isquith PK. Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P). Odessa, FL: Psychological Assessment Resources; 2005.

    BACKGROUND
  • Gresham FM, Elliott SN. Social Skills Improvement System-Rating Scales. Minneapolis, MN: Pearson Assessments; 2008.

    BACKGROUND
  • Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.

    PMID: 6525886BACKGROUND
  • Invernizzi MA, Sullivan A, Meier JD, Swank L. Phonological Awareness Literacy Screening: Preschool Charlottesville, VA: University of Virginia; 2004.

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 20096145BACKGROUND
  • Justice 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 21880055BACKGROUND
  • National 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/

    PMID: 25077268BACKGROUND
  • 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.

  • 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.

Study Officials

  • John Cairney, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 4, 2015

Study Start

June 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations