- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02432443
Play and Pre-Literacy Among Young Children (PLAY)
21 mars 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
53
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8H 4L8
- Boys and Girls Club of Hamilton
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Hamilton, Ontario, Canada, L8P 0A1
- McMaster Innovation Park
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 ans à 4 ans (Enfant)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La 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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Motor and pre-literacy program
First group to receive the motor and pre-literacy program.
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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.
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Comparateur actif: Wait-list comparison
Second group to receive the motor and pre-literacy program after the experimental arm has completed the program.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change from baseline in Peabody Developmental Motor Scales-2 at 11-12 weeks
Délai: Baseline and 11-12 weeks
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Baseline and 11-12 weeks
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Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 11-12 weeks
Délai: Baseline and 11-12 weeks
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Baseline and 11-12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from baseline in parental engagement in motor and pre-literacy activities at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Baseline and 15-16 weeks.
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Change from baseline in Peabody Developmental Motor Scales-2 at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Baseline and 15-16 weeks.
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Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Baseline and 15-16 weeks.
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Change from baseline in Pictorial Scale of Perceived Competence and Social Acceptance for Young Children (Preschool-Kindergarten version) scale at 11-12 weeks
Délai: Baseline and 11-12 weeks.
|
Baseline and 11-12 weeks.
|
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Change from baseline in pre-literacy skills (Phonological Awareness Literacy Screening: Preschool and Preschool Word and Print Awareness Test) at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Baseline and 15-16 weeks.
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Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Parent-reported measure of executive function
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Baseline and 15-16 weeks.
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Change from baseline in Behavior Rating Inventory of Executive Function®-Preschool Version (BRIEF®-P) scale at 11-12 weeks
Délai: Baseline and 11-12 weeks.
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Parent-reported measure of executive function
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Baseline and 11-12 weeks.
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Change from baseline in Social Skills Improvement System (parent version) scale at 15-16 weeks
Délai: Baseline and 15-16 weeks.
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Parent-reported measure of social skills and behavioral problems
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Baseline and 15-16 weeks.
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Change from baseline in Social Skills Improvement System (parent version) scale at 11-12 weeks
Délai: Baseline and 11-12 weeks.
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Parent-reported measure of social skills and behavioral problems
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Baseline and 11-12 weeks.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Harter S, Pike R. The pictorial scale of perceived competence and social acceptance for young children. Child Dev. 1984 Dec;55(6):1969-82.
- 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/
- 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.
- 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
- 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.
- Folio 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.
- Invernizzi 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.
- 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
- 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.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2015
Achèvement primaire (Réel)
1 août 2016
Achèvement de l'étude (Réel)
1 août 2016
Dates d'inscription aux études
Première soumission
24 avril 2015
Première soumission répondant aux critères de contrôle qualité
28 avril 2015
Première publication (Estimation)
4 mai 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 mars 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 mars 2017
Dernière vérification
1 mars 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- INCH-0415
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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