Combined Movement and Storytelling Intervention on Physical Performance in Children
NCT ID: NCT06016296
Last Updated: 2024-08-09
Study Results
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Basic Information
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RECRUITING
NA
144 participants
INTERVENTIONAL
2024-03-14
2025-04-15
Brief Summary
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Detailed Description
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It is expected to recruit 12 children from each classes group (without distinction of sex). The distribution of the classes groups (12 classes group) will be in 3 experimental groups (6 classes group, n ± 72 children) and 3 control groups (6 classes group, n ± 72 children). The distribution by clusters or strata is justified by the fact that the use of individual randomization would imply a high probability of contaminating the control groups, since it is unfeasible to prohibit children interaction in classrooms or school recreational spaces (i.e., playgrounds, hallways, laboratories), which is where the study intervention will be carried out. The sample size calculation indicates that the ideal number of participants per group is 10. As agreed in a previous study, a mean difference of 3.22 total score of locomotor skills domains was used for this calculation as the minimum difference necessary for substantial clinical relevance, with a standard deviation of 0.70 points, considering an alpha level of 0.05 with a power of 80% and an expected loss of 15%. The GPower program (version 3.1.9.6, Franz Faul, Universiät Kiel, Kiel, Germany) will be used to calculate the statistical power.
The 12 classes group will be selected in 4 upper middle level classes (2 experimental and 2 control; age range between 3 to 4 years), 4 transition level 1 classes (2 experimental and 2 control; age range between 4 to 5 years) and 4 transition level 2 classes (2 experimental and 2 control; age range between 5 to 6 years), which will be randomized by stratified sampling, which consists of segmenting the classes that agreed to participate in the study according to educational levels (strata) and then performing a random sampling on each one of them, using R statistical software, version 4.1.2. This study is considered double-blind because the measurements will be performed by professionals external to the research.
The investigators estimate the participation of 144 children residing in the Maule region, Chile who meet the following inclusion criteria: (i) be enrolled in the educational center (school, college or kindergarten) that commits to participate in the intervention; (ii) age range between 3 to 6 years old; (iii) attend ≥ 85% of the sessions scheduled for the combined movement and storytelling intervention (CMSI). As for the exclusion criteria, will be the following: (i) children with musculoskeletal injuries or medical contraindications (i.e., congenital heart disease, fever, diarrhea or general malaise) that would prevent their normal performance in the assessments and intervention and; (ii) children with permanent educational needs mentioned in Decree Nº83 of the Chilean Ministry of Education, such as, visual, hearing, intellectual or multiple disabilities, dysphasia or autistic disorder.
The current protocol has been reviewed and approved by the Scientific Ethics Committee of the Universidad Católica del Maule, Chile (approval number: N°105/2021, 04 August 2021) and developed following the Declaration of Helsinki for work with human beings.
Before starting the intervention, during the last week of March 2024 (for two weeks), children will be evaluated in the variables considered for the research, later, from the third week of March to the first week of June 2024 (12 weeks) will participate in CMSI. After the intervention (second week of June 2024), for two weeks, the children will undergo the same initial assessments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Upper middle level experimental groups
The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (upper middle). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
Combined Movement and Storytelling Intervention
The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.
Upper middle level control groups
The upper middle level control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
No interventions assigned to this group
Transition level 1 experimental groups
The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 1). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
Combined Movement and Storytelling Intervention
The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.
Transition level 1 control groups
The transition level 1 control groups (n= 2 classes; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
No interventions assigned to this group
Transition level 2 experimental groups
The intervention will be implemented by early childhood educators, who will be previously trained in Combined Movement and Storytelling Intervention (CMSI). Each session will take place in the classroom where the preschoolers usually attend, which will depend on the admission policies of each educational community regarding to level classes (transition level 2). The intervention will last 12 weeks (36 sessions), distributed in 3 weekly sessions (Monday, Wednesday and Friday) of 40 minutes per session. The CMSI is based on 2 previous studies, and a book related to CMSI. Twelve unpublished motor stories were elaborated, of which one per week will be executed distributed in 3 sessions per week with the corresponding progressions for each session carried out, placing the children in a sequence of stories that begin with the presentation of a motivating character that will accompany children's in the development of the whole story.
Combined Movement and Storytelling Intervention
The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.
Transition level 2 control groups
The transition level 2 control groups (n= 2; n= 24 children) will participate in the assessments (initial and final) and will be asked to maintain their regular session of their educational establishments. At the end of the intervention period (according to the results obtained), the control groups children, parents and/or legal guardians, managers and coordinators of each community will be contacted and provided with the material so that they can replicate the experience. In addition, the educators of these establishments (teachers and classroom assistants) will be trained in the CMSI strategy.
No interventions assigned to this group
Interventions
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Combined Movement and Storytelling Intervention
The 40-minute sessions will include three moments: (i) warm-up (5 minutes), which consists of joint mobility exercises and introduction to the motor story of the week; (ii) main part (25 minutes), which incorporates the narration of the motor story by the educator initially, as well as the participation of the children, through their own corporeality with movements based mainly on FMS (locomotion skills and object control) and two way verbal interaction based on questions allusive to the narration delivered by the educator or direct verbal participation cast by each child and; (iii) cool down (10 minutes), where space is provided for the children to gradually return to calm, together with feedback on the contents addressed during the session.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age range between 3 to 6 years old.
* Attend ≥ 85% of the sessions scheduled for the CMSI.
Exclusion Criteria
* Children with permanent educational needs mentioned in Decree Nº83 of the Chilean Ministry of Education, such as, visual, hearing, intellectual or multiple disabilities, dysphasia or autistic disorder.
3 Years
6 Years
ALL
Yes
Sponsors
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Universidad Católica del Maule
OTHER
Responsible Party
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Pablo Valdés-Badilla
Academic-Researcher of Department of Physical Activity Sciences
Principal Investigators
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Pablo Valdés-Badilla, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad Católica del Maule
Locations
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Poliderportivo San Clemente
San Clemente, Maule Region, Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Related Links
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Chilean Ministry of Education. Diversificacion de la enseñanza
Test of gross motor development-2
Prueba de Desarrollo del Lenguaje para Pre-Escolares TELEPRE 1
Other Identifiers
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105/2021
Identifier Type: -
Identifier Source: org_study_id
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