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Combined Movement and Storytelling Intervention on Physical Performance in Children (CMSI&Child)

U

Universidad Católica del Maule

Status

Enrolling

Conditions

Preschool Children

Treatments

Other: Combined Movement and Storytelling Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT06016296
105/2021

Details and patient eligibility

About

This study protocol aims to analyze and compare the effects of combined movement and storytelling intervention (CMSI) on fundamental motor skills (locomotor skills and object control), language development (language comprehension, language expression, vocabulary and language description), and physical activity levels (light, moderate to vigorous intensity, and sedentary time) in children aged 3 to 6 years. The sample will consist of 144 children of 12 classes group, randomly assigned to 3 experimental groups (n= 72 children) and 3 control groups (n= 72 children), belonging to 4 classes group of upper middle level classes (2 experimental and 2 control), 4 transition level 1 classes (2 experimental and 2 control) and 4 transition level 2 classes (2 experimental and 2 control). The experimental groups will perform the CMSI for 3 sessions (40-minute per session) per week over 12-weeks (using one motor story per week), while the control groups will not receive any treatment. The main outcome will provide information about fundamental motor skills, language development, and physical activity levels. It is hypothesized that the CMSI has the potential to generate significant increases in selected assessments. If this intervention proves to be beneficial, if could contribute to preschoolers children curricula.

Full description

The study includes an experimental design (randomized controlled trial), double-blind, repeated measures and parallel groups (6 interventions and 6 controls) considering previous studies and a quantitative approach. The methodology followed will be the Consolidated Standards of Reporting Trials Statement (CONSORT) methodology.

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.

Enrollment

144 estimated patients

Sex

All

Ages

3 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Be enrolled in the educational center (school, college or kindergarten) that commits to participate in the intervention.
  • Age range between 3 to 6 years old.
  • Attend ≥ 85% of the sessions scheduled for the CMSI.

Exclusion criteria

  • 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.
  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

144 participants in 6 patient groups

Upper middle level experimental groups
Experimental group
Description:
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.
Treatment:
Other: Combined Movement and Storytelling Intervention
Upper middle level control groups
No Intervention group
Description:
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.
Transition level 1 experimental groups
Experimental group
Description:
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.
Treatment:
Other: Combined Movement and Storytelling Intervention
Transition level 1 control groups
No Intervention group
Description:
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.
Transition level 2 experimental groups
Experimental group
Description:
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.
Treatment:
Other: Combined Movement and Storytelling Intervention
Transition level 2 control groups
No Intervention group
Description:
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.

Trial contacts and locations

1

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Central trial contact

Pablo Valdés-Badilla, PhD; Rodrigo Vargas-Vitoria, PhD

Data sourced from clinicaltrials.gov

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