Embodied learning-based phonemic training to improve executive functions
| ISRCTN | ISRCTN16516721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16516721 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Universidad Autonoma de Manizales |
| Funder | Ministerio de Ciencia, Tecnología e Innovación |
- Submission date
- 25/12/2024
- Registration date
- 31/12/2024
- Last edited
- 25/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study explores how combining body movements with learning sounds of words (called FONEMACOR) can improve thinking skills in preschool children. The goal is to see if this method helps with skills like self-control and flexible thinking in children aged 5 to 6 years.
Who can participate?
Children aged 5 to 6 years can participate in this study.
What does the study involve?
Participants will be divided into three groups:
The first group will learn to recognize and manipulate sounds in words while doing physical activities like running, jumping, and throwing.
The second group will learn the same sound tasks but with minimal movement, mostly sitting and using printed materials.
The third group will continue with their usual classroom activities, which involve minimal movement.
The study will last for 8 weeks, with measurements taken before and after to see the effects.
What are the possible benefits and risks of participating?
Benefits may include improved thinking skills, self-control, and flexible thinking. There are no significant risks expected from participating in this study.
Where is the study run from?
Universidad Autónoma de Manizales (Colombia)
When is the study starting and how long is it expected to run for?
March 2023 to March 2025
Who is funding the study?
Ministerio de Ciencia y Tecnología - Minciencias (Colombia)
Who is the main contact?
Piedad Rocío Lerma Castaño, piedad.lermac@autonoma.edu.co
Contact information
Public, Scientific, Principal investigator
Calle 21 # 28-b15 Barrio tenerife
Neiva
410001
Colombia
 ORCID ID |
0000-0002-9546-8436 |
|---|---|
| Phone | +57 (0)3215470008 |
| piedad.lermac@autonoma.edu.co |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Participant information sheet | 46611 PIS (Spanish).pdf |
| Scientific title | Effect of phonemic awareness training based on embodied learning (FONEMACOR) on inhibitory control and cognitive flexibility in children 5 to 6 years old |
| Study acronym | FONEMACOR |
| Study objectives | There are significant differences in inhibitory control and cognitive flexibility in the groups of children aged 5 to 6 years who receive a phonemic awareness training program based on embodied learning (FONEMACOR) and those of the same age who receive training without embodied learning. |
| Ethics approval(s) |
Approved 22/05/2024, Research Ethics, Bioethics and Scientific Integrity Committee Scientific CEIBIC-UAM (Antigua Estación del Ferrocarril, Manizales, 170001, Colombia; +57 (0)(6)8727272 ext 105; comitedebioeticauam@autonoma.edu.co), ref: Acta No. 172 de 2024 - 225-172 |
| Health condition(s) or problem(s) studied | Executive functions in typically developing children 5 to 6 years of age |
| Intervention | Experimental Group 1: Children will receive embodied learning-based training consisting of teaching phonemic awareness tasks (identify phonemes, skip phonemes, segment words into phonemes, synthesize phonemes and substitute phonemes) based on the CONCRES training designed and validated by Bertel and Suarez, 2023 that will include the combination of movements of fundamental motor skills such as throwing, catching, kicking, dribbling, hitting, walking, running, jumping, hopping called FONEMACOR. The training consists of 24 sessions of 60 minutes during 8 weeks. Experimental Group 2: CONCRES training with an emphasis on Phonological Awareness designed and validated by (Bertel and Suarez, 2023) consists of teaching phonemic awareness tasks (identify phonemes, omit phonemes, segment words into phonemes, synthesize phonemes and substitute phonemes) teaching that involves minimal movements, i.e., sitting in a chair with print letters, sheets, etc. Control Group: Classroom project applied in the institution (teaching involving minimal motor movements (i.e., sitting in a chair with paper and pencil). Randomization method: Simple randomization, groups will be matched for sex, age and IQ. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Inhibitory Control is measured using the Flanker Inhibitory Control and Attention task from the NIH Toolbox at baseline and at the end of the intervention at 9 weeks. |
| Key secondary outcome measure(s) |
1. Variable Phonemic awareness measured with the test for the evaluation of phonological knowledge of syllabic and phonemic type (PECO) Ramos and Cuadrado (2019) at baseline and at the end of the intervention at 9 weeks. |
| Completion date | 21/03/2025 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 6 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Total final enrolment | 72 |
| Key inclusion criteria | 1. Children with typical development 2. Be in good health conditions to participate in physical activities that will be performed during the study 3. Children between 5 and 6 years of age who are enrolled in preschool 4. Children with normal hearing screening |
| Key exclusion criteria | 1. Children diagnosed with neurological disorders and neuromotor disorders 2. Children with psychiatric disorders 3. Children with speech sound or language development disorders 4. Children with phonological language problems |
| Date of first enrolment | 30/06/2024 |
| Date of final enrolment | 30/07/2024 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Neiva Huila
410003
Colombia
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Piedad Rocío Lerma Castaño (piedadlermac@autonoma.edu.co) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | in Spanish version 1 |
04/06/2015 | 31/12/2024 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- 46611 PIS (Spanish).pdf
- in Spanish
Editorial Notes
25/03/2025: The overall study end date was changed from 31/03/2025 to 21/03/2025.
27/12/2024: Study's existence confirmed by the Research Ethics, Bioethics and Scientific Integrity Committee Scientific CEIBIC-UAM.
