Kindergarten ChildrenNCT06304454
Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes
A study testing Board game intervention in people with Kindergarten Children, run by Brain In Game scientific-technical service at 1 site in Spain.
Trial summary
Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Kindergarten Children
- What is being tested?
- Board game intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2024to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be enrolled in an ordinary educational center.
- To provide informed consent from both parents and the participant's agreement to participate in the study.
Who cannot join
- Sensory/comprehension difficulties that make it impossible to carry out the program activities.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Education, Psychology and Social Work; University of Lleida
Lleida, 25001
About this study
Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.
The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group.
Read the detailed description
The hypothesis from this study are: i) the experimental group will show a significantly greater improvement in the neuropsychological tasks that measure cognitive and emotional processes compared to the active control group after the intervention; ii) the experimental group will show a significantly greater improvement in the tests evaluated by their parents after the intervention compared to the active control group. All hypotheses will be controlled for age and socioeconomic status.
- Conditions
- Kindergarten Children
- Being tested
- Board game intervention
- Keywords
- Cognitive change, Emotional change, Child development, Kindergarten
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Board game interventionOther
5 weeks / 2 sessions each week / 1 hour each session
| Study group | Role | What they receive |
|---|---|---|
| Cognitive and emotional board games | Experimental | An experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers. Receives: Other: Board game intervention |
| Motor/Luck board games | Active comparator | A control group that will be on board games that do not directly activate cognitive and emotional processes. These games are classified as motor or luck board games. Receives: Other: Board game intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Memory
Change in visual memory from baseline to post intervention. The task to assess visual memory is the subtest Picture Memory from the WPPSI-IV. This subtest consists of the child viewing a stimulus page of pictures for a specified time and then to select those same pictures from the options given. When the response is correct was scored 1, and 0 when incorrect. The task finished when the child made 3 consecutive mistakes. The total score is the sum of scores on Items 1-35, which ranged from 0 to 35.
Measured: Baseline and Post-intervention (after 5 weeks)
Processing speed and inhibition
Change in processing speed and inhibition from baseline to post intervention. The task used to assess these outcomes is included in the neuropsychological battery NEPSY-II. The task Naming and Inhibition consists of two blocks: a series of white and black shapes (circles and squares) and a series of arrows with different directions (up and down). The first part of each block is the task of shape/direction naming (in this case, a child had to name the shapes/direction he/she saw) at a rapid pace and the inhibition task. The second part if the inhibition task, in which the child need to change the rule: if he/she saw a square, he/she was to say "circle " and so forth or if he/she saw an up direction, need to say down. Each task record the number of corrected/non-corrected mistakes and the amount of time the child spent doing each task.
Measured: Baseline and Post-intervention (after 5 weeks)
Affect recognition
Change in affect recognition from baseline to post intervention. This subtest from the NEPSY-II assesses a child's ability to recognize six different emotional expressions (happiness, sadness, anger, disgust, fear, and a neutral expression) from photographs of children's faces in different tasks (select two photographs with identical affect from 3 or 4; select one of the four photographs that depicted identical affect as a photograph at the top of a page in the stimulus book). When the response is correct was scored 1, and 0 when incorrect. The total score is the sum of scores on Items 1-25, which ranged from 0 to 25. This subtest also gave the total of incorrect responses for each emotion.
Measured: Baseline and Post-intervention (after 5 weeks)
Secondary outcomes (2)
Hollingshead Index (Hollingshead, 1975)
Sociodemographic data (age, sex, school year and socioeconomic status)
Measured: Baseline
CHEXI (Giménez et al. 2022)
Change in common behavioral executive functions from baseline to post intervention.
The test consists of 24 items with 5 response options ranging from 1 (Definitely not true) to 5 (Definitely true). Two factors have been considered: WM and Inhibition. In this study, responders are the parents of the children. Higher ratings mean poor executive functioning.
Measured: Baseline and Post-intervention (after 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Jan 2024
- Primary completion29 Feb 2024
- Study completion15 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kindergarten ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster RCT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain In Game scientific-technical service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304454
- Sponsor's protocol ID
- P5_BG
- Status last verified
- Mar 2024
- First submitted
- 29 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Passolunghi MC, Costa HM. Working memory and early numeracy training in preschool children. Child Neuropsychol. 2016;22(1):81-98. doi: 10.1080/09297049.2014.971726. Epub 2014 Nov 4.
PubMed 25366543Passolunghi MC, Lanfranchi S, Altoe G, Sollazzo N. Early numerical abilities and cognitive skills in kindergarten children. J Exp Child Psychol. 2015 Jul;135:25-42. doi: 10.1016/j.jecp.2015.02.001. Epub 2015 Mar 25.
PubMed 25818537Giménez, A., López-Zamora, M., Vila, O., Sánchez, A., & Thorell, L. B. (2022). Fiabilidad y validez de la versión española del
Hollingshead, A. B. (1975). Four factor index of social status. Retrieved from: https://sociology.yale.edu/sites/default/files/files/yjs_fall_2011.pdf#page=21
Korkman, M., Kirk, U., & Kemp, S. (2007). NEPSY-II (2nd Ed.). San Antonio: Pearson PsychCorp.
Wechsler, D. (2014). WPPSI-IV, Escala de Inteligencia de Wechsler para preescolar y primaria (4th Ed.). Madrid/Barcelona: Pearson Clinical Assessment Spain.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Board Games at Kindergarten (5 Years Old) to Improve Cognitive and Emotional Processes
- ClinicalTrials.gov ID
- NCT06304454
- Acronym / sponsor ID
- P5_BG
- Conditions
- Kindergarten Children
- Keywords
- Cognitive change, Emotional change, Child development, Kindergarten
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brain In Game scientific-technical serviceUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive (i.e. executive functions, memory) and socio-emotional (i.e. affection recognition) processes emerges at first years. These processes have been frequently related to adequate academic performance in the scientific literature (Passolunghi et al, 2015). Current research aimed at training cognitive processes found promising results using board game as a cognitive tool in children (Passolunghi \& Costa, 2016). Considering the growing interest of teachers in this playful and possibly educational, cognitive and socio-emotional resource, a game program for these purposes has been designed to be used in kindergarten classrooms.
The main aim of the present study is to test the efficacy of a cognitive and emotional training program in the classroom based on board games in kindergarten students (5 years old). For this, there will be an experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers, and a control group that will be on board games that do not directly activate cognitive and emotional processes. At the end of the interventions, the groups will be compensated by carrying out inversely both board game programs. The classes will be randomly assigned to an experimental group and a passive control group.
Detailed description
The hypothesis from this study are: i) the experimental group will show a significantly greater improvement in the neuropsychological tasks that measure cognitive and emotional processes compared to the active control group after the intervention; ii) the experimental group will show a significantly greater improvement in the tests evaluated by their parents after the intervention compared to the active control group. All hypotheses will be controlled for age and socioeconomic status.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster RCT
| Arm | Type | Receives |
|---|---|---|
| Cognitive and emotional board games | Experimental | Other: Board game interventionAn experimental group that will carry out the cognitive and emotional game program in the classroom implemented by the teachers of the participating centers. |
| Motor/Luck board games | Active comparator | Other: Board game interventionA control group that will be on board games that do not directly activate cognitive and emotional processes. These games are classified as motor or luck board games. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- To be enrolled in an ordinary educational center.
- To provide informed consent from both parents and the participant's agreement to participate in the study.
Key exclusion criteria (1 listed)
- Sensory/comprehension difficulties that make it impossible to carry out the program activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Board game intervention5 weeks / 2 sessions each week / 1 hour each session | Other | Cognitive and emotional board games, Motor/Luck board games |
Primary outcome
Visual Memory
Time frame: Baseline and Post-intervention (after 5 weeks)
Change in visual memory from baseline to post intervention. The task to assess visual memory is the subtest Picture Memory from the WPPSI-IV. This subtest consists of the child viewing a stimulus page of pictures for a specified time and then to select those same pictures from the options given. When the response is correct was scored 1, and 0 when incorrect. The task finished when the child made 3 consecutive mistakes. The total score is the sum of scores on Items 1-35, which ranged from 0 to 35.
Processing speed and inhibition
Time frame: Baseline and Post-intervention (after 5 weeks)
Change in processing speed and inhibition from baseline to post intervention. The task used to assess these outcomes is included in the neuropsychological battery NEPSY-II. The task Naming and Inhibition consists of two blocks: a series of white and black shapes (circles and squares) and a series of arrows with different directions (up and down). The first part of each block is the task of shape/direction naming (in this case, a child had to name the shapes/direction he/she saw) at a rapid pace and the inhibition task. The second part if the inhibition task, in which the child need to change the rule: if he/she saw a square, he/she was to say "circle " and so forth or if he/she saw an up direction, need to say down. Each task record the number of corrected/non-corrected mistakes and the amount of time the child spent doing each task.
Affect recognition
Time frame: Baseline and Post-intervention (after 5 weeks)
Change in affect recognition from baseline to post intervention. This subtest from the NEPSY-II assesses a child's ability to recognize six different emotional expressions (happiness, sadness, anger, disgust, fear, and a neutral expression) from photographs of children's faces in different tasks (select two photographs with identical affect from 3 or 4; select one of the four photographs that depicted identical affect as a photograph at the top of a page in the stimulus book). When the response is correct was scored 1, and 0 when incorrect. The total score is the sum of scores on Items 1-25, which ranged from 0 to 25. This subtest also gave the total of incorrect responses for each emotion.
2 secondary outcomes
Hollingshead Index (Hollingshead, 1975)
Time frame: Baseline
CHEXI (Giménez et al. 2022)
Time frame: Baseline and Post-intervention (after 5 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 25366543Passolunghi MC, Costa HM. Working memory and early numeracy training in preschool children. Child Neuropsychol. 2016;22(1):81-98. doi: 10.1080/09297049.2014.971726. Epub 2014 Nov 4.
- Background: PubMed 25818537Passolunghi MC, Lanfranchi S, Altoe G, Sollazzo N. Early numerical abilities and cognitive skills in kindergarten children. J Exp Child Psychol. 2015 Jul;135:25-42. doi: 10.1016/j.jecp.2015.02.001. Epub 2015 Mar 25.
- BackgroundGiménez, A., López-Zamora, M., Vila, O., Sánchez, A., & Thorell, L. B. (2022). Fiabilidad y validez de la versión española del
- BackgroundHollingshead, A. B. (1975). Four factor index of social status. Retrieved from: https://sociology.yale.edu/sites/default/files/files/yjs_fall_2011.pdf#page=21
- BackgroundKorkman, M., Kirk, U., & Kemp, S. (2007). NEPSY-II (2nd Ed.). San Antonio: Pearson PsychCorp.
- BackgroundWechsler, D. (2014). WPPSI-IV, Escala de Inteligencia de Wechsler para preescolar y primaria (4th Ed.). Madrid/Barcelona: Pearson Clinical Assessment Spain.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Board game intervention in people with Kindergarten Children, run by Brain In Game scientific-technical service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Memory (time frame: Baseline and Post-intervention (after 5 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304454, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.