NCT06304454

Brief 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). 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

February 29, 2024

Last Update Submit

March 8, 2024

Conditions

Keywords

Cognitive changeEmotional changeChild developmentKindergarten

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline and Post-intervention (after 5 weeks)

Secondary Outcomes (2)

  • Hollingshead Index (Hollingshead, 1975)

    Baseline

  • CHEXI (Giménez et al. 2022)

    Baseline and Post-intervention (after 5 weeks)

Study Arms (2)

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.

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.

Other: Board game intervention

Interventions

5 weeks / 2 sessions each week / 1 hour each session

Cognitive and emotional board gamesMotor/Luck board games

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Sensory/comprehension difficulties that make it impossible to carry out the program activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Education, Psychology and Social Work; University of Lleida

Lleida, 25001, Spain

Location

Related Publications (6)

  • 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.

    PMID: 25366543BACKGROUND
  • Passolunghi 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.

    PMID: 25818537BACKGROUND
  • Giménez, A., López-Zamora, M., Vila, O., Sánchez, A., & Thorell, L. B. (2022). Fiabilidad y validez de la versión española del

    BACKGROUND
  • 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

    BACKGROUND
  • Korkman, M., Kirk, U., & Kemp, S. (2007). NEPSY-II (2nd Ed.). San Antonio: Pearson PsychCorp.

    BACKGROUND
  • Wechsler, D. (2014). WPPSI-IV, Escala de Inteligencia de Wechsler para preescolar y primaria (4th Ed.). Madrid/Barcelona: Pearson Clinical Assessment Spain.

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double (outcomes assessor and participants)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster RCT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 12, 2024

Study Start

January 15, 2024

Primary Completion

February 29, 2024

Study Completion

March 15, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations