NCT04823338

Brief Summary

Good development of executive functions at school has been related to a better adaptation of children in different areas of their daily life and, especially, with adequate academic performance. Taking into account the importance of play in childhood, some interventions aimed at training these cognitive processes have been based on the use of playful elements, such as modern board games. Although it is still an unexplored field of research, some studies with older elementary school children and with ADHD children have found significant improvements in executive functions after training that had the board game as a key intervention element. However, we still do not have studies that have explored the possible cognitive benefits of its use throughout the primary stage with the general population. For this reason, the main objective of this study is to test the effectiveness of a cognitive training program based on modern board games in primary education children (6 to 12 years old).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 16, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

March 23, 2021

Last Update Submit

October 8, 2021

Conditions

Keywords

executive functionmodern board and card gamescognitive trainingschool-age children

Outcome Measures

Primary Outcomes (6)

  • Change in verbal updating from baseline to post intervention

    Verbal keep track task (Tamnes et al., 2010)

    Baseline and post intervention (after 6 weeks)

  • Change in visuospatial updating from baseline to post intervention

    Visuospatial keep track task (Tamnes et al., 2010)

    Baseline and post intervention (after 6 weeks)

  • Change in inhibition from baseline to post intervention

    5 digits test (Sedó, 2004)

    Baseline and post intervention (after 6 weeks)

  • Change in cognitive flexibility from baseline to post intervention

    5 digits test (Sedó, 2004)

    Baseline and post intervention (after 6 weeks)

  • Change in reasoning from baseline to post intervention

    TONI-4 (Ruíz-Fernández, 2019)

    Baseline and post intervention (after 6 weeks)

  • Change in verbal fluency from baseline to post intervention

    Phonological and semantic fluency (letter M and animals, ENFEN, Portellano \& Martínez-Arias, R. Zumárraga, 2009)

    Baseline and post intervention (after 6 weeks)

Secondary Outcomes (2)

  • Change in behavioral executive functions from baseline to post intervention

    Baseline and post intervention (after 6 weeks)

  • Change in emotional and behavioral problems from baseline to post intervention

    Baseline and post intervention (after 6 weeks)

Other Outcomes (4)

  • Time spent on less-structured activities

    Baseline

  • Player satisfaction

    During the intervention

  • Sociodemographic data (age, sex, school year and socioeconomic status)

    Baseline

  • +1 more other outcomes

Study Arms (2)

Conectar Jugando Online Program

EXPERIMENTAL

The program consisted of 12 one-hour intervention sessions. The sessions were biweekly with a total duration of 6 weeks. The modern board and card games used in the program were Bee Alert (Knizia, 2012), Monster Match (Gruhl \& Weir, 2018), Sherlock Express (Kermarrec, 2019), Streams (Itsubaki, 2011) and Blurble (Bernard, 2013). The play sessions were carried out in groups of between 2 and 4 boys and girls of similar ages (same school stage) formed according to the availability of the participants. In the sessions, the physical games were projected on the videoconference tool by the researcher and the participating boys and girls carried out their actions using their voice and the platform tools. The program was gamified though a narrative about a space travel to different planets in discovering new games and get different mission badges and super team badges in their logbook.

Behavioral: Conectar Jugando Online Program

Wait-list group

NO INTERVENTION

Wait-list

Interventions

Online play sessions with modern board and card games guided by the study researchers

Also known as: Modern board and card games
Conectar Jugando Online Program

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • be enrolled in a public, private or subsidized ordinary educational center
  • provide informed consent from both parents and the participant's agreement to participate in the study

You may not qualify if:

  • comprehension difficulties due to language reasons
  • sensory difficulties that make it impossible to carry out the program activities
  • not having the necessary equipment to monitor the sessions online

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 (4)

  • Benzing V, Schmidt M, Jager K, Egger F, Conzelmann A, Roebers CM. A classroom intervention to improve executive functions in late primary school children: Too 'old' for improvements? Br J Educ Psychol. 2019 Jun;89(2):225-238. doi: 10.1111/bjep.12232. Epub 2018 Jun 26.

    PMID: 29947142BACKGROUND
  • Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

    PMID: 23020641BACKGROUND
  • Estrada-Plana V, Esquerda M, Mangues R, March-Llanes J, Moya-Higueras J. A Pilot Study of the Efficacy of a Cognitive Training Based on Board Games in Children with Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Trial. Games Health J. 2019 Aug;8(4):265-274. doi: 10.1089/g4h.2018.0051. Epub 2019 Jan 17.

    PMID: 30653355BACKGROUND
  • Fadhli, M., Brick, B., Setyosari, P., Ulfa, S., & Kuswandi, D. (2020). A Meta-Analysis of Selected Studies on the Effectiveness of Gamification Method for Children. International Journal of Instruction, 13(1), 845-854. https://doi.org/10.29333/iji.2020.13154a

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Interventional (Clinical trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 30, 2021

Study Start

December 16, 2020

Primary Completion

May 27, 2021

Study Completion

June 16, 2021

Last Updated

October 11, 2021

Record last verified: 2021-10

Locations