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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04823338
Other study ID # NCT2021CJ
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2020
Est. completion date June 16, 2021

Study information

Verified date October 2021
Source Brain In Game scientific-technical service
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

As hypotheses, it is established that: i) the experimental group will present a significantly greater improvement in the neuropsychological tasks that measure executive functions and associated cognitive processes compared to the passive control group after the intervention; ii) the experimental group will present a significantly greater improvement in the tests evaluated by their parents after the intervention compared to the passive control group. All hypotheses will be controlled for age, estimate of IQ and socioeconomic status, as well as previous experience in board games and other cognitive activities.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 16, 2021
Est. primary completion date May 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Conectar Jugando Online Program
Online play sessions with modern board and card games guided by the study researchers

Locations

Country Name City State
Spain Faculty of Education, Psychology and Social Work; University of Lleida Lleida

Sponsors (3)

Lead Sponsor Collaborator
Brain In Game scientific-technical service Atención, Familia, Infancia, Mayores (AFIM21), Mercurio Distribuciones

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Benzing V, Schmidt M, Jäger 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. — View Citation

Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27. Review. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Time spent on less-structured activities adapted from "Parent Survey of Typical Child Time Spent in Less-structured Activities" (Barker et al., 2014) In this survey, parents are asked (with the help of their children) about the time their children dedicate to less-structured and recreational activities using a using a 7-point scale (from lowest to highest frequency). High scores on each item mean a higher frequency in that activity. The sum of all the scores on each item (where 1= 'Never' and 7 = 'Daily') results in a typical less-structured activity score. Baseline
Other Player satisfaction Visual analogue scale created ad hoc
The scale consists of two questions:
Degree of satisfaction in reference to the play session
Degree of satisfaction in reference to the modern board and card games used in the play session Participants respond using a 5-option scale consisting of 5 stars (1 star = Not at all satisfied; 5 = Very satisfied)
During the intervention
Other Sociodemographic data (age, sex, school year and socioeconomic status) Hollingshead Index (Hollingshead, 1975) Baseline
Other Parent Play Beliefs "The Parent Play Beliefs Scale (PPBS)" (Fogle & Mendez, 2006) It consists of 30 items with 5 response options ranging from 1 (Disagree) to 5 (Strongly agree). Two subscales have been considered: a) Play support; b) Acedemic focus.
The Play Support subscale refers to parents' positive beliefs about the relevance of play for children's development and about their participation in play with children. High scores on this subscale indicate that parents enjoy play, prioritize play, and view it as a means of teaching.
The Academic focus subscale is made up of elements about the parents' emphasis on academic skills and the belief that play can promote their development. The Academic focus subscale is made up of elements about the parents' emphasis on academic skills and the belief that play can promote their development. High scores on this subscale would indicate that parents see the academic role of play as important.
Baseline and post intervention (after 6 weeks)
Primary Change in verbal updating from baseline to post intervention Verbal keep track task (Tamnes et al., 2010) Baseline and post intervention (after 6 weeks)
Primary Change in visuospatial updating from baseline to post intervention Visuospatial keep track task (Tamnes et al., 2010) Baseline and post intervention (after 6 weeks)
Primary Change in inhibition from baseline to post intervention 5 digits test (Sedó, 2004) Baseline and post intervention (after 6 weeks)
Primary Change in cognitive flexibility from baseline to post intervention 5 digits test (Sedó, 2004) Baseline and post intervention (after 6 weeks)
Primary Change in reasoning from baseline to post intervention TONI-4 (Ruíz-Fernández, 2019) Baseline and post intervention (after 6 weeks)
Primary 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 Change in behavioral executive functions from baseline to post intervention ATENTO (Luque & Sánchez-Sánchez, 2019) Baseline and post intervention (after 6 weeks)
Secondary Change in emotional and behavioral problems from baseline to post intervention SENA (Sistema de Evaluación de Niños y Adolescentes, Fernández-Pinto, L Santamaría, Sánchez-Sánchez, F Carrasco, & Del Barrio, 2015) Baseline and post intervention (after 6 weeks)
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