Cognitive ChangeCJ-OnlineNCT04823338
Conectar Jugando Online: Board Games to Improve Executive Function in School-age Children (CJ-Online)
A study testing Conectar Jugando Online Program in people with Cognitive Change and Child Development, run by Brain In Game scientific-technical service at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Child Development
- What is being tested?
- Conectar Jugando Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2020to 16 Jun 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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
Official title: Conectar Jugando Online: Effectiveness of an Online Modern Board Game-based Cognitive Training to Improve Executive Function in School-age Children by a Randomized Controlled Trial
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).
Read the detailed 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.
- Conditions
- Cognitive Change, Child Development
- Being tested
- Conectar Jugando Online Program
- Keywords
- executive function, modern board and card games, cognitive training, school-age children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conectar Jugando Online ProgramBehavioural
Also called Modern board and card games
Online play sessions with modern board and card games guided by the study researchers
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Conectar Jugando Online Program |
| Wait-list group | No intervention | Wait-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in verbal updating from baseline to post intervention
Verbal keep track task (Tamnes et al., 2010)
Measured: Baseline and post intervention (after 6 weeks)
Change in visuospatial updating from baseline to post intervention
Visuospatial keep track task (Tamnes et al., 2010)
Measured: Baseline and post intervention (after 6 weeks)
Change in inhibition from baseline to post intervention
5 digits test (Sedó, 2004)
Measured: Baseline and post intervention (after 6 weeks)
Change in cognitive flexibility from baseline to post intervention
5 digits test (Sedó, 2004)
Measured: Baseline and post intervention (after 6 weeks)
Change in reasoning from baseline to post intervention
TONI-4 (Ruíz-Fernández, 2019)
Measured: 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)
Measured: Baseline and post intervention (after 6 weeks)
Secondary outcomes (2)
Change in behavioral executive functions from baseline to post intervention
ATENTO (Luque \& Sánchez-Sánchez, 2019)
Measured: Baseline and post intervention (after 6 weeks)
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)
Measured: Baseline and post intervention (after 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start16 Dec 2020
- Primary completion27 May 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies 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
- Interventional (Clinical trial)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain In Game scientific-technical service
- Sponsor type
- University, hospital or other
- Collaborators
- Atención, Familia, Infancia, Mayores (AFIM21), Mercurio Distribuciones
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823338
- Sponsor's protocol ID
- NCT2021CJ
- Acronym
- CJ-Online
- Status last verified
- Oct 2021
- First submitted
- 23 Mar 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29947142Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
PubMed 23020641Estrada-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.
PubMed 30653355Fadhli, 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conectar Jugando Online: Effectiveness of an Online Modern Board Game-based Cognitive Training to Improve Executive Function in School-age Children by a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04823338
- Acronym / sponsor ID
- CJ-Online / NCT2021CJ
- Conditions
- Cognitive Change, Child Development
- Keywords
- executive function, modern board and card games, cognitive training, school-age children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Brain In Game scientific-technical serviceUniversity, hospital or other
- Collaborators
- Atención, Familia, Infancia, Mayores (AFIM21), Mercurio Distribuciones
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 30 Mar 2021 (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.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional (Clinical trial)
| Arm | Type | Receives |
|---|---|---|
| Conectar Jugando Online Program | Experimental | Behavioral: Conectar Jugando Online ProgramThe 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. |
| Wait-list group | No intervention | –Wait-list |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Conectar Jugando Online ProgramAlso: Modern board and card gamesOnline play sessions with modern board and card games guided by the study researchers | Behavioural | Conectar Jugando Online Program |
Primary outcome
Change in verbal updating from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
Verbal keep track task (Tamnes et al., 2010)
Change in visuospatial updating from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
Visuospatial keep track task (Tamnes et al., 2010)
Change in inhibition from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
5 digits test (Sedó, 2004)
Change in cognitive flexibility from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
5 digits test (Sedó, 2004)
Change in reasoning from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
TONI-4 (Ruíz-Fernández, 2019)
Change in verbal fluency from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
Phonological and semantic fluency (letter M and animals, ENFEN, Portellano \& Martínez-Arias, R. Zumárraga, 2009)
2 secondary outcomes
Change in behavioral executive functions from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
Change in emotional and behavioral problems from baseline to post intervention
Time frame: Baseline and post intervention (after 6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Background: PubMed 29947142Benzing 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.
- Background: PubMed 23020641Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.
- Background: PubMed 30653355Estrada-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.
- BackgroundFadhli, 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
- Individual participant dataSharing planned: Undecided
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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 Conectar Jugando Online Program in people with Cognitive Change and Child Development, 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 3 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: finished, as of the sponsor's last update on 11 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in verbal updating from baseline to post intervention (time frame: Baseline and post intervention (after 6 weeks)). The study lists 6 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 NCT04823338, which also lists 4 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 11 Oct 2021.