Child DevelopmentIMDNCT04831229
The Influence of Interactive Media on Child Development in Early Childhood
A study testing Children will perform activities on interactive tablet and Children will perform passive on interactive tablet in people with Child Development, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
Trial summary
Introduction: In the last decade the prevalence of the use of interactive media (smartphone, tablet) by children has grown worldwide. However, it is not yet known what its effects are on the development of children in early childhood and whether the form of use (passive or active) influences this practice. Read more about this study
- Who is it for?
- Ages 24 to 42 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Children will perform activities on interactive tablet and Children will perform passive on interactive tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Aug 2022to 21 Jun 2025
- 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 24 to 42 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion criteria are considered: children aged 24 to 36 months regularly enrolled in the Municipal Children's Education Centers (CMEIS);
- Participating in the study, children with limited experiences in the use of interactive media, <420 minutes / week or 60 minutes / day, which is within the recommendations of the Brazilian Society of Pediatrics (2019) and participation in research authorized and consented by parents or guardians. Being able to handle a tablet.
- Exclusion criteria include: hildren with neurological disorders such as cerebral palsy or syndromes that affect cognitive, linguistic and motor aspects, autism, moderate to severe hearing loss, mental or psychiatric disorders, prematurity and low birth weight.
- children with neurological disorders such as cerebral palsy or syndromes that affect cognitive, linguistic and motor aspects, autism, moderate to severe hearing loss, mental or psychiatric disorders, prematurity and low birth weight.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal dos Vales do Jequitinhonha e Mucuri
Diamantina, Minas Gerais, 39100000
About this study
Official title: The Influence of Interactive Media on Child Development in Children From 24 to 36 Months of Age: Protocol of a Randomized Controlled Clinical Trial
Introduction: In the last decade the prevalence of the use of interactive media (smartphone, tablet) by children has grown worldwide. However, it is not yet known what its effects are on the development of children in early childhood and whether the form of use (passive or active) influences this practice. In view of this, the present study aims to assess, through a randomized clinical trial (RCT), whether the form of use of mobile interactive media interferes with the Methods: The investigators propose an RCT with 64 children aged 24 to 36 months and their parents. Initially, identification, information about the child and history of media use will be carried out through the Questionnaire on the Use of Interactive Media, economic classification (Brazil Economic Classification Criterion). Then, the quality of the school environment (Infant / Toddler Environment Rating Scale) will be observed and, finally, measures of cognitive, motor and language development through the Bayley III Scale and Auditory Vocabulary Test. For follow-up purposes, parents will be asked to complete the Daily Record Board. Children will be randomly randomized into two groups: Active Interactive Media Group: children will use the media actively (games) and Passive Interactive Media Group: children will use the media passively (content viewing). Both groups will participate in the intervention for 30 minutes, three times a week, for 16 weeks. After this period, children will be reassessed for cognitive, language and fine motor development, receptive vocabulary and analysis of the Daily Record Board.
Discussion: The results can provide (1) information on which form of use has the most benefits for children (2) guide parents, educators and health professionals on how to offer interactive media.
Trial registration: This clinical trial was submitted to and approved by the Research Ethics Committee of Universidade Federal dos Vales do Jequitinhonha e Mucuri (CAAE 29490420.9.0000.5108). The complete protocol was registered in the Clinical Trials REBEC ( https://ensaiosclinicos.gov.br) under number RBR-8j3tzw Keywords: Child Development, Tablet, Interactive Tutorial, Clinical Trial.
Read the detailed description
The interactive media has different modes and levels of interactivity, being considered the use of active mode, when the child uses it with a high level of interactivity, performing tasks such as dragging, rotating and zooming on an object (as in games) or mode passive, when participants have a low level of interactivity, participants only understand the display of screen content and basic activities such as touching specific objects (eg play / pause when viewing videos and stories). The growth in the use of interactive media is mainly attributed to greater ease of access, due to its portability, as they are light, mobile and intuitive, being used from moments of leisure and entertainment to educational learning.
Both groups will receive interventions with the Interactive Tablet Media for 30 minutes, three times a week for a period of 16 weeks. The interventions will be carried out in an environment provided by the educational institution.
In the week before the start of the interventions, specific training will be carried out (on / off, ringing, double-tapping, increasing / decreasing, holding, increasing / decreasing volume) on the use of the equipment with the participating children. Children who are not included or who are excluded will remain in their classrooms carrying out activities already provided for in the institutional calendar.
Physiotherapists and physiotherapy students will be in the rooms conducting the interventions and elucidating possible doubts that may arise regarding the handling of the equipment.
Experimental Intervention 1 AIMG children will perform active activities on the interactive tablet media. The games and applications that will be used during this intervention were selected through a search in the online application store compatible with the tablet used during the intervention (Google Play). The search term used was "games for children aged 2 to 3 years" and they were analyzed for the following criteria: (1) interactivity: critical thinking, active participation, decision making; (2) learning: activities that stimulate cognitive development, fine motor, receptive language, expressive and social-emotional language (see table 1 to view activities); (3) suitability: age, period of development, multiple domains and (4) results: challenging activity, not frustrating, providing feedback.
Experimental Intervention 2 PIMG children will go to the intervention room where they will use interactive tablet media in passive activities, such as: watching videos and children's stories that they often watch at home. This survey will be possible thanks to the questionnaire on the Use of Interactive Media where parents will list which drawings, stories and videos children use to watch.
Treatment Contrast The main difference between the types of interventions is the mode of use and the level of interactivity of the interactive media, where the AIMG actively performs activities, that is, there is user interaction with the equipment through touch or verbal response and the performance of activities like rotating an object, dragging and zooming. PIMG is not the same, the user is just a spectator, having contact with the equipment only when switching on / off, choosing the content, performing activities such as increasing / decreasing the volume and touching certain specific objects such as giving "play" / pause ". Both groups will have a total of 48 intervention sessions.
Sample Size Calculation The G.Power 3.1® statistical program was used to determine the number of children. The sample size was based on the study by Huber and collaborators (2018) with results from the comparison of executive function tests in Australian children aged 24 to 48 months. For the trial, 64 children and their parents or guardians will be needed (n = 64). Participants will be randomly randomized into two groups: active interactive media group (n = 32) and passive interactive media group (n = 32), considering an independent t test with 80% power (beta error, type I), equal alpha at 0.05 and effect size of 0.63.
Data Management Plan Personal, demographic and economic data will be collected only once, before interventions start. Each child will be identified by code using the initial CMEI of origin and ascending order of numbering. This identification will be carried out by a person who will not participate in any phase of the research and will be stored in a safe place.
The data generated after evaluation will be analyzed and displayed in graphs, tables or images. They will be saved and stored on the computers of the main researchers, password protected, and on online platforms and will be accessed through common software. Data that is available on paper will be kept in a key office. It is important to note that all data will be treated confidentially.
The data will be preserved for at least five years after the end of the research by the responsible physiotherapist (SG), who will be closely supervised by the supervising professor (JS). If the project is discontinued by the responsible physiotherapist, the supervising professor will assume the role of the person responsible for the project at the Federal University of Vallyes do Jequitinhonha and Mucuri, Campus JK. Responsibility and decision making will be signed between all members of the project team in a homogeneous manner, always ensuring the security and quality of the data.
Data analysis A specific database will be elaborated in the Software SPSS22.0 (Statistical Package for the Social Sciences) in which specific research data will be allocated. For purposes of descriptive analysis, the frequency distribution of the categorical variables involved in the study evaluation and analysis of measures of central tendency and dispersion of continuous variables will be carried out. The normality of the data will be tested using the Kolmogorov-Smirnov test. For statistical analysis, in the case of parametric distribution, paired T tests will be used to compare the scores of the Bayley Test intragroup in the pre and post intervention moments with media. The student T test will be used to compare between the AIMG and PIMG groups. In case of non-parametric distribution, the Mann-Whitney and Kruskal-Wallis tests will be used. The significance level of 5% will be considered. All children in the groups will be reassessed, as an intention-to-treat analysis will be performed. This strategy analyzes the data of all participants included in the group for which they were selected, regardless of whether they completed the intervention.
Shielding In all phases of the project, care with blinding will be taken and supervised. Initially, as previously mentioned, the randomization of the participants will be blinded because it will be carried out by a person without involvement in the research. Assessors will also be blinded as they will not have access to which group the child and their parents are participating in and the same is identical for the groups. In the case of participants and physiotherapists and physiotherapy students who are connected to the intervention, blinding will be carried out as far as possible. One of the measures to be taken to avoid contact and contamination between groups is to carry out the intervention at different times. Physiotherapists and physiotherapy students involved in the treatment of AIMG will not be involved in providing PIMG intervention and vice versa. Outcome evaluators (statisticians) will also be completely blinded.
Ethic This study will be carried out in accordance with the Declaration of Helsinki. It was submitted and approved by the Research Ethics Committee (REC) of the Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM). The complete protocol will be registered in the Clinical Trials and in the Brazilian Registry of Clinical Trials. Participants will be asked for consent prior to any project related procedures.
This work was carried out with the support of the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) - Financing Code and by the Research Support Foundation of the State of Minas Gerais - FAPEMIG (CDS - APQ-01887-17). Funders will not influence any decision making about the conduct of the study and will have no relationship with the manuscripts from the study
- Conditions
- Child Development
- Being tested
- Children will perform activities on interactive tablet, Children will perform passive on interactive tablet
- Keywords
- Child Development, Tablet, Interactive Tutorial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children will perform activities on interactive tabletOther
Also called active interactive tablet
AIMG will actively perform activities with user interaction with the equipment through touch or verbal response. Both groups will have a total of 48 intervention sessions.
Children will perform passive on interactive tabletOther
Also called Passive interactive tablet
The PIMG is just a spectator, having contact with the equipment only when switching on / off, "play" / pause ". Both groups will have a total of 48 intervention sessions.
| Study group | Role | What they receive |
|---|---|---|
| Active Interactive Media Group | Active comparator | AIMG children will perform active activities on the interactive tablet media. The games and applications that will be used during this intervention were selected through a search in the online application store compatible with the tablet used during the intervention (Google Play). The search term used was "games for children aged 2 to 3 years" and they were analyzed for the following criteria: (1) interactivity: critical thinking, active participation, decision making; (2) learning: activities that stimulate cognitive development, fine motor, receptive language, expressive and social-emotional language (see table 1 to view activities); (3) suitability: age, period of development, multiple domains and (4) results: challenging activity, not frustrating, providing feedback Receives: Other: Children will perform activities on interactive tablet; Other: Children will perform passive on interactive tablet |
| Passive Interactive Media Group | Active comparator | PIMG children will go to the intervention room where they will use interactive tablet media in passive activities, such as: watching videos and children's stories that they often watch at home. This survey will be possible thanks to the questionnaire on the Use of Interactive Media where parents will list which drawings, stories and videos children use to watch. Receives: Other: Children will perform activities on interactive tablet; Other: Children will perform passive on interactive tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
To assess development in the cognitive domain, the Bayley III scale will be used, which assesses children from one to 42 months of age. The total score is converted into a balanced score and / or composed using tables provided in the manual. The composite score is based on age standards, where the child is rated from 40 to 160. The average score is 100, with ± 15 points standard deviation. This score will classify children into ranges: much higher (> 130 points), higher (between 129 to 120 points), above average (119 to 110 points), average (109 to 90 points), below average (89 at 80 points), borderline (79 to 70 points) and extremely low (69 or less points).
Measured: Tests performed before the intervention
Motor development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
To assess development in the Motor domain, the Bayley III scale will be used, which assesses children from one to 42 months of age. The total score is converted into a balanced score and / or composed using tables provided in the manual. The composite score is based on age standards, where the child is rated from 40 to 160. The average score is 100, with ± 15 points standard deviation. This score will classify children into ranges: much higher (> 130 points), higher (between 129 to 120 points), above average (119 to 110 points), average (109 to 90 points), below average (89 at 80 points), borderline (79 to 70 points) and extremely low (69 or less points).
Measured: Tests performed before the intervention
Language development was chosen as a primary outcome measure.
The assess the receptive vocabulary of children, a validated instrument, the Auditory Vocabulary Test (TVAud - A33o), will also be used.According to age and score, children will be classified as follows: 2 year old children: medium level (17 and 28 points); low (12 and 16 points), very low (6 and 11 points) and high (29 and 33 points). 3-year-old children: medium level (24 and 31 points), low (21 and 23 points), very low (17 and 20 points) and high (31 and 33 points).
Measured: Tests performed before the intervention
Change Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
To assess development in cognitive, motor and linguistic domains, the Bayley III scale will be used, which assesses children from one to 42 months of age in order to identify developmental delay. The score can be converted into balanced scores and / or composed through the use of tables provided in the manual. The approximate duration of the scale application is 50 minutes. The Bayley III test is the gold standard for development assessment and validated for the Brazilian population.
Measured: Tests performed after 16 weeks of intervention
Change Motor development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
To assess development in motor domains, the Bayley III scale will be used, which assesses children from one to 42 months of age in order to identify developmental delay. The score can be converted into balanced scores and / or composed through the use of tables provided in the manual. The approximate duration of the scale application is 50 minutes. The Bayley III test is the gold standard for development assessment and validated for the Brazilian population.
Measured: Tests performed after 16 weeks of intervention
Change language development was chosen as a primary outcome measure.
- assess the receptive vocabulary of children, a validated instrument, the Auditory Vocabulary Test (TVAud - A33o), will also be used.
Measured: Tests performed after 16 weeks of intervention
Secondary outcomes (2)
For the purpose of identifying and controlling variables that may interfere with child development- For economic classification
For economic classification, the Brazilian Economic Classification Criterion (CCBB) of the Brazilian Association of Research Companies (ABEP) 2019, based on this score, the family's economic.
Measured: Tests performed before the intervention
The quality of the school environment children experience
The quality of the school environment children experience, the Infant/Toddler Environment Rating Scale (ITERS-R) will be used. To assess opportunities children have at home, the Affordances in the Home Environment for Motor Development (AHEMD) will be used. The scale has 39 items distributed in seven subscales that are indicators of quality: (1) space and furniture; (2) personal care routine; (3) speaking and understanding; (4) activities; (5) interaction; (6) program structure; (7) parents and staff. In the environment to be evaluated in the early childhood education institution.
Measured: Tests performed before the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start21 Aug 2022
- Primary completion21 Jul 2024
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (43)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We propose an RCT with 64 children aged 24 to 36 months and their parents. Measures of cognitive, motor and language development through the Bayley III Scale and Auditory Vocabulary Test. For follow-up purposes, parents will be asked to complete the Daily Record Board. Children will be randomly randomized into two groups: Active Interactive Media Group: children will use the media actively (games) and Passive Interactive Media Group: children will use the media passively (content viewing). Both groups will participate in the intervention for 30 minutes, three times a week, for 16 weeks. After this period, children will be reassessed for cognitive, language and fine motor development, receptive vocabulary and analysis of the Daily Record Board.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and Mucuri
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Sponsor
- Investigators
- Juliana D Nunes Santos, PHD, Study director, Federal University of the Valleys of Jequitinhonha and Mucuri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04831229
- Sponsor's protocol ID
- 4.035.263
- Other IDs
- RBR-8j3tzw
- Acronym
- IMD
- Status last verified
- Apr 2026
- First submitted
- 25 Mar 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Personal, demographic and economic data will be collected only once, before interventions start. Each child will be identified by code using the initial CMEI of origin and ascending order of numbering. This identification will be carried out by a person who will not participate in any phase of the research and will be stored in a safe place. The data generated after evaluation will be analyzed and displayed in graphs, tables or images. They will be saved and stored on the computers of the main researchers, password protected, and on online platforms and will be accessed through common software. Data that is available on paper will be kept in a key office. It is important to note that all data will be treated confidentially. The data will be preserved for at least five years after the end of the research by the responsible physiotherapist (SG), who will be closely supervised by the supervising professor (JS)
Publications
Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.
PubMed 27565361Bernard JY, Padmapriya N, Chen B, Cai S, Tan KH, Yap F, Shek L, Chong YS, Gluckman PD, Godfrey KM, Kramer MS, Saw SM, Muller-Riemenschneider F. Predictors of screen viewing time in young Singaporean children: the GUSTO cohort. Int J Behav Nutr Phys Act. 2017 Sep 5;14(1):112. doi: 10.1186/s12966-017-0562-3.
PubMed 288702193. Common Sense Media. The common sense census: media use by kids age zero to eight. 2017.
4. Piñeiro ES, González CR. Repercusión de la interactividad y los nuevos medios de comunicación en los procesos educativos. Investigación y Postgrado. 2006;21(1):187-209.
5. Agnaldo Pedra A, Mayer RE Albertin AL. Role of Interactivity in Learning from Engineering Animations. Appl. Cognit. Psychol.2015. p. 614-20.
6. Rideout V. Learning at home: families' educational media use in America. The Joan Ganz Cooney Center: New York; 2014.
7. Merchant G. Keep taking the tablets : iPads, story apps and early literacy. Australian Journal of Language and Literacy. 2015;38:3-11.
8. Piotrowski JT, Krcmar M. Reading with hotspots: Young children's responses to touchscreenstories. Computers in Human Behavior [Internet]. 2017; 70(0747-5632):[328-34 pp.].
Wu CS, Fowler C, Lam WY, Wong HT, Wong CH, Yuen Loke A. Parenting approaches and digital technology use of preschool age children in a Chinese community. Ital J Pediatr. 2014 May 7;40:44. doi: 10.1186/1824-7288-40-44.
PubMed 24887105COUNCIL ON COMMUNICATIONS AND MEDIA. Media and Young Minds. Pediatrics. 2016 Nov;138(5):e20162591. doi: 10.1542/peds.2016-2591.
PubMed 27940793Wood E, Petkovski M, De Pasquale D, Gottardo A, Evans MA, Savage RS. Parent Scaffolding of Young Children When Engaged with Mobile Technology. Front Psychol. 2016 May 10;7:690. doi: 10.3389/fpsyg.2016.00690. eCollection 2016.
PubMed 27242603Guedes SDC, Morais RLS, Santos LR, Leite HR, Nobre JNP, Santos JN. CHILDREN'S USE OF INTERACTIVE MEDIA IN EARLY CHILDHOOD - AN EPIDEMIOLOGICAL STUDY. Rev Paul Pediatr. 2019 Nov 25;38:e2018165. doi: 10.1590/1984-0462/2020/38/2018165. eCollection 2020.
PubMed 3177841014. Ré AHN. Crescimento, maturação e desenvolvimento na infância e adolescência: Implicações para o esporte. Motricidade [Internet]. 2011; 7:55-67. Available from: http://www.scielo.mec.pt/pdf/mot/v7n3/v7n3a08.pdf.
Daelmans B, Darmstadt GL, Lombardi J, Black MM, Britto PR, Lye S, Dua T, Bhutta ZA, Richter LM; Lancet Early Childhood Development Series Steering Committee. Early childhood development: the foundation of sustainable development. Lancet. 2017 Jan 7;389(10064):9-11. doi: 10.1016/S0140-6736(16)31659-2. Epub 2016 Oct 4. No abstract available.
PubMed 2771760716. Pediatria SBd. Saúde da Criança e Adolescentes na Era Digital. Manual de Orientação. In: Adolescência Dd, editor. 2016.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Interactive Media on Child Development in Children From 24 to 36 Months of Age: Protocol of a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04831229
- Acronym / sponsor ID
- IMD / 4.035.263
- Conditions
- Child Development
- Keywords
- Child Development, Tablet, Interactive Tutorial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Federal University of the Valleys of Jequitinhonha and MucuriUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 21 Aug 2022 (actual)
- Primary completion
- 21 Jul 2024 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 5 Apr 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.
Introduction: In the last decade the prevalence of the use of interactive media (smartphone, tablet) by children has grown worldwide. However, it is not yet known what its effects are on the development of children in early childhood and whether the form of use (passive or active) influences this practice. In view of this, the present study aims to assess, through a randomized clinical trial (RCT), whether the form of use of mobile interactive media interferes with the Methods: The investigators propose an RCT with 64 children aged 24 to 36 months and their parents. Initially, identification, information about the child and history of media use will be carried out through the Questionnaire on the Use of Interactive Media, economic classification (Brazil Economic Classification Criterion). Then, the quality of the school environment (Infant / Toddler Environment Rating Scale) will be observed and, finally, measures of cognitive, motor and language development through the Bayley III Scale and Auditory Vocabulary Test. For follow-up purposes, parents will be asked to complete the Daily Record Board. Children will be randomly randomized into two groups: Active Interactive Media Group: children will use the media actively (games) and Passive Interactive Media Group: children will use the media passively (content viewing). Both groups will participate in the intervention for 30 minutes, three times a week, for 16 weeks. After this period, children will be reassessed for cognitive, language and fine motor development, receptive vocabulary and analysis of the Daily Record Board.
Discussion: The results can provide (1) information on which form of use has the most benefits for children (2) guide parents, educators and health professionals on how to offer interactive media.
Trial registration: This clinical trial was submitted to and approved by the Research Ethics Committee of Universidade Federal dos Vales do Jequitinhonha e Mucuri (CAAE 29490420.9.0000.5108). The complete protocol was registered in the Clinical Trials REBEC ( https://ensaiosclinicos.gov.br) under number RBR-8j3tzw Keywords: Child Development, Tablet, Interactive Tutorial, Clinical Trial.
Detailed description
The interactive media has different modes and levels of interactivity, being considered the use of active mode, when the child uses it with a high level of interactivity, performing tasks such as dragging, rotating and zooming on an object (as in games) or mode passive, when participants have a low level of interactivity, participants only understand the display of screen content and basic activities such as touching specific objects (eg play / pause when viewing videos and stories). The growth in the use of interactive media is mainly attributed to greater ease of access, due to its portability, as they are light, mobile and intuitive, being used from moments of leisure and entertainment to educational learning.
Both groups will receive interventions with the Interactive Tablet Media for 30 minutes, three times a week for a period of 16 weeks. The interventions will be carried out in an environment provided by the educational institution.
In the week before the start of the interventions, specific training will be carried out (on / off, ringing, double-tapping, increasing / decreasing, holding, increasing / decreasing volume) on the use of the equipment with the participating children. Children who are not included or who are excluded will remain in their classrooms carrying out activities already provided for in the institutional calendar.
Physiotherapists and physiotherapy students will be in the rooms conducting the interventions and elucidating possible doubts that may arise regarding the handling of the equipment.
Experimental Intervention 1 AIMG children will perform active activities on the interactive tablet media. The games and applications that will be used during this intervention were selected through a search in the online application store compatible with the tablet used during the intervention (Google Play). The search term used was "games for children aged 2 to 3 years" and they were analyzed for the following criteria: (1) interactivity: critical thinking, active participation, decision making; (2) learning: activities that stimulate cognitive development, fine motor, receptive language, expressive and social-emotional language (see table 1 to view activities); (3) suitability: age, period of development, multiple domains and (4) results: challenging activity, not frustrating, providing feedback.
Experimental Intervention 2 PIMG children will go to the intervention room where they will use interactive tablet media in passive activities, such as: watching videos and children's stories that they often watch at home. This survey will be possible thanks to the questionnaire on the Use of Interactive Media where parents will list which drawings, stories and videos children use to watch.
Treatment Contrast The main difference between the types of interventions is the mode of use and the level of interactivity of the interactive media, where the AIMG actively performs activities, that is, there is user interaction with the equipment through touch or verbal response and the performance of activities like rotating an object, dragging and zooming. PIMG is not the same, the user is just a spectator, having contact with the equipment only when switching on / off, choosing the content, performing activities such as increasing / decreasing the volume and touching certain specific objects such as giving "play" / pause ". Both groups will have a total of 48 intervention sessions.
Sample Size Calculation The G.Power 3.1® statistical program was used to determine the number of children. The sample size was based on the study by Huber and collaborators (2018) with results from the comparison of executive function tests in Australian children aged 24 to 48 months. For the trial, 64 children and their parents or guardians will be needed (n = 64). Participants will be randomly randomized into two groups: active interactive media group (n = 32) and passive interactive media group (n = 32), considering an independent t test with 80% power (beta error, type I), equal alpha at 0.05 and effect size of 0.63.
Data Management Plan Personal, demographic and economic data will be collected only once, before interventions start. Each child will be identified by code using the initial CMEI of origin and ascending order of numbering. This identification will be carried out by a person who will not participate in any phase of the research and will be stored in a safe place.
The data generated after evaluation will be analyzed and displayed in graphs, tables or images. They will be saved and stored on the computers of the main researchers, password protected, and on online platforms and will be accessed through common software. Data that is available on paper will be kept in a key office. It is important to note that all data will be treated confidentially.
The data will be preserved for at least five years after the end of the research by the responsible physiotherapist (SG), who will be closely supervised by the supervising professor (JS). If the project is discontinued by the responsible physiotherapist, the supervising professor will assume the role of the person responsible for the project at the Federal University of Vallyes do Jequitinhonha and Mucuri, Campus JK. Responsibility and decision making will be signed between all members of the project team in a homogeneous manner, always ensuring the security and quality of the data.
Data analysis A specific database will be elaborated in the Software SPSS22.0 (Statistical Package for the Social Sciences) in which specific research data will be allocated. For purposes of descriptive analysis, the frequency distribution of the categorical variables involved in the study evaluation and analysis of measures of central tendency and dispersion of continuous variables will be carried out. The normality of the data will be tested using the Kolmogorov-Smirnov test. For statistical analysis, in the case of parametric distribution, paired T tests will be used to compare the scores of the Bayley Test intragroup in the pre and post intervention moments with media. The student T test will be used to compare between the AIMG and PIMG groups. In case of non-parametric distribution, the Mann-Whitney and Kruskal-Wallis tests will be used. The significance level of 5% will be considered. All children in the groups will be reassessed, as an intention-to-treat analysis will be performed. This strategy analyzes the data of all participants included in the group for which they were selected, regardless of whether they completed the intervention.
Shielding In all phases of the project, care with blinding will be taken and supervised. Initially, as previously mentioned, the randomization of the participants will be blinded because it will be carried out by a person without involvement in the research. Assessors will also be blinded as they will not have access to which group the child and their parents are participating in and the same is identical for the groups. In the case of participants and physiotherapists and physiotherapy students who are connected to the intervention, blinding will be carried out as far as possible. One of the measures to be taken to avoid contact and contamination between groups is to carry out the intervention at different times. Physiotherapists and physiotherapy students involved in the treatment of AIMG will not be involved in providing PIMG intervention and vice versa. Outcome evaluators (statisticians) will also be completely blinded.
Ethic This study will be carried out in accordance with the Declaration of Helsinki. It was submitted and approved by the Research Ethics Committee (REC) of the Federal University of the Valleys of Jequitinhonha and Mucuri (UFVJM). The complete protocol will be registered in the Clinical Trials and in the Brazilian Registry of Clinical Trials. Participants will be asked for consent prior to any project related procedures.
This work was carried out with the support of the Coordination for the Improvement of Higher Education Personnel - Brazil (CAPES) - Financing Code and by the Research Support Foundation of the State of Minas Gerais - FAPEMIG (CDS - APQ-01887-17). Funders will not influence any decision making about the conduct of the study and will have no relationship with the manuscripts from the study
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We propose an RCT with 64 children aged 24 to 36 months and their parents. Measures of cognitive, motor and language development through the Bayley III Scale and Auditory Vocabulary Test. For follow-up purposes, parents will be asked to complete the Daily Record Board. Children will be randomly randomized into two groups: Active Interactive Media Group: children will use the media actively (games) and Passive Interactive Media Group: children will use the media passively (content viewing). Both groups will participate in the intervention for 30 minutes, three times a week, for 16 weeks. After this period, children will be reassessed for cognitive, language and fine motor development, receptive vocabulary and analysis of the Daily Record Board.
| Arm | Type | Receives |
|---|---|---|
| Active Interactive Media Group | Active comparator | Other: Children will perform activities on interactive tablet, Other: Children will perform passive on interactive tabletAIMG children will perform active activities on the interactive tablet media. The games and applications that will be used during this intervention were selected through a search in the online application store compatible with the tablet used during the intervention (Google Play). The search term used was "games for children aged 2 to 3 years" and they were analyzed for the following criteria: (1) interactivity: critical thinking, active participation, decision making; (2) learning: activities that stimulate cognitive development, fine motor, receptive language, expressive and social-emotional language (see table 1 to view activities); (3) suitability: age, period of development, multiple domains and (4) results: challenging activity, not frustrating, providing feedback |
| Passive Interactive Media Group | Active comparator | Other: Children will perform activities on interactive tablet, Other: Children will perform passive on interactive tabletPIMG children will go to the intervention room where they will use interactive tablet media in passive activities, such as: watching videos and children's stories that they often watch at home. This survey will be possible thanks to the questionnaire on the Use of Interactive Media where parents will list which drawings, stories and videos children use to watch. |
Who may qualify
- Ages
- 24 to 42 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Inclusion criteria are considered: children aged 24 to 36 months regularly enrolled in the Municipal Children's Education Centers (CMEIS);
- Participating in the study, children with limited experiences in the use of interactive media, <420 minutes / week or 60 minutes / day, which is within the recommendations of the Brazilian Society of Pediatrics (2019) and participation in research authorized and consented by parents or guardians. Being able to handle a tablet.
- Exclusion criteria include: hildren with neurological disorders such as cerebral palsy or syndromes that affect cognitive, linguistic and motor aspects, autism, moderate to severe hearing loss, mental or psychiatric disorders, prematurity and low birth weight.
- children with neurological disorders such as cerebral palsy or syndromes that affect cognitive, linguistic and motor aspects, autism, moderate to severe hearing loss, mental or psychiatric disorders, prematurity and low birth weight.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Children will perform activities on interactive tabletAlso: active interactive tabletAIMG will actively perform activities with user interaction with the equipment through touch or verbal response. Both groups will have a total of 48 intervention sessions. | Other | Active Interactive Media Group, Passive Interactive Media Group |
| Children will perform passive on interactive tabletAlso: Passive interactive tabletThe PIMG is just a spectator, having contact with the equipment only when switching on / off, "play" / pause ". Both groups will have a total of 48 intervention sessions. | Other | Active Interactive Media Group, Passive Interactive Media Group |
Primary outcome
Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
Time frame: Tests performed before the intervention
To assess development in the cognitive domain, the Bayley III scale will be used, which assesses children from one to 42 months of age. The total score is converted into a balanced score and / or composed using tables provided in the manual. The composite score is based on age standards, where the child is rated from 40 to 160. The average score is 100, with ± 15 points standard deviation. This score will classify children into ranges: much higher (> 130 points), higher (between 129 to 120 points), above average (119 to 110 points), average (109 to 90 points), below average (89 at 80 points), borderline (79 to 70 points) and extremely low (69 or less points).
Motor development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
Time frame: Tests performed before the intervention
To assess development in the Motor domain, the Bayley III scale will be used, which assesses children from one to 42 months of age. The total score is converted into a balanced score and / or composed using tables provided in the manual. The composite score is based on age standards, where the child is rated from 40 to 160. The average score is 100, with ± 15 points standard deviation. This score will classify children into ranges: much higher (> 130 points), higher (between 129 to 120 points), above average (119 to 110 points), average (109 to 90 points), below average (89 at 80 points), borderline (79 to 70 points) and extremely low (69 or less points).
Language development was chosen as a primary outcome measure.
Time frame: Tests performed before the intervention
The assess the receptive vocabulary of children, a validated instrument, the Auditory Vocabulary Test (TVAud - A33o), will also be used.According to age and score, children will be classified as follows: 2 year old children: medium level (17 and 28 points); low (12 and 16 points), very low (6 and 11 points) and high (29 and 33 points). 3-year-old children: medium level (24 and 31 points), low (21 and 23 points), very low (17 and 20 points) and high (31 and 33 points).
Change Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
Time frame: Tests performed after 16 weeks of intervention
To assess development in cognitive, motor and linguistic domains, the Bayley III scale will be used, which assesses children from one to 42 months of age in order to identify developmental delay. The score can be converted into balanced scores and / or composed through the use of tables provided in the manual. The approximate duration of the scale application is 50 minutes. The Bayley III test is the gold standard for development assessment and validated for the Brazilian population.
Change Motor development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
Time frame: Tests performed after 16 weeks of intervention
To assess development in motor domains, the Bayley III scale will be used, which assesses children from one to 42 months of age in order to identify developmental delay. The score can be converted into balanced scores and / or composed through the use of tables provided in the manual. The approximate duration of the scale application is 50 minutes. The Bayley III test is the gold standard for development assessment and validated for the Brazilian population.
Change language development was chosen as a primary outcome measure.
Time frame: Tests performed after 16 weeks of intervention
o assess the receptive vocabulary of children, a validated instrument, the Auditory Vocabulary Test (TVAud - A33o), will also be used.
2 secondary outcomes
For the purpose of identifying and controlling variables that may interfere with child development- For economic classification
Time frame: Tests performed before the intervention
The quality of the school environment children experience
Time frame: Tests performed before the intervention
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 14 Apr 2026.
- Background: PubMed 27565361Radesky JS, Christakis DA. Increased Screen Time: Implications for Early Childhood Development and Behavior. Pediatr Clin North Am. 2016 Oct;63(5):827-39. doi: 10.1016/j.pcl.2016.06.006.
- Background: PubMed 28870219Bernard JY, Padmapriya N, Chen B, Cai S, Tan KH, Yap F, Shek L, Chong YS, Gluckman PD, Godfrey KM, Kramer MS, Saw SM, Muller-Riemenschneider F. Predictors of screen viewing time in young Singaporean children: the GUSTO cohort. Int J Behav Nutr Phys Act. 2017 Sep 5;14(1):112. doi: 10.1186/s12966-017-0562-3.
- Background3. Common Sense Media. The common sense census: media use by kids age zero to eight. 2017.
- Background4. Piñeiro ES, González CR. Repercusión de la interactividad y los nuevos medios de comunicación en los procesos educativos. Investigación y Postgrado. 2006;21(1):187-209.
- Background5. Agnaldo Pedra A, Mayer RE Albertin AL. Role of Interactivity in Learning from Engineering Animations. Appl. Cognit. Psychol.2015. p. 614-20.
- Background6. Rideout V. Learning at home: families' educational media use in America. The Joan Ganz Cooney Center: New York; 2014.
- Background7. Merchant G. Keep taking the tablets : iPads, story apps and early literacy. Australian Journal of Language and Literacy. 2015;38:3-11.
- Background8. Piotrowski JT, Krcmar M. Reading with hotspots: Young children's responses to touchscreenstories. Computers in Human Behavior [Internet]. 2017; 70(0747-5632):[328-34 pp.].
- Background: PubMed 24887105Wu CS, Fowler C, Lam WY, Wong HT, Wong CH, Yuen Loke A. Parenting approaches and digital technology use of preschool age children in a Chinese community. Ital J Pediatr. 2014 May 7;40:44. doi: 10.1186/1824-7288-40-44.
- Background: PubMed 27940793COUNCIL ON COMMUNICATIONS AND MEDIA. Media and Young Minds. Pediatrics. 2016 Nov;138(5):e20162591. doi: 10.1542/peds.2016-2591.
- Background: PubMed 27242603Wood E, Petkovski M, De Pasquale D, Gottardo A, Evans MA, Savage RS. Parent Scaffolding of Young Children When Engaged with Mobile Technology. Front Psychol. 2016 May 10;7:690. doi: 10.3389/fpsyg.2016.00690. eCollection 2016.
- Background: PubMed 31778410Guedes SDC, Morais RLS, Santos LR, Leite HR, Nobre JNP, Santos JN. CHILDREN'S USE OF INTERACTIVE MEDIA IN EARLY CHILDHOOD - AN EPIDEMIOLOGICAL STUDY. Rev Paul Pediatr. 2019 Nov 25;38:e2018165. doi: 10.1590/1984-0462/2020/38/2018165. eCollection 2020.
- The complete protocol was registered in the Brazilian Registry of Clinical Trials -REBECLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Personal, demographic and economic data will be collected only once, before interventions start. Each child will be identified by code using the initial CMEI of origin and ascending order of numbering. This identification will be carried out by a person who will not participate in any phase of the research and will be stored in a safe place. The data generated after evaluation will be analyzed and displayed in graphs, tables or images. They will be saved and stored on the computers of the main researchers, password protected, and on online platforms and will be accessed through common software. Data that is available on paper will be kept in a key office. It is important to note that all data will be treated confidentially. The data will be preserved for at least five years after the end of the research by the responsible physiotherapist (SG), who will be closely supervised by the supervising professor (JS)
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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.
Juliana D Nunes Santos, PHD study director
Federal University of the Valleys of Jequitinhonha and Mucuri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children will perform activities on interactive tablet and Children will perform passive on interactive tablet in people with Child Development, run by Federal University of the Valleys of Jequitinhonha and Mucuri at 1 site in Brazil.
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 4 inclusion and 0 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 14 Apr 2026. 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 Brazil. 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?
Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media. (time frame: Tests performed before the intervention). 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 NCT04831229, which also lists 43 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 14 Apr 2026.