Clinical trial NCT04704206: The Influence of Interactive Media on Child Development in Children
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Keywords: Child Development
Tablet
Interactive Tutorial
Lead sponsor: Federal University of the Valleys of Jequitinhonha and Mucuri
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2021-01-11
Enrollment: 128
Sex: ALL
Minimum age (years): 24
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We propose an RCT with 128 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.
Primary purpose: OTHER

Brief 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. 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 128 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 = 128). Participants will be randomly randomized into two groups: active interactive media group (n = 64) and passive interactive media group (n = 64), 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

Eligibility criteria: Inclusion Criteria:

* 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.

Primary outcomes:
measure: Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
timeFrame: Tests performed before the intervention
measure: Language development was chosen as a primary outcome measure.
timeFrame: Tests performed before the intervention
measure: Change Cognitive development was chosen as a primary outcome measure, as interactive media it is known to be affected by interactive media.
timeFrame: Tests performed after 16 weeks of intervention
measure: Change language development was chosen as a primary outcome measure.
timeFrame: Tests performed after 16 weeks of intervention
Secondary outcomes:
measure: For the purpose of identifying and controlling variables that may interfere with child development- For economic classification
timeFrame: Tests performed before the intervention
measure: The quality of the school environment children experience
timeFrame: Tests performed before the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Juliana D Nunes, Dr
role: STUDY_DIRECTOR
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