The Influence of Interactive Media on Child Development in Children

NCT04704206 | Unknown DMC

• 2 other identifiers: APQ-01887-17RBR-8j3tzw
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Child Development

Keywords

Child Development; Tablet; Interactive Tutorial

Outcome Measures

Primary Outcomes (4)

• 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 Bayley III test is the gold standard for development assessment and validated for the Brazilian population.This score can be converted into balanced scores and / or composed through the use of tables provided in the manual. The composite score is based on age norms, where the child is classified from 40 to 160. The average score is 100, with standard deviation ± 15 points. This score will classify children in 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 to 80 points), borderline (79 to 70 points) and extremely low (69 or less points).

  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).

  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.

  Tests performed after 16 weeks of intervention

• Change language development was chosen as a primary outcome measure.

  o assess the receptive vocabulary of children, a validated instrument, the Auditory Vocabulary Test (TVAud - A33o), will also be used.

  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

  Tests performed before the intervention

• The quality of the school environment children experience

  Tests performed before the intervention

Study Arms (2)

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

Other: Children will perform activities 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.

Other: Children will perform activities on interactive tablet

Interventions

Children will perform activities on interactive tablet OTHER

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.

Also known as: active interactive tablet

Active Interactive Media Group; Passive Interactive Media Group

Eligibility Criteria

• Age: 24 Months - 42 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of the Valleys of Jequitinhonha and Mucuri: lead
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

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Related Links

• The complete protocol was registered in the Brazilian Registry of Clinical Trials -REBEC

Study Officials

• Juliana D Nunes, Dr

  Federal University of the Valleys of Jequitinhonha and Mucuri

  STUDY DIRECTOR

Central Study Contacts

Juliana Dr Nobre, Mestre

CONTACT

38999265675; junobre2007@yahoo.com.br

Juliana Dr Nobre, Ms

CONTACT

38 9992 65675; junobre2007@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Randomization will be carried out by means of a simple drawing where an independent researcher, not involved in the intervention or evaluation of the participants, will allocate the participants and it will be hidden using opaque and closed envelopes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 11, 2021
• Study Start: August 21, 2021
• Primary Completion: August 21, 2022
• Study Completion: August 21, 2023
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 5 years
• Access Criteria: Request to the responsible physiotherapist