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      A Multicomponent Intervention to Reduce Screen Time Among Children Aged 2-5 Years in Chandigarh, North India: Protocol for a Randomized Controlled Trial

      , MPH 1 , , MD, PhD 1 , , , PhD 2 , , MD 3
      (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      multimedia, digital-media, preschooler, sedentary behaviors, toddler, sedentary, screen, children, youth

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          Excessive digital screen exposure (≥1 hour per day) is associated with limited growth and development in children.


          This study aims to develop and assess a multicomponent intervention program's effectiveness in reducing excessive screen time among children aged 2-5 years.


          A theory-based multicomponent intervention known as Program to Lower Unwanted Media Screens (PLUMS) at the household level has been developed. It is based on the social cognitive theory for children and self-determination theory for caregivers. After pretesting, a randomized control trial will be conducted to assess this intervention's effectiveness among healthy children aged 2-5 (±3 months) years and their primary caregivers who have at least one digital media gadget at home in zone three of Chandigarh (population of 2,730,035). A sample size of 428 children is estimated per arm. PLUMS includes disseminating specific information, education, communication in the form of videos and posters to the primary caregivers, and conducting motivational interviewing as and when needed. Children will be provided suggestions for playful activities as alternatives to digital media gadgets. The primary outcome is the mean change in the duration of screen time, and secondary outcomes are sleep duration and patterns, emotional-behavioral problems, and level of physical activity of the children. Per-protocol and intention-to-treat analyses will be conducted using SPSS for Macintosh, Version 25.0.


          The intervention package will be disseminated once a week for 8 weeks to the participants via the caregivers' preferred means of communication. The endline assessment will be done immediately postintervention and after the 6 months of follow-up. The Institute's ethics committee, Postgraduate Institute of Medical Education and Research, Chandigarh, India, has approved this study (INT/IEC/2019/000711). The Indian Council of Medical Research, New Delhi (3/1/3/Next-100/JRF-2015/HRD), and PGIMER, Chandigarh (71/2-Edu-16/92, Dated 08/01/2018) funded this study.


          PLUMS might be effective in reducing excessive screen time among children aged 2-5 years in a North Indian Union Territory.

          Trial Registration

          Clinical Trial Registry India CTRI/2017/09/009761; https://tinyurl.com/53q6dpjs

          International Registered Report Identifier (IRRID)


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          Most cited references53

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          SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

          High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.
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            Prevalence and development of psychiatric disorders in childhood and adolescence.

            This longitudinal community study assessed the prevalence and development of psychiatric disorders from age 9 through 16 years and examined homotypic and heterotypic continuity. A representative population sample of 1420 children aged 9 to 13 years at intake were assessed annually for DSM-IV disorders until age 16 years. Although 3-month prevalence of any disorder averaged 13.3% (95% confidence interval [CI], 11.7%-15.0%), during the study period 36.7% of participants (31% of girls and 42% of boys) had at least 1 psychiatric disorder. Some disorders (social anxiety, panic, depression, and substance abuse) increased in prevalence, whereas others, including separation anxiety disorder and attention-deficit/hyperactivity disorder (ADHD), decreased. Lagged analyses showed that children with a history of psychiatric disorder were 3 times more likely than those with no previous disorder to have a diagnosis at any subsequent wave (odds ratio, 3.7; 95% CI, 2.9-4.9; P<.001). Risk from a previous diagnosis was high among both girls and boys, but it was significantly higher among girls. Continuity of the same disorder (homotypic) was significant for all disorders except specific phobias. Continuity from one diagnosis to another (heterotypic) was significant from depression to anxiety and anxiety to depression, from ADHD to oppositional defiant disorder, and from anxiety and conduct disorder to substance abuse. Almost all the heterotypic continuity was seen in girls. The risk of having at least 1 psychiatric disorder by age 16 years is much higher than point estimates would suggest. Concurrent comorbidity and homotypic and heterotypic continuity are more marked in girls than in boys.
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              Executive function in preschoolers: a review using an integrative framework.

              During the last 2 decades, major advances have been made in understanding the development of executive functions (EFs) in early childhood. This article reviews the EF literature during the preschool period using an integrative framework. The framework adopted considers EF to be a unitary construct with partially dissociable components (A. Miyake et al., 2000). The authors focus on 3 EF components: working memory, response inhibition, and shifting. For the present purposes, the central executive is conceived of as a central attention system that is involved in all EF component operations. Research to date suggests that elementary forms of the core EF components are present early during the preschool period. Changes in EF during the latter half of the preschool period appear to be due to the development of attention and integration of component EFs. Finally, the review outlines a number of areas that warrant further investigation if researchers are to move forward in understanding early EF development. Copyright (c) 2008 APA.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                February 2021
                11 February 2021
                : 10
                : 2
                : e24106
                [1 ] Department of Community Medicine and School of Public Health Postgraduate Institute of Medical Education and Research Chandigarh India
                [2 ] Department of Pediatrics Postgraduate Institute of Medical Education and Research Chandigarh India
                [3 ] Department of Psychiatry Postgraduate Institute of Medical Education and Research Chandigarh India
                Author notes
                Corresponding Author: Madhu Gupta madhugupta21@ 123456gmail.com
                Author information
                ©Nimran Kaur, Madhu Gupta, Prahbhjot Malhi, Sandeep Grover. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.02.2021.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 4 September 2020
                : 8 October 2020
                : 2 December 2020
                : 15 December 2020
                Custom metadata
                This paper was peer reviewed by the PGIMER Doctoral Committee. See the Multimedia Appendix for the peer-review report;

                multimedia,digital-media,preschooler,sedentary behaviors,toddler,sedentary,screen,children,youth


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