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Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents: Randomized Controlled Trial  \n\n| Euno Kim1*, BSN, RN; Hajae Jeon2,3*, MPH; Junghan Lee4, MD, PhD; Hyangkyeong Oh5,6, MA; Meelim Kim7,8,9, BCBA, PhD; Jaeyong Shin 10, MD, PhD; Eunjoo Kim6,11, MD, PhD |\n| --- |\n| 1College of Nursing, Yonsei University, Seoul, Republic of Korea\u003Cbr>2Department of Public Health, Graduate School, Yonsei University, Seoul, Republic of Korea 3Institute for Innovation in Digital Healthcare, Yonsei University, Seoul, Republic of Korea\u003Cbr>4Division of Child and Adolescent Psychiatry, Department of Psychiatry and Institute of Behavioral Science in Medicine, Severance Children’s Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea\u003Cbr>5Department of Convergence Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea 6Institute of Behavioral Science in Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea\u003Cbr>7Herbert Wertheim School of Public Health and Human Longevity Science, University of California, San Diego, CA, United States 8The Qualcomm Institute, University of California, San Diego, CA, United States\u003Cbr>9The Design Lab, University of California, San Diego, CA, United States\u003Cbr>10Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea\u003Cbr>11Department of Psychiatry, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea\u003Cbr>*these authors contributed equally\u003Cbr>Corresponding Author:\u003Cbr>Eunjoo Kim, MD, PhD Department of Psychiatry\u003Cbr>Gangnam Severance Hospital, Yonsei University College of Medicine\u003Cbr>211 Eonjuro, Gangnam-gu Seoul\u003Cbr>Republic of Korea Phone: 82 0220193345\u003Cbr>[Email:](Email: ejkim96@yuhs.ac)[ ](Email: ejkim96@yuhs.ac)[ejkim96@yuhs.ac](Email: ejkim96@yuhs.ac)\u003Cbr>Abstract |\n\nBackground: Digital therapeutics (DTx) for children and adolescents with mental health problems have been developed in the health care industry. Despite reports of side effects from DTx for children and adolescents, there have been no guidelines to address the prevention of DTx overdependence among young users.  \nObjective: This study aimed to identify the requirements for guidelines to prevent DTx overdependence in children and adolescents and to develop and evaluate these guidelines.  \nMethods: We conducted 2 phases. This study first involved a phase I survey to develop guidelines, including assessments of smartphone usage and mental health conditions. The second phase evaluated the guidelines’ effectiveness, reliability, necessity, and satisfaction using a visual analog scale through a randomized controlled trial. Participants—45 children and adolescents aged 9-16 years and 42 caregivers—were randomly assigned to the experimental and control groups.  \nResults: Phase I revealed that blocking mobile applications and notifications (mean 8.5, SD 1.8) and parental monitoring (mean 8.5, SD 2.1) were effective preventive features. Caregivers, children, and adolescents expressed concerns about the side effects and overdependence of DTx and decreased effects due to nonindividualized guidelines in subjective responses to the phase I survey. Based on these insights, personalized guidelines for phase II were developed, in which overall mean visual analog scale scores for guideline evaluation were higher in the experimental group, except for necessity among caregivers (mean 8.5, SD 1.3 versus mean 8.7, SD 1.2) .  \nConclusions: Both caregivers and children and adolescents demonstrated the need for guidelines to prevent overdependence on DTx distinct from smartphone usage. Tailored guidelines may be acceptable for use in real-world therapeutic protocols.  \n[https://www.jmir.org/2025/1/e69248](https://www.jmir.org/2025/1/e69248)  \nXSL• FO  \nRenderX  \nJ Med Internet Res 2025 | vol. 27 | e69248 | p. 1 (page number not","cbCaiucX5HCEDFzQ","https://ap.wps.com/l/cbCaiucX5HCEDFzQ","pdf",595828,16,"English","# Abstract\n## Background\n## Objective\n## Methods\n## Results\n## Conclusions\n# Introduction","[{\"question\":\"What problem does this study address regarding digital therapeutics (DTx)?\",\"answer\":\"It addresses the prevention of overdependence on DTx in children and adolescents despite reports of side effects.\"},{\"question\":\"How were the guidelines developed and evaluated?\",\"answer\":\"The study used two phases: a Phase I survey to develop guidelines and a Phase II randomized controlled trial to evaluate effectiveness, reliability, necessity, and satisfaction.\"},{\"question\":\"What preventive features were identified as effective in Phase I?\",\"answer\":\"Blocking mobile applications and notifications and implementing parental monitoring were identified as effective preventive features.\"}]","Developing and Evaluating Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents - Randomized Controlled Trial | PDF",1790752578]