Trial reportJournal of medical Internet research2025
Developing and Evaluating Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents: Randomized Controlled Trial.
Trial report in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- AVATA Cure Digital Therapeutics for Social Communication in Children With Autism Spectrum Disorder: A Pilot Clinical Trial.Psychiatry investigation · 2026Article
- Digital therapeutics for stress in health science students at under-resourced universities: A narrative review.Health SA = SA Gesondheid · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDigital 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.
objectiveThis study aimed to identify the requirements for guidelines to prevent DTx overdependence in children and adolescents and to develop and evaluate these guidelines.
methodsWe 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.
resultsPhase 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).
conclusionsBoth 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. Guidelines to prevent overdependence on DTx in children and adolescents and to achieve a balance between their benefits and risks need to be established.
trial registrationClinical Research Information Service (CRiS) of the Republic of Korea KCT0008893; https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25609.
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