Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Nov 25, 2024
Date Accepted: Oct 15, 2025
Developing and Evaluating Guidelines to Prevent Overdependence on Digital Therapeutics in Children and Adolescents: Randomized Controlled Trial
ABSTRACT
Background:
Digital therapeutics (DTx) for children and adolescents (ChAd) with mental health problems have been developed in the healthcare industry. Despite reports of side effects from DTx for ChAd, there have been no guidelines to address prevention of DTx overdependence among young users.
Objective:
This study aimed to identify the requirements for guidelines to prevent DTx overdependence in ChAd and to develop and evaluate these guidelines.
Methods:
Conducted in two phases, the study first involved a basic 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 (VAS) through a randomized controlled trial. Participants—45 ChAd aged 9–16 years and 42 caregivers—were randomly assigned to the experimental and control groups.
Results:
Phase I revealed that blocking other applications and notifications (mean: 8.5, SD: 1.8), as well as parental monitoring (mean: 8.5, SD: 2.1), were effective preventive features. Caregivers and ChAd expressed concerns about the side effects and overdependence of DTx and decreased effects due to non-individualized guidelines in subjective responses to the basic survey. Based on these insights, personalized guidelines for Phase II were developed, in which overall mean VAS scores for guideline evaluation were higher in the experimental group, except for necessity among caregivers (mean: 8.5, SD: 1.3 vs. mean: 8.7, SD: 1.2).
Conclusions:
Both caregivers and ChAd demonstrated the need for guidelines to prevent DTx overdependence distinct from smartphone usage. Tailored guidelines to prevent DTx overdependence may be acceptable for use in real-world therapeutic protocols. Guidelines to prevent overdependence on DTx in ChAd and to achieve a balance between their benefits and risks need to be established. Clinical Trial: This study was registered with the Clinical Research Information Service (KCT0008893).
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