Evaluation D'une Application D'éducation Thérapeutique Dans La Prise En Charge De Jeunes Ayant Un Usage Modéré Ou Problématique Des Écrans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Digital Addiction Scale
研究概览
简要总结
This single-center, controlled, and randomized study evaluates the effectiveness of the Phonix Care app in regulating screen use among young people aged 11 to 25. Faced with high and often concerning levels of screen consumption among youth, this research aims to provide an innovative intervention method beyond current psychotherapeutic and pharmacological approaches, which are often limited by the risk of relapse and the difficulty in delaying the short-term rewards offered by screen activities [1, 2, 3]. Phonix Care is designed to encourage awareness and self-regulation of screen use, thus promoting more responsible and autonomous behavior.
The primary outcome measure is based on a problematic screen use score derived from the Digital Addiction Scale. Secondary objectives include examining the effects of the app on screen consumption, physical health, mental health, and motivation towards studies, measured through a series of questionnaires and objective evaluations.
The study is conducted on 138 subjects, divided into two groups: an experimental group and a control group, over a participation period of six months. Statistical analyses will include descriptive analyses, multiple linear regression, and mediation models to assess the impact of Phonix Care.
The expected outcomes of this research include significant contributions to the scientific literature regarding screen use among youth, as well as advances in adolescent and young adult health and psychology. In practice, the evaluation of Phonix Care could lead to the development of an effective medical device to quantify and treat problematic screen use, offering a complementary therapy to existing methods to prevent or remedy this issue.
- Winkler A, Dörsing B, Rief W, Shen Y, Glombiewski JA. Treatment of Internet addiction: A meta-analysis. Clinical Psychology Review. 2013;33(2):317-29. https://doi.org/10.1016/j.cpr.2012.12.005
- Xu LX, Wu LL, Geng XM, Wang ZL, Guo XY, Song KR, Liu GQ, Deng LY, Zhang JT, Potenza MN. A review of psychological interventions for Internet addiction. Psychiatry Research. 2021;302: 114016. https://doi.org/10.1016/j.psychres.2021.114016
- Zajac K, Ginley MK, Chang R, Petry NM. Treatments for Internet gaming disorder and Internet addiction: A systematic review. Psychology of Addictive Behaviors. 2017;31(8):979-94. https://doi.org/10.1037/adb0000315
详细描述
Quality assurance: A risk analysis of our application was conducted by an external organization, Surgiqual Institute. Their audit validated that our cybersecurity systems and risk management procedures were state-of-the-art in compliance with medical legislation applicable to our application. They produced a document to state that, based on their audit, they affirm the responsibility for ensuring the technical and legislative compliance of our application.
Data checks: each data type had to match with a user profile template (JSON FORMAT) :
- unique_encrypted_code_name (characters AND number)
- usage_data (characters)
- date (characters : DD-MM-YY)
- screen_type (characters)
- app_name : (characters)
- usage_data_per_app : usage_value (number)
- questionnaire_data (characters)
- date (characters : DD-MM-YY)
- questionnaire_name (characters)
- questionnaire_item : questionnaire_response (number)
- additional_personal_data (characters)
Source data verification: a preliminary technical study (with 15 participants) was conducted to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
In this study, it is impossible for participants to be blinded, as they know whether or not the Phonix Care tool is configured on their screens. However, we measure our primary and secondary judgment criteria at the first measurement time, before assigning subjects to one of the two groups. At the first stage, measurements are therefore collected blind to the conditions. In addition, the data analyses are carried out blind to the groups.
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To have an Android-compatible smartphone.
- •To be enrolled in middle school, high school, or university.
- •To be between 11 and 25 years old.
排除标准
- •To have a poor understanding of the French language.
- •To have participated in another interventional study in the same field within the last six months.
- •To undergo psychological and/or medical follow-up related to screen addiction.
- •To undergo pharmacological treatment for screen addiction disorder.
- •To exceed the VRB threshold of 4500 euros.
研究组 & 干预措施
Phonix Care experimental group
The experimental arm involves modifying the functionalities of the user's digital devices (e.g., computer, smartphone, tablet, gaming console). The objective is to allow individuals access only to essential digital functionalities such as calls, alarms, work tools, camera, and unlock recreational digital functionalities only if the user engages in non-digital leisure activities (e.g., cultural, sports, family, artistic activities). The smartphone sensors validate the activities performed to earn digital time that can be spent by the user. Gradually, the user progresses a virtual animal until reaching the third stage of therapeutic education.
A phoenix will evolve simultaneously with the user when they engage in non-digital recreational activities.
For 5 months, all participants' cross-platform screen-usage data are monitored with fine granularity, including the frequency of app openings, schedules of opening, and names of app openings.
干预措施: Phonix Care (Device)
Observational group
For 5 months, all participants' cross-platform screen-usage data are monitored with fine granularity, including the frequency of app openings, schedules of opening, and names of app openings.
结局指标
主要结局
Digital Addiction Scale
时间窗: pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.
The primary outcome measure is a problematic screen usage score ranging from 25 to 125 points, calculated from an online assessment questionnaire translated into French from the Digital Addiction Scale (Hawi et al., 2019). Participants respond to 25 statements in which they are asked to select the option that best reflects their thoughts on their screen usage, with the following response options: 1 "never"; 2 "rarely"; 3 "sometimes"; 4 "often"; and 5 "always". The statements describe nine criteria related to problematic screen usage: preoccupation; tolerance; deprivation; conflicts; associated problems; deception; attraction to other activities; relapse; and mood modification. The higher the participants' total score, the more problematic their screen usage is reported. This information is collected at two measurement times: before and after the experiment. We control for the pre-experiment level, and our primary outcome measure refers to the measurement taken after the experiment.
次要结局
- Regulation of Screen Time Consumption(pre-intervention (T0), post-intervention (T0 + 5 months), with a completion duration of 0 minutes (data is collected passively).)
- International Physical Activity Questionnaire(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)
- Sleep Schedules diary(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)
- Revised Screen for Child Anxiety Related Emotional Disorders (SCARED-R)(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)
- University of Laval Loneliness Scale (ULS)(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)
- Rosenberg Self-Esteem Scale(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)
- Education Motivation Scale (EMS)(pre-intervention (T0), post-intervention (T0 + 5 months), with an estimated completion duration of 15 minutes.)