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临床试验/NCT07092787
NCT07092787尚未招募不适用

Reducing Smartphone Overuse for Adolescents With Attention-Deficit Hyperactive Disorder: A Randomized Controlled Trial

Education University of Hong Kong0 个研究点目标入组 120 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Number of notifications

研究概览

简要总结

This study will develop and evaluate a smartphone-based behavioral intervention for adolescents with Attention-Deficit Hyperactive Disorder (ADHD) and smartphone overuse in Hong Kong. The main questions it aims to answer are:

  • Can a smartphone-based intervention lower self-reported smartphone dependence and objective smartphone usage?
  • Can a smartphone-based intervention lower parent-rated and self-rated ADHD symptoms?
  • Are there differences in electroencephalogram (EEG) in the smartphone salient vs smartphone non-salient conditions after intervention?

Adolescent participants will:

  • report weekly smartphone use patterns based on app screencap for 12 weeks
  • complete online surveys on smartphone dependency and ADHD symptoms for 3 times
  • receive 10-minute EEG recordings to gather resting-state EEG data in a natural and relaxing state for 3 times

Parent participants will:

  • provide a valid clinical report to confirm the adolescent's diagnosis of ADHD
  • complete online surveys to report on the adolescent's smartphone usage and ADHD symptoms for 3 times

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •full-scale IQ above 85
  • •right-handedness to control for hemispheric dominance
  • •a confirmed diagnosis of ADHD
  • •ratings of current symptoms of ADHD on the Strengths and Weaknesses of Attention Deficit Hyperactivity Disorder Symptoms and Normal Behaviour Scale
  • •on a stable dose of ADHD medication for at least 4 weeks prior to trial entry or was taking no medication, with no plan to start or change medication type or dosage for the duration of the study
  • •over 2 hours of daily smartphone use within the last 4 weeks excluding educational apps
  • •a total score on the Smartphone Addiction Scale - Short Version (SAS-SV) above 31 and 33 for male and female adolescents, respectively

排除标准

  • •severe physical or sensory disabilities that may alter the participation in the intervention
  • •major depressive episode, bipolar disorder, substance abuse/dependence within the last 6 months
  • •significant neurological conditions (e.g., epilepsy, traumatic brain injury) that could affect cognitive and behavioral functioning
  • •concurrent participation in other ADHD interventions (e.g., clinical trials) excluding standard care

研究组 & 干预措施

Smartphone Intervention

Experimental

The treatment group will receive a 12-week individualized smartphone-based behavioral intervention based on the following strategies. They will be contacted once a week to collect the objective smartphone use patterns and check for compliance of the intervention strategies.

干预措施: Smartphone-based behavioral intervention (Behavioral)

Control

Placebo Comparator

The control group will receive information about the known benefits and risks of SO and activate their smartphones' screentime monitoring setting. They will be contacted once a week to collect the objective smartphone use patterns, but they will self-monitor their smartphone usage.

干预措施: Self-monitoring of smartphone use (Other)

结局指标

主要结局

Number of notifications

时间窗: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months

Objective smartphone use data will be collected via smartphone apps (e.g., "ScreenTime" on Apple or "Digital Wellbeing" on Android) to trace the pattern of smartphone use of each participant. Participants will send screenshots of the number of notifications received over the previous 7 days on their phones.

Smartphone dependence

时间窗: Baseline, 13 weeks, and 12 months

To allow for comparisons with existing studies, we will use the Smartphone Addiction Scale - Short Version validated in Hong Kong, which was designed for the assessment of smartphone dependence and showed good reliability and validity. The scale has ten items, such as "Missing planned work due to smartphone use" and "I will never give up using my smartphone even when my daily life is already greatly affected by it". Each item was measured by 6-point scales, from 1= "strongly disagree" to 6 = "strongly agree". Total score on the scale will be used to assess the degree of each participant's smartphone dependence, with suggested cut-off values of smartphone overuse for male and female was 31 and 33, respectively.

Minutes of smartphone use

时间窗: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months

Objective smartphone use data will be collected via smartphone apps (e.g., "ScreenTime" on Apple or "Digital Wellbeing" on Android) to trace the pattern of smartphone use of each participant. Participants will send screenshots of the minutes of smartphone use over the previous 7 days on their phones.

Categories of smartphone use

时间窗: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months

Objective smartphone use data will be collected via smartphone apps (e.g., "ScreenTime" on Apple or "Digital Wellbeing" on Android) to trace the pattern of smartphone use of each participant. Participants will send screenshots of the distribution of minutes spent according to categories of use (social networking, games, entertainment, productivity, etc.) over the previous 7 days on their phones.

Number of screen unlocks or "pickups"

时间窗: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months

Objective smartphone use data will be collected via smartphone apps (e.g., "ScreenTime" on Apple or "Digital Wellbeing" on Android) to trace the pattern of smartphone use of each participant. Participants will send screenshots of the number of screen unlocks or "pickups" over the previous 7 days on their phones.

次要结局

  • ADHD symptoms(Baseline, 13 weeks, and 12 months)
  • Resting-state EEG frequency(Baseline, 13 weeks, and 12 months)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

YUM Yen Na Cherry

Associate Professor

Education University of Hong Kong

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