Reducing Smartphone Overuse for Adolescents With Attention-Deficit Hyperactive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorEducation University of Hong Kong
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smartphone-based behavioral intervention
BehavioralThe proposed study will use a behavioral smartphone-based intervention in a 12-week RCT among clinically diagnosed ADHD adolescents in Hong Kong. Guided by a conceptual framework on SO in ADHD, we will implement specific strategies that counter the potentially addictive qualities of smartphones using built-in smartphone functions that have been previously shown to be effective.
Self-monitoring of smartphone use
Other interventionParticipants will receive information about the known benefits and risks of SO and activate their smartphones' screentime monitoring setting. They will receive weekly reminders to submit their smartphone usage data.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Smartphone InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Minutes of smartphone use
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.
Time frame
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months2
Categories of smartphone use
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.
Time frame
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months3
Number of screen unlocks or "pickups"
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.
Time frame
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months4
Number of notifications
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.
Time frame
Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 monthsSecondary outcomes
1
ADHD symptoms
Parents will rate their child's behaviors on a 7-point scale using the Strengths and Weaknesses of Attention Deficit Hyperactivity Disorder Symptoms and Normal Behaviour Scale, which rephrased the 18 ADHD items of the DSM into neutral or positive statements. Scores of each statement range from -3 (far above average) to +3 (far below average), anchoring on normative behavior in age-matched adolescents. Two subscales on inattention and hyperactivity-impulsivity symptoms can be derived. Adolescents will also self-rate their ADHD symptoms.
Time frame
Baseline, 13 weeks, and 12 months2
Resting-state EEG frequency
During the EEG recording process, adolescent participants will be asked to relax and avoid swallowing and movements that may cause artifacts. For 5 min of recording, participants will look at a blank piece of paper on the table. For another 5 min of recording, they will look at their own smartphone, face-down with notifications and sound turned off, on the table. The order will be counterbalanced across participants. The target outcome measures are alpha (8-12Hz) and delta (1-4Hz) EEG frequency bands.
Time frame
Baseline, 13 weeks, and 12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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