NCT07092787

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
25mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

July 10, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

July 10, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

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

  • 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.

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

  • 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.

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

  • 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.

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

  • Smartphone dependence

    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.

    Baseline, 13 weeks, and 12 months

Secondary Outcomes (2)

  • ADHD symptoms

    Baseline, 13 weeks, and 12 months

  • Resting-state EEG frequency

    Baseline, 13 weeks, and 12 months

Study Arms (2)

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.

Behavioral: Smartphone-based behavioral intervention

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.

Other: Self-monitoring of smartphone use

Interventions

The 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.

Smartphone Intervention

Participants 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.

Control

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yum YN, Li X, Poon KY, Leung CH. Reducing smartphone overuse for adolescents with attention-deficit hyperactive disorder: study protocol for a randomized controlled trial. BMC Psychiatry. 2025 Oct 31;25(1):1043. doi: 10.1186/s12888-025-07493-w.

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Yen Na Yum

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 30, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Aggregate and anonymized data will be shared in open access publications, but individual participant data will not shared to protect the privacy of the participants, as stipulated in the ethical review approval.