Attention Deficit Hyerpactivity DisorderNCT07092787
Reducing Smartphone Overuse for Adolescents With Attention-Deficit Hyperactive Disorder
A study testing Smartphone-based behavioral intervention and Self-monitoring of smartphone use in people with Attention Deficit Hyerpactivity Disorder and Smartphone Addiction, run by Education University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Attention Deficit Hyerpactivity Disorder, Smartphone Addiction
- What is being tested?
- Smartphone-based behavioral intervention and Self-monitoring of smartphone use
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Reducing Smartphone Overuse for Adolescents With Attention-Deficit Hyperactive Disorder: A Randomized Controlled 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?
Read more
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
- Being tested
- Smartphone-based behavioral intervention, Self-monitoring of smartphone use
- Medical subject headings
- Internet Addiction Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based behavioral interventionBehavioural
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.
Self-monitoring of smartphone useOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Self-monitoring of smartphone use |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 13 weeks, and 12 months
Secondary outcomes (2)
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.
Measured: Baseline, 13 weeks, and 12 months
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.
Measured: Baseline, 13 weeks, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyerpactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YUM Yen Na Cherry, Education University of Hong Kong
- Investigators
- Yen Na Yum, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092787
- Sponsor's protocol ID
- 2023-2024-0412
- Other IDs
- HHB/H/41/208
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41174591
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Smartphone Overuse for Adolescents With Attention-Deficit Hyperactive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07092787
- Acronym / sponsor ID
- 2023-2024-0412
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Intervention | Experimental | Behavioral: Smartphone-based behavioral interventionThe 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. |
| Control | Placebo comparator | Other: Self-monitoring of smartphone useThe 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-based behavioral interventionThe 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. | Behavioural | Smartphone Intervention |
| Self-monitoring of smartphone useParticipants 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. | Other | Control |
Primary outcome
Minutes of smartphone use
Time frame: 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
Time frame: 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"
Time frame: 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.
Number of notifications
Time frame: 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
Time frame: 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.
2 secondary outcomes
ADHD symptoms
Time frame: Baseline, 13 weeks, and 12 months
Resting-state EEG frequency
Time frame: Baseline, 13 weeks, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 41174591Yum 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yen Na Yum principal investigator
The Education University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based behavioral intervention and Self-monitoring of smartphone use in people with Attention Deficit Hyerpactivity Disorder and Smartphone Addiction, run by Education University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yen Na Yum ((+852) 29488225, yyum@eduhk.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minutes of smartphone use (time frame: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 weeks, and 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07092787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.