Monitor Adverse EventsADHDNCT06934746
Evaluation of Screen Time and Digital Media on ADHD
An observational study of Monitor Adverse Events, run by Assiut University.
Trial summary
1. Assess how different types of digital media influence inattention, impulsivity, and hyperactivity in children with ADHD. 2. Analyze the role of screen time duration, content type, parental supervision, and socioeconomic status in ADHD symptom severity. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Monitor Adverse Events
- What is being tested?
- DSM-5 criteria.
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to Oct 2026
- How long will I take part?
- 130 Weeks
- Phase
- Observational
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Neuro-psychiatric Outpatient clinic in Assiut University Children Hospita
Who may be able to join
- Diagnosed children with ADHD, confirmed by DSM-5 and Gilliam ADHD rating scale. • Parental consent for participation.
Who cannot join
- Comorbid neurodevelopmental disorders (e.g., autism, intellectual disability). • Chronic medical conditions affecting cognitive or behavioral function.
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
- Assess how different types of digital media influence inattention, impulsivity, and hyperactivity in children with ADHD.
- Analyze the role of screen time duration, content type, parental supervision, and socioeconomic status in ADHD symptom severity.
Read the detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in children, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Studies suggest that its prevalence has risen due to improved recognition and changing diagnostic criteria. Children with ADHD experience significant challenges in school performance, including difficulty sustaining attention, frequent careless mistakes, and trouble following instructions, all of which contribute to lower academic achievement and increased need for special education support. ADHD is linked to problematic eating behaviors, as irregular meal patterns, increased consumption of unhealthy foods, and a higher risk of obesity due to impulsivity and poor self-regulation. Beyond academics and nutrition, ADHD also affects sleep quality, emotional regulation, and social interactions, leading to increased behavioral issues and conflicts with peers and family members. The widespread use of digital media further complicates these challenges, as excessive screen time has been associated with exacerbating ADHD symptoms and negatively impacting cognitive and emotional development. These findings highlight the urgent need for targeted interventions to support children with ADHD across multiple aspects of their daily lives
- Conditions
- Monitor Adverse Events
- Being tested
- DSM-5 criteria.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSM-5 criteria.Other
The DSM-5 defines three levels of ADHD severity based on symptom count and frequency: 1. Mild ADHD • Symptom Count: Just meets the diagnostic criteria (6 symptoms in children for either inattention or hyperactivity/impulsivity). • Frequency: Symptoms occur but are not excessively frequent. 2. Moderate ADHD • Symptom Count: More than the minimum required for diagnosis. • Frequency: Symptoms occur frequently (e.g., several times a week). 3. Severe ADHD • Symptom Count: Many symptoms well beyond the diagnostic threshold. • Frequency: Symptoms occur daily or multiple times per day.(National Center for Biotechnology Information, n.d.)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inattention Symptoms Measured by the ADHD Rating Scale-IV
Evaluate the change in inattention symptoms before and after exposure to different types of digital media (e.g., videos, games, educational apps) using the ADHD Rating Scale-IV completed by parents or caregivers.
Measured: Baseline (Day 1) and after 6 months of follow-up
Change in Hyperactivity/Impulsivity Symptoms Measured by the ADHD Rating Scale-IV
Assess the change in hyperactivity and impulsivity symptoms in children with ADHD in relation to total daily screen time, content type, and level of parental supervision, using the ADHD Rating Scale-IV.
Measured: Baseline (Day 1) and after 6 months of follow-up
Secondary outcomes (1)
Correlation between Socioeconomic Status and ADHD Symptom Severity
Analyze the association between family socioeconomic status (SES) and the severity of ADHD symptoms after 6 months of exposure to digital media, using standardized SES assessment tools and ADHD Rating Scale-IV scores.
Measured: After 6 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monitor Adverse EventsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
- Target duration
- 130 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Gamil Sadek Zakka, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934746
- Sponsor's protocol ID
- role of digital media in ADHD
- Acronym
- ADHD
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Screen Time and Digital Media on ADHD
- ClinicalTrials.gov ID
- NCT06934746
- Acronym / sponsor ID
- ADHD / role of digital media in ADHD
- Conditions
- Monitor Adverse Events
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 18 Apr 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.
- Assess how different types of digital media influence inattention, impulsivity, and hyperactivity in children with ADHD.
- Analyze the role of screen time duration, content type, parental supervision, and socioeconomic status in ADHD symptom severity.
Detailed description
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most prevalent neurodevelopmental disorders in children, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Studies suggest that its prevalence has risen due to improved recognition and changing diagnostic criteria. Children with ADHD experience significant challenges in school performance, including difficulty sustaining attention, frequent careless mistakes, and trouble following instructions, all of which contribute to lower academic achievement and increased need for special education support. ADHD is linked to problematic eating behaviors, as irregular meal patterns, increased consumption of unhealthy foods, and a higher risk of obesity due to impulsivity and poor self-regulation. Beyond academics and nutrition, ADHD also affects sleep quality, emotional regulation, and social interactions, leading to increased behavioral issues and conflicts with peers and family members. The widespread use of digital media further complicates these challenges, as excessive screen time has been associated with exacerbating ADHD symptoms and negatively impacting cognitive and emotional development. These findings highlight the urgent need for targeted interventions to support children with ADHD across multiple aspects of their daily lives
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 130 Weeks
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neuro-psychiatric Outpatient clinic in Assiut University Children Hospita
Key inclusion criteria (1 listed)
- Diagnosed children with ADHD, confirmed by DSM-5 and Gilliam ADHD rating scale. • Parental consent for participation.
Key exclusion criteria (1 listed)
- Comorbid neurodevelopmental disorders (e.g., autism, intellectual disability). • Chronic medical conditions affecting cognitive or behavioral function.
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 |
|---|---|---|
| DSM-5 criteria.The DSM-5 defines three levels of ADHD severity based on symptom count and frequency: 1. Mild ADHD • Symptom Count: Just meets the diagnostic criteria (6 symptoms in children for either inattention or hyperactivity/impulsivity). • Frequency: Symptoms occur but are not excessively frequent. 2. Moderate ADHD • Symptom Count: More than the minimum required for diagnosis. • Frequency: Symptoms occur frequently (e.g., several times a week). 3. Severe ADHD • Symptom Count: Many symptoms well beyond the diagnostic threshold. • Frequency: Symptoms occur daily or multiple times per day.(National Center for Biotechnology Information, n.d.) | Other | – |
Primary outcome
Change in Inattention Symptoms Measured by the ADHD Rating Scale-IV
Time frame: Baseline (Day 1) and after 6 months of follow-up
Evaluate the change in inattention symptoms before and after exposure to different types of digital media (e.g., videos, games, educational apps) using the ADHD Rating Scale-IV completed by parents or caregivers.
Change in Hyperactivity/Impulsivity Symptoms Measured by the ADHD Rating Scale-IV
Time frame: Baseline (Day 1) and after 6 months of follow-up
Assess the change in hyperactivity and impulsivity symptoms in children with ADHD in relation to total daily screen time, content type, and level of parental supervision, using the ADHD Rating Scale-IV.
1 secondary outcome
Correlation between Socioeconomic Status and ADHD Symptom Severity
Time frame: After 6 months of follow-up
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 18 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Monitor Adverse Events, run by Assiut University.
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 1 inclusion and 1 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 18 Apr 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. 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 Janice Gamil Sadek, MD (01288823678, Janes.14224026@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inattention Symptoms Measured by the ADHD Rating Scale-IV (time frame: Baseline (Day 1) and after 6 months of follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.