A Random Controlled Trial of Home-based Digital Therapy for Treating ADHD in Children

NCT ID
NCT07552909
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games

Enrollment: 146 participants (Estimated).

What is being studied

  • Device: Home-based digital therapy with brain-controlled games

Who may be eligible

Ages
7 Years to 11 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Children aged 7 years 0 months to 11 years 11 months * Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above * Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85 * Children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks) * Informed consent must be obtained from the patient/guardian and from participants Exclusion Criteria: * Auditory or visual illness or disorder * Inability to use software (e.g., color blindness, impaired hand function, or disability) * Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders * Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders * Attention deficit disorder caused by organic neurological diseases or other organic diseases * Previous regular ADHD medication use as prescribed by a doctor, but without efficacy * Past or present gaming addiction * Previous neurofeedback-like "brain control game" interventions * Previous physical therapy such as magnetic stimulation.

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: China

  • Shanghai Municipality, China: 1

Sample of listed locations

  • Weiping Xia — Shanghai, Shanghai Municipality, 200092, China — Recruiting

Study details

Start date
August 24, 2025
Primary completion date
December 31, 2026
Completion date
December 31, 2026
First posted
April 27, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07552909
Registry last updated
September 8, 2026
QualifiedStudies registry data refreshed
September 28, 2026
QualifiedStudies record fetched
September 28, 2026

View NCT07552909 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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