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

NCT07552909 | Recruiting DMC

• 1 other identifier: XH-25-007
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

Explore the interventional effects of neurofeedback games on school-aged children with mild to moderate ADHD, with the aim of providing evidence-based new methods for intervening in the core symptoms of ADHD in children.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

Attention deficit hyperactivity disorder; Randomized Controlled; Digital Brain-controlled

Outcome Measures

Primary Outcomes (2)

• Inattention

  Assess using the Inattention subscale scores from the parent version of the Swanson, Nolan, and Pelham-IV (SNAP-IV) 47-item Rating Scale. The Inattention subscale consists of the first 9 items of the parent version of the 47-item SNAP-IV scale, directly corresponding to the DSM-5 diagnostic criteria for inattentive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much). The subscale score is calculated as the mean of items 1-9 (range 0-3). Higher scores indicate greater symptom severity. Based on established clinical norms (Swanson, 2001), a mean score of ≥ 1.67 is defined as the threshold for a "positive" symptomatic response (clinical significance) for Inattention. Previous studies have demonstrated that this subscale possesses exceptional psychometric properties, with internal consistency (Cronbach's α) reported as high as 0.95 in recent clinical evaluations (Enemuo et al., 2022; Hall et al., 2020).

  The first week after the intervention

• Hyperactivity-Impulsivity

  Assess using the Hyperactivity-Impulsivity subscale scores from the parent version of the SNAP-IV questionnaire. The Hyperactivity-Impulsivity subscale consists of items 10-18 of the parent version of the 47-item SNAP-IV scale, corresponding to the DSM-5 criteria for hyperactive and impulsive symptoms. Each item is rated on a 4-point Likert scale: 0 (not at all), 1 (just a little), 2 (quite a bit), and 3 (very much).The subscale score is calculated as the mean of items 10-18 (range 0-3). Higher scores reflect increased severity of hyperactivity and impulsivity. According to standardized norms, a mean score of ≥ 1.50 is used as the cut-off point to determine a "positive" symptomatic status (clinical significance) for Hyperactivity-Impulsivity. Extensive psychometric evaluations have reported exceptional reliability for this subscale, with a Cronbach's α coefficient reported as high as 0.92 to 0.94 in clinical samples (Bussing et al., 2008; Hall et al., 2020).

  The first week after the intervention

Secondary Outcomes (1)

• executive function

  The first week after the intervention

Study Arms (2)

control group

NO INTERVENTION

Control group: Participants will receive standard clinical care, with treatment strategies determined by the clinician based on their clinical experience, professional knowledge, and the specific condition of the school-aged child with ADHD. This includes outpatient guidance and ADHD health education from the doctor. No study-specific interventions will be applied during this period, and participants will be followed up at predetermined time points.

Intervention group

EXPERIMENTAL

For children in the intervention group, the entire training process will be completed at home. Each training session will last for 30 minutes, and a total of 30 sessions will be completed within 2 months of enrollment. All training frequency and duration will be presented in a quantifiable format.

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

Interventions

Home-based digital therapy with brain-controlled games DEVICE

Home-based brain-controlled training for children with ADHD is completed in a home environment. The training session lasts for 30 minutes daily, with a total of 30 sessions to be completed within a 2-month period. All training frequency and duration are presented in a quantifiable format. The training process incorporates engaging game elements. AI technology is used to provide real-time monitoring and difficulty adjustments, ensuring that each child's training intensity and content are personalized and optimized based on their individual needs. Eye-tracking technology is integrated into the game training to further enhance the training effects on visual attention and cognitive control, making the training more comprehensive and multi-faceted.

Intervention group

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Weiping Xia

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Weiping Xia, PhD

  Department of Clinical Psychology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School

  STUDY DIRECTOR

Central Study Contacts

Weiping Xia, PhD

CONTACT

+8613761137709; summertree20@163.com

Yiting Wu, Master

CONTACT

+8618201750534; estherwyt@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The differences in evaluation results between the intervention and control groups will be analyzed using a repeated measures analysis of variance from a general linear model. Missing data will be handled using the Last Observation Carried Forward (LOCF) method. Inter-group bias will be controlled through measures such as random assignment, consistent training of evaluators, and blinded evaluations where the evaluators are unaware of the subjects' treatment status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: April 27, 2026
• Study Start: August 24, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)