NCT05435651

Digital Therapy for Treating Attention Deficit Hyperactivity Disorder

A Randomized Clinical Trial to Assess The Effectiveness and Safety of Digital Therapy for Treating Attention Deficit Hyperactivity Disorder in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD. Investigators will also evaluate the safety of digital therapy for intervention treatment of childhood attention deficit hyperactivity disorder.

Detailed description

ADHD is a common neurodevelopmental disorder characterized by a persistent pattern of inattention and/or hyperactivity and impulsivity, resulting in functional impairment in multiple settings.The prevalence in China is estimated to be 6.26%. Front-line intervention for ADHD includes pharmacological and non-pharmacological interventions, which have shown short-term efficacy.There are limitations to current best practices for the treatment of ADHD. Relating to pharmacotherapy, they are accompanied by adverse events in many children, do not normalize functioning , and adherence rates over time are generally low. Pharmacotherapy may not be suitable for some patients.Relating to non-pharmacological interventions, barriers to access limit the use of non-pharmacological interventions, given a shortage of properly trained paediatric mental health specialists and variability in insurance coverage for such services. Digital therapy for ADHD may address these limitations with improved access, minimal side-effects, and low potential for abuse.There are studies show that digital intervention can significantly increase attentional functioning of children with ADHD.At present, there are few related researches on digital therapy in China.The total number of ADHD children is large in China, and electronic products are very popular in Chinese families.If digital therapies suitable for ADHD children in China can be developed, it will be of great significance for the promotion of human health. Therefore, investigators designed the study to explore the effect of Multitask game-based digital therapy versus Schulte Grid digital game on attentional functioning (measured by the TOVA), ADHD symptoms, executive functioning, and clinical impairment, in children diagnosed with ADHD in China.Safety, tolerability, and compliance were also assessed. The study will be a blinded (investigators and outcome assessors), randomized, parallel group, follow-up study of the sustained effects of 28 days of treatment with either Multitask game-based digital therapy or Schulte Grid digital game. The trial will consist of 3 visits: Screening, FU-Day 14 visit and FU-Day 28 visit.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Multitask game-based digital therapy	To practice multitask-game on the system for approximately 25 minutes/day at least 5 days a week.
BEHAVIORAL	Schulte Grid digital game	To practice Schulte Grid digital game on the system for approximately 25 minutes/day at least 5 days a week.

Timeline

• Start date: 2022-07-16
• Primary completion: 2024-06-01
• Completion: 2024-07-01
• First posted: 2022-06-28
• Last updated: 2026-03-27

Locations

1 site across 1 country: China