Digital therapy for treating ADHD in children

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

This study is testing a new game-based digital therapy for children with ADHD to see if it helps improve their attention and reduce symptoms better than a different type of game.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 6 Years to 12 Years
• Sex: All
• Sponsor: Children's Hospital of Fudan University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05435651 on ClinicalTrials.gov

What this trial studies

This study explores the effects of a multitask game-based digital therapy compared to a Schulte Grid digital game on attentional functioning, ADHD symptoms, executive functioning, and clinical impairment in children diagnosed with ADHD. The research aims to evaluate the safety and efficacy of digital therapy as an intervention for childhood ADHD, addressing limitations of current pharmacological and non-pharmacological treatments. Given the high prevalence of ADHD in China and the popularity of electronic products among families, this study seeks to develop accessible digital therapies that can improve health outcomes for affected children.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 8 to 12 years with a confirmed diagnosis of ADHD who are not currently undergoing pharmacological treatment.

Not a fit: Patients with current uncontrolled psychiatric diagnoses or those optimally treated with existing pharmacological regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this digital therapy could provide a safer and more accessible treatment option for children with ADHD, potentially improving their attentional functioning and overall quality of life.

How similar studies have performed: Other studies have shown that digital interventions can significantly enhance attentional functioning in children with ADHD, indicating a promising avenue for treatment.

Eligibility criteria

Inclusion Criteria:

* Age 8 years to 12 years, inclusive, at the time of parental informed consent.
* Male or female.
* Confirmed ADHD diagnosis , any presentation , at Screening based on DSM-V criteria and established via the MINI-KID administered by a trained clinician.
* Screening/Baseline score on the clinician-rated ADHDRS-IV score 24.
* Screening/Baseline score on the TOVA API -1.8.
* Not undergoing pharmacological treatment with methylphenidate or amphetamine-based products at time of Screening ; or, if undergoing pharmacolog ical treatment , must be willing and appropriate (i.e. not optimally treated in the investigator's judgment) to wash out of current regimen.
* Estimated IQ score\~ 80 as assessed by Wechsler Intelligence Scale for Children-Fourth Edition ,WISC-IV.
* Ability to comply with all the testing and requirements.

Exclusion Criteria:

* Current, controlled (requiring a restricted medicatio n) or uncontrolled, comorbid psychiatric diagnosis , based on MINI-KID and subsequent clinical interviewing, with significant symptoms including but not limited to post-traumatic stress disorder , psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder , conduct disorder , or other symptomatic manifestatio ns that in the opinion of the Investigator may confound study data/assessments .
* Children who are currently at risk of suicide or have attempted suicide; children who have a history of suicide or are currently exhibiting active suicidal ideation or self-harm.
* Unable to stop taking ADHD medication.
* Motor condition (e.g., physical deformity of the hands/arms ; prostheses) that prevents playing the digital therapy as reported by the parent or observed by the investigator .
* Recent history (within the past 6 months) of suspected substance abuse or dependence.
* History of seizures (exclusive of febr ile seizures) , or significant motor or vocal tics, including but not limited to Tourette 's Disorder.
* Diagnosis of or parent-reported color blindness.
* Uncorrected visual acuity (Confirmed in-clinic via ability of subject to play the game).
* With severe mental retardation.
* Any other medical condition that in the opinion of the investigato r may confound study data/assessments.

Where this trial is running

Shanghai, Shanghai

• Children's hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Daqian Zhu, PhD

Conditions Attention Deficit Hyperactivity Disorder; Digital therapy