Status:
RECRUITING
Digital Therapy for Treating Attention Deficit Hyperactivity Disorder
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief 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 functi...
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 prev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05435651
Start Date
July 16 2022
End Date
June 1 2024
Last Update
February 7 2024
Active Locations (1)
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1
Children's hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102