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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06369714
Other study ID # CHEC2023-296
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 24, 2023
Est. completion date February 24, 2025

Study information

Verified date April 2024
Source Changhai Hospital
Contact Yuanhao Cai, MBBS
Phone 15001969690
Email 15552283399@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date February 24, 2025
Est. primary completion date February 24, 2025
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD. - Digital Cancellation Test total score<50 points. - Raven's Standard Progressive Matrices score=85. - 6 years = Age<12 years. - No interventions for ADHD received within 4 weeks. - No color blindness. Exclusion Criteria: - Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions. - Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders. - Patients with comorbid conduct disorders. - Patients with severe traumatic brain injury or neurological disorders. - Patients with a history of severe somatic diseases. - Patients with a history of substance or drug dependency.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Concerta
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
Device:
Digital therapeutics
30 sessions of digital therapeutics, each lasting 30 minutes, will be conducted with a frequency of once every 1-2 days over an 8-week period.

Locations

Country Name City State
China Changhai Hospital, Naval Medical University Shanghai Shanghai
China Changzheng Hospital, Naval Medical University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Lei Lei, MD

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Swanson, Nolan, and Pelham IV Rating Scale The Swanson, Nolan, and Pelham IV Rating Scales (SNAP-IV) will be completed by parents to assess the severity of ADHD symptoms. The values range from 0 to 3, with lower scores indicating a better outcome. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ADHD will be used to assess the number of core symptoms. There are a total of 18 core symptoms, with fewer symptoms indicating a better outcome. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary Questionnaire-Children with Difficulties The Questionnaire-Children with Difficulties (QCD) will be completed by parents to assess the social abilities of participants. The total questionnaire score is 57, and a score below 30 suggests impaired functioning. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary Behavior Rating Inventory of Executive Function The Behavior Rating Inventory of Executive Function (BRIEF) will be completed by parents to assess changes in executive function. The normal standards for scores vary by age, with lower scores indicating a better outcome. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary Continuous Performance Test A newly designed Continuous Performance Test (CPT) will be administered to participants by investigators, with higher accuracy rates indicating a better outcome. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary Digital Cancellation Test The Digit Cancellation Test (DCT) will be administered to participants by investigators, with higher scores indicating a better outcome. Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
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