Visual Focused Play Intervention for Children With ADHD

Study Overview
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Brief Summary
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This is a single-center, randomized, double-blind, sham-controlled study that will recruit children with attention deficit hyperactivity disorder and randomly assign them to a test group and a control group. The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect. Treatment will be required at least 5 times per week for 2 weeks, with each game or video session lasting 30 minutes. Clinical scales and functional near-infrared spectroscopic imaging will be performed before and at the end of the 2 weeks of treatment, respectively.

Official Title
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Efficacy of Visual Focusing Game on Children With Attention Deficit Hyperactivity Disorder and Mechanisms of Functional Near-Infrared Spectroscopic Imaging

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Behavioral: Playing the game
* Behavioral: Watching the gameplay video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meeting the diagnostic criteria for ADHD in the U.S. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5); Aged 6-14 years old; Right-handedness (habitual or good use of the right hand in daily life, work, study and labor activities); Voluntarily agree to sign an informed consent form; Exclusion Criteria: Wechsler Intelligence Scale for Children (WISC) <80 points; The cranial CT or MRI found that there are clear infarction foci, soft foci, occupations and other organic lesions; Suffering from serious physical diseases or other severe mental diseases, such as schizophrenia, bipolar disorder, etc; Inability to cooperate with fNIRS data collection

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients in the test group will be given a visual focus game to play and the patients in the control group will be given an animated video of the game that had no therapeutic effect.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group<br>The patients in the test group will be given a visual focus game to play, and the treatment will be required at least 5 times per week for 2 weeks, with each session lasting 30 minutes. | Behavioral: Playing the game<br>* The intervention is based on a parkour game in which the player runs forward as a cartoon character, avoiding obstacles in front of him/her while collecting gold coins and various props. In this process, players need to stay focused and operate in time to avoid obstacles or collect rewards, and as time goes on, the difficulty of the game increases until eventually they cannot avoid obstacles. As time goes on, the difficulty of the game will increase until the end of the game when you can't avoid the obstacles.<br>|
| Sham Comparator: Control Group<br>The patients in the control group were given an animated video of the game that had no therapeutic effect, and the video will be required at least 5 times per week for 2 weeks, with each session lasting 30 minutes. | Behavioral: Watching the gameplay video<br>* The intervention consists of a 30-minute non-therapeutic video of a parkour game, which is paused every 10 minutes and requires the patient to click continue until the end of the video. No other action is required.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment | The Attention Deficit Hyperactivity Disorder Rating Scale is commonly used to determine whether children have symptoms of ADHD, how severe they are, and how impaired they are. As such, it is a combination of symptom and functional impairment ratings (e.g., unless it is at least moderately impaired to rate a 2 or 3 on a symptom). This is usually done by the clinician based on information provided by the parent/guardian or teacher. | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Parent Symptom Questionnaire scores between baseline and post-treatment | The Parent Symptom Questionnaire is a child behavior rating scale for parents developed by Conners that is easy to understand and takes parents only 5 to 10 minutes to complete. The scale is primarily used to assess attention deficit hyperactivity disorder in children and can reflect the effectiveness of treatment. | Baseline and 2 weeks | 
| Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment | Functional near-infrared spectroscopic imaging is a safe and fast screening method. It reflects brain activity by measuring blood oxygen levels in the cerebral cortex with promptness, accuracy, and short duration. | Baseline and 2 weeks |