Visual Focused Play Intervention for Children With ADHD

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Playing the game; Behavioral: Watching the gameplay video

Study type: Interventional

Funder types: Other

Identifiers

NCT06140979

KY20232300-F-1

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Test Group

Experimental group

Description:

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.

Treatment:

Behavioral: Playing the game

Control Group

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Watching the gameplay video