## Protocol Section
### Identification Module
**NCT ID:** NCT06140979

**Brief Title:** Visual Focused Play Intervention for Children With ADHD

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

#### Organization Study ID Info
**ID:** KY20232300-F-1
#### Organization
**Class:** OTHER
**Full Name:** Xijing Hospital
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-21

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-11-10

**Type:** ESTIMATED

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2023-11-21
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-12
**Study First Submit QC Date:** 2023-11-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xijing Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Attention Deficit Hyperactivity Disorder

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Behavioral: Playing the game

**Label:** Test Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**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.

**Intervention Names:**

- Behavioral: Watching the gameplay video

**Label:** Control Group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Test Group

**Description:** 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.

**Name:** Playing the game

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** 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.

**Name:** Watching the gameplay video

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment

**Time Frame:** Baseline and 2 weeks

#### Secondary Outcomes

**Description:** 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.

**Measure:** Change in the Parent Symptom Questionnaire scores between baseline and post-treatment

**Time Frame:** Baseline and 2 weeks

**Description:** 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.

**Measure:** Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment

**Time Frame:** Baseline and 2 weeks

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 14 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mincai8787@hotmail.com

**Name:** Min Cai

**Phone:** 86-15353508787

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** The First Affiliated Hospital of the Air Force Medical University

**Name:** Min Cai

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Anguera JA, Boccanfuso J, Rintoul JL, Al-Hashimi O, Faraji F, Janowich J, Kong E, Larraburo Y, Rolle C, Johnston E, Gazzaley A. Video game training enhances cognitive control in older adults. Nature. 2013 Sep 5;501(7465):97-101. doi: 10.1038/nature12486.

**PMID:** 24005416

**Citation:** Barkley RA. Attention-deficit/hyperactivity disorder, self-regulation, and time: toward a more comprehensive theory. J Dev Behav Pediatr. 1997 Aug;18(4):271-9.

**PMID:** 9276836

**Citation:** Pandian GSB, Jain A, Raza Q, Sahu KK. Digital health interventions (DHI) for the treatment of attention deficit hyperactivity disorder (ADHD) in children - a comparative review of literature among various treatment and DHI. Psychiatry Res. 2021 Mar;297:113742. doi: 10.1016/j.psychres.2021.113742. Epub 2021 Jan 19.

**PMID:** 33515870

**Citation:** Kollins SH, Childress A, Heusser AC, Lutz J. Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD. NPJ Digit Med. 2021 Mar 26;4(1):58. doi: 10.1038/s41746-021-00429-0.

**PMID:** 33772095

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019958

- Term: Attention Deficit and Disruptive Behavior Disorders

- ID: D000065886

- Term: Neurodevelopmental Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000020820

- Term: Dyskinesias

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4594

- Name: Attention Deficit Disorder with Hyperactivity

- Relevance: HIGH

- As Found: Attention Deficit Hyperactivity Disorder

- ID: M9999

- Name: Hyperkinesis

- Relevance: HIGH

- As Found: Hyperactivity

- ID: M21830

- Name: Attention Deficit and Disruptive Behavior Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M30644

- Name: Neurodevelopmental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006948

- Term: Hyperkinesis

- ID: D000001289

- Term: Attention Deficit Disorder with Hyperactivity

### Misc Info Module

- Version Holder: 2024-05-24
