Visual Focused Play Intervention for Children With ADHD

November 18, 2023 updated by: Xijing Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test Group
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
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.
Sham Comparator: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment
Time Frame: Baseline and 2 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the Parent Symptom Questionnaire scores between baseline and post-treatment
Time Frame: Baseline and 2 weeks
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
Time Frame: Baseline and 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Min Cai, The First Affiliated Hospital of the Air Force Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 10, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY20232300-F-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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