Visual Focused Play Intervention for Children With ADHD

NCT ID: NCT06140979

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Playing the game

Intervention Type BEHAVIORAL

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.

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.

Group Type SHAM_COMPARATOR

Watching the gameplay video

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Cai

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of the Air Force Medical University

Central Contacts

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Min Cai

Role: CONTACT

86-15353508787

References

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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.

Reference Type RESULT
PMID: 24005416 (View on PubMed)

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.

Reference Type RESULT
PMID: 9276836 (View on PubMed)

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.

Reference Type RESULT
PMID: 33515870 (View on PubMed)

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.

Reference Type RESULT
PMID: 33772095 (View on PubMed)

Other Identifiers

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KY20232300-F-1

Identifier Type: -

Identifier Source: org_study_id