Visual Focused Play Intervention for Children With ADHD

NCT06140979 | Unknown DMC

• 1 other identifier: KY20232300-F-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the Parent Symptom Questionnaire scores between baseline and post-treatment

  Baseline and 2 weeks

• Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment

  Baseline and 2 weeks

Study Arms (2)

Test Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

Playing the game 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.

Test Group

Watching the gameplay video 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.

Control Group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Min Cai

  The First Affiliated Hospital of the Air Force Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Cai

CONTACT

86-15353508787; mincai8787@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 21, 2023
• Study Start: November 10, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share