Clinical trial NCT06140979: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Attention Deficit Hyperactivity Disorder Rating Scale scores between baseline and post-treatment
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Change in the Parent Symptom Questionnaire scores between baseline and post-treatment
timeFrame: Baseline and 2 weeks
measure: Changes in Functional Near-Infrared Spectral Imaging between Baseline and Post-Treatment
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of the Air Force Medical University
name: Min Cai
role: PRINCIPAL_INVESTIGATOR
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.
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.
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.
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.