臨床研究等提出・公開システム

Date of registration	May. 29, 2025
Last modified on	Sept. 05, 2025
Trial ID	jRCT1032250139

Scientific Title	Computer Game-Based Interventions for Children with Attention Deficit/Hyperactivity Disorder (ADHD)
Public Title	Computer Game-Based Interventions for Children with Attention Deficit/Hyperactivity Disorder (ADHD)

Contact for Scientific Queries	Name	Seki Masaki
	Affiliation	Okute Hospital
	Address	121 Okutecho, Mizunami, Gifu 509-6471, Japan
	Telephone	+81-572-63-2231
	E-mail	adhdgameresearch@gmail.com
Contact for Public Queries	Name	Hamada Takehiko
	Affiliation	Waseda University, Waseda Research Institute for Science and Engineering
	Address	3-4-1 Okubo, Shinjuku-ku, Tokyo 169-8555, Japan
	Telephone	+81-3-3203-7613
	E-mail	takehiko.hamada@moegi.waseda.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 29, 2025
Actual date of first enrollment		May. 30, 2025
Target sample size		35
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Male or female children with a primary diagnosis of ADHD based on the DSM-5 diagnostic criteria. All presentations are included: predominantly inattentive, predominantly hyperactive/impulsive, or combined type 2) Age between 6 and 10 years at the time of obtaining consent
	Exclusion Criteria	1) Participants with an intellectual disability
	Age Minimum	6age old over
	Age Maximum	10age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Pediatric Attention Deficit/Hyperactivity Disorder
Intervention(s)		The intervention involves joint play of a computer game by children with ADHD and their parents. The intervention will be conducted for 30 minutes per day, three times per week, over a period of four weeks.
Health Condition(s) Code		D001289
Primary Outcome(s)		Japanese version of the ADHD RS-IV (Parent-rated)
Secondary Outcome(s)		Japanese version of the Vinland-II Adaptive Behavoir Scales Japanese version of the Children's Sleep Habits Questionnaire (CSHQ)

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Yoyogi Mental Clinic Research Ethics Committee
Address	Sendagaya 4-26-11, 3rd Floor, Shibuya-ku, Tokyo
Telephone	+81-3-6804-2227
E-Mail	cns_jimu@triad-j.co.jp
Approval Status	Approval
Date of approval	April. 30, 2025

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
4	Sept. 05, 2025	(this page)	Changes
3	July. 17, 2025	Detail	Changes
2	May. 29, 2025	Detail	Changes
1	May. 29, 2025	Detail

List of change history