臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 03, 2024
Last modified on	Oct. 03, 2024
Trial ID	jRCT1062240058

Scientific Title	Effectiveness of the sleep education program for parents of children with autism spectrum disorder and sleep disturbance
Public Title	Sleep education program for children with autism spectrum disorder and sleep disturbance

Contact for Scientific Queries	Name	Honami Koyama
	Affiliation	Shimane University
	Address	1060 Nishikawatu-cho, Matsue-shi, Shimae
	Telephone	+81-852-32-6266
	E-mail	yamaguchi.h@edu.shimane-u.ac.jp
Contact for Public Queries	Name	Honami Koyama
	Affiliation	Shimane University
	Address	1060 Nishikawatu-cho, Matsue-shi, Shimae
	Telephone	+81-852-32-6266
	E-mail	yamaguchi.h@edu.shimane-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 10, 2023
Actual date of first enrollment		Dec. 10, 2023
Target sample size		40
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	health services research
Key inclusion & exclusion criteria	Inclusion Criteria	1) Parents of children aged 4 to 10 years old with an ASD diagnosis, 2) Parents of children who have sleep-related problems at least three times a week for at least three months (sleep-related problems were defined as difficulty going to sleep, late bedtimes, problems getting children to sleep, nighttime awakening, or early morning awakening), 3) parents of children who are not taking medication for psychiatric symptoms or who have been taking medication for more than 30 days without a change in medication, and 4) those who can use an online meeting application at home and participate in an online program.
	Exclusion Criteria	1) Parents of children who are being treated with medication for psychiatric symptoms and who may have their medication changed during the research period, 2) Parents of children with medical conditions that affect sleep and who are not being treated for these conditions
	Age Minimum	4age old over
	Age Maximum	10age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autism spectrum disorder
Intervention(s)		The program consists of preparatory videos, sessions (lectures and group work), and homework. Sessions consist of 10-20 minute lectures and approximately 30 minute group work, and are held once a week for each session lasts 90 minutes and is held three times a week. 120 minutes of follow-up sessions will be held 12 weeks after the program ends. Sessions will be held using Zoom, a video calling application via the internet. During the program, participating parents will complete optional homework assignments.
Health Condition(s) Keyword		autism, autism spectrum disorder, sleep disorder, insomnia, children
Intervention(s) Keyword		sleep education program
Health Condition(s) Code		D000067877
Intervention(s) Code		D001521
Primary Outcome(s)		Sleep onset latency before and after intervention
Secondary Outcome(s)		CSHQ-J, CBCL, GHQ-30, PNPS, homework completion rate, participant satisfaction survey

Primary Sponsor	Shimane University

Secondary Sponsor

Source of Monetary Support	Public Health Research Foundation
Secondary Sponsor	Not applicable

Name of Certified Review Board	Research Ethics Review Committee for Human Subjects at the Faculty of Education, Shimane University
Address	1060, Nishikawatsu-cho, Matsue city, Shimane, Shimane
Telephone	+81-852-32-6251
E-Mail	edu-jimu@office.shimane-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 31, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none