Sleep education program for children with autism spectrum disorder and sleep disturbance

JRCT ID: jRCT1062240058

Registered date:03/10/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Autism spectrum disorder
• Date of first enrollment: 10/12/2023
• Target sample size: 40
• Study type: Interventional
• 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.

Outcome(s)

• Primary Outcome: Sleep onset latency before and after intervention
• Secondary Outcome: CSHQ-J, CBCL, GHQ-30, PNPS, homework completion rate, participant satisfaction survey

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: <= 10age old
• Gender: Both
• Include 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.
• Exclude 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

Related Information

• Primary Sponsor: Honami Koyama
• Source(s) of Monetary Support: Public Health Research Foundation