Sleep education program for parents of children with ASD

JRCT ID: jRCT1060230054

Registered date:08/09/2023

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Autism Spectrum disorder
• Date of first enrollment: 08/09/2023
• Target sample size: 5
• Study type: Interventional

Intervention(s)

The program implemented in this study consists of preparatory videos, sessions (lectures and group work), and homework. preparatory videos are one or two videos of about 10 minutes each that are distributed one week before each session.
Sessions consist of a 10-minute lecture and 40-minute group work, with the first and second sessions held once every two weeks, and the third and subsequent sessions held once a week, for 60 minutes each, on 8 fixed days. 12 weeks after the end of the program, a follow-up session is held for 120 minutes. Sessions will be conducted via Zoom, a video call application over the Internet.
The sessions will be facilitated and explained by the principal investigator. During the duration of the program, the research subjects will conduct homework as assigned on a voluntary basis.

Outcome(s)

• Primary Outcome: Summary statistics of sleep onset latency (bedtime - bedtime) calculated from the child's bedtime and bedtime over a 2-week period recorded in a sleep diary completed by the parent.

Secondary Outcome

1) Total sleep time, frequency and number of hours of nighttime awakenings, and sleep efficiency of the child as measured by a sleep diary completed by the parent
2) Child Sleep Habits Questionnaire Japanese version (CSHQ-J)
3) Child Behavior Checklist (CBCL)
4) The Scale of Interpersonal Responsiveness (SRS-2)
5) Japanese version of the Mental Health Questionnaire (GHQ-30)
6) Positive and Negative Parenting Behavior Scale (PNPS)
7) Parent Satisfaction Questionnaire
8) Parent Interview Rating Scale for Autism Spectrum Disorders, Text Revision (PARS-TR)
9) Degree of intellectual functioning of the child

Key inclusion & exclusion criteria

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

Include criteria

1) Parents of children between the ages of 4 and 10 years at the time consent is obtained and who have a diagnosis of ASD
2) Parents of children who reported sleep onset latency of 30 minutes or longer for at least 3 nights per week for a period of at least 3 months.
3) Parents of children whose scores on the Japanese version of the Children's Sleep Habits Questionnaire (CSHQ-J) are above the cut-off value (41 points).
4) Parents of children who have not been treated with psychotropic drugs or who are on medication and have not changed their medication for more than 30 days
5) Parents of children with a developmental index or intelligence quotient obtained by the new K-type developmental test, Tanaka-Binay Intelligence Test, WISC, etc.
6) Who can utilize the application to receive the distance program
7) Who can prepare the communication environment for the distance program
8) Those who are willing to fill out a daily sleep diary during the program implementation period.

Exclude criteria

1) Parents of children who are being treated with medication for psychiatric symptoms and who may experience medication changes during the study period
2) Parents of children with medical conditions that affect sleep (e.g., epilepsy, skin conditions, etc.)
3) Other persons deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: Yoshihiro Maegaki