Sleep education program for parents of children with ASD

Not Applicable

Suspended

Conditions: Autism Spectrum disorder
autism, autism spectrum disorder, sleep disorder, insomnia, children
D000067877

Registration Number: JPRN-jRCT1060230054

Lead Sponsor: Yoshihiro Maegaki

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: All

Target Recruitment: 5

Inclusion 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.

Exclusion 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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<br>2) Child Sleep Habits Questionnaire Japanese version (CSHQ-J)<br>3) Child Behavior Checklist (CBCL)<br>4) The Scale of Interpersonal Responsiveness (SRS-2)<br>5) Japanese version of the Mental Health Questionnaire (GHQ-30)<br>6) Positive and Negative Parenting Behavior Scale (PNPS)<br>7) Parent Satisfaction Questionnaire<br>8) Parent Interview Rating Scale for Autism Spectrum Disorders, Text Revision (PARS-TR)<br>9) Degree of intellectual functioning of the child