JRCT ID: jRCT1060230108
Registered date:12/03/2024
Research on the prevention of sleep problems in children with developmental disabilities.
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Developmental disability and suspected developmental disability |
| Date of first enrollment | 07/03/2024 |
| Target sample size | 40 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Changes in children's sleep questionnaire scores at two time points, Time1 and Time2 (6 months later). |
|---|---|
| Secondary Outcome | Changes in sleep habits (FISH items) and sleep problems (Child Sleep Questionnaire) at time points T1, T2 and T3 as objective variables, SDQ (total and subscale scores), SRS-2 (T scores and subscale scores), ADHD-RS (total and subscale scores) and AIS total scores |
Key inclusion & exclusion criteria
| Age minimum | >= 4age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) Are 4- and 5-year-old children at the start of the study 2) The child is using a child development support centre or office or other rehabilitation services |
| Exclude criteria | 1) A person whose age is 18 years or older 2) Who can agree to complete three questionnaires |
Related Information
| Primary Sponsor | Honami Yamaguchi |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yamaguchi Honami |
| Address | 1060 Nishikawatu-cho, Matsue-shi, Shimae Shimane Japan 690-8504 |
| Telephone | +81-859-32-6266 |
| yamaguchi.h@edu.shimane-u.ac.jp | |
| Affiliation | Shimane University |
| Scientific contact | |
| Name | Yamaguchi Honami |
| Address | 1060 Nishikawatu-cho, Matsue-shi, Shimae Shimane Japan 690-8504 |
| Telephone | +81-859-32-6266 |
| yamaguchi.h@edu.shimane-u.ac.jp | |
| Affiliation | Shimane University |