Research on the prevention of sleep problems in children with developmental disabilities.

JRCT ID: jRCT1060230108

Registered date:12/03/2024

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
• Study type: Observational

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