Status:
UNKNOWN
Behavioral Sleep Intervention and Infant Sleep and Social-emotional Development
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Infant Sleep Problem
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
An estimated 30-50% of infants have frequent problematic night wakings. Sleep disturbances have been linked to various adverse outcomes in children, including social-emotional development delay. Despi...
Detailed Description
Study Design: The study design was a parallel group RCT with two groups (Behavioral sleep intervention and Control) and three assessment points. Sleep was assessed by actigraphy (and sleep daily) and ...
Eligibility Criteria
Inclusion
- Infant age range 5-18 months;
- Sleep problem lasting at least 2 weeks, manifested in an average of ≥30 minutes sleep onset latency, and/or ≥2 awakenings per night based on parent reports;
- Both mother and father willing to participate in study procedures.
Exclusion
- Infant pervasive developmental disorder or significant medical illness;
- Any concurrent treatment for infant sleep problems.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04048785
Start Date
April 1 2020
End Date
December 31 2021
Last Update
December 21 2020
Active Locations (1)
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1
Shanghai children's medicial center affiliated shanghai jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China