NCT05806450

Development of Sleep Intervention for Parent and Child

Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Sungshin Women's University · Academic / Other
• Sex: All
• Age: 6 Months – 24 Months
• Healthy volunteers: Accepted

Summary

This study aims to develop and test the intervention program to help manage parental thoughts in parents with child sleep problems.

Detailed description

Pediatric sleep problems are common and persistent, which result in negative outcomes without appropriate intervention. Behavioral sleep interventions (BSI) are evidence-based sleep training methods for improving pediatric sleep. However, parental factors (e.g., parental dysfunctional beliefs about child sleep) can interfere with the implementation of BSI. For example, being too worried or having misperceptions about infant sleep may interfere with the parent's ability to successfully and persistently implement BSIs. Therefore, parental thoughts and beliefs should be considered as an important target in the context of pediatric sleep interventions. This study aims to develop a cognitive intervention that identifies and targets parental misperceptions about child's sleep, and test the efficacy of the intervention through a randomized controlled trial.

Conditions

• Behavioral Insomnia of Childhood

Interventions

Type	Name	Description
BEHAVIORAL	Intervention	Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep
OTHER	Active control condition	Psychoeducation about basic sleep structure and sleep hygiene

Timeline

• Start date: 2023-03-10
• Primary completion: 2025-06-11
• Completion: 2025-06-30
• First posted: 2023-04-10
• Last updated: 2025-05-14

Locations

1 site across 1 country: South Korea