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RecruitingNot ApplicableNCT05806450

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

Sponsor

Sungshin Women's University

Enrollment

190 participants

Start Date

Mar 10, 2023

Study Type

INTERVENTIONAL

Conditions

Behavioral Insomnia of Childhood

Summary

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

Eligibility

Min Age: 6 MonthsMax Age: 24 Months

Inclusion Criteria6

  • Child's primary nighttime caregiver (mothers or fathers) of full-term, healthy, singleton, 6 to 24 months old
  • Caregiver participants aged between 19 to 65 years
  • The caregiver who is a native speaker of Korean (a person who is able to listen, speak, and write in Korean, and does not have any difficulties in understanding the Korean language)
  • Residents of South Korea
  • Sleep arrangements without restriction for using an auto-videosomnography device: (1) parent-child sleep separately (one should not change the sleep arrangement only for the participation in the study); (2) if parents and child share a bed, the child's own space should be large enough for the videosomnography camera to capture child body solely.
  • Be available on devices with the camera (e.g., tablets, personal computers) for the online intervention/session

Exclusion Criteria9

  • Child's gestational age before 37 weeks or after 42 weeks
  • Children with developmental disability
  • Caregiver participant (or partner) who is currently working the night shift or night duty
  • Caregiver participant who has a history of sleep disorders besides insomnia
  • Caregiver participant who has lifetime bipolar disorder, schizophrenia spectrum, and other psychotic disorders, alcohol, caffeine, or other substance substance-related disorders, neurocognitive disorders, thyroid-related disorders, or epilepsy
  • Caregiver participant who is currently experiencing a major depressive disorder, panic disorder (only if ≥ 4 nocturnal panic attacks in the past month), or post-traumatic stress-related problems
  • Caregiver participant who is using medications or substances that directly affect sleep
  • Caregiver participant who is currently getting cognitive behavioral therapy for insomnia (CBTi)
  • Pregnant women

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Interventions

BEHAVIORALIntervention

Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep

OTHERActive control condition

Psychoeducation about basic sleep structure and sleep hygiene

Locations(1)

Sungshin Women's University

Seoul, South Korea

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NCT05806450