Clinical trial NCT05806450: Development of Sleep Intervention for Parent and Child
Official title: Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Insomnia of Childhood
Keywords: pediatric sleep problems
sleep intervention
cognitive behavioral therapy (CBT)
Lead sponsor: Sungshin Women's University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2023-04-10
Enrollment: 190
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Parental cognition about child sleep
timeFrame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Child sleep diary
timeFrame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Child sleep (objective measurement)
timeFrame: changes from baseline to 4 weeks
Secondary outcomes:
measure: Parental sleep diary
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Parental sleep (objective measurement)
timeFrame: changes from baseline to 4 weeks
measure: Parental insomnia
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Parental sleep disturbance
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Child sleep environment and parental interaction
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Anxiety
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Depression
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
Other outcomes:
measure: Parental cognition about sleep
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Marital satisfaction
timeFrame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention
measure: Circadian rhythm
timeFrame: baseline assessment to identify circadian types that reflect an individual's preferred time of day for activity
Locations:
city: Seoul
country: Korea, Republic of
facility: Sungshin Women's University
Study officials:
affiliation: Sungshin Women's University
name: Sooyeon Suh, PhD
role: PRINCIPAL_INVESTIGATOR
References: