Development of Sleep Intervention for Parent and Child
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention, Active control condition.
- Who it may be relevant to
- Registry conditions: Behavioral Insomnia of Childhood. Basic parameters: 6 months — 24 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of a Cognitive-Behavioral Intervention to Improve Infant and Parent Sleep Based on Big Data Analytics
Overview
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.
Interventions
- 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
Primary outcome measures
- Parental cognition about child sleep [Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Child sleep diary [Time frame: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Child sleep (objective measurement) [Time frame: changes from baseline to 4 weeks]
Secondary outcome measures (7)
- Parental sleep diary [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Parental sleep (objective measurement) [Time frame: changes from baseline to 4 weeks]
- Parental insomnia [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Parental sleep disturbance [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Child sleep environment and parental interaction [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Anxiety [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
- Depression [Time frame: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Sungshin Women's University — Seoul
Identifiers
NCT: NCT05806450 · NRF-2021S1A5A2A03061721