Development of Sleep Intervention for Parent and Child

Sungshin Women's University

Status: Enrolling

Conditions: Behavioral Insomnia of Childhood

Treatments: Other: Active control condition; Behavioral: Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05806450

NRF-2021S1A5A2A03061721

Details and patient eligibility

About

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

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Intervention condition

Experimental group

Description:

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

Treatment:

Behavioral: Intervention

Active control condition

Active Comparator group

Description:

Psychoeducation about basic sleep structure and sleep hygiene

Treatment:

Other: Active control condition