Development of Sleep Intervention for Parent and Child

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Intervention
  Structured online intervention consists of three weekly sessions of cognitive therapy and psychoeducation about child sleep
• Другое Active control condition
  Psychoeducation about basic sleep structure and sleep hygiene

Первичные конечные точки

• Parental cognition about child sleep [Срок оценки: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Child sleep diary [Срок оценки: Changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Child sleep (objective measurement) [Срок оценки: changes from baseline to 4 weeks]

Вторичные конечные точки (7)

• Parental sleep diary [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Parental sleep (objective measurement) [Срок оценки: changes from baseline to 4 weeks]
• Parental insomnia [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Parental sleep disturbance [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Child sleep environment and parental interaction [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Anxiety [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]
• Depression [Срок оценки: changes from baseline to 4 weeks, and 4 weeks and 12 weeks post-intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Sungshin Women's University — Seoul

Идентификаторы

NCT: NCT05806450 · NRF-2021S1A5A2A03061721

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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