A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood

Официальное название

Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study

Обзор

The global incidence of mental illness among children and adolescents is rising, drawing increasing attention to early risk factors and preventive strategies. Behavioral sleep problems, which affect up to 50% of infants in the local population, are closely linked to impaired self-regulation-a core factor underlying many psychological disorders and a promising target for early intervention. Enhancing self-regulation may not only alleviate sleep problems but also mitigate long-term mental health risks. This study aims to develop an intervention toolkit based on current guidelines and high-quality evidence, integrating parent education with dynamic sleep assessment and longitudinal evaluation of self-regulation in infants. The project seeks to establish the efficacy of this approach, identify moderators of intervention outcomes, and provide an evidence base for personalized sleep interventions in clinical practice.

Вмешательства

• Поведенческое Parental sleep enhancement intervention
  The sleep intervention toolkit for this project is designed based on relevant research and guidelines. Two structured parental intervention sessions, each lasting 2 hours, will be conducted by qualified paediatricians in an intervention room within the Department of Child Health. The first session will be held within 2 weeks after the baseline evaluation, followed by the second session 2 weeks later. Up to 3 caregivers per child may attend, at least one of whom must be a parent. Each session wil

Первичные конечные точки

• Sleep efficiency (SE) measured by Actigraphy [Срок оценки: Baseline, 1 month, 6 months and 12 months]

Вторичные конечные точки (6)

• Sleep onset latency (SOL) measured by Actigraphy [Срок оценки: Baseline, 1 month, 6 months and 12 months]
• Wake after sleep onset (WASO) measured by Actigraphy [Срок оценки: Baseline, 1 month, 6 months, and 12 months]
• The number of nighttime awakenings (NW) measured by Actigraphy [Срок оценки: Baseline, 1 month, 6 months and 12 months]
• Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ) [Срок оценки: Baseline, 1 month, 6 months, and 12 months]
• Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS) [Срок оценки: Baseline, 1 month, 6 months, and 12 months]
• Self-regulation ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2) [Срок оценки: Baseline, 1 month, 6 months, and 12 months]

Критерии участия

Критерии включения

• Children aged 6-36 months
• Diagnosed with behavioural insomnia (sleep latency > 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes)
• Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems)
• Parental consent for participation

Критерии исключения

• Chronic diseases
• History of head trauma
• Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome)
• Developmental delay, epilepsy, or other neurological/metabolic disorders
• Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Childrens' Hospital of Soochow University — Сучжоу

Идентификаторы

NCT: NCT07420504 · 2025CS038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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