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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorChildren's Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Parental sleep enhancement intervention

    Behavioral

    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 will accommodate a maximum of three families. Adherence to the intervention will be enhanced through health education on child sleep, sharing each child's sleep status to guide tailored intervention plans, as well as providing timely sleep and developmental reports during the intervention and at each follow-up visit.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: infants and toddlers with behavioural insomniaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sleep efficiency (SE) measured by Actigraphy

Sleep efficiency is defined as the percentage of total sleep time (sleep period determined by the actigraphy) to the total time spent in bed (from the time children go to bed to the time they finally get up in the morning). A higher percentage reflects more continuous and higher-quality sleep. As SE is closely related to SOL and nighttime awakings, it is selected as the primary outcome of the current study.Through the built-in accelerometer and other sensors, the actigraphy can be used to monitor an individual's activity level and sleep situation, thereby analysing the child's sleep patterns such as sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measures. Moreover, the actigraphy is validated with parental records of sleep diaries.

Time frame
Baseline, 1 month, 6 months and 12 months

Secondary outcomes

1

Sleep onset latency (SOL) measured by Actigraphy

In this study, SOL serves as the indicator of sleep initiation difficulty, with a threshold exceeding 20 minutes indicating prolonged sleep onset. Improvement in SOL (i.e., shortened latency) following the intervention will suggest enhanced self-regulation capacity and reduced reliance on parental assistance at bedtime. Moreover, the actigraphy is validated with parental records of sleep diaries.

Time frame
Baseline, 1 month, 6 months and 12 months
2

Wake after sleep onset (WASO) measured by Actigraphy

Wake after sleep onset (WASO) is defined as the total duration of wakefulness between initial sleep onset and final morning awakening. Longer WASO indicates poorer nighttime sleep quality. Improvements (reductions) following intervention indicate better sleep consolidation. Moreover, the actigraphy is validated with parental records of sleep diaries.

Time frame
Baseline, 1 month, 6 months, and 12 months
3

The number of nighttime awakenings (NW) measured by Actigraphy

The number of nighttime awakenings (NW) refers to the total number of awakening events lasting more than 5 minutes per night. A frequency of two or more awakenings per night may indicate poor nighttime sleep quality. This indicator will be reported to assess the degree of fragmentation of nighttime sleep. Improvements (reductions) following intervention indicate better sleep consolidation. Moreover, the actigraphy is validated with parental records of sleep diaries.

Time frame
Baseline, 1 month, 6 months and 12 months
4

Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ)

BISQ is a parent-reported instrument designed to screen for sleep problems in infants and toddlers. This study will use the standardised Chinese version, which covers multiple aspects of early childhood sleep, including sleep onset conditions, total sleep duration, nighttime awakenings, co-sleeping, and overall sleep patterns.

Time frame
Baseline, 1 month, 6 months, and 12 months

Other outcomes

1

Maternal excessive daytime sleepiness measured by the Epworth Sleepiness Scale (ESS)

Maternal daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS), an 8-item self-reported questionnaire employing a 4-point Likert scale of 0 to 3. It measures how likely a person is to doze off or fall asleep in 8 common, sedentary situations of daily life. Higher scores indicate greater daytime sleepiness, with a score of 10 or above indicating excessive daytime sleepiness.

Time frame
Baseline, 1 month, 6 months, and 12 months
2

Maternal mental health measured by the World Health Organisation Five Well-Being Index (WHO-5)

Maternal mental health will be assessed using the World Health Organization Five Well-Being Index (WHO-5), a 5-item self-reported questionnaire employing a 6-point Likert scale of 0 to 5. These items reflect positive mood, vitality, and general interests over the preceding 14 days. Higher scores indicate greater well-being.

Time frame
Baseline, 1 month, 6 months and 12 months
3

Maternal parenting stress measured by the Parenting Stress Index-Short Form (PSI-SF)

Maternal parenting stress will be assessed using the Parenting Stress Index-Short Form (PSI-SF), a 36-item parent-reported questionnaire consisting of three subscales including parental distress, parent-child dysfunctional interaction, and difficult child. The total score ranges from 36 to 180. A score of 85 or less indicates a normal level of parental stress. A score between 86 and 90 represents a critically high level. A score greater than 90 suggests a high level of parental stress, and a score of 99 or above indicates an extremely high level of parental stress.

Time frame
Baseline, 6 months and 12 months
4

Maternal occupational stress measured by the Chinese Version of Copenhagen Psychosocial Questionnaire (COPSOQ)

Maternal occupational stress will be assessed using the short version of the Copenhagen Psychosocial Questionnaire (COPSOQ), a 44-item self-reported questionnaire consisting of eight subscales. Higher scores in the job demands and job insecurity subscales reflect greater occupational stress, whereas higher scores in the personal impact and development, interpersonal relationships and leadership, and job satisfaction subscales indicate lower levels of occupational stress.

Time frame
Baseline and 12 months

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