Behavioural Insomnia of Childhood
Conditions
Keywords
infant, sleep intervention, clinical cohort, toddler, self-regulation
Brief summary
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.
Interventions
BEHAVIORALParental 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 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.
Sponsors
Children's Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
1. Children aged 6-36 months 2. Diagnosed with behavioural insomnia (sleep latency \> 20 minutes and/or ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes) 3. Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems) 4. Parental consent for participation
Exclusion criteria
1. Chronic diseases 2. History of head trauma 3. Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome) 4. Developmental delay, epilepsy, or other neurological/metabolic disorders 5. Participation in a new intervention program within the past 4 weeks, and/or initiation of new medication within the past 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep efficiency (SE) measured by Actigraphy | Baseline, 1 month, 6 months and 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep onset latency (SOL) measured by Actigraphy | Baseline, 1 month, 6 months and 12 months | 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. |
| Wake after sleep onset (WASO) measured by Actigraphy | Baseline, 1 month, 6 months, and 12 months | 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. |
| The number of nighttime awakenings (NW) measured by Actigraphy | Baseline, 1 month, 6 months and 12 months | 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. |
| Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ) | Baseline, 1 month, 6 months, and 12 months | 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. |
| Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS) | Baseline, 1 month, 6 months, and 12 months | ISAS and TSAS were developed and validated by the Provincial Research Working Group of Chinese Infant and Toddler Sleep Assessment Scale for children aged 4-11 months and 12-35 months, respectively. Total scores, derived from all items, reflect sleep quality, with responses rated on a four-point Likert scale of 1 to 4. Higher scores indicate poorer sleep quality. |
| Self-regulation ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2) | Baseline, 1 month, 6 months, and 12 months | The ASQ:SE-2 is an internationally recognised developmental screening tool for assessing social-emotional development in children aged 1 to 72 months. The questionnaire assesses a child's development across 7 specific behavioural dimensions: 1. Self-Regulation: ability to calm or settle themselves. 2. Compliance: ability to follow rules and respond to limits. 3. Social-Communication: use of gestures, sounds, and words to interact with others. 4. Adaptive Functioning: ability to manage daily routines like eating, sleeping, and toileting. 5. Autonomy: ability to act independently and demonstrate self-confidence. 6. Affect: expression of feelings and emotions. 7. Interpersonal interaction: ability to engage with parents, other adults and children. A higher score indicates more concerning behaviours. |
Countries
China
Outcome results
None listed