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
BEHAVIORALSleep enhancement intervention
1. Establish a consistent and regular pre-bedtime routine. Individual activities suitable for infants include bathing, touching, story reading, and etc are selected. The whole activity process should gradually move to the children's bedroom and end in the children's bedroom, so that children can gradually establish the relationship between the bedroom, bed and sleep. 2. Place infants on the bed when they are on the verge of falling asleep. Guide parents to recognize the signs of children's sleepiness. Put them on the bed when the child sends sleepy signals but while still awake, which will improve their ability to fall asleep independently. 3. Method of graduated extinction. Caregivers are allowed to briefly comfort the child after a period of crying. The waiting time of the progressive method depends on the specific situation. Parents wait a few minutes after the child gives a crying signal before going to comfort them, and gradually extend the waiting time.
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 0-3 years. 2. Diagnosed with behavioural insomnia. 3. Parental consent for participation.
Exclusion criteria
1. Chronic diseases or history of head trauma. 2. Other primary sleep disorders (e.g., OSA, narcolepsy, restless leg syndrome). 3. Developmental delay, epilepsy, or other neurological/metabolic disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nighttime sleep efficiency 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 watch) to the total time spent in bed (from the time children try to fall asleep to the time they finally wake up in the morning). A higher percentage represents a more continuous and higher-quality night's sleep. 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 nighttime sleep efficiency. The team technician will export the relevant sleep indicators recorded by the actigraphy and calculate relevant outcome measure. Moreover, the actigraphy is validated with parental records of sleep diaries. |
| Daytime napping pattern measured by Actigraphy | Baseline, 1 month, 6 months and 12 months | Record children's sleep behaviour during the day with the actigraphy. Two main indicators are evaluated: 1. Number of naps: the number of independent sleep events that occurred during the day and lasted to the actigraphy's recognition criteria. 2. Total nap duration: cumulative time (minutes) for all sleep events during the day (defined as the time between the last awakening in the morning and the time you go to bed at night). This outcome measure is mainly reflected by the average time of daytime napping per day, which will be reported at different points to assess sleep-wake distribution throughout the day. |
| Nocturnal awakening pattern measured by Actigraphy | Baseline, 1 month, 6 months, and 12 months | The actigraphy is used to objectively quantify wakefulness events during nighttime sleep. Two main indicators are evaluated: 1. Number of awakenings: the total number of awakening events that meet the actigraphy's recognition criteria each time during the main sleep period. 2. Total Awakening Duration: the cumulative time (minutes) of all awakening events that meet the criteria. This outcome measure is reflected by the average total duration of nocturnal awakenings per day, which will be reported to assess the degree of fragmentation of nighttime sleep. |
| Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ) | Baseline, 1 month, 6 months, and 12 months | BISQ is a questionnaire tool used to assess the sleep of infants. The questionnaire aims to collect information on infant sleep behaviour through parent-reported methods to help professionals more fully understand and evaluate infants' sleep quality and patterns. This questionnaire evaluates the changes in children's sleep duration, co-sleeping situation, night-waking situation, falling-asleep situation, and overall sleep patterns. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-regulating ability measured by the Age and Stage Questionnaires: Social and Emotional-2 (ASQ:SE-2) | Baseline, 1 month, 6 months, and 12 months | ASQ:SE-2 is a screening tool used to identify infants and young children who may be at risk for social or emotional difficulties. It relies on parents' or caregivers' observations of their child's behaviour. The questionnaire assesses a child's development across 8 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. Interaction with People: ability to engage with parents, other adults and children. 8. Overall (a general section for additional comments). A higher score indicates more concerning behaviours. |
| Temperament measured by the series of Carey Children Temperament Questionnaire | Baseline and 12 months | This instrument employs a standardized assessment to evaluate innate behavioral patterns and reactivity in infants. Derived from the Thomas and Chess taxonomy, it measures core temperament dimensions including activity level, rhythmicity, adaptability, approach/withdrawal, threshold of responsiveness, intensity of reaction, quality of mood, distractibility, abd persistence. The resulting profile aids in researching individual differences in developmental trajectories and informing individualized caregiving and educational strategies. |
Outcome results
None listed