A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parental sleep enhancement intervention.
- Who it may be relevant to
- Registry conditions: Behavioural Insomnia of Childhood. Basic parameters: 6 months — 36 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
Overview
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
- Behavioral 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
Primary outcome measures
- Sleep efficiency (SE) measured by Actigraphy [Time frame: Baseline, 1 month, 6 months and 12 months]
Secondary outcome measures (6)
- Sleep onset latency (SOL) measured by Actigraphy [Time frame: Baseline, 1 month, 6 months and 12 months]
- Wake after sleep onset (WASO) measured by Actigraphy [Time frame: Baseline, 1 month, 6 months, and 12 months]
- The number of nighttime awakenings (NW) measured by Actigraphy [Time frame: Baseline, 1 month, 6 months and 12 months]
- Subjective sleep quality measured by the Brief Infant Sleep Questionnaires (BISQ) [Time frame: Baseline, 1 month, 6 months, and 12 months]
- Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS) [Time frame: 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) [Time frame: Baseline, 1 month, 6 months, and 12 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Childrens' Hospital of Soochow University — Suzhou
Identifiers
NCT: NCT07420504 · 2025CS038