Behavioural Insomnia of ChildhoodSuSleepNCT07420504
A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood
A study testing Parental sleep enhancement intervention in people with Behavioural Insomnia of Childhood, run by Children's Hospital of Soochow University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Behavioural Insomnia of Childhood
- What is being tested?
- Parental sleep enhancement intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Childrens' Hospital of Soochow University
Suzhou, Jiangsu
Tingyu Rong, Doctor, 86+0512-80691135, tyrong@suda.edu.cn
About this study
Official title: Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
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.
- Conditions
- Behavioural Insomnia of Childhood
- Being tested
- Parental sleep enhancement intervention
- Keywords
- infant, sleep intervention, clinical cohort, toddler, self-regulation
- Medical subject headings
- Self-Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parental sleep enhancement interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| infants and toddlers with behavioural insomnia | Experimental | Session 1
* Baseline feedback: Interpret parental sleep reports, actigraphy, and questionnaire data.
* Daily schedule adjustment: Review current routines and guide age-appropriate daily adjustments.
* Sleep environment modification: Introduce optimal sleep environment settings.
* Bedtime routine development:Demonstrate how to establish an individualised bedtime routine .
* Putting to bed drowsy but awake: Introduce signals of sleepiness and highlight the principle.
* Graduated extinction: Detailed guidance on graduated extinction, in which parents delay responding to children's nighttime crying.
* Parental rehearsal: Conduct parental rehearsal and provide tracking booklets with sleep diaries.
Session 2
* Implementation review: Assess implementation feedback and troubleshoot barriers.
* Sleep education: Deliver education on paediatric sleep architecture and developmental impacts.
* Individualized adjustment: Provide tailored protocol modifications based on individual feedback. Receives: Behavioral: Parental sleep enhancement intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 6 months and 12 months
Secondary outcomes (6)
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.
Measured: Baseline, 1 month, 6 months and 12 months
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.
Measured: Baseline, 1 month, 6 months, and 12 months
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.
Measured: Baseline, 1 month, 6 months and 12 months
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.
Measured: Baseline, 1 month, 6 months, and 12 months
Subjective sleep quality measured by the Infant/Toddler Sleep Assessment Scale (ISAS/TSAS)
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.
Measured: 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)
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:
- Self-Regulation: ability to calm or settle themselves.
- Compliance: ability to follow rules and respond to limits.
- Social-Communication: use of gestures, sounds, and words to interact with others.
- Adaptive Functioning: ability to manage daily routines like eating, sleeping, and toileting.
- Autonomy: ability to act independently and demonstrate self-confidence.
- Affect: expression of feelings and emotions.
- Interpersonal interaction: ability to engage with parents, other adults and children.
A higher score indicates more concerning behaviours.
Measured: Baseline, 1 month, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioural Insomnia of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingyu Rong, Children's Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420504
- Sponsor's protocol ID
- 2025CS038
- Acronym
- SuSleep
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected in this study will not be made available for sharing. The informed consent obtained from the participants does not include provision for public data sharing. To protect participant privacy and confidentiality, and in accordance with the ethical approvals governing this study, the data will be kept securely by the research team and will not be deposited in a public repository.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study
- ClinicalTrials.gov ID
- NCT07420504
- Acronym / sponsor ID
- SuSleep / 2025CS038
- Conditions
- Behavioural Insomnia of Childhood
- Keywords
- infant, sleep intervention, clinical cohort, toddler, self-regulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Children's Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infants and toddlers with behavioural insomnia | Experimental | Behavioral: Parental sleep enhancement interventionSession 1 * Baseline feedback: Interpret parental sleep reports, actigraphy, and questionnaire data. * Daily schedule adjustment: Review current routines and guide age-appropriate daily adjustments. * Sleep environment modification: Introduce optimal sleep environment settings. * Bedtime routine development:Demonstrate how to establish an individualised bedtime routine . * Putting to bed drowsy but awake: Introduce signals of sleepiness and highlight the principle. * Graduated extinction: Detailed guidance on graduated extinction, in which parents delay responding to children's nighttime crying. * Parental rehearsal: Conduct parental rehearsal and provide tracking booklets with sleep diaries. Session 2 * Implementation review: Assess implementation feedback and troubleshoot barriers. * Sleep education: Deliver education on paediatric sleep architecture and developmental impacts. * Individualized adjustment: Provide tailored protocol modifications based on individual feedback. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parental sleep enhancement interventionThe 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. | Behavioural | infants and toddlers with behavioural insomnia |
Primary outcome
Sleep efficiency (SE) measured by Actigraphy
Time frame: 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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No. The individual participant data collected in this study will not be made available for sharing. The informed consent obtained from the participants does not include provision for public data sharing. To protect participant privacy and confidentiality, and in accordance with the ethical approvals governing this study, the data will be kept securely by the research team and will not be deposited in a public repository.
Related trials for Behavioural Insomnia of Childhood
Recruiting
Development of Sleep Intervention for Parent and Child
Behavioral Insomnia of Childhood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parental sleep enhancement intervention in people with Behavioural Insomnia of Childhood, run by Children's Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (SE) measured by Actigraphy (time frame: Baseline, 1 month, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.