[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625274":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Children's Hospital of Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"infants and toddlers with behavioural insomnia","EXPERIMENTAL","Session 1\n\n* Baseline feedback: Interpret parental sleep reports, actigraphy, and questionnaire data.\n* Daily schedule adjustment: Review current routines and guide age-appropriate daily adjustments.\n* Sleep environment modification: Introduce optimal sleep environment settings.\n* Bedtime routine development:Demonstrate how to establish an individualised bedtime routine .\n* Putting to bed drowsy but awake: Introduce signals of sleepiness and highlight the principle.\n* Graduated extinction: Detailed guidance on graduated extinction, in which parents delay responding to children's nighttime crying.\n* Parental rehearsal: Conduct parental rehearsal and provide tracking booklets with sleep diaries.\n\nSession 2\n\n* Implementation review: Assess implementation feedback and troubleshoot barriers.\n* Sleep education: Deliver education on paediatric sleep architecture and developmental impacts.\n* Individualized adjustment: Provide tailored protocol modifications based on individual feedback.",[13],"Behavioral: Parental sleep enhancement intervention",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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 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.",[9],null,[22],{"facility":23,"status":20,"city":24,"state":25,"zip":20,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Childrens' Hospital of Soochow University","Suzhou","Jiangsu","China","CN",{"type":29,"coordinates":30},"Point",[31,32],120.59538,31.30408,{"lat":32,"lon":31},[35],{"name":36,"role":37,"phone":38,"phoneExt":20,"email":39},"Tingyu Rong, Doctor","CONTACT","86+0512-80691135","tyrong@suda.edu.cn",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Tingyu Rong","Resident\u002FAssistant research fellow","100625274","a-longitudinal-study-of-parental-sleep-intervention-for-behavioral-insomnia-in-early-childhood-100625274",false,"NCT07420504","A Longitudinal Study of Parental Sleep Intervention for Behavioral Insomnia in Early Childhood","Efficacy of Parental Sleep Intervention on Infants and Toddlers With Behavioural Insomnia: A Longitudinal Follow-up Study","SuSleep","Inclusion Criteria:\n\n1. Children aged 6-36 months\n2. Diagnosed with behavioural insomnia (sleep latency \\> 20 minutes and\u002For ≥ 2 nighttime awakenings per night, each lasting at least 5 minutes)\n3. Daytime functional impairment (eg., excessive sleepiness, inattention, emotional problems)\n4. Parental consent for participation\n\nExclusion Criteria:\n\n1. Chronic diseases\n2. History of head trauma\n3. Other primary sleep disorders (e.g., obstructive sleep disorder, narcolepsy, restless leg syndrome)\n4. Developmental delay, epilepsy, or other neurological\u002Fmetabolic disorders\n5. Participation in a new intervention program within the past 4 weeks, and\u002For initiation of new medication within the past 4 weeks.","ALL","6 Months","36 Months",{"count":56,"type":57},30,"ESTIMATED","INTERVENTIONAL",[60],"NA","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.",[63],"Behavioural Insomnia of Childhood",[65,66,67,68,69],"infant","sleep intervention","clinical cohort","toddler","self-regulation","NOT_YET_RECRUITING","2026-07-08",{"date":73,"type":74},"2026-07-10","ACTUAL",{"date":76,"type":57},"2026-08",{"date":78,"type":57},"2028-08",{"name":5,"class":6},1]