[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"preschool-child-development\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:preschool-child-development":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100656280","efficacy-of-a-group-based-and-digital-parent-sleep-intervention-in-hk-preschoolers-with-ndds-100656280",false,"NCT07822490","Efficacy of a Group-based and Digital Parent Sleep Intervention in HK Preschoolers With NDDs","Efficacy of a Group-based and Digital Parent Sleep Intervention in Hong Kong Preschoolers With Neurodevelopmental Disorders (NDD) on Sleep and Behaviors: A Three-arm Randomized Controlled Trial","Inclusion Criteria:\n\n1. Cantonese-speaking preschoolers aged 2 to 7 years and their parents\n2. Children currently studying in a kindergarten in Hong Kong\n3. Clinical DSM-5 diagnosis within the category of neurodevelopmental disorders (NDDs)\n4. Presence of child sleep disturbances, defined as a score ≥52 on the Children's Sleep Habits Questionnaire (CSHQ)\n5. Written informed consent provided by a parent or legal guardian\n\nExclusion Criteria:\n\n1. Children with a prominent medical condition known to interfere with sleep continuity and quality (e.g., severe eczema)\n2. Children or parents with a physical or mental condition requiring more intensive clinical intervention (e.g., parental intellectual disability)\n3. Children currently receiving regular medical or psychological treatment for existing sleep problems\n4. Children with a past history of physical or psychological abuse\n5. Parents lacking parenting capacity or the ability to care for the child's daily living activities due to psychological or medical reasons","ALL","2 Years","7 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Neurodevelopmental disorders (NDDs) in preschoolers are frequently accompanied by persistent sleep disturbances, such as delayed sleep onset and reduced sleep duration, which exacerbate behavioral problems, impair cognitive development, and increase parental stress. While behavioral parent education effectively improves sleep hygiene, access to in-person clinical programs remains limited by high parent dropout rates. Digital delivery offers a flexible, scalable alternative, yet randomized controlled trials (RCTs) evaluating both face-to-face and self-help mobile app formats specifically for preschoolers across NDDs remain scarce. This study is a three-arm RCT designed to evaluate and compare the efficacy of a parent-based sleep intervention delivered via face-to-face group sessions combined with usual care (UC) versus a digital self-help mobile application combined with UC, against UC alone in Hong Kong preschoolers with NDDs. The study also assesses downstream effects on child daytime behaviors, parental stress, and parent sleep\u002Fmood outcomes over a 12-month period.",[27,28,29],"Neurodevelopmental Disorders (NDD)","Preschool Child Development","Sleep",[31,32,33,29,34,35,36],"Randomized Controlled Trial","Neurodevelopmental Disorders","Early Childhood","Parent-Based Intervention","Actigraphy","Digital Intervention","NOT_YET_RECRUITING","2026-09-10",{"date":40,"type":41},"2026-09-16","ACTUAL",{"date":43,"type":21},"2026-09-15",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"Chinese University of Hong Kong","OTHER"]