[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599950":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":23,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":23,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":32,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I","EXPERIMENTAL","Immediate CBT-I for typically developing children using a 4-session digital intervention.",[13],"Behavioral: CBT-I",{"label":15,"type":6,"description":16,"interventionNames":17},"Waitlist Control","Participants in the waitlist control will have delayed treatment (4 weeks later).",[13],[19],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"BEHAVIORAL","Cognitive behavioral therapy for insomnia",[9,15],null,[25],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Christina S McCrae, PhD","CONTACT","813-974-1804","christinamccrae@usf.edu",[31],{"facility":5,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-82.45843,27.94752,{"lat":42,"lon":41},[45],{"name":26,"role":27,"phone":23,"phoneExt":23,"email":23},{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Christina McCrae","Professor","100599950","digital-cognitive-behavioral-treatment-of-insomnia-in-youth-an-rct-examining-feasibility-acceptability-and-efficacy-of-nitecapp-jr-100599950",false,"NCT07091149","Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr","NiteCAPP JR","Inclusion Criteria:\n\nChild inclusion:\n\n1. 6-12 yrs\n2. Verbal IQ \\> 70 (to ensure verbal skills are sufficient to participate in treatment)\n3. participation of child's parent or legal guardian living in the same home\n4. child diagnosed with insomnia, 5) willing to accept random assignment.\n\nInsomnia:\n\n1\\) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and\u002For waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score \\>8\n\nCaregiver inclusion:\n\n1. ability to read and understand English at the 5th grade level\n2. willing to accept random assignment.\n\nExclusion Criteria:\n\nChild exclusion:\n\n1. child unable to provide informed consent or child unable to provide assent\n2. child unwilling to accept random assignment\n3. child participation in another randomized research project\n4. child unable to complete forms or implement treatment procedures due to cognitive impairment\n5. child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin as described in #7 (see Notes below for details)\n7. child stimulants, sleep medications (prescribed or OTC), and\u002For melatonin within the last 1 month (unless stabilized on medication for 3+ months)\n8. child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n9. child other conditions adversely affecting trial participation.\n\nCaregiver exclusion criteria:\n\n1. unable to provide informed consent\n2. unwilling to accept random assignment\n3. caregiver participation in another randomized research project\n4. unable to complete forms or implement treatment procedures due to cognitive impairment\n5. caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial","ALL","6 Years","12 Years",{"count":61,"type":62},40,"ESTIMATED","INTERVENTIONAL",[65],"NA","The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.",[68],"Insomnia",[70,71,72,73],"dCBTi","digital intervention","insomnia","children","2026-06-11",{"date":76,"type":77},"2026-06-15","ACTUAL",{"date":79,"type":77},"2025-04-10",{"date":81,"type":62},"2027-05-01",{"name":5,"class":6},1]