[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543009":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":43,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":19,"overallStatus":28,"whyStopped":19,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"University of South Florida","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SLEEP: COPE","EXPERIMENTAL","Content includes both standard CBT-I techniques \\[sleep hygiene, stimulus control, sleep restriction, cognitive therapy\\] as well as those targeting children with ODD and their parents. Active child participation is a goal but may be limited due to age\u002Fabilities. Parents will work with children to implement behavioral strategies.",[13],"Behavioral: SLEEP: COPE",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","Standard CBT-I techniques along with modules targeting noncompliance in children with ODD and their parents.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Melanie A Stearns, PhD","CONTACT","8139748110","mstearns@usf.edu",[27],{"facility":5,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"RECRUITING","Tampa","Florida","33620-8100","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-82.45843,27.94752,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":19,"phoneExt":19,"email":25},"Melanie Stearns, PhD",{"type":44,"investigatorFullName":45,"investigatorTitle":46,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Melanie Stearns","Assistant Professor","100543009","sleep-cope-sleep-intervention-for-oppositional-children-100543009",false,"NCT06350292","SLEEP-COPE: Sleep Intervention for Oppositional Children","SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions","Inclusion criteria:\n\n1. Child ages 8-12 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child\u002Fparent participation in another randomized research project\n4. Parent 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\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation","ALL","8 Years","12 Years",{"count":58,"type":59},25,"ESTIMATED","INTERVENTIONAL",[62],"NA","Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.",[65,66],"Insomnia Chronic","Oppositional Defiant Disorder","2025-03-24",{"date":69,"type":70},"2025-03-28","ACTUAL",{"date":72,"type":70},"2024-04-01",{"date":74,"type":59},"2025-10-01",{"name":5,"class":6},1]