[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609386":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":38,"studyPopulation":38,"armGroups":47,"interventions":60,"overallOfficials":69,"centralContacts":73,"locations":79,"responsibleParty":114,"collaborators":117,"id":119,"slug":38,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":38,"eligibilityCriteria":123,"healthyVolunteers":124,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":38,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":81,"whyStopped":38,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Children's Hospital Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline for total score sleep quality using the Pittsburgh Sleep Quality Index.","A self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The sum of scores yields one global score with a minimum score of 0 and a maximum score of 21. A higher score indicates more self-reported sleep problems.","Baseline to 14 months",[14,17,20,23,26,29,32,35],{"measure":15,"description":16,"timeFrame":12},"Change from baseline for total insomnia severity score sleep health using the insomnia severity index.","7-item scale assessing the perceived severity of insomnia symptoms. The sum of scores yields a total score with a minimum score of 0 and a maximum score of 28. A higher score indicates more severe insomnia symptoms.",{"measure":18,"description":19,"timeFrame":12},"Change from baseline for total evening circadian preference score sleep health using the Children's Morningness and Eveningness Preference.","Evening Circadian Preference is a reliable and valid 10-item measure of circadian preference among youth",{"measure":21,"description":22,"timeFrame":12},"Change from baseline for total sleep related impairment score sleep health using the PROMIS sleep related impairment questionnaire.","PROMIS is a well-validated 8-item measure which assesses self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. A total raw score can range from 8 to 40, with a higher score indicating more sleep related impairment.",{"measure":24,"description":25,"timeFrame":12},"Change from baseline for sleep duration estimates from sleep diaries.","Sleep diary asks participants about daily morning estimates of sleep the night prior parameters yield a reliable and valid clinical index of self-reported sleep duration.",{"measure":27,"description":28,"timeFrame":12},"Change from baseline for quality of life and functioning using the PROMIS Global Health Questionnaire.","The PROMIS Scale Global Health is a ten-item patient reported measure of physical, mental and social health.",{"measure":30,"description":31,"timeFrame":12},"Change from baseline for academic functioning using official transcripts provided by participants.","Academic Functioning Youth participants will be asked to provider their official academic transcripts.",{"measure":33,"description":34,"timeFrame":12},"Change from baseline for overall mental health using your self-report (youth)","Youth Self-Report (YSR) is a widely used self-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 224 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.",{"measure":36,"description":37,"timeFrame":12},"Change from baseline for overall mental health using child-behavior checklist (parent).","Child Behavior Checklist (CBCL) completed by parents is a widely used child-report measure that assesses problem behaviors across multiple domains and provides a summary of total problems which can range from 0 to 198 in raw scores; a higher score indicates more self-reported problems. Raw scores are converted to standardized T-scores, which are adjusted for age and gender and are used to compare a youth's score to a normative sample.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","CROSSOVER","TREATMENT",{"masking":44,"maskingDescription":38,"whoMasked":45},"SINGLE",[46],"PARTICIPANT",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Sleep Health Education (SHE)","ACTIVE_COMPARATOR","Participants will be given access to a program, developed for the proposed project, with American Academy of Sleep Medicine (AASM) videos, worksheets and sleep diaries aimed to improve sleep health.",[53],"Behavioral: Sleep Health Education (SHE)",{"label":55,"type":56,"description":57,"interventionNames":58},"Transdiagnostic Sleep and Circadian intervention (TS-C-STEP","EXPERIMENTAL","In the TS-C-STEP condition, all participants initially are given access to the TS-C program. TS-C is an evidence based cognitive behavioral sleep intervention. Youth will be stepped up to higher levels of care dependent on their progress with the program.",[59],"Behavioral: TS-C-STEP",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":38},"BEHAVIORAL","TS-C-STEP","Cognitive behavioral sleep intervention.",[55],{"type":62,"name":49,"description":67,"armGroupLabels":68,"otherNames":38},"Health Education",[49],[70],{"name":71,"affiliation":5,"role":72},"Lauren Asarnow,, PhD","PRINCIPAL_INVESTIGATOR",[74],{"name":75,"role":76,"phone":77,"phoneExt":38,"email":78},"Mariam Adeyeba, PhD","CONTACT","3233569224","madeyeba@chla.usc.edu",[80,97],{"facility":5,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"RECRUITING","Los Angeles","California","90027","United States","US",{"type":88,"coordinates":89},"Point",[90,91],-118.24368,34.05223,{"lat":91,"lon":90},[94,95],{"name":75,"role":76,"phone":77,"phoneExt":38,"email":78},{"name":96,"role":72,"phone":38,"phoneExt":38,"email":38},"Lauren Asarnow, PhD",{"facility":98,"status":81,"city":99,"state":100,"zip":101,"country":85,"countryCode":86,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":88,"coordinates":103},[104,105],-82.99879,39.96118,{"lat":105,"lon":104},[108,112],{"name":109,"role":76,"phone":110,"phoneExt":38,"email":111},"Jacob Holycross","614.938.0169","Jacob.Holycross@nationwidechildrens.org",{"name":113,"role":72,"phone":38,"phoneExt":38,"email":38},"Jennifer Hughes, PhD",{"type":72,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Lauren Asarnow","Medical Staff\u002FUSC Faculty CWR • Neurology CWR",[118],{"name":98,"class":6},"100609386",false,"NCT07213908","Comparing Two School-Based Sleep Health Interventions To Promote Sleep Quality in Youth","Inclusion Criteria:\n\n* Age 12-18 years old\n* Sleep health problem (i.e. insomnia, evening circadian preference, short sleep duration, poor sleep quality)\n* Able to participate in a general education classroom.\n\nExclusion Criteria:\n\n* Previous participation in the study;\n* Symptoms or illness that precludes informed consent or engagement in study procedures ; youth not fluent in English, parent not fluent in English, or Spanish.",true,"ALL","12 Years","18 Years",{"count":129,"type":130},1320,"ESTIMATED","INTERVENTIONAL",[133],"NA","The goal of this clinical trial is to conduct a comparative effectiveness trial that will evaluate two school-based interventions to improve adolescent sleep health: the standard Sleep Health Education (SHE) and a stepped care version of the Transdiagnostic Sleep and Circadian intervention (TS-C-STEP). The main questions it aims to answer \\[is\u002Fare\\]:\n\n* TS-C-STEP will yield superior outcomes relative to SHE at post-treatment and up to 12 months following treatment.\n* In this large and diverse sample, vulnerable subgroups (e.g. socioeconomically disadvantaged, racial, ethnic, rural, and youth with comorbid learning and\u002For mental health conditions) will experience greater benefits from TS-C-STEP compared to SHE on primary and secondary outcomes.\n\nResearchers will compare sleep quality to determine which intervention is most effective.",[136],"Sleep",[138,136,139,140],"Adolescents","Schools","Cognitive Behavioral Sleep Intervention","2026-05-21",{"date":143,"type":144},"2026-05-26","ACTUAL",{"date":146,"type":144},"2026-03-31",{"date":148,"type":130},"2030-06-01",{"name":5,"class":6},2]