[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100333674":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":29,"armGroups":41,"interventions":54,"overallOfficials":62,"centralContacts":66,"locations":74,"responsibleParty":91,"collaborators":29,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":29,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":29,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":114,"overallStatus":119,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Stockholm University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Change in sleep impairment by using The Insomnia Severity Index (ISI)","The ISI is a seven-item measure that yields a quantitative index of sleep impairment and treatment outcome. Participants rate the following components on a 5-point Likert scale ranging from 0 (not at all) to 4 (extremely): (a) severity of sleep-onset, sleep-maintenance, and early morning awakening problems; (b) satisfaction with current sleep pattern; (c) interference with daily functioning; (d) noticeability of impairment attributed to the sleep problem; and (e) level of distress caused by the sleep problem. Total scores range from 0 to 28, with higher scores indicating greater perceived insomnia severity.","Baseline, post intervention (8 weeks), 3 months post intervention follow-up and 6 months post intervention follow-up",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Sleep diaries by using Actigraphy","An actigraph is a small instrument worn on the wrist or ankle to measure body movement and nighttime sleep parameters.",{"measure":18,"description":19,"timeFrame":12},"Quality of sleep by using Athens Insomnia Scale (AIS)","AIS is a self-administered questionnaire assessing the quality of sleep.",{"measure":21,"description":22,"timeFrame":12},"Everyday functioning by using Developmental disabilities modification of the Children's Global Assessment scale (DD-CGAS)","The DD-CGAS is an instrument used by clinicians to rate patients' global everyday functioning.",{"measure":24,"description":25,"timeFrame":12},"Anxiety problems by using Spence Children's Anxiety Scale","The SCAS is a 38-item parent report measure of children's anxiety.",{"measure":27,"description":28,"timeFrame":12},"Emotion regulation difficulties by using The brief version of Difficulties in Emotion Regulation Scale (DERS-16)","The DERS-16 is a brief version of self-report measure of emotion regulation difficulties.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Sleep problems are common in adolescents with autism spectrum disorder (ASD)1. Internet-based Cognitive behaviour therapy for insomnia (iCBT-I) is considered as an evidence-based treatment for insomnia 2. To date, no Internet-based CBT-I delivered treatment for sleep problems in adolescents with ASD has been undertaken. The objective of the study is to investigate the efficacy and effectiveness of the Internet-based CBT-I for sleep problems in adolescents with ASD.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Internet-based CBT-I","EXPERIMENTAL","N= 120 participants are offered Internet-based Cognitive behaviour therapy for insomnia (CBT-I)",[47],"Behavioral: Internet-based CBT-I",{"label":49,"type":50,"description":51,"interventionNames":52},"Internet-based psychoeducation","ACTIVE_COMPARATOR","N= 120 participants are offered Internet-based psychoeducation about sleep problems in ASD.",[53],"Behavioral: Internet-based psychoeducation",[55,59],{"type":56,"name":43,"description":57,"armGroupLabels":58,"otherNames":29},"BEHAVIORAL","The adapted Internet-based CBT-I for adolescents with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 8 weekly modules and each module consists of several website pages that will be presented in a fixed order, with preprogrammed modules containing information, interactive questionnaires, descriptions of exercises and movies.",[43],{"type":56,"name":49,"description":60,"armGroupLabels":61,"otherNames":29},"Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 8 weeks modules.",[49],[63],{"name":64,"affiliation":5,"role":65},"Nora Choque Olsson, PhD","PRINCIPAL_INVESTIGATOR",[67,71],{"name":64,"role":68,"phone":69,"phoneExt":29,"email":70},"CONTACT","+46703788827","nora.choque-olsson@psychology.su.se",{"name":72,"role":68,"phone":29,"phoneExt":29,"email":73},"Markus Jansson-Fröjmark, Professor","markus.jansson-frojmark@ki.se",[75],{"facility":76,"status":29,"city":77,"state":78,"zip":29,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Nora Choque Olsson","Stockholm","Sverige","Sweden","SE",{"type":82,"coordinates":83},"Point",[84,85],18.06871,59.32938,{"lat":85,"lon":84},[88,89],{"name":64,"role":68,"phone":29,"phoneExt":29,"email":29},{"name":90,"role":68,"phone":29,"phoneExt":29,"email":29},"Markus Jansson-Fröjmark, PhD",{"type":65,"investigatorFullName":76,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PhD, Principal investigator","100333674","internet-delivered-cognitive-behaviour-therapy-for-sleep-problems-in-asd-100333674",false,"NCT03624400","Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in ASD","Internet-delivered Cognitive Behaviour Therapy for Sleep Problems in Adolescents with Autism Spectrum Disorder","Inclusion Criteria:\n\n* Adolescents with a clinical ASD diagnosis based on the Diagnostic and Statistical Manual-fifth edition (DSM-5). Participants have been investigated with the Autism Diagnostic Observation Schedule (ADOS).\n* Insomnia diagnosis or sleep problems according to DSM-5\n* Intelligence quotient (IQ) \\> 70 according to Wechsler Intelligence Scale for Children - fourth edition\n* Psychiatric comorbidities according to DSM-5: anxiety disorders or depression.\n\nExclusion Criteria:\n\n* The presence of clinically assessed self-injury\n* High risk of suicidal behaviour\n* borderline personality disorder or any form of schizophrenia or related disorders;\n* substance abuse as well as physical illness or condition that was largely influence sleep condition.","ALL","13 Years","17 Years",{"count":104,"type":105},240,"ESTIMATED","INTERVENTIONAL",[108],"NA","This trial investigates the behavioural effects of Internet-based Cognitive behaviour therapy for insomnia (CBT-I) in adolescents with autism spectrum disorder with sleep problems. This is a randomised controlled trial.",[111,112,113],"Autism Spectrum Disorder","Sleep Disturbance","Insomnia",[115,116,117,118],"Autism spectrum disorder","Sleep","Cognitive-behavioral treatment","Internet delivered treatment","NOT_YET_RECRUITING","2024-11-26",{"date":122,"type":123},"2024-11-29","ACTUAL",{"date":125,"type":105},"2025-01-15",{"date":127,"type":105},"2029-12-30",{"name":5,"class":6},1]