[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547130":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":32,"collaborators":34,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":20,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":20},{"fullName":5,"class":6},"Värmland County Council, Sweden","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single case experimental arm","EXPERIMENTAL","ABA intervention with multiple baselines and follow up measurements",[13],"Behavioral: Applied Behavior Analysis",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Applied Behavior Analysis","Applied Behavior Analysis focusing on nocturnal awakenings. It starts with identification of target behaviors and goals. A functional analysis is conducted to analyze the underlying function of a behavior in connection to the problem. A treatment plan is formulated, including strategies to achieve the goals, and methods to evaluate. Families receive education sleep hygiene. Adaptations focus on antecedents and consequences, with an emphasis on positive reinforcement of favorable behaviors. Various components of Cognitive Behavioral Therapy may be applicable. These include changes in sleep environment, stimulus control, bedtime routines with visual support and prompting. Sleep restriction and bedtime fading are included. Modified extinction techniques with parental presence can be applied, gradually phasing out parental immediate presence. The intervention continues until goals are achieved or for a maximum of 8 sessions (each lasting up to 60 minutes) spread over 8 weeks.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Sverre Wikström","Region Värmland","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Sverre Wikström, Assoc Prof","CONTACT","+46703456327","sverre.wikstrom@regionvarmland.se",{"type":33,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[35,38],{"name":36,"class":37},"Uppsala University","OTHER",{"name":39,"class":6},"Uppsala County Council, Sweden","100547130","sleep-in-children-with-autism-and-intellectual-disability-100547130",false,"NCT06403969","Sleep in Children With Autism and Intellectual Disability","SLEEP - in Children With Autism and Intellectual Disability: Investigation and Treatment","SLEEP-AID IT","Inclusion Criteria:\n\n* Insomnia AND\n* Autism AND\n* Intellectual Disability.\n\nExclusion Criteria:\n\n* Started puberty OR\n* Epilepsy OR\n* Ongoing melatonin treatment OR\n* Obstructive sleep apnea","ALL","6 Years","12 Years",{"count":52,"type":53},15,"ESTIMATED","INTERVENTIONAL",[56],"NA","Purposes: Establish proof-of-concept for home polysomnography in the assessment of sleep disorders among prepubertal school children with autism and intellectual disabilities combined; To explore the diagnostic yield of polysomnography for these individuals; To examine the feasibility and treatment effect of Applied Behavior Analysis (ABA) for insomnia, focusing on sleep maintenance difficulties, in these children.\n\nMethod: Single-case experimental design with multiple baselines and with multiple participants, with a focus on feasibility. N=15 prepubertal children, aged 6-12 years, with autism and intellectual disabilities combined, and difficulties in maintaining nighttime sleep. Assessment with home polysomnography + actigraphy. Intervention with ABA, including functional analysis, measurable goals, and behavior modification based on the functional analysis. Outcome measures from actigraphy and sleep diary with multiple data points at baseline and after treatment. Feasibility is examined as adherence to assessment and treatment, as well as in a qualitative study of parental experiences.",[59,60,61],"Insomnia","Autism","Intellectual Disability",[63,64,65,66],"applied behavior analysis","polysomnography","insomnia","autism","NOT_YET_RECRUITING","2024-05-03",{"date":70,"type":71},"2024-05-08","ACTUAL",{"date":73,"type":53},"2024-05-14",{"date":75,"type":53},"2026-06-30",{"name":5,"class":6}]