[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490974":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":115,"collaborators":117,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":26,"studyType":145,"phases":146,"briefSummary":148,"conditions":149,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"University of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PACT + Management as usual","EXPERIMENTAL","PACT + management (MAU - see comparator intervention). PACT is a parent-mediated and video-aided intervention designed to improve socio-communicative functioning in children with ASD. The intervention is based on theory and research on pre-linguistic and early social interaction and language development. The programme focuses on changing the interaction in the parent-child dyad in order to enhance communication and language development and skills in children with ASD.\n\nThe overall focus of the intervention is to guide parents to provide a sensitive, highly adapted interaction context in which their own responses and language are matched to the child's communication competence and language comprehension. Parents learn to identify windows of opportunity to facilitate joint interactions, enhance emerging communication, elicit child intentionality and support language comprehension, thereby aiming to ameliorate abnormal developmental pathways.",[13],"Behavioral: PACT",{"label":15,"type":16,"description":17,"interventionNames":18},"Management as usual","ACTIVE_COMPARATOR","Enhanced management as usual (MAU). MAU is delivered by the regional Child and Adolescent Mental Health Center (CAMHS). All participants will have equal access to seek advice via a telephone hotline in the trial period (12 months).\n\nFollowing the diagnosis of ASD, the parents will be offered psychoeducation as usual in the local CAMHS. A telephone \"hotline\" open to all participants will offer pedagogical advice and try to help the parents to collaborate and engage with their professional partners in the municipality. The parents will also be able to contact the CAMHS when needed. The hotline team will be able to consult with the responsible clinician at the CAMHS. The clinician should always be notified within the same day, if a parent describes acute worsening of the child's condition, risk of suicidality, or severe aggression. The responsible clinician will be able to refer the child to further assessment and treatment within the CAMHS without any significant delay.",[19],"Behavioral: MAU",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","PACT","Paediatric Autism Communication Therapy",[9],null,{"type":22,"name":28,"description":15,"armGroupLabels":29,"otherNames":26},"MAU",[15],[31],{"name":32,"affiliation":33,"role":34},"Niels Bilenberg, Professor","Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark","STUDY_CHAIR",[36],{"name":32,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+4599448683","Niels.Bilenberg@rsyd.dk",[41,56,68,80,92,103],{"facility":42,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Child and Adolescent Mental Health Center, Aabenraa, Region of Southern Denmark","RECRUITING","Aabenraa","6200","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],9.41741,55.04434,{"lat":52,"lon":51},[55],{"name":32,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":57,"status":43,"city":58,"state":26,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Child and Adolescent Mental Health Center, Aalborg, North Denmark Region","Aalborg","9000",{"type":49,"coordinates":61},[62,63],9.9187,57.048,{"lat":63,"lon":62},[66],{"name":67,"role":37,"phone":26,"phoneExt":26,"email":26},"Marlene Lauritsen, Professor",{"facility":69,"status":43,"city":70,"state":26,"zip":71,"country":46,"countryCode":47,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Child and Adolescent Psychiatric Dept., Skejby, Aarhus University Hospital","Aarhus","8200",{"type":49,"coordinates":73},[74,75],10.21076,56.15674,{"lat":75,"lon":74},[78],{"name":79,"role":37,"phone":26,"phoneExt":26,"email":26},"Per H Thomsen, Professor",{"facility":81,"status":43,"city":82,"state":26,"zip":83,"country":46,"countryCode":47,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Child and Adolescent Mental Health Center, Capital Region of Denmark","Hellerup","2900",{"type":49,"coordinates":85},[86,87],12.57093,55.73204,{"lat":87,"lon":86},[90],{"name":91,"role":37,"phone":26,"phoneExt":26,"email":26},"Birgitte Fagerlund, Professor",{"facility":93,"status":43,"city":94,"state":26,"zip":95,"country":46,"countryCode":47,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Child and Adolescent Mental Health Center, Odense, Region of Southern Denmark","Odense","5000",{"type":49,"coordinates":97},[98,99],10.38831,55.39594,{"lat":99,"lon":98},[102],{"name":32,"role":37,"phone":26,"phoneExt":26,"email":26},{"facility":104,"status":43,"city":105,"state":26,"zip":106,"country":46,"countryCode":47,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Department of Child and Adolescent Psychiatry, Copenhagen University Hospital","Roskilde","4000",{"type":49,"coordinates":108},[109,110],12.08035,55.64152,{"lat":110,"lon":109},[113],{"name":114,"role":37,"phone":26,"phoneExt":26,"email":26},"Pia Jeppesen, Professor",{"type":116,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[118,120,122,124,126,128],{"name":119,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research",{"name":121,"class":6},"Region Capital Denmark",{"name":123,"class":6},"Region Zealand",{"name":125,"class":6},"Region of Southern Denmark",{"name":127,"class":6},"Central Denmark Region",{"name":129,"class":130},"Regionshospital Nordjylland","OTHER_GOV","100490974","paediatric-autism-communication-therapy-pact-in-children-with-autism-spectrum-disorder-100490974",false,"NCT05673096","Paediatric Autism Communication Therapy (PACT) in Children With Autism Spectrum Disorder","Paediatric Autism Communication Therapy (PACT) Combined With Management as Usual Compared to Management as Usual Alone in Children With Autism Spectrum Disorder - a Pragmatic, National, Randomised Clinical Trial","DAN-PACT","Inclusion Criteria:\n\n* Children aged 2 through 6 years (both inclusive)\n* A diagnosis of ASD meeting the criteria for International Classification of Diseases; Tenth Edition (ICD-10): Diagnose codes: DF84.0, DF84.1, DF84.5, DF84.8\n* An Autism Diagnostic Observation Schedule, 2nd Edition Calibrated Severity Score (ADOS-2 CSS) ≥ 4\n* The ASD diagnosis must be verified by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), Autism Spectrum Disorder Checklist\n* The ASD diagnosis must be the primary developmental disorder (comorbid conditions allowed) and conferred at a clinical conference\n* Parents must have sufficient Danish (or English) language skills to communicate with the therapist\n* Signed informed consent by parents or holders of legal guardianship\n\nExclusion Criteria:\n\n* Children having a sibling already included in the trial\n* Hearing and visual impairment in child or parent\n* Parent not available for regular sessions with the therapist, evaluated at the consent meeting","ALL","2 Years","6 Years",{"count":143,"type":144},280,"ESTIMATED","INTERVENTIONAL",[147],"NA","Paediatric Autism Communication Therapy (PACT) is a naturalistic developmental behavioural interventions to reduce autism symptoms. The aim of this trial is to assess the beneficial and harmful effects of PACT in 2-6 year-old children with a recent diagnosis of autism spectrum disorder.",[150],"Autism Spectrum Disorder","2024-12-05",{"date":153,"type":154},"2024-12-11","ACTUAL",{"date":156,"type":154},"2023-03-13",{"date":158,"type":144},"2026-12-31",{"name":5,"class":6},6]