[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593675":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":30,"collaborators":20,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":20,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":20,"overallStatus":52,"whyStopped":20,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":20},{"fullName":5,"class":6},"Universitätsklinikum Hamburg-Eppendorf","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study group","EXPERIMENTAL","study group",[13],"Behavioral: Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART","The group program for adolescents with ASD takes place weekly. Each session lasts 100 minutes (including a break), and the training includes a total of 12 sessions. The intervention is manualized and is based on the theoretical foundations of Cognitive Behavioral Therapy, Mindfulness-Based Therapy, and the TEACCH approach (Mesibov et al., 2005). Parallel to the adolescents, their parents will participate in a separate group training, which will be conducted in five sessions of 100 minutes each and is closely linked in content to the adolescent group training.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Johannes Boettcher, Dr.","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+49 152 22832379","j.boettcher@uke.de",{"type":24,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Johannes Boettcher","Research group leader and principle investigator","100593675","early-phase-1-hamburg-emotion-awareness-and-regulation-group-training-for-autistic-adolescents-heart-100593675",false,"NCT07009522","Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)","HEART","Autistic adolescents will be included in the study, recruited from various departments of the Clinic for Child and Adolescent Psychiatry, Psychotherapy, and Psychosomatics at UKE, as well as from autism therapy centers. Eligible participants are adolescents aged 13 to 18 years who meet the criteria for a primary diagnosis of an autism spectrum disorder-including early childhood autism (ICD-10: F84.0), atypical autism (ICD-10: F84.1), and Asperger's syndrome (ICD-10: F84.5)-and who have sufficient knowledge of the German language. The diagnosis should be confirmed based on developmental history, the ADOS-2 assessment, and a clinical diagnosis from a specialized clinician. Additionally, only autistic adolescents exhibiting difficulties in emotion regulation (measured by the Emotion Regulation Inventory (EDI-SF), T-score ≥ 60) will be included. Exclusion criteria are: below-average cognitive abilities, IQ ≤ 85 (ICD-10: F70); lack of German language skills; or significant visual or hearing impairments that cannot be corrected. Furthermore, patients with severe neurological or psychiatric conditions (e.g., epilepsy, syndromic disorders with neuropsychiatric involvement, psychoses) or current acute suicidality, as assessed clinically, will be excluded.","ALL","13 Years","18 Years",{"count":44,"type":45},21,"ESTIMATED","INTERVENTIONAL",[48],"EARLY_PHASE1","The study focuses on a group training program called HEART aimed at helping adolescents with Autism Spectrum Disorder improve emotional regulation. It will use a pilot trial to evaluate the program's feasibility and effectiveness. The findings aim to advance scientific understanding and support the development of effective, evidence-based interventions to strengthen psychosocial support for autistic adolescents.",[51],"Study Group","NOT_YET_RECRUITING","2025-09-22",{"date":55,"type":56},"2025-09-26","ACTUAL",{"date":58,"type":45},"2026-01-15",{"date":60,"type":45},"2027-02-15",{"name":5,"class":6}]