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Search / Trial NCT07009522

Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)

Launched by UNIVERSITÄTSKLINIKUM HAMBURG-EPPENDORF · May 29, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The HEART trial is a research study designed to help autistic teenagers learn how to better manage their emotions. The program includes group training sessions that aim to teach these adolescents skills for understanding and regulating their feelings. Researchers will compare the results of participants in the training group with those on a waiting list to see how effective the program is. The goal is to gather important information that can lead to better support and resources for young people on the autism spectrum.

To participate, teens aged 13 to 18 years who have a confirmed diagnosis of Autism Spectrum Disorder (like early childhood autism or Asperger's syndrome) are eligible. They should also have some challenges with managing their emotions. Participants will need to speak German and not have other significant cognitive or health issues that could interfere with the study. While the trial is not currently recruiting participants, those who qualify will have the opportunity to take part in a program that could make a positive difference in their emotional well-being.

Gender

ALL

Eligibility criteria

  • Autistic adolescents will be included in the study group, 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. Adolescents who meet the same inclusion and exclusion criteria will be included in the waitlist control group.

About Universitätsklinikum Hamburg Eppendorf

Universitätsklinikum Hamburg-Eppendorf (UKE) is a leading academic medical center in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, UKE integrates state-of-the-art facilities with a multidisciplinary approach, fostering collaboration among top-tier researchers, clinicians, and healthcare professionals. The institution is dedicated to improving patient outcomes by conducting rigorous scientific investigations that address critical health challenges, ultimately contributing to the development of novel therapies and enhancing medical knowledge.

Locations

Patients applied

0 patients applied

Trial Officials

Johannes Boettcher, Dr.

Principal Investigator

Universitätsklinikum Hamburg-Eppendorf

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported