Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents
Official title: Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
Run by Universitätsklinikum Hamburg-Eppendorf · NCT07009522 · Data updated 2026-11-12
A group-based behavior therapy called HEART tests whether helping autistic teens learn to recognize and regulate their emotions is feasible and beneficial.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Enrollment | 21 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 1 site (Hamburg, Free and Hanseatic City of Hamburg) |
| Status | Recruiting |
| Started | January 15, 2026 |
| Main results expected | December 15, 2026 |
| Study ends | February 15, 2027 |
| Registry record updated | July 14, 2026 |
| Trial ID | NCT07009522 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Autistic adolescents aged 13-18 with emotion regulation difficulties (EDI-SF T-score ≥ 60), sufficient German language knowledge, and no significant cognitive or sensory barriers.
✕Probably not a fit
Participants without marked emotion regulation difficulties or those outside the specified age range or language requirements may not experience direct benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase pilot trial investigates the HEART program, a group behavioral therapy designed for autistic adolescents aged 13 to 18 to improve emotional regulation. The study will assess feasibility, acceptability, and preliminary effectiveness in a clinical setting at the University Medical Center Hamburg-Eppendorf. Participants must have a primary ASD diagnosis and significant emotion regulation difficulties, and will be recruited from psychiatry/psychotherapy departments and autism centers. The intervention builds on proven methods adapted for adolescents with ASD and uses a manualized approach to standardize delivery. Outcomes will inform future larger trials and the potential for integrating HEART into psychosocial care for autistic youth.
Why it matters
Potential benefit: If successful, HEART could provide a structured, evidence-based option to help autistic adolescents better manage their emotions and reduce associated psychosocial challenges.
How similar studies have gone: Previous behavioral therapy methods adapted for ASD have shown promise in improving emotion regulation, but this exact HEART group format in German clinical settings is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, Germany Recruiting
Study contacts
- Principal investigator: Johannes Boettcher, Dr. — Universitätsklinikum Hamburg-Eppendorf
- Study coordinator: Johannes Boettcher, Dr.
- Email: j.boettcher@uke.de
- Phone: +49 152 22832379
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ADBest TREAT Registry for adults with atopic dermatitis
A registry in Germany is collecting real-world data from adults with atopic dermatitis to see how treatments are used and how the disease affects quality of life.
-
Robot-assisted sleeve gastrectomy with Hugo system feasibility
This study tests whether sleeve gastrectomy can be safely done using the Hugo robotic system in adults with severe obesity.
-
Keep blood pressure at 85 or more during surgery to prevent delirium in older adults with hypertension
In older adults with high blood pressure undergoing non-heart surgery, researchers test if keeping mean arterial pressure at or above 85 mmHg during surgery reduces postoperative delirium.
-
Intergenerational Mentoring to Reduce Loneliness and Improve Well-Being
This project tests intergenerational mentoring between seniors 60+ and youths aged 12–21 in Hamburg to see if it reduces loneliness and improves mental well-being and quality of life.
-
30-minute cycling immediately before nivolumab and ipilimumab for metastatic melanoma
This trial will test whether a 30-minute cycling session immediately before nivolumab plus ipilimumab boosts immune activity and improves outcomes for people with metastatic melanoma.
-
Beta-hydroxybutyrate to boost immunotherapy in multiple myeloma
This study will test whether raising blood beta-hydroxybutyrate with a ketogenic diet or oral ketone supplements can safely improve responses to CAR‑T or BCMA‑directed bispecific therapy in adults with multiple myeloma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.