NCT07009522

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Adolescents with Autism Spectrum Disorder (ASD) often experience significant difficulties in emotional regulation due to increasing developmental challenges, which can lead to a higher prevalence of psychological comorbidities such as anxiety disorders and depression. Despite the urgent need for specific therapeutic interventions, this area remains largely underrepresented in clinical practice and research. The present study aims to address this gap by investigating the feasibility and effectiveness of the behavioral therapy program "Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART). A pilot trial will be used to evaluate the feasibility and acceptability of the intervention. The intervention group will participate in a group training adapted to the needs of adolescents with ASD. This pilot study could significantly contribute to the scientific understanding of emotion regulation in adolescents with ASD and support the development of practically relevant evidence-based interventions. The study's findings could have important implications for clinical practice. The group training is based on proven behavioral therapy methods established among therapists in Germany. The manualized manual for the adapted application of these methods with autistic adolescents could thus serve as a foundation for improving psychosocial care for this target group.

Conditions

• Study Group

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-15
• Primary completion: 2026-12-15
• Completion: 2027-02-15
• First posted: 2025-06-06
• Last updated: 2025-09-26