Clinical trial NCT07009522: Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
Official title: Hamburg Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Waiting List Control Group
Study Group
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The design implements a prospective randomized controlled trial with a factorial design involving two groups: the study group and the waiting list control group.
Primary purpose: TREATMENT

Brief 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 randomized controlled 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 randomized controlled trial design will be used to evaluate the effects of the intervention. The intervention group will participate in a group training adapted to the needs of adolescents with ASD, while the control group will undergo a waitlist control condition (Treatment As Usual). 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.

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.

Primary outcomes:
measure: Emotion Dysregulation
timeFrame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention.
Secondary outcomes:
measure: Autistic Traits
timeFrame: Lead-in period" (6 weeks before randomization; T0)
measure: Quality of Life and psychological well-being
timeFrame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
measure: Self-perceived depressive symptoms
timeFrame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
measure: Self-perceived anxiety symptoms
timeFrame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
measure: Quality of Parent-Adolescent Communication
timeFrame: Lead-in period" (6 weeks before randomization; T0); start ("Baseline," T1) and end (T2) of the treatment, as well as 6 weeks (T3) and 12 weeks (T4) after the completion of the 3-month intervention
measure: Patient satisfaction
timeFrame: (T4) after the completion of the 3-month intervention
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Johannes Boettcher, Dr.
role: PRINCIPAL_INVESTIGATOR
References: