Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)

Overview

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 "Hands-on 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.

Interventions

• Behavioral Hands-on 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 a

Primary outcome measures

• Emotion Dysregulation [Time frame: 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 outcome measures (6)

• Autistic Traits [Time frame: Lead-in period" (6 weeks before randomization; T0)]
• Quality of Life and psychological well-being [Time frame: 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]
• Self-perceived depressive symptoms [Time frame: 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]
• Self-perceived anxiety symptoms [Time frame: 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]
• Quality of Parent-Adolescent Communication [Time frame: 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]
• Patient satisfaction [Time frame: (T4) after the completion of the 3-month intervention]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Germany · 1 center

• University Medical Center Hamburg-Eppendorf — Hamburg

Identifiers

NCT: NCT07009522 · LPEK-0914 · 04/107

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗