About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART
BehavioralThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Emotion Dysregulation
The Emotion Dysregulation Inventory - Short Form (EDI-SF, Mazefsky, Day, et al., 2018; Mazefsky, Yu, et al., 2018) is a 13-item questionnaire designed to assess emotion regulation problems in children and adolescents through self-report and parent-report. The items are answered on a five-point Likert scale, ranging from 1 = "not at all" to 5 = "very severe." The questionnaire evaluates two scales: "Reactivity" and "Dysphoria." Higher scores indicate greater emotional dysregulation. The primary outcome criterion is emotion regulation, which will be assessed from the parent perspective using the EDI-SF.
Secondary outcomes
Autistic Traits
The Social Responsiveness Scale (SRS-16; Constantino et al., 2003) is a quantitative measure of autistic traits in children, adolescents, and adults. The SRS-16 (Sturm et al., 2017) is a 16-item parent questionnaire designed to assess social, communicative, and rigid behaviors in children and adolescents for dimensional autism diagnostics. The items are answered on a four-point response scale, ranging from 1 = "not at all" to 4 = "almost always." A total score is calculated by summing the items. The total score ranges from 16 to 80, with higher values indicating greater severity of impairment. The SRS has demonstrated good psychometric properties and cross-cultural validity for the assessment of ASD (Bölte et al., 2008, 2011).
Quality of Life and psychological well-being
The KIDSCREEN-10 (Ravens-Sieberer et al., 2010) is a brief, standardized instrument for assessing the quality of life and psychological well-being of children and adolescents aged 8 to 18 years from self-report and parent perspective. The KIDSCREEN-10 includes a total of 10 items focusing on various dimensions of quality of life, including emotional well-being, social well-being, physical health, and joy of life. The items are answered on a five-point response scale, ranging from 1 = "not at all true" to 5 = "completely true." The questionnaire is characterized by good psychometric validity and reliability and is suitable for use across different populations (Ravens-Sieberer et al., 2010).
Self-perceived depressive symptoms
The Beck Depression Inventory for Youth - Second Edition (BDI-Y-2; Beck et al., 2001) is a self-report questionnaire designed to assess the severity of depressive disorder in children and adolescents aged 7 to 18 years. For adults aged 18 and above, the Beck Depression Inventory-II (BDI-II) is used. The 20 items measure negative thoughts of the child or adolescent about themselves, their life, and the future, as well as feelings of sadness and physiological symptoms of depression, based on the diagnostic criteria of DSM-5. The German version of the instrument demonstrates acceptable psychometric properties (Beck et al., 2001; Siefen \& Busch, 2018).
Self-perceived anxiety symptoms
The Beck Anxiety Inventory for Youth - Second Edition (BAI-Y-2; Beck et al., 2001) is a self-report questionnaire designed to assess the severity of anxiety in children and adolescents aged 7 to 18 years. For adults aged 18 and above, the Beck Anxiety Inventory (BAI) is used. The 20 items assess specific and generalized anxieties, including fears related to school, fear of injury, and health-related anxieties. Additionally, the inventory captures various symptoms of anxiety, such as rumination and worry-driven thoughts, as well as physiological symptoms, based on the diagnostic criteria of DSM-5. The German version of the instrument demonstrates acceptable psychometric properties (Beck et al., 2001; Siefen \& Busch, 2018).
Sponsors and contacts
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