Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents (HEART)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Emotion Dysregulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Investigator)
入排标准
- 年龄范围
- 13 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Study group
study group
干预措施: Hands-on Emotion Awareness and Regulation Group Training for Autistic Adolescents - HEART (Behavioral)
结局指标
主要结局
Emotion Dysregulation
时间窗: 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.
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.
次要结局
- Autistic Traits(Lead-in period" (6 weeks before randomization; T0))
- Quality of Life and psychological well-being(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(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(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(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((T4) after the completion of the 3-month intervention)
研究者
Johannes Boettcher
Research group leader and principle investigator
Universitätsklinikum Hamburg-Eppendorf