Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Gaia AG
- 入组人数
- 236
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to find out if autimia, a digital health intervention, can help adults with ASD (Autism Spectrum Disorder) manage their daily lives and improve their well-being.
The main questions it aims to answer are:
- Does autimia, together with regular treatment, improve health outcomes after three months better than regular treatment alone?
- Are the positive effects of autimia still noticeable after six months?
Researchers will compare two groups:
- Intervention group: Participants use the autimia intervention and continue their usual treatment.
- Control group: Participants continue with their usual treatment only.
Participants will:
- Participate in a video call with a specialist to confirm a diagnosis of ASD
- Fill out questionnaires online at the start of the study, after 3 months, and after 6 months
- Continue with their usual treatment (both groups) and use autimia, a digital health intervention, for six months (intervention group only)
详细描述
This pragmatic, two-arm randomized controlled trial evaluates the effectiveness of autimia, a certified medical device (CE-marked, risk class I), when used alongside regular treatment. The study compares the addition of this digital health intervention to treatment as usual (TAU) against TAU alone. Designed as an interactive online program, autimia incorporates recognized elements of cognitive behavioral therapy (CBT), behavior change, and patient education.
To ensure the inclusion of the appropriate target population, participants undergo a video-based diagnostic consultation with trained clinical professionals. This session involves a semi-structured interview and a standardized social behavior observation based on the ADOS-2 to confirm the diagnosis according to ICD-10-GM criteria.
Following confirmation, participants are randomly assigned to one of two groups. The intervention group receives immediate access to autimia for six months alongside their usual treatment. The control group continues their regular treatment and is granted access to the intervention after a six-month waiting period.
Data is collected from both groups via online questionnaires at the start of the study, after three months, and after six months. The primary evaluation of effectiveness will be conducted at the three-month follow-up. Data collected at the six-month mark will be utilized to assess the stability of the observed intervention effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •prior suspected diagnosis of ASD by a healthcare professional
- •diagnosis of ASD (ICD-10 codes: F84.5, F84.0, F84.1) confirmed in a semi-structured diagnostic interview conducted as a telemedical consultation
- •increased levels of psychological distress (DASS-21 total score ≥ 21)
- •stable treatment (medication, psychotherapy, no treatment, …) for at least 30 days at the time of inclusion
- •sufficient knowledge of the German language
- •basic IT skills required for independent use of a digital intervention
- •consent to participation
排除标准
- •plans to change treatment (medication, psychotherapy, …) in the upcoming 3 months after inclusion
- •diagnosis of another severe psychiatric disorder (acute severe affective disorder, acute psychotic disorder, acute substance use disorder, borderline personality disorder, antisocial personality disorder)
- •acute suicidality
- •currently being under legal guardianship for healthcare decisions
研究组 & 干预措施
autimia
Participants will receive access to the digital health intervention autimia in addition to TAU.
干预措施: autimia (Behavioral)
Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).