Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder

Официальное название

Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)

Обзор

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)

Подробное описание

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.

Вмешательства

• Поведенческое autimia
  Participants allocated to the intervention group will receive access to autimia in addition to treatment as usual (TAU). autimia is a digital health intervention designed for individuals with ASD (Autism Spectrum Disorder), accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT), health behavior change, and patient education. Topics addressed by autimia are self-acceptance and self-worth, stress management and coping skills,

Первичные конечные точки

• 21-item Depression, Anxiety, and Stress Scales (DASS-21) total score [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Work and Social Adjustment Scale (WSAS) total score [Срок оценки: 3 months]
• Social Responsiveness Scale for Adults (SRS-A) total score [Срок оценки: 3 months]
• Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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
• IQ ≥ 80
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• GAIA AG — Hamburg

Идентификаторы

NCT: NCT07638657 · autimia RCT 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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