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

Condition(s) studied

Investigational drug(s) / intervention(s)

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, optimizing the environment and communication, as well as understanding emotions and social interactions. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their progress. Once registered, the program remains accessible for six months.

Study summary

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)

Eligibility

Primary outcome measure(s)

• 21-item Depression, Anxiety, and Stress Scales (DASS-21) total score — 3 months
  The DASS-21 is a 21-item PROM to assess psychological distress. The total score is the sum of all items and ranges from 0 to 63. Higher total scores indicate greater psychological distress and thus a worse outcome, whereas lower scores indicate fewer symptoms and a better outcome.

Trial sites (1)

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