An interventional study of autimia in Autism Spectrum Disorder, sponsored by Gaia AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Gaia AG · Not applicable, Interventional, and Treatment
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:
Researchers will compare two groups:
Participants will:
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.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 236 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Gaia AG is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive access to the digital health intervention autimia in addition to TAU.
Behavioral: autimia
Participants allocated to the control group will receive access to treatment as usual (TAU).
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.
21-item Depression, Anxiety, and Stress Scales (DASS-21) total score
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.
Time frame: 3 months
Work and Social Adjustment Scale (WSAS) total score
The WSAS is a 5-item PROM to assess functional impairment in work, home life, and social activities. The total score is the sum of all items and ranges from 0 to 40. Higher total scores indicate greater disability and thus a worse outcome, whereas lower scores indicate less disability and a better outcome.
Time frame: 3 months
Social Responsiveness Scale for Adults (SRS-A) total score
The SRS-A is a 65-item PROM to assess social symptomatology in adults with ASD. The total score is the sum of all items and ranges from 0 to 195. Higher total scores indicate greater social impairment and thus a worse outcome, whereas lower scores indicate fewer symptoms and a better outcome.
Time frame: 3 months
Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
The MSWS is a PROM to assess self-esteem. The emotional self-esteem subscale consists of 7 items to assess emotional self-worth. The subscale score is the sum of these items and ranges from 7 to 49. Lower scores indicate lower self-esteem and thus a worse outcome, whereas higher scores indicate higher self-esteem and a better outcome.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Mar 2027, 9 months after the start.
Of 823 interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 9 months is below that.
How these figures are worked out, and which studies are left out of them.
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