Autism Spectrum Disorder Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
GAIA AG
RECRUITING
Hamburg
Contact Information
Primary
Linda T. Betz, PhD
linda.betz@gaia-group.com
+49 40 3510520
Backup
Anja Specht, MSc.
anja.specht@gaia-group.com
+49 40 3510520
Time Frame
Start Date: 2026-06-12
Estimated Completion Date: 2027-06
Participants
Target number of participants: 236
Treatments
Experimental: autimia
Participants will receive access to the digital health intervention autimia in addition to TAU.
No_intervention: Control group
Participants allocated to the control group will receive access to treatment as usual (TAU).
Related Therapeutic Areas
Sponsors
Leads: Gaia AG

This content was sourced from clinicaltrials.gov