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NCT Number: NCT07638657

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

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)

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, Germany

Location status: Recruiting

Location contact

Anja Specht

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

autimia

Behavioral

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.

Primary outcomes

  1. 21-item Depression, Anxiety, and Stress Scales (DASS-21) total score

    Time frame: 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.

Secondary outcomes

  1. Work and Social Adjustment Scale (WSAS) total score

    Time frame: 3 months

    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.

  2. Social Responsiveness Scale for Adults (SRS-A) total score

    Time frame: 3 months

    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.

  3. Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anja Specht, MSc.

CONTACT

[email protected]

+49 40 3510520

Linda T. Betz, PhD

CONTACT

[email protected]

+49 40 3510520

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Registry information

Official study title

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

Acronym: alnico

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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