Autism Spectrum Disorder
Conditions
Brief 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)
Detailed description
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.
Interventions
BEHAVIORALautimia
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.
Sponsors
Gaia AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Work and Social Adjustment Scale (WSAS) total score | 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. |
| Social Responsiveness Scale for Adults (SRS-A) total score | 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. |
| Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score | 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. |
Countries
Germany
Contacts
CONTACTLinda T. Betz, PhD
CONTACTAnja Specht, MSc.
PRINCIPAL_INVESTIGATORIsabel Dziobek, Prof. Dr.
Humboldt-Universität zu Berlin
Outcome results
None listed