Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder (alnico)
Investigating Autimia, a Digital Intervention for Patients With Autism Spectrum Disorder: Randomized Controlled Trial (Alnico Trial)
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)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Linda T. Betz, PhD
- 전화번호: +49 40 3510520
- 이메일: linda.betz@gaia-group.com
연구 연락처 백업
- 이름: Anja Specht, MSc.
- 전화번호: +49 40 3510520
- 이메일: anja.specht@gaia-group.com
연구 장소
-
-
-
Hamburg, 독일
- 모병
- GAIA AG
-
연락하다:
- Anja Specht
- 이메일: anja.specht@gaia-group.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: 대조군
통제 그룹에 할당된 참가자는 평상시처럼 치료를 받을 수 있습니다(TAU).
|
|
|
실험적: autimia
Participants will receive access to the digital health intervention autimia in addition to 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
21-item Depression, Anxiety, and Stress Scales (DASS-21) total score
기간: 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.
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Work and Social Adjustment Scale (WSAS) total score
기간: 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.
|
3 months
|
|
Social Responsiveness Scale for Adults (SRS-A) total score
기간: 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 months
|
|
Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
기간: 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.
|
3 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Isabel Dziobek, Prof. Dr., Humboldt-Universität zu Berlin
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- autimia RCT 2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
자폐 스펙트럼 장애에 대한 임상 시험
-
University Hospital, Basel, SwitzerlandGebert Rüf-Stiftung모집하지 않고 적극적으로ESBL(Extended Spectrum Beta Lactamases) 대장균스위스