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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Linda T. Betz, PhD
- 電話番号：+49 40 3510520
- メール：linda.betz@gaia-group.com
研究連絡先のバックアップ
- 名前：Anja Specht, MSc.
- 電話番号：+49 40 3510520
- メール：anja.specht@gaia-group.com
研究場所
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Hamburg、ドイツ
- 募集
- GAIA AG
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コンタクト：
- Anja Specht
- メール：anja.specht@gaia-group.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：対照群
対照群に割り当てられた参加者は、通常どおり治療を受けることができます (TAU)。
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実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
21-item Depression, Anxiety, and Stress Scales (DASS-21) total score
時間枠：3 months
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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.
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3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Work and Social Adjustment Scale (WSAS) total score
時間枠：3 months
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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.
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3 months
|
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Social Responsiveness Scale for Adults (SRS-A) total score
時間枠：3 months
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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.
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3 months
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Multidimensional Self Esteem Scale (MSWS) emotional self-esteem subscale score
時間枠：3 months
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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.
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3 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Isabel Dziobek, Prof. Dr.、Humboldt-Universität zu Berlin
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- autimia RCT 2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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