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临床试验/NCT07838272
NCT07838272已完成不适用

Enhancing Emotion Regulation in Children With Autism Through Extended Reality

Johannes Kepler University of Linz1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年2月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
Feasibility of XR-environment usage during emotion regulation training with autistic children

研究概览

简要总结

Pilot study on the development of an Extended Reality (XR) application to support emotion regulation in children with Autism Spectrum Disorder (ASD) (random assignment to an experimental group, N = 10, and a control group, N = 10).

The matched control group with autistic children of the same age receives emotion regulation coaching without the use of virtual reality.

Few studies systematically captured the transfer of XR-supported learning into real life. One study investigated the transfer of breathing techniques into everyday life, where children with ASD successfully transferred these techniques to daily life and applied learned breathing patterns in anxiety-inducing situations. The use of XR systems is considered as low-risk.

Primary Hypotheses:

  • Feasibility analysis of the described XR-supported coaching
  • Reduced Emotional Dysregulation between T1 and T2

Secondary Hypotheses:

  • Reduced Parental stress between T1 and T2
  • Reduced internalising/externalising behaviors between T1 and T2
  • Exploratory analyses of physiological parameter changes during intervention period

详细描述

The majority of children with autism experience significant challenges in the domain of emotion regulation. These difficulties frequently result in conflict situations, bullying, school refusal, and increased stress for the child's social environment, particularly within the family and school context. Common therapeutic and coaching-oriented interventions are typically based on cognitive-behavioral therapy (CBT) approaches and include psycho-education, exposure techniques, and skills training. However, CBT-based interventions in children with ASD often yield only modest long-term effects. This limitation is partly attributed to the restricted generalisation of skills acquired within therapeutic settings to diverse/unpredictable real-life situations . Realistic and adaptive learning environments are therefore of critical importance for optimising learning outcomes in children with ASD-an opportunity increasingly enabled by technological advances in Virtual and Extended Reality systems.

Extended Reality (XR) is an umbrella term encompassing Virtual Reality (VR; fully immersive visual experiences), Augmented Reality (AR; real-world experiences enhanced with virtual or auditory stimuli), and the integration of biosignal parameters. High-quality simulations that allow for a substantial degree of immersion in the virtual environment are considered essential for generating therapeutically effective experiences and facilitating the internalisation of adaptive strategies.

In addition, digitally designed and gamified elements can enhance motivation-particularly in the acquisition of emotion regulation strategies, which are often associated with negative emotional experiences. Another notable advantage is that potentially hazardous real-life situations, such as crossing a street, can be practiced safely and in a stepwise, adaptive manner within XR environments.

To date, XR applications have primarily focused on training isolated skills, especially social competencies and emotion recognition. Only a limited number of studies have reported standardised outcome measures, sample sizes remain small, no formal guidelines for XR implementation currently exist, and independent replication trials of specifically developed XR paradigms are lacking. Recent technological advances, however, offer substantial potential for the development of standardised and methodologically comparable applications across independent clinical and research settings.

Few studies have systematically examined the transfer of XR-acquired skills into everyday life. One study investigated the transfer of breathing techniques into daily contexts and found that children with ASD successfully applied learned breathing patterns in anxiety-provoking situations. The use of XR systems is generally considered low-risk. In some cases, symptoms of "cybersickness" (e.g., nausea, dizziness, headaches) may occur; however, individual risk and symptom manifestation can be systematically assessed before and during application

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
9 Years 至 15 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of Autism Spectrum Disorder (ASD), without sensory impairments.
  • •Sufficient German language proficiency of both children and parents to enable participation in the training (German instructions and explanations) and valid completion of questionnaires.
  • •Inclusion of children presenting with behavioral problems.

排除标准

  • •Children whose families do not consent to anonymized data processing.
  • •Children whose families do not consent to the transmission of video-based recordings of everyday stressors for integration into the XR training.
  • •Children with an IQ < 85.

研究组 & 干预措施

Emotion-Regulation supported through Extended Reality

Experimental

Experimental-group will experience emotion-regulation-coaching plus extended-reality exposure to intensively train emotion-regulation strategies

干预措施: Emotion regulation coaching (Behavioral)

Emotion-Regulation supported through Extended Reality

Experimental

Experimental-group will experience emotion-regulation-coaching plus extended-reality exposure to intensively train emotion-regulation strategies

干预措施: Extended Reality (Behavioral)

Control group gets training without extended reality exposure

Active Comparator

The age-matched control group will receive a comparable emotion-regulation-coaching but not additionally extended reality exposure

干预措施: Emotion regulation coaching (Behavioral)

结局指标

主要结局

Feasibility of XR-environment usage during emotion regulation training with autistic children

时间窗: End of treatment at 6 weeks

Self constructed feedback-questionnaire for a) parents and b) children with ratings on a 4-point Likert-scale (min=1, max=4) respectively: * Experimental and Control-group * 13 questions on emotion-coaching and study organisation * Experimental group additionally: --\> 13 XR-specific items for evaluating VR-specific experiences. * Higher scores can mean better or worse (explanation and description when reported) * Descriptive reports on group-mean-scores of single-items

Cybersickness Questionnaire in Virtual Reality (CSQ-VR)

时间窗: After first week of treatment (after first VR-exposure)

German, unvalidated, adapted version, self reported through child with ratings on a 7-point Likert-scale (min=1, max=7). * Experimental group only * 6 questions * higher scores mean worse

Emotion Dysregulation Change (EDI)

时间窗: From enrollment to the end of treatment at 6 weeks

Emotion Dysregulation change for children of both groups using the Emotion Dysregulation Inventory (EDI; parental rated questionnaire with 30 items on a Likert scale 1-5; min=0, max=4) at each time point. Higher scores mean worse The EDI provides 2 scales: Reactivity (24 items) and Dysphoria (6 items).

Behavior problems

时间窗: From enrollment to the end of treatment at 6 weeks

Parents take daily notes by a self-constructed problem-behavior diary which assesses frequency of occurrence, intensity, support offered by parents, new strategies applied.

次要结局

  • Parental Stress Change(From enrollment to the end of treatment at 6 weeks)
  • Spence Children's Anxiety Scale (SCAS)(From enrollment to the end of treatment at 6 weeks)
  • Internal and External Probleme Behavior change(From enrollment to the end of treatment at 6 weeks)
  • Physiological Parameters(From enrollment to the mid (week 3) and end of treatment at 6 weeks)

研究者

发起方
Johannes Kepler University of Linz
申办方类型
Other
责任方
Sponsor

研究点 (1)

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