An interventional study of Extended Reality and Emotion regulation coaching in Autism and Emotion Regulation Difficulties, sponsored by Johannes Kepler University of Linz. Completed at 1 site in Austria. Open to participants aged 9 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Johannes Kepler University of Linz · Not applicable, Interventional, and Treatment
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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:
Secondary Hypotheses:
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
1,033 studies on the registry are indexed under Autistic Disorder; 269 are open to participants now.
This study's enrollment of 24 is below the median of 49 across 813 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Johannes Kepler University of Linz is the lead sponsor of 34 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Experimental-group will experience emotion-regulation-coaching plus extended-reality exposure to intensively train emotion-regulation strategies
Behavioral: Extended Reality · Behavioral: Emotion regulation coaching
The age-matched control group will receive a comparable emotion-regulation-coaching but not additionally extended reality exposure
Behavioral: Emotion regulation coaching
Extended Reality exposure will be additionally used to train children in using emotion regulation techniques during stressful daily life situations
Emotion regulation training based on worksheets, exercises and education
Feasibility of XR-environment usage during emotion regulation training with autistic children
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
Time frame: End of treatment at 6 weeks
Cybersickness Questionnaire in Virtual Reality (CSQ-VR)
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
Time frame: After first week of treatment (after first VR-exposure)
Emotion Dysregulation Change (EDI)
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).
Time frame: From enrollment to the end of treatment at 6 weeks
Behavior problems
Parents take daily notes by a self-constructed problem-behavior diary which assesses frequency of occurrence, intensity, support offered by parents, new strategies applied.
Time frame: From enrollment to the end of treatment at 6 weeks
Parental Stress Change
Parental stress change between T1(enrollment) and T2 (6weeks) evaluated with Parental Stress Inventory (PSI) which is a parental rated questionnaire providing child- and general-parental related stressors on a 5-point Likert-scale (min=1, max=5); higher means less; scores need to be recoded (e.g. 1=5, 2=4; 3=3; 4=2; 5=1)
Time frame: From enrollment to the end of treatment at 6 weeks
Spence Children's Anxiety Scale (SCAS)
Anxiety change of all children between T1 (enrollment) to T2 (6 weeks) using the Spence Children's Anxiety Scale (SCAS), which provides six specific subscales (Obsessive Compulsive Disorder, Social Phobia, Panic Agoraphobia, Separation Anxiety, Physical Injury Fears, Generalised Anxiety) The SCAS is rated by children on a 4-point Likert scale (min=0, max=3; smaller score means less anxiety)
Time frame: From enrollment to the end of treatment at 6 weeks
Internal and External Probleme Behavior change
Child's psycho-emotional change between T1 (enrollment) to T2 (6 weeks) according to internal and external problem behavior are assessed by the Strength and Difficulties Questionnaire (SDQ) through parental ratings on a 3-point Likert scale (min=0, max =2; higher means worse).
Time frame: From enrollment to the end of treatment at 6 weeks
Physiological Parameters
A biosignal ring (SENSTREAM (c)) was used to measure physiological arousal during coaching sessions. Analyses will use the electrodermal activity as a reliable parameter for arousal levels during physical or mental tasks. The ring was offered (optional use through children who participated in the study) and if agreed - used on the 1st, 3rd and 6th coaching appointment. Exploratory analyses compare mean-scores between theses 3 time points.
Time frame: From enrollment to the mid (week 3) and end of treatment at 6 weeks
Plan to share: No — Data might be shared on request by the responsible author
Ran from Feb 2026 to primary completion in Aug 2026, 5 months.
Of 355 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's 5 months is below that.
Counting every sponsor, half of 367 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Johannes Kepler University of Linz