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AzTrials

AutismERAC-XRNCT07838272

Enhancing Emotion Regulation in Children With Autism Through Extended Reality

A study testing Extended Reality and Emotion regulation coaching in people with Autism and Emotion Regulation Difficulties, run by Johannes Kepler University of Linz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 9 to 15 years
Conditions the study is for
Autism, Emotion Regulation Difficulties
What is being tested?
Extended Reality and Emotion regulation coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteAustria
Study dates
18 Feb 2026to 13 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Austria1 site
  • Autismuskompetenzzentrum - Hospital of St.John of God

    Linz, Upper Austria, 4020

Other trials in Austria

About this study

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.

Read more

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
Read the detailed description

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

Being tested
Extended Reality, Emotion regulation coaching
Keywords
Autism, Emotion Regulation, Extended Reality, Virtual Reality, Intervention Study
Medical subject headings
Autistic Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended RealityBehavioural

    Extended Reality exposure will be additionally used to train children in using emotion regulation techniques during stressful daily life situations

  • Emotion regulation coachingBehavioural

    Emotion regulation training based on worksheets, exercises and education

Study groups in NCT07838272
Study groupRoleWhat they receive
Emotion-Regulation supported through Extended RealityExperimentalExperimental-group will experience emotion-regulation-coaching plus extended-reality exposure to intensively train emotion-regulation strategies
Receives: Behavioral: Extended Reality; Behavioral: Emotion regulation coaching
Control group gets training without extended reality exposureActive comparatorThe age-matched control group will receive a comparable emotion-regulation-coaching but not additionally extended reality exposure
Receives: Behavioral: Emotion regulation coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: End of treatment at 6 weeks

  2. 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

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

  3. 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).

    Measured: From enrollment to the end of treatment at 6 weeks

  4. 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.

    Measured: From enrollment to the end of treatment at 6 weeks

Secondary outcomes (4)
  1. 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)

    Measured: From enrollment to the end of treatment at 6 weeks

  2. 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)

    Measured: From enrollment to the end of treatment at 6 weeks

  3. 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).

    Measured: From enrollment to the end of treatment at 6 weeks

  4. 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.

    Measured: From enrollment to the mid (week 3) and end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2026
  2. Study start18 Feb 2026
  3. Primary completion13 Aug 2026
  4. Study completion13 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07838272
Sponsor's protocol ID
1218/2025
Acronym
ERAC-XR
Status last verified
Mar 2026
First submitted
24 Aug 2026
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data might be shared on request by the responsible author

Publications

  • Vasarainen, M., Paavola, S., & Vetoshkina, L. (2021). A systematic literature review on extended reality: Virtual, augmented and mixed reality in working life. International Journal of Virtual Reality, 21(2), 1-28. DOI: 10.20870/IJVR.2021.21.2.4620

  • Toma MV, Turcu CE, Turcu CO, Vlad S, Tiliute DE, Pascu P. Extended Reality-Based Mobile App Solutions for the Therapy of Children With Autism Spectrum Disorders: Systematic Literature Review. JMIR Serious Games. 2024 Feb 19;12:e49906. doi: 10.2196/49906.

    PubMed 38373032
  • Lorenzo, G. G., Newbutt, N. N., & Lorenzo-Lledó, A. A. (2023). Designing virtual reality tools for students with Autism Spectrum Disorder: A systematic review. Education and Information Technologies, 28(8), 9557-9605. DOI: 10.1007/s10639-022-11545-z

  • Ip, H. H., Wong, S. W., Chan, D. F., Byrne, J., Li, C., Yuan, V. S., ... & Wong, J. Y. (2018). Enhance emotional and social adaptation skills for children with autism spectrum disorder: A virtual reality enabled approach. Computers & Education, 117, 1-15. DOI: 10.1016/j.compedu.2017.09.010

  • Bossenbroek R, Wols A, Weerdmeester J, Lichtwarck-Aschoff A, Granic I, van Rooij MMJW. Efficacy of a Virtual Reality Biofeedback Game (DEEP) to Reduce Anxiety and Disruptive Classroom Behavior: Single-Case Study. JMIR Ment Health. 2020 Mar 24;7(3):e16066. doi: 10.2196/16066.

    PubMed 32207697
  • Beck KB, Conner CM, Breitenfeldt KE, Northrup JB, White SW, Mazefsky CA. Assessment and Treatment of Emotion Regulation Impairment in Autism Spectrum Disorder Across the Life Span: Current State of the Science and Future Directions. Child Adolesc Psychiatr Clin N Am. 2020 Jul;29(3):527-542. doi: 10.1016/j.chc.2020.02.003. Epub 2020 Apr 3.

    PubMed 32471600
  • Bowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002.

    PubMed 19362699

Questions about this trial

What is this clinical trial studying?

A study testing Extended Reality and Emotion regulation coaching in people with Autism and Emotion Regulation Difficulties, run by Johannes Kepler University of Linz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of XR-environment usage during emotion regulation training with autistic children (time frame: End of treatment at 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07838272, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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