NCT07838272

Brief 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). 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
Last Updated

September 24, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

August 24, 2026

Last Update Submit

September 17, 2026

Conditions

AutismEmotion Regulation Difficulties

Keywords

AutismEmotion RegulationExtended RealityVirtual RealityIntervention Study

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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).

    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.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (4)

  • 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

Study Arms (2)

Emotion-Regulation supported through Extended Reality

EXPERIMENTAL

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

Behavioral: Extended RealityBehavioral: Emotion regulation coaching

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

Behavioral: Emotion regulation coaching

Interventions

Extended RealityBEHAVIORAL

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

Emotion-Regulation supported through Extended Reality
Emotion regulation coachingBEHAVIORAL

Emotion regulation training based on worksheets, exercises and education

Control group gets training without extended reality exposureEmotion-Regulation supported through Extended Reality

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autismuskompetenzzentrum - Hospital of St.John of God

Linz, Upper Austria, 4020, Austria

Location

Related Publications (7)

  • 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

    BACKGROUND

  • 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.

    PMID: 38373032BACKGROUND

  • 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

    BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 32207697BACKGROUND

  • 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.

    PMID: 32471600BACKGROUND

  • 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.

    PMID: 19362699BACKGROUND

MeSH Terms

Conditions

Autistic DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2026

First Posted

September 24, 2026

Study Start

February 18, 2026

Primary Completion

August 13, 2026

Study Completion

August 13, 2026

Last Updated

September 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Data might be shared on request by the responsible author

Locations

AU(1)