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Completed

NCT Number: NCT07838272

Enhancing Emotion Regulation in Children With Autism Through Extended Reality

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

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Key information

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Autismuskompetenzzentrum - Hospital of St.John of God

Linz, Upper Austria, 4020, Austria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Extended Reality

Behavioral

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

Emotion regulation coaching

Behavioral

Emotion regulation training based on worksheets, exercises and education

Primary outcomes

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

    Time frame: 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
  2. Cybersickness Questionnaire in Virtual Reality (CSQ-VR)

    Time frame: 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
  3. Emotion Dysregulation Change (EDI)

    Time frame: 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).

  4. Behavior problems

    Time frame: 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.

Secondary outcomes

  1. Parental Stress Change

    Time frame: From enrollment to the end of treatment at 6 weeks

    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)

  2. Spence Children's Anxiety Scale (SCAS)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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)

  3. Internal and External Probleme Behavior change

    Time frame: From enrollment to the end of treatment at 6 weeks

    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).

  4. Physiological Parameters

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

    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.

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Sponsors and collaborators

Lead sponsor

Johannes Kepler University of Linz

Other

Collaborators

  • Hospital of St.John of God, Linz
  • Interdisciplinary Transformation University Austria

Registry information

Acronym: ERAC-XR

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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