Autism Spectrum DisorderSTEPSNCT06438536
STEPS: A Virtual Reality-based Intervention for Adults With Autism.
A study testing Virtual Reality-based Social Cognitive Training in people with Autism Spectrum Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual Reality-based Social Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 2 May 2024to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18 years or older
- Ability to give informed consent
- Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
- T-score on SRS-A self-report ≥ 60
Who cannot join
- Rejecting informed consent
- A diagnosis of organic brain disease
- Intellectual disability (IQ ˂ 70)
- A command of spoken Danish or English inadequate for engaging in therapy
- ADHD-diagnosis with untreated symptoms
- Displaying an imminent homicidal or suicidal risk
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark
Copenhagen, Hellerup, 2900
About this study
Official title: STEPS (Social Cognitive Training Enhancing Pro-functional Skills): A Clinical Randomized Trial Evaluating the Effect of a Virtual Reality-based Intervention for Adults With Autism.
The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism.
The main questions it aims to answer are:
Read more
- Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD?
- Is Virtual Reality-based social cognitive training cost-effective?
Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness.
Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.
Read the detailed description
Adults with autism spectrum disorders (ASD) constitute an increasingly recognized population with largely unaddressed public health needs. Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD, as well as other psychiatric disorders.
Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially, to achieve adequate vocational functioning (i.e. job/educational achievements) as well as inflicting immensely on their quality of life. At current, no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD.
Virtual reality-based treatment offers the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient.
Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective. While the potential beneficial effects of virtual reality exposure to challenging social situations, that taps social cognitive functions, are evident and virtual reality therapies are promising in general, the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD.
The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) versus treatment as usual. We expect to find VRSCT to be more beneficial in improving social cognitive deficits, daily life functioning, and quality of life in adults with ASD.
If the results of the current trial are positive, this short-term, manualised treatment using well-tested VR-software, can easily be implemented in clinical practice, that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients. Additionally, it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual Reality-based Social Cognitive Training
- Keywords
- Randomized clinical trial (RCT), Virtual Reality (VR), Social cognitive training, Cognitive remediation, Digital intervention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-based Social Cognitive TrainingBehavioural
Virtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality-based Social Cognitive Training (VRSCT) | Experimental | Patients in the experimental group will be offered 10 individual sessions of targeted, virtual reality assisted psychotherapy embedded in cognitive behavioral therapy (CBT), that aims at enhancing social cognition and daily life functioning. If the patient consents, two additional sessions will be offered in which the patient's relatives are invited to participate (one in the beginning of treatment and one at the end of treatment). The aim of the relative involvement is to enhance transfer from the therapy to the patients daily life. The treatment will be conducted by psychologists with an extensive knowledge in providing virtual reality assisted therapy. The treatment is manualized, and the therapists will receive ongoing supervision by a senior clinician having ≥ 25 years of experience in conducting assessment, treatment, and research with the autism spectrum population. Receives: Behavioral: Virtual Reality-based Social Cognitive Training |
| Treatment as Usual (TAU) | No intervention | The treatment-as-usual (TAU) group will receive the standard treatment offered to adults diagnosed with ASD in Denmark. This commonly consists of four psychoeducational sessions as well as limited supportive counseling. Some adults with ASD also receive practical help in daily life situations in community settings. The TAU will be mapped upon trial completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale, Adult Version, Self-report
The primary outcome is level of social impairment is measured by the Social Responsiveness Scale, Second Edition, Adult version, Self-report (SRS-2A) at cessation of treatment at 3-months.
SRS-2A measures the presence and severity of social impairment in everyday life. The SRS-2A is a commonly used measure in autism spectrum research and has demonstrated good reliability and validity.
SRS-2A is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life.
Follow-up assessments will comprise ratings of the previous two-week period.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Secondary outcomes (5)
Social Responsiveness Scale, Adult Version, Informant Report
Social Responsiveness Scale, Adult Version, Informant Report is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Social Interaction Anxiety Scale (SIAS)
SIAS is a self-report questionnaire measuring social anxiety in social interaction. SIAS consists of 20 items that are rated on a 5-point Likert scale ranging from 0 (not at all characteristic of me) to 4 (extremely characteristic of me). Item 5, 9 and 11 are positively worded items and have reverse scoring. A total SIAS score is generated by summing the ratings ranging from 0 to 80. Higher scores reflects a higher degree of social anxiety in social interaction.
Measured: Baseline, 3 month follow-up and 6 month follow-up
The Empathy Quotient
The Empathy Quotient (EQ) is a 60-item questionnaire designed to measure empathy in adults. Each item is scored on a 4-point scale (strongly agree, slightly agree, slightly disagree, strongly disagree).
Items 1, 6, 19, 22, 25, 26, 35, 36, 37, 38, 41, 42, 43, 44, 52, 54, 55, 57, 58, 59, and 60 are assigned two points if rated as 'strongly agree' and one point if rated 'slightly agree.'
Items 4, 8, 10, 11, 12, 14, 15, 18, 21, 27, 28, 29, 32, 34, 39, 46, 48, 49, and 50 are assigned two points if rated as 'strongly disagree' and one point if rated 'slightly disagree.'
The minimum score achievable is 0, and the maximum score is 80. A higher score indicates higher levels of empathy in adults.
Measured: Baseline, 3 month follow-up and 6 month follow-up
The High Risk Social Challenge Task (HiSoC)
The High Risk Social Challenge task (HiSoC) is a standardized, performance-based task assessing social skills in terms of affect, odd behaviour and language and social-interpersonal skills. Following a short verbal instruction, the participants are being video-taped for 45 seconds while performing a task.
HiSoC consists of 16 items that are rated on a 5-point Likert scale from 1 to 5. Smaller ratings reflect low levels of appropriate, effective social behavior. Larger ratings reflect high levels of appropriate, effective social behavior. A total HiSoC score is generated by summing the rating ranging from 16 to 80. Higher scores reflects a higher degree of social skills.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Emotion Recognition Task (CANTAB ERT)
Computer-morphed images derived from the facial features of real individuals, each showing a specific emotion, are displayed on the screen, one at a time. Each face is displayed for 200ms and then immediately covered up to prevent residual processing of the image. The participant must select which emotion the face displayed from 6 options (sadness, happiness, fear, anger, disgust or surprise).The outcome measures for ERT cover percentage and number correct or incorrect and overall response latencies, which can be looked at either across individual emotions or across all emotions at once.
Measured: Baseline, 3 month follow-up and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start2 May 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- The study is a high-quality randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 140 adults with ASD will be allocated to receive either 12 weeks of Virtual Reality-based Social Cognitive Training (VRSCT) + treatment as usual (TAU) or TAU. All participants will be assessed at baseline and at 3- and 6-months post-baseline.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louise Birkedal Glenthoej, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Louise B. Glenthøj, DrMSc, Principal investigator, Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438536
- Sponsor's protocol ID
- H-23055504
- Acronym
- STEPS
- Status last verified
- Jun 2026
- First submitted
- 23 May 2024
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andresen J, Jeppesen ACE, Due AS, Mariegaard LS, Parvaiz R, Hjorthoj C, Pinkham AE, Nordentoft M, Letnar G, Jepsen JRM, Glenthoj LB. The Effect of Virtual Reality-Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial. JMIR Res Protoc. 2026 Jan 5;15:e72854. doi: 10.2196/72854.
PubMed 41490522
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEPS (Social Cognitive Training Enhancing Pro-functional Skills): A Clinical Randomized Trial Evaluating the Effect of a Virtual Reality-based Intervention for Adults With Autism.
- ClinicalTrials.gov ID
- NCT06438536
- Acronym / sponsor ID
- STEPS / H-23055504
- Conditions
- Autism Spectrum Disorder
- Keywords
- Randomized clinical trial (RCT), Virtual Reality (VR), Social cognitive training, Cognitive remediation, Digital intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism.
The main questions it aims to answer are:
- Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD?
- Is Virtual Reality-based social cognitive training cost-effective?
Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness.
Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.
Detailed description
Adults with autism spectrum disorders (ASD) constitute an increasingly recognized population with largely unaddressed public health needs. Research on effective interventions for adults with ASD lags far behind that dedicated to children with ASD, as well as other psychiatric disorders.
Adults with ASD show prominent social cognitive deficits that impede their daily functioning such as being able to interact socially, to achieve adequate vocational functioning (i.e. job/educational achievements) as well as inflicting immensely on their quality of life. At current, no robust and replicated evidence exists on a pro-functional treatment targeting social cognitive deficits in adults with ASD.
Virtual reality-based treatment offers the possibility of creating artificial experiences in real time, that make the user feel immersed and able to interact as if it was the real world. Additionally, virtual reality therapy allows for personalization of the therapy to match the specific social challenges of each patient.
Preliminary findings suggest virtual reality exposure to lead to faster symptom reduction than traditional therapy and may therefore be cost-effective. While the potential beneficial effects of virtual reality exposure to challenging social situations, that taps social cognitive functions, are evident and virtual reality therapies are promising in general, the research field is in urgent need of evidence on the effectiveness of virtual reality therapy in adults with ASD.
The STEPS trial evaluates the effect of a Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) versus treatment as usual. We expect to find VRSCT to be more beneficial in improving social cognitive deficits, daily life functioning, and quality of life in adults with ASD.
If the results of the current trial are positive, this short-term, manualised treatment using well-tested VR-software, can easily be implemented in clinical practice, that is in the psychiatric out-patient facilities or in community-based facilities where it can benefit a large group of suffering ASD patients. Additionally, it can be adapted for use in related clinical target groups such as adolescents with ASD or patients with psychosis experiencing social cognitive and functional deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a high-quality randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. A total of 140 adults with ASD will be allocated to receive either 12 weeks of Virtual Reality-based Social Cognitive Training (VRSCT) + treatment as usual (TAU) or TAU. All participants will be assessed at baseline and at 3- and 6-months post-baseline.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-based Social Cognitive Training (VRSCT) | Experimental | Behavioral: Virtual Reality-based Social Cognitive TrainingPatients in the experimental group will be offered 10 individual sessions of targeted, virtual reality assisted psychotherapy embedded in cognitive behavioral therapy (CBT), that aims at enhancing social cognition and daily life functioning. If the patient consents, two additional sessions will be offered in which the patient's relatives are invited to participate (one in the beginning of treatment and one at the end of treatment). The aim of the relative involvement is to enhance transfer from the therapy to the patients daily life. The treatment will be conducted by psychologists with an extensive knowledge in providing virtual reality assisted therapy. The treatment is manualized, and the therapists will receive ongoing supervision by a senior clinician having ≥ 25 years of experience in conducting assessment, treatment, and research with the autism spectrum population. |
| Treatment as Usual (TAU) | No intervention | –The treatment-as-usual (TAU) group will receive the standard treatment offered to adults diagnosed with ASD in Denmark. This commonly consists of four psychoeducational sessions as well as limited supportive counseling. Some adults with ASD also receive practical help in daily life situations in community settings. The TAU will be mapped upon trial completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age of 18 years or older
- Ability to give informed consent
- Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
- T-score on SRS-A self-report ≥ 60
Key exclusion criteria (6 listed)
- Rejecting informed consent
- A diagnosis of organic brain disease
- Intellectual disability (IQ ˂ 70)
- A command of spoken Danish or English inadequate for engaging in therapy
- ADHD-diagnosis with untreated symptoms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-based Social Cognitive TrainingVirtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning. | Behavioural | Virtual Reality-based Social Cognitive Training (VRSCT) |
Primary outcome
Social Responsiveness Scale, Adult Version, Self-report
Time frame: Baseline, 3 month follow-up and 6 month follow-up
The primary outcome is level of social impairment is measured by the Social Responsiveness Scale, Second Edition, Adult version, Self-report (SRS-2A) at cessation of treatment at 3-months. SRS-2A measures the presence and severity of social impairment in everyday life. The SRS-2A is a commonly used measure in autism spectrum research and has demonstrated good reliability and validity. SRS-2A is a 65-item rating scale, scored on on a 4-point Likert Scale (0-3). Each item is scaled from 0 (never true) to 3 (almost always true), generating a total score ranging from 0 to 195. The SRS-2A is provides a continuous measure of social impairment, where a higher score reflects a greater degree of difficulties with social interactions in everyday life. Follow-up assessments will comprise ratings of the previous two-week period.
5 secondary outcomes
Social Responsiveness Scale, Adult Version, Informant Report
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Social Interaction Anxiety Scale (SIAS)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
The Empathy Quotient
Time frame: Baseline, 3 month follow-up and 6 month follow-up
The High Risk Social Challenge Task (HiSoC)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Emotion Recognition Task (CANTAB ERT)
Time frame: Baseline, 3 month follow-up and 6 month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 41490522Andresen J, Jeppesen ACE, Due AS, Mariegaard LS, Parvaiz R, Hjorthoj C, Pinkham AE, Nordentoft M, Letnar G, Jepsen JRM, Glenthoj LB. The Effect of Virtual Reality-Based Social Cognitive Training for Autistic Adults: Protocol for STEPS (Social Cognitive Training Enhancing Pro-Functional Skills) Randomized Clinical Trial. JMIR Res Protoc. 2026 Jan 5;15:e72854. doi: 10.2196/72854.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise B. Glenthøj, DrMSc principal investigator
Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-based Social Cognitive Training in people with Autism Spectrum Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 Jun 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Social Responsiveness Scale, Adult Version, Self-report (time frame: Baseline, 3 month follow-up and 6 month follow-up). 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 NCT06438536, which also lists 1 linked publication.
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 25 Jun 2026.