STEPS: A Virtual Reality-based Intervention for Adults With Autism.

Not Applicable

Recruiting

• Conditions: Autism Spectrum Disorder
• Interventions: Behavioral: Virtual Reality-based Social Cognitive Training

• Registration Number: NCT06438536
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief 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. 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?

2. 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 Timeline

• Status Verified: 2024-05
• Study Start: 2024-05-02
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2026-07-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age of 18 years or older
2. Ability to give informed consent
3. Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
4. T-score on SRS-A self-report ≥ 60

Exclusion Criteria

1. Rejecting informed consent
2. A diagnosis of organic brain disease
3. Intellectual disability (IQ ˂ 70)
4. A command of spoken Danish or English inadequate for engaging in therapy
5. ADHD-diagnosis with untreated symptoms
6. Displaying an imminent homicidal or suicidal risk

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality-based Social Cognitive Training (VRSCT)	Virtual Reality-based Social Cognitive Training	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.

Primary Outcome Measures

Name	Time	Method
Social Responsiveness Scale, Adult Version, Self-report	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.

Secondary Outcome Measures

Name	Time	Method
Social Interaction Anxiety Scale (SIAS)	Baseline, 3 month follow-up and 6 month follow-up	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.
The High Risk Social Challenge Task (HiSoC)	Baseline, 3 month follow-up and 6 month follow-up	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.
Social Responsiveness Scale, Adult Version, Informant Report	Baseline, 3 month follow-up and 6 month follow-up	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.
The Empathy Quotient	Baseline, 3 month follow-up and 6 month follow-up	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.
Emotion Recognition Task (CANTAB ERT)	Baseline, 3 month follow-up and 6 month follow-up	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.

Trial Locations

Locations (1)

Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark; 🇩🇰 Copenhagen, Hellerup, Denmark