Clinical trial NCT06438536: STEPS: A Virtual Reality-based Intervention for Adults With Autism.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Randomized clinical trial (RCT)
Virtual Reality (VR)
Social cognitive training
Cognitive remediation
Digital intervention
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Social Responsiveness Scale, Adult Version, Self-report
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
Secondary outcomes:
measure: Social Responsiveness Scale, Adult Version, Informant Report
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Social Interaction Anxiety Scale (SIAS)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: The Empathy Quotient
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: The High Risk Social Challenge Task (HiSoC)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Emotion Recognition Task (CANTAB ERT)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
Other outcomes:
measure: CAT-Q (Camouflaging Autistic Traits Questionnaire)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: SR-AS (Questionnaire on sensory reactions)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Beck Depression Inventory (BDI)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Intolerance of Uncertainty Scale (IUS-12)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: General Alexithymia Factor Score (GAFS-8)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: The Repetitive Behaviour Questionnaire-3 (RBQ-3)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Inventory of Psychotic-Like Anomalous Self-Experiences (IPASE)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Green Paranoid Thought Scale (GPTS)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Adult ADHD Self-Report Scale (ASRS)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Social Skills Performance Assessment (SSPA)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: WHO-5 Well-Being Index (WHO-5)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: General Self Efficacy Scale (GSE)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: EuroQOL five dimensions questionnaire (EQ-5D)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Defeatist Performance Attitude Scale (DPAS)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Temple University Community Participation Measure (TUCP)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Personal and Social Performance Scale (PSP)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Davos Assessment of the Cognitive Biases Scale (DACOBS)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: The Awareness of Social Inference Test - Short Form, part 2 Social Inference, Minimal (TASIT-S)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: The Hinting Task
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Behavior Rating Inventory of Executive Function - Adult Version, Self-Report (BRIEF-A, Self-Report)
timeFrame: Baseline, 3 month follow-up and 6 month follow-up
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3 month follow-up
measure: Negative Effects Questionnaire (NEQ)
timeFrame: 3 month follow-up
measure: Multimodal Presence Scale, Modified Shortened Danish Version (MPS-MSDV)
timeFrame: 3 and 10 weeks post baseline
measure: Virtual Reality Simulation Sickness Questionnaire, Modified Danish Version (VRSSQ-MDV)
timeFrame: 3 and 10 weeks post baseline
measure: Readiness for Therapy Questionnaire (RTQ)
timeFrame: 1 week post baseline
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen, Mental Health Services in the Capital Region, Denmark
state: Hellerup
Study officials:
affiliation: Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen
name: Louise B. Glenthøj, DrMSc
role: PRINCIPAL_INVESTIGATOR
References: