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

NCT06438536 | Recruiting DMC

• 1 other identifier: H-23055504
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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. 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. 2.Is Virtual Reality-based social cognitive training cost-effective?

Conditions

Autism Spectrum Disorder

Keywords

Randomized clinical trial (RCT); Virtual Reality (VR); Social cognitive training; Cognitive remediation; Digital intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 month follow-up and 6 month follow-up

Secondary Outcomes (5)

• Social Responsiveness Scale, Adult Version, Informant Report

  Baseline, 3 month follow-up and 6 month follow-up

• Social Interaction Anxiety Scale (SIAS)

  Baseline, 3 month follow-up and 6 month follow-up

• The Empathy Quotient

  Baseline, 3 month follow-up and 6 month follow-up

• The High Risk Social Challenge Task (HiSoC)

  Baseline, 3 month follow-up and 6 month follow-up

• Emotion Recognition Task (CANTAB ERT)

  Baseline, 3 month follow-up and 6 month follow-up

Other Outcomes (25)

• CAT-Q (Camouflaging Autistic Traits Questionnaire)

  Baseline, 3 month follow-up and 6 month follow-up

• SR-AS (Questionnaire on sensory reactions)

  Baseline, 3 month follow-up and 6 month follow-up

• Beck Depression Inventory (BDI)

  Baseline, 3 month follow-up and 6 month follow-up

Study Arms (2)

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.

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.

Interventions

Virtual Reality-based Social Cognitive Training BEHAVIORAL

Virtual reality assisted social cognitive training embedded in cognitive behavioral therapy, that aims at enhancing social cognition and daily life functioning.

Virtual Reality-based Social Cognitive Training (VRSCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead

Study Sites (1)

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

Copenhagen, Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Louise B. Glenthøj, DrMSc

  Copenhagen Research Centre for Mental Health (CORE), Mental Health Centre Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Andresen, MSc Psych

CONTACT

20360116; johannes.andresen@regionh.dk

Alberte Cathrine E. Jeppesen, MSc Psych

CONTACT

20311064; alberte.cathrine.ehrhardt.jeppesen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stratified block randomization with concealed randomization sequences will be conducted after baseline assessment. Independent assessors blinded to the treatment will evaluate outcomes. Analysis of outcomes will be carried out following the intention-to-treat principles.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DMSc, PhD, psychologist with specialization in psychiatry and specialist in psychotherapy

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 3, 2024
• Study Start: May 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)