Virtual Reality Experiences as Tools to Support Mental Health in Parents of Children With Autism

NCT05852795 | Completed

• 1 other identifier: CNR-IRIB-PRO-2023-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness is a technique that involves the intentional and non-judgmental regulation of attention to the present moment, with curiosity, openness, and acceptance, as per its definition. Mindfulness-based interventions (MBIs) have been used to manage mood disorders in various clinical and non-clinical settings, including neurological patients and cardiovascular diseases. Studies have consistently demonstrated that MBIs reduce depressive and anxiety symptoms, as well as rumination. MBIs are considered an alternative and effective treatment for reducing psychological stress in the management of different health conditions. Virtual reality (VR) has recently been proposed as an intermediate interface to help patients with emotional dysregulation learn mindfulness practices. Within this context, new approaches to mental health integrating advanced technologies such as VR can play a critical role. In this interventional study we will seek to demonstrate the effectiveness of a virtual reality-mediated mindfulness-based intervention in a particular group of people who are constantly experiencing psychological distress due to caring for children with autism spectrum disorders (ASD).

Conditions

Autism Spectrum Disorder; Parents

Keywords

Autism; Parents; Virtual Reality; Mental health; Mindfulness; Parental wellbeing

Outcome Measures

Primary Outcomes (4)

• Parental Stress Index/Short Form (PSI/SF)

  The Parenting Stress Index/Short Form (PSI/SF) is a self-administered questionnaire that aims to identify factors that may negatively impact a child's development

  The test needs approximately 10 minutes to complete

• Mindful Attention Awareness Scale (MAAS)

  The Mindful Attention Awareness Scale (MAAS) consists of 15 items, each scored on a Likert scale ranging from 1 (almost always) to 6 (almost never). The total score on the MAAS ranges from a minimum of 15 (reflecting a response of 1 on all items) to a maximum of 90 (reflecting a response of 6 on all items). Higher scores on the MAAS indicate greater clinical improvement in a patient's capacity for present moment awareness.

  The test needs approximately 10 minutes to complete

• State-Trait Anxiety Inventory (STAI)

  The total State-Trait Anxiety Inventory (STAI) score is between 20 and 80 with a predictive threshold value of anxious symptomatology set at 40. The level of severity can also be defined according to a scalar criterion: from 40 to 50 mild form, from 50 to 60 moderate, \> of 60 serious.

  The test needs approximately 10 minutes to complete

• Beck Depression Inventory (BDI)

  The Beck Depression Inventory is a depression rating scale that can be used with individuals 13 years of age and older and assesses symptoms of depression on a scale of 0 to 3 based on 21 specific items.

  The test needs approximately 10 minutes to complete

Secondary Outcomes (2)

• Heart rate (HR)

  The test needs approximately 30 minutes

• Heart rate variability (HRV)

  The test needs approximately 30 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

VR-based and audio-based mindfulness experience. Partecipants watch VR scenario and receive a guided mindfulness practice.

Other: Virtual Reality-mediated Mindfulness-Based Interventions

Control Group

OTHER

VR-based mindfulness experience. Participants watch VR scenario without experiencing voice guided mindfulness practice.

Other: Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience

Interventions

Virtual Reality-mediated Mindfulness-Based Interventions OTHER

The Experimental will undergo 8 weekly sessions of immersive experience lasting 30 minutes. Each session is divided as follows: * First phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). * Second phase: Detection of physiological parameters with Oculus instrumentation turned ON during mindfulness experience (10 minutes * Third phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). This intervention will produce a multisensory experience merging visual and digital auditory stimuli. The audio recording also included some ambient natural sound effects, to make the practice more immersive.

Experimental group

Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience OTHER

The Control will undergo 8 weekly sessions of immersive experience lasting 30 minutes. Each session is divided as follows: * First phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). * Second phase: Detection of physiological parameters with Oculus instrumentation turned ON during mindfulness experience (10 minutes * Third phase: Detection of physiological parameters with Oculus equipment switched off (10 minutes). This intervention will produce a monosensorial experience with video guided stimulation of naturalistic scenarios.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being parent of a child diagnosed with autism
• absence of pharmacotherapy that could interfere with the measured data (psychoactive drugs, anti-hypertensive, anti-depressants)
• no significant visual impairment

You may not qualify if:

• history of psychiatric diagnosis
• presence of medical disorders (heart disease or blood pressure, neurological disorders, epilepsy)

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

Location

Related Publications (3)

• Failla C, Marino F, Bernardelli L, Gaggioli A, Doria G, Chila P, Minutoli R, Mangano R, Torrisi R, Tartarisco G, Bruschetta R, Arcuri F, Cerasa A, Pioggia G. Mediating Mindfulness-Based Interventions with Virtual Reality in Non-Clinical Populations: The State-of-the-Art. Healthcare (Basel). 2022 Jun 29;10(7):1220. doi: 10.3390/healthcare10071220.

  PMID: 35885747 BACKGROUND

• Puglisi A, Capri T, Pignolo L, Gismondo S, Chila P, Minutoli R, Marino F, Failla C, Arnao AA, Tartarisco G, Cerasa A, Pioggia G. Social Humanoid Robots for Children with Autism Spectrum Disorders: A Review of Modalities, Indications, and Pitfalls. Children (Basel). 2022 Jun 25;9(7):953. doi: 10.3390/children9070953.

  PMID: 35883937 BACKGROUND

• Marino F, Failla C, Carrozza C, Ciminata M, Chila P, Minutoli R, Genovese S, Puglisi A, Arnao AA, Tartarisco G, Corpina F, Gangemi S, Ruta L, Cerasa A, Vagni D, Pioggia G. Mindfulness-Based Interventions for Physical and Psychological Wellbeing in Cardiovascular Diseases: A Systematic Review and Meta-Analysis. Brain Sci. 2021 May 29;11(6):727. doi: 10.3390/brainsci11060727.

  PMID: 34072605 BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Antonio Cerasa

  antonio.cerasa@irib.cnr.it

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 10, 2023
• Study Start: June 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 15, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)