Clinical trial NCT05852795: Virtual Reality Experiences as Tools to Support Mental Health in Parents of Children With Autism
Official title: Evaluating the Behavioral Effect of a Virtual Reality-mediated Mindfulness-based Interventions on Parents of Children With Autism: a Randomized Controlled Trial (RCT) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parents
Keywords: Autism
Parents
Virtual Reality
Mental health
Mindfulness
Parental wellbeing
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: In this study participants will be randomly assigned to an experimental or control groups according to the main treatment. Participants in the experimental group will undergo 8 VR sessions by observing a scenario accompanied by a voice audio guide, whereas participants in the control group will complete the 8 VR sessions by observing scenery accompanied only by the sounds of nature. All groups will be treated one time a week for 1h sessions for 8 consecutive weeks.

Participant recruitment: The families of children with ASD will be recruited at the clinical facilities of the Institute for Biomedical Research and Innovation of the National Research Council of Italy (IRIB-CNR) in Messina as part of an ongoing research program.

Allocation of the sample: Eligible participants who will meet the inclusion criteria will receive written information about the procedure and be asked to sign the consent form indicating their willingness to participate in the study. Only qualified individuals who provided informed consent will be randomly assigned to the experimental or control group in a 1:1 manner. Participants will then receive information regarding the allocation result. The randomization will be performed using a computer-generated, site-stratified, randomization schedule. Randomization will be stratified according to age, sex and educational level. For each stratum, random numbers will be assigned to the participants and put into envelopes; it will be determined randomly whether the even or odd number would enter the experimental group. Participants will be assigned to the study according to the numbers they received on opening the envelopes.

Withdrawn criteria: Participants will be considered withdrawn if any of the following occurs: (1) participant chooses to withdraw from the study at any time, (2) intolerable adverse effects, (3) major violation of the study protocol, and (4) other circumstances that would endanger the health of the subject if he/she would to continue his/her participation in the trial.

Immersive virtual environments: Virtual reality experience will be made by using 8 relaxing virtual scenarios (e.g., naturalistic environments) created by BECOME s.r.l. (https://www.discoverbecome.com). The virtual experiences will be offered through the Oculus Quest 2 (marketed since November 2021 as Meta Quest 2)

Sample size: Power size calculation will be performed with GPower 3.1. Considering an anticipated effect size (f) of 1, an alpha set at 0.05, 2 groups, and a 0.95 statistical power, the total sample size required is N = 46.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Parental Stress Index/Short Form (PSI/SF)
timeFrame: The test needs approximately 10 minutes to complete
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: The test needs approximately 10 minutes to complete
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: The test needs approximately 10 minutes to complete
measure: Beck Depression Inventory (BDI)
timeFrame: The test needs approximately 10 minutes to complete
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: The test needs approximately 30 minutes
measure: Heart rate variability (HRV)
timeFrame: The test needs approximately 30 minutes
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: antonio.cerasa@irib.cnr.it
name: Antonio Cerasa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.