Autism Spectrum DisorderMind-VRNCT05852795
Virtual Reality Experiences as Tools to Support Mental Health in Parents of Children With Autism
A study testing Virtual Reality-mediated Mindfulness-Based Interventions and Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience in people with Autism Spectrum Disorder and Parents, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Parents
- What is being tested?
- Virtual Reality-mediated Mindfulness-Based Interventions and Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of psychiatric diagnosis
- presence of medical disorders (heart disease or blood pressure, neurological disorders, epilepsy)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
About this study
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
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).
Read the 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.
- Conditions
- Autism Spectrum Disorder, Parents
- Being tested
- Virtual Reality-mediated Mindfulness-Based Interventions, Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience
- Keywords
- Autism, Parents, Virtual Reality, Mental health, Mindfulness, Parental wellbeing
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-mediated Mindfulness-Based InterventionsOther
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.
Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experienceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | VR-based and audio-based mindfulness experience. Partecipants watch VR scenario and receive a guided mindfulness practice. Receives: Other: Virtual Reality-mediated Mindfulness-Based Interventions |
| Control Group | Other | VR-based mindfulness experience. Participants watch VR scenario without experiencing voice guided mindfulness practice. Receives: Other: Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The test needs approximately 10 minutes to complete
Secondary outcomes (2)
Heart rate (HR)
The BioHarness 3 uses an electrocardiogram (ECG) sensor to detect the electrical activity of the heart and calculate heart rate in beats per minute (bpm).
Measured: The test needs approximately 30 minutes
Heart rate variability (HRV)
The BioHarness 3 measures the time intervals between successive heart beats and calculates Heart Rate Variability (HRV) in milliseconds (ms).
Measured: The test needs approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Jun 2022
- Primary completion1 Apr 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cerasa, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Antonio Cerasa, Principal investigator, antonio.cerasa@irib.cnr.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852795
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-001
- Acronym
- Mind-VR
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35885747Puglisi 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.
PubMed 35883937Marino 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.
PubMed 34072605
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05852795
- Acronym / sponsor ID
- Mind-VR / CNR-IRIB-PRO-2023-001
- Conditions
- Autism Spectrum Disorder, Parents
- Keywords
- Autism, Parents, Virtual Reality, Mental health, Mindfulness, Parental wellbeing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual Reality-mediated Mindfulness-Based InterventionsVR-based and audio-based mindfulness experience. Partecipants watch VR scenario and receive a guided mindfulness practice. |
| Control Group | Other | Other: Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experienceVR-based mindfulness experience. Participants watch VR scenario without experiencing voice guided mindfulness practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- history of psychiatric diagnosis
- presence of medical disorders (heart disease or blood pressure, neurological disorders, epilepsy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-mediated Mindfulness-Based InterventionsThe 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. | Other | Experimental group |
| Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experienceThe 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. | Other | Control Group |
Primary outcome
Parental Stress Index/Short Form (PSI/SF)
Time frame: The test needs approximately 10 minutes to complete
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
Mindful Attention Awareness Scale (MAAS)
Time frame: The test needs approximately 10 minutes to complete
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.
State-Trait Anxiety Inventory (STAI)
Time frame: The test needs approximately 10 minutes to complete
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.
Beck Depression Inventory (BDI)
Time frame: The test needs approximately 10 minutes to complete
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.
2 secondary outcomes
Heart rate (HR)
Time frame: The test needs approximately 30 minutes
Heart rate variability (HRV)
Time frame: The test needs approximately 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 35885747Failla 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.
- Background: PubMed 35883937Puglisi 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.
- Background: PubMed 34072605Marino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Cerasa principal investigator
antonio.cerasa@irib.cnr.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-mediated Mindfulness-Based Interventions and Virtual Reality-mediated Mindfulness-Based Interventions without audio guided experience in people with Autism Spectrum Disorder and Parents, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress Index/Short Form (PSI/SF) (time frame: The test needs approximately 10 minutes to complete). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05852795, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.