AutismNCT06278168
Awareness Training in Children With Autism Spectrum Disorder.
A study testing Awareness training with using Oculus. and Awareness training without using Oculus in people with Autism and Autism Spectrum Disorder, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster… Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- Awareness training with using Oculus. and Awareness training without using Oculus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 12 Jun 2023to 8 May 2025
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 85<IQ<115
Who cannot join
- presence of other medical disorders
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Flavia Marino, +393395798263, flavia.marino@irib.cnr.it
Maria Valeria Maiorana, +393285856656, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Raising Awareness of Autism Spectrum Disorder in Children: Promoting Understanding and Support
The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- Awareness training with using Oculus., Awareness training without using Oculus
- Keywords
- autism, children, ASD, awareness
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness training with using Oculus.Other
The protocol consists of 2 phases:one conducted in groups,one individually. In the first session, through interactive activities such as passing a wool ball while sharing passions and interests, and filling out personal cards, participants get to know each other and develop an atmosphere of mutual acceptance.
In the second session,participants explore neurodiversity through viewing videos, guided discussions and creating symbols representative of the group concept. Optical illusions are explored to understand differences in individual perception.In addition, issues of hypersensitivity and hyposensitivity are addressed,encouraging participants to reflect on their special interests and ways of presenting themselves. The second phase consists of 12 individual meetings to promote emotional well-being and self-awareness. During the meetings, the Oculus device will be used in which relaxation videos will be shown. In addition, heart rate will be detected with sensors placed in the chest.
Awareness training without using OculusOther
The control group will carry out the same steps as the experimental group, heart rate will be taken through the use of sensors but in this case the Oculus device will not be used to watch relaxation videos.
| Study group | Role | What they receive |
|---|---|---|
| Experimental awareness group | Experimental | Twenty children in the experimental group will undergo individual training in which they will watch relaxation videos with the Oculus device. The group sessions will be the same for both groups. Receives: Other: Awareness training with using Oculus. |
| Traditional awareness group | Other | Twenty children in the control group will undergo individual training without using Oculus device. The group sessions will be the same for both groups. Receives: Other: Awareness training without using Oculus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months.
The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max
160). For each sub-scale higher score corresponds to better performance.
Measured: The test needs approximately 65-80 minutes to complete.
Multidimensional Anxiety Scale for Children-Second Edition (MASC 2)
MASC 2 is an assessment tool for anxiety-related symptoms consisting of a self-report questionnaire and rating scales for parents. it consists of 50 items.
Measured: The test needs approximately 15 minutes
Screen for Child Anxiety Related Disorders (SCARED)
The SCARED - Screen for child Anxiety Related Emotional Disorders questionnaire is considered one of the best tools for measuring childhood anxiety. The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia. Also, evaluate symptoms related to school phobias.
Measured: The estimated time for administration of this sub-test is about 10-15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start12 Jun 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion8 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AutismStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Messina, Italy
- Responsible party
- Principal investigator, Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Flavia Marino, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06278168
- Sponsor's protocol ID
- CNR-IRIB-PRO-2024-002
- Status last verified
- Feb 2024
- First submitted
- 19 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Bruin EI, Blom R, Smit FM, van Steensel FJ, Bogels SM. MYmind: Mindfulness training for Youngsters with autism spectrum disorders and their parents. Autism. 2015 Nov;19(8):906-14. doi: 10.1177/1362361314553279. Epub 2014 Oct 27.
PubMed 25348866Louise L.Hayes, Joseph Ciarrochi (2015). Adolescenti in crescita. L'ACT per aiutare i giovani a gestire le emozioni, raggiungere obiettivi, costruire relazioni sociali. Franco Angeli
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raising Awareness of Autism Spectrum Disorder in Children: Promoting Understanding and Support
- ClinicalTrials.gov ID
- NCT06278168
- Acronym / sponsor ID
- CNR-IRIB-PRO-2024-002
- Conditions
- Autism, Autism Spectrum Disorder
- Keywords
- autism, children, ASD, awareness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Messina, Italy
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 8 May 2025 (estimated)
- First posted
- 26 Feb 2024 (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.
The proposed protocol aims to facilitate awareness and understanding of autism spectrum disorder among children aged 8 to 14 with an IQ between 85 and 115. Conducted once a week for 60 minutes, the protocol encompasses two initial group sessions followed by 5 group meetings, introducing activities to foster self-awareness, cognitive understanding, and an inclusive environment. Subsequently, the protocol advances to 12 individual sessions focused on emotional well-being and self-awareness, integrating Oculus technology and chest sensors for heart rate monitoring. Initiating the intervention, individual family meetings are scheduled to outline intervention goals and phases. The initial group sessions focus on social bonding, cognitive understanding, and creating an accepting atmosphere among participants. Utilizing activities addressing neurodiversity awareness and technological tools like tablets, the sessions encourage discussions on individual differences and sensitivities. The subsequent individual sessions are structured to explore personal values, identify inner critical voices, and develop emotional awareness through exercises exploring emotions and physical sensations. Progressively, the intervention introduces mindfulness, guiding participants to acknowledge emotions as normal and encouraging alignment of daily actions with personal values. Following this, sessions center on building observational skills, recognizing past behaviors, and fostering strengths tied to values. Participants are encouraged to distinguish between their critical "consultant" and the value-driven "explorer," fostering personal growth and reflection. The protocol's later stages delve into identifying personal strengths linked to core values and exploring value-driven goals. Visual exercises, metaphors, and flexible self-views are emphasized, promoting adaptability and self-evolution. The protocol concludes by advocating a flexible self-view, embracing change, and connecting oneself to ever-evolving metaphors like "a cup with changing contents" or "the ever-changing sky." These sessions culminate with visual relaxation facilitated through Oculus technology while simultaneously monitoring participants' heart rates using chest sensors. This comprehensive approach integrates technological tools with emotional and cognitive exercises, providing a multifaceted framework to enhance self-awareness and promote acceptance within the context of neurodiversity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental awareness group | Experimental | Other: Awareness training with using Oculus.Twenty children in the experimental group will undergo individual training in which they will watch relaxation videos with the Oculus device. The group sessions will be the same for both groups. |
| Traditional awareness group | Other | Other: Awareness training without using OculusTwenty children in the control group will undergo individual training without using Oculus device. The group sessions will be the same for both groups. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 85<IQ<115
Key exclusion criteria (1 listed)
- presence of other medical disorders
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 |
|---|---|---|
| Awareness training with using Oculus.The protocol consists of 2 phases:one conducted in groups,one individually. In the first session, through interactive activities such as passing a wool ball while sharing passions and interests, and filling out personal cards, participants get to know each other and develop an atmosphere of mutual acceptance. In the second session,participants explore neurodiversity through viewing videos, guided discussions and creating symbols representative of the group concept. Optical illusions are explored to understand differences in individual perception.In addition, issues of hypersensitivity and hyposensitivity are addressed,encouraging participants to reflect on their special interests and ways of presenting themselves. The second phase consists of 12 individual meetings to promote emotional well-being and self-awareness. During the meetings, the Oculus device will be used in which relaxation videos will be shown. In addition, heart rate will be detected with sensors placed in the chest. | Other | Experimental awareness group |
| Awareness training without using OculusThe control group will carry out the same steps as the experimental group, heart rate will be taken through the use of sensors but in this case the Oculus device will not be used to watch relaxation videos. | Other | Traditional awareness group |
Primary outcome
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Time frame: The test needs approximately 65-80 minutes to complete.
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months. The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.
Multidimensional Anxiety Scale for Children-Second Edition (MASC 2)
Time frame: The test needs approximately 15 minutes
MASC 2 is an assessment tool for anxiety-related symptoms consisting of a self-report questionnaire and rating scales for parents. it consists of 50 items.
Screen for Child Anxiety Related Disorders (SCARED)
Time frame: The estimated time for administration of this sub-test is about 10-15 minutes.
The SCARED - Screen for child Anxiety Related Emotional Disorders questionnaire is considered one of the best tools for measuring childhood anxiety. The SCARED is a child and parent self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder, and social phobia. Also, evaluate symptoms related to school phobias.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 25348866de Bruin EI, Blom R, Smit FM, van Steensel FJ, Bogels SM. MYmind: Mindfulness training for Youngsters with autism spectrum disorders and their parents. Autism. 2015 Nov;19(8):906-14. doi: 10.1177/1362361314553279. Epub 2014 Oct 27.
- BackgroundLouise L.Hayes, Joseph Ciarrochi (2015). Adolescenti in crescita. L'ACT per aiutare i giovani a gestire le emozioni, raggiungere obiettivi, costruire relazioni sociali. Franco Angeli
- Individual participant dataSharing planned: No
Related trials for Autism
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
Flavia Marino principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Awareness training with using Oculus. and Awareness training without using Oculus in people with Autism and Autism Spectrum Disorder, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Germana Doria (+393465142289, germana.doria@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) (time frame: The test needs approximately 65-80 minutes to complete.). The study lists 3 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 NCT06278168, which also lists 2 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 26 Feb 2024.