Awareness Training in Children With Autism Spectrum Disorder.

NCT ID: NCT06278168

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-12
• Study Completion Date: 2025-05-08

Brief 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental awareness group

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.

Group Type: EXPERIMENTAL

Awareness training with using Oculus.

Intervention Type: 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.

Traditional awareness group

Twenty children in the control group will undergo individual training without using Oculus device. The group sessions will be the same for both groups.

Group Type: OTHER

Awareness training without using Oculus

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Awareness training without using Oculus

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 85<IQ<115

Exclusion Criteria

• presence of other medical disorders

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Messina, Italy

OTHER

Sponsor Role: collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

OTHER

Sponsor Role: lead

Responsible Party

Flavia Marino

Head of unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Flavia Marino

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Messina, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Germana Doria

Role: CONTACT

germana.doria@irib.cnr.it

+393465142289

Maria Valeria Maiorana

Role: CONTACT

mariavaleria.maiorana@irib.cnr.it

+393285856656

Facility Contacts

Flavia Marino

Role: primary

flavia.marino@irib.cnr.it

+393395798263

Maria Valeria Maiorana

Role: backup

mariavaleria.maiorana@irib.cnr.it

+393285856656

References

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.

Reference Type: BACKGROUND

PMID: 25348866 (View on PubMed)

Louise 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

Reference Type: BACKGROUND

Other Identifiers

CNR-IRIB-PRO-2024-002

Identifier Type: -

Identifier Source: org_study_id