NCT06278168

Awareness Training in Children With Autism Spectrum Disorder.

Status unknown NA Last updated 26 February 2024

What this trial tests

NA trial testing Awareness training with using Oculus. in Autism in 40 participants. Status unknown.

Timeline

12 June 2023

Primary endpoint
1 June 2024

8 May 2025

Quick facts

Lead sponsor	Istituto per la Ricerca e l'Innovazione Biomedica
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	12 June 2023
Primary completion	1 June 2024
Estimated completion	8 May 2025
Sites	1 location across Italy

Drugs / interventions tested

• Awareness training with using Oculus.
• Awareness training without using Oculus

Conditions studied

• Autism — all drugs for Autism →
• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica — full company profile →

Who can join

Adults 8 to 14, any sex, with Autism or Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.