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Clinical Trials/NCT06278168
NCT06278168
Recruiting
Not Applicable

Raising Awareness of Autism Spectrum Disorder in Children: Promoting Understanding and Support

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country40 target enrollmentJune 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Enrollment
40
Locations
1
Primary Endpoint
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2023
End Date
May 8, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Responsible Party
Principal Investigator
Principal Investigator

Flavia Marino

Head of unit

Istituto per la Ricerca e l'Innovazione Biomedica

Eligibility Criteria

Inclusion Criteria

  • 85\<IQ\<115

Exclusion Criteria

  • presence of other medical disorders

Outcomes

Primary Outcomes

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.

Study Sites (1)

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