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Clinical Trials/NCT06181864
NCT06181864
Recruiting
Not Applicable

Emotional Regulation to Manage Anxiety and Anger in Individuals With Autism

Istituto per la Ricerca e l'Innovazione Biomedica1 site in 1 country40 target enrollmentMay 10, 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
Screen for Child Anxiety Related Disorders (SCARED)
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The objective of the study is to learn about and manage emotions such as anxiety and anger. The activities are aimed at identifying and managing emotions such as anxiety and anger, through the recognition of the changes that occur at a physiological, cognitive, behavioral and communicative level. In the first sessions, children will be exposed to the emotion of happiness through pleasant activities and involved in relaxation exercises. In subsequent sessions, anger and then anxiety will be addressed first. Social tools will be introduced and ways of thinking and perspective useful to children will be addressed. Furthermore, they will learn to use all the tools and strategies necessary to face and overcome the various emotions and situations in a functional manner. In the final sessions, children will work to design a cognitive-behavioral intervention program for themselves and other group members to improve the management of anxiety and anger. The expected results concern the acquisition of adequate emotional regulation; the construction of functional thoughts, social tools, thinking and perspective tools, adequate strategies for managing emotions; the design of a cognitive-behavioral intervention program in daily life and the strengthening of relational, social, empathic and resilient skills within the peer group and families.

Registry
clinicaltrials.gov
Start Date
May 10, 2023
End Date
February 10, 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

  • Proven diagnosis of autism;

Exclusion Criteria

  • presence of other medical disorders

Outcomes

Primary Outcomes

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.

Multidimensional Anxiety Scale for Children (MASC2)

Time Frame: The estimated time for administration of this sub-test is about 10-15 minutes.

The Multidimensional Anxiety Scale for Children 2nd Edition (MASC 2™) is a questionnaire for assessing the main dimensions of anxiety in children and adolescents. The scale was constructed using a bottom-up empirical approach to ensure that numerous symptom dimensions were included. The item selection procedure categorized the different dimensions of anxiety into emotional, cognitive, physical and behavioral symptoms. The end result of this process was the creation of a multidimensional measure of childhood anxiety that included four factors (physical symptoms, social anxiety, separation anxiety/panic, and danger avoidance) and six subscales (tension/restlessness, somatic /autonomic, perfectionism, anxious coping, humiliation/rejection and performance anxiety).

Study Sites (1)

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