Emotional Regulation in Individuals With Autism

December 13, 2023 updated by: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Emotional Regulation to Manage Anxiety and Anger in Individuals With Autism

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98164
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Flavia Marino
        • Sub-Investigator:
          • Giovanni Pioggia
        • Sub-Investigator:
          • Paola Chilà
        • Sub-Investigator:
          • Roberta Minutoli
        • Sub-Investigator:
          • Noemi Vetrano
        • Sub-Investigator:
          • Chiara Failla
        • Sub-Investigator:
          • Germana Doria
        • Sub-Investigator:
          • Ileana Scarcella
        • Sub-Investigator:
          • Alfio Puglisi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Proven diagnosis of autism;
  • QS ≥ 75;

Exclusion Criteria:

  • presence of other medical disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Twenty children from the experimental group will undergo the treatment using Robot Nao.
Other: NAO intervention
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Test of Emotional Vocabulary (TLE) and the Test of emotion comprehension (TEC). The tests will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 15 sessions, one per week lasting one hour and thirty minutes. the children are guided by the voice of the robot Nao. The robot guides them in carrying out practical and relaxation activities. Consequently, audio visual feedback will be provided, via the robot, to return information to the subject about the accuracy of the response.
Other: Control group
Twenty children belonging to the control group will be subjected to the same training but in a traditional way.
Other: Traditional intervention
The subjects will undergo a pre-intervention assessment phase that will consist of administering the Test of Emotional Vocabulary (TLE) and the Test of emotion comprehension (TEC). The tests will be re-submitted at the end of the intervention. Having ascertained the presence of the inclusion criteria and following randomization of the sample, the Experimental Group constituted of 20 children, will be administered the research task, which involves 15 sessions, one per week lasting one hour and thirty minutes. The children are guided by the instructions of the operator who guides them in carrying out practical and relaxation activities. Consequently, the operator will provide feedback, to return information to the subject regarding the accuracy of the response.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
The estimated time for administration of this sub-test is about 10-15 minutes.
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.
The estimated time for administration of this sub-test is about 10-15 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

Comune di Messina

Investigators

  • Principal Investigator: Flavia Marino, Istituto per la Ricerca e l'Innovazione Biomedica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Actual)

November 21, 2023

Study Completion (Estimated)

February 10, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IRIB-PRO-2023-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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