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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Comune di Messina

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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