Emotional Regulation in Individuals With Autism

Autism Spectrum Disorder Clinical Trial

Official title:

Emotional Regulation to Manage Anxiety and Anger in Individuals With Autism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181864
• Other study ID #: CNR-IRIB-PRO-2023-011
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: February 10, 2025

Study information

• Verified date: December 2023
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Germana Doria
• Phone: +393465142289
• Email: germana.doria[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 10, 2025
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

Inclusion Criteria:

• Proven diagnosis of autism;

• QS = 75;

Exclusion Criteria:

• presence of other medical disorders

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (2)

Lead Sponsor	Collaborator
Istituto per la Ricerca e l'Innovazione Biomedica	Comune di Messina

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Attwood T. Esplorare i sentimenti, terapia cognitivo comportamentale per gestire ansia e rabbia, Armando Editore 2013

Conner CM, Elias R, Smith IC, White SW. Emotion Regulation and Executive Function: Associations with Depression and Anxiety in Autism. Res Autism Spectr Disord. 2023 Mar;101:102103. doi: 10.1016/j.rasd.2023.102103. Epub 2023 Jan 9. — View Citation

Conner CM, White SW, Scahill L, Mazefsky CA. The role of emotion regulation and core autism symptoms in the experience of anxiety in autism. Autism. 2020 May;24(4):931-940. doi: 10.1177/1362361320904217. Epub 2020 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Anxiety Scale for Children (MASC2)	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.
Primary	Screen for Child Anxiety Related Disorders (SCARED)	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.