Clinical trial NCT06181864: Emotional Regulation in Individuals With Autism
Official title: Emotional Regulation to Manage Anxiety and Anger in Individuals With Autism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: autism
children
emotional regulation
anxiety
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Messina, Italy
First posted: 2023-12-26
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Proven diagnosis of autism;
* QS ≥ 75;

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Multidimensional Anxiety Scale for Children (MASC2)
timeFrame: The estimated time for administration of this sub-test is about 10-15 minutes.
measure: Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: The estimated time for administration of this sub-test is about 10-15 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Istituto per la Ricerca e l'Innovazione Biomedica
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attwood T. Esplorare i sentimenti, terapia cognitivo comportamentale per gestire ansia e rabbia, Armando Editore 2013
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.
citation: 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.