Skip to content

Emotional Dysregulation and Other Psychopathological Dimensions in Clinical Preschoolers

Clinical Characterization of Preschool Children With Internalizing and Externalizing Symptoms: The Role of Empathy, Restricted and Repetitive Behaviors, Emotional-Behavioral Dysregulation, and Executive Functions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07805668
Enrollment
40
Registered
2026-09-04
Start date
2025-10-14
Completion date
2026-11-30
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Behavioral and Emotional Disorder With Onset in Childhood

Brief summary

The purpose of the study is to investigate the emotional-behavioral dysregulation and its possible correlation with the main demographic and psychopathological variables in a sample of preschool children with internalizing and externalizing disorders.

Detailed description

This observational study aims to collect data (both prospective and retrospective from 2025) regarding a sample of children aged between 3 and 6 years who were referred in a naturalistic setting to the Department of Developmental Psychiatry and Psychopharmacology at the IRCCS Stella Maris Foundation and to the Child Neuropsychiatry Unit of the IRCCS Giannina Gaslini (multicenter study) for diagnostic assessment, and who received a diagnosis of an internalizing and/or externalizing disorder following the clinical assessment. Through a back-translation procedure, our research group translated and adapted into Italian the "Emotion Dysregulation Inventory Young Child (EDI-YC)" questionnaire for the assessment of emotional-behavioral dysregulation in preschool children. Children will be enrolled according to the eligibility criteria and after informed consent for participation in the study has been signed by both parents/legal guardians. For the collection of retrospective data only, as provided for by the study, and where explicit consent from the parents/legal guardians could not be obtained, the data will be collected in accordance with Article 110-bis, paragraph 4, of the Italian Privacy Code. The data about emotional-behavioral dysregulation obtained from the completion of the EDI-YC will be correlated with data obtained from other questionnaires and from the clinical assessment in order to achieve a characterization of clinical phenotypes based on the psychopathological dimensions investigated. Executive functions will be investigated in the sample of preschool children through a correlation analysis between BRIEF-P scores and EEG recordings

Interventions

None listed

Sponsors

IRCCS Fondazione Stella Maris
Lead SponsorOTHER
Gaslini Children's Hospital
CollaboratorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years

Inclusion criteria

Inclusion criteria: * Age between 3 and 6 years * Presence of an internalizing and/or externalizing disorder * Parent completion of the questionnaires * Parent/caregiver signed informed consent for participation in the study

Exclusion criteria

* Age greater than 6 years

Design outcomes

Primary

MeasureTime frameDescription
EDI-YC (Emotional Dysregulation Inventory-Young Child)BaselineEDI-YC is a questionnaire developed to assess emotional dysregulation (ED) in children aged 2 to 5 years, both with and without neuropsychological disabilities. Parents are asked to rate their children's emotional behaviors by assigning a score reflecting the frequency and intensity of emotional dysregulation manifestations (0 = not at all; 4 = very serious).

Secondary

MeasureTime frameDescription
BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)BaselineBRIEF-P is a parent questionnaire that assesses various aspects of Executive Functions in preschool-aged children, including Inhibition, Emotional Control, Shifting/Flexibility, Planning and Organization, and Working Memory. Parents evaluate, using a 3-point rating scale (1 = never; 3 = always), the frequency with which the behaviors described in each item occur.
Sleep-wake EEG recordingUp to 24 weeksSleep-wake EEG is an electroencephalographic recording that evaluates brain electrical activity during wakefulness and sleep.

Countries

Italy

Contacts

CONTACTvalentina viglione
valentina.viglione@fsm.unipi.it39050886293

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026