Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07805668

Emotional Dysregulation and Other Psychopathological Dimensions in Clinical Preschoolers

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Behavioral and Emotional Disorder With Onset in Childhood Behavior

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Stella Maris

Pisa, Italy, 56128

Location status: Recruiting

Location contact

valentina viglione, MD

CONTACT

[email protected]

050886293

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. EDI-YC (Emotional Dysregulation Inventory-Young Child)

    Time frame: Baseline

    EDI-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 outcomes

  1. BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)

    Time frame: Baseline

    BRIEF-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.

  2. Sleep-wake EEG recording

    Time frame: Up to 24 weeks

    Sleep-wake EEG is an electroencephalographic recording that evaluates brain electrical activity during wakefulness and sleep.

Study contacts

Contact information is provided by the study sponsor or research team.

valentina viglione

CONTACT

[email protected]

39050886293

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

  • Gaslini Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.