An observational study in Behavioral and Emotional Disorder With Onset in Childhood, sponsored by IRCCS Fondazione Stella Maris. Recruiting at 1 site in Italy. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by IRCCS Fondazione Stella Maris · Observational
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.
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
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 40 is below the median of 235 across 341 observational studies indexed under Behavior.
Browse Behavior studies →IRCCS Fondazione Stella Maris is the lead sponsor of 46 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the study, patients aged between 3 and 6 years who were referred in a naturalistic setting for diagnostic assessment, and who received a diagnosis of an emotional-behavioral disorder following the routine clinical assessment, will be enrolled.
Inclusion Criteria:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
EDI-YC (Emotional Dysregulation Inventory-Young Child)
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).
Time frame: Baseline
BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)
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.
Time frame: Baseline
Sleep-wake EEG recording
Sleep-wake EEG is an electroencephalographic recording that evaluates brain electrical activity during wakefulness and sleep.
Time frame: Up to 24 weeks
Started Oct 2025 (actual). Primary completion is estimated for Oct 2026, 11 months after the start.
Of 113 non-industry observational studies under Behavior, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 57. This study's planned 11 months is below that.
Counting every sponsor, half of 119 studies reached it within 17 months; a quarter within 6 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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IRCCS Fondazione Stella Maris