Behavioral and Emotional Disorder With Onset in ChildhoodNCT07805668
Emotional Dysregulation and Other Psychopathological Dimensions in Clinical Preschoolers
An observational study of Behavioral and Emotional Disorder With Onset in Childhood, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Behavioral and Emotional Disorder With Onset in Childhood
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2025to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Age greater than 6 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Stella Maris
Pisa, Italy, 56128
valentina viglione, MD, 050886293, valentina.viglione@fsm.unipi.it
About this study
Official 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
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.
Read the 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
- Medical subject headings
- Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
Sleep-wake EEG recording
Sleep-wake EEG is an electroencephalographic recording that evaluates brain electrical activity during wakefulness and sleep.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start14 Oct 2025
- Primary completion8 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral and Emotional Disorder With Onset in ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805668
- Sponsor's protocol ID
- EmpRip3-6 24
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07805668
- Acronym / sponsor ID
- EmpRip3-6 24
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- Gaslini Children's Hospital
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Age greater than 6 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)
Time frame: Baseline
Sleep-wake EEG recording
Time frame: Up to 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Behavioral and Emotional Disorder With Onset in Childhood, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact valentina viglione (39050886293, valentina.viglione@fsm.unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDI-YC (Emotional Dysregulation Inventory-Young Child) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.