Clinical trial Recruiting at 1 site Observational Ages 3 to 6

Emotional Dysregulation in preschoolers with behavior and mood problems

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

Run by IRCCS Fondazione Stella Maris · NCT07805668 · Data updated 2026-11-12

This observational study tests how emotional dysregulation relates to other signs in 3–6 year olds with internalizing or externalizing disorders.

Quick facts

Study typeObservational
Ages3 Years to 6 Years
SexAll
Enrollment40 (estimated)
SponsorIRCCS Fondazione Stella Maris
Academic / other
Locations1 site (Pisa, Italy)
StatusRecruiting
StartedOctober 14, 2025
Main results expectedOctober 8, 2026
Study endsNovember 30, 2026
Registry record updatedSeptember 4, 2026
Trial IDNCT07805668 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Preschool children aged 3–6 with diagnosed internalizing and/or externalizing disorders and whose parents provide consent.

Probably not a fit

Children without dysregulation may show limited relevance of the specific dysregulation measures for guiding care.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study collects prospective and retrospective data on preschool children referred for diagnostic assessment at two Italian centers. It uses the Italian version of the Emotion Dysregulation Inventory for Young Children (EDI-YC) to measure dysregulation and compares it with other clinical assessments and questionnaires. Data will help describe clinical phenotypes of emotional-behavioral dysregulation in this age group. Inclusion requires 3–6 years old, a diagnosed internalizing and/or externalizing disorder, and parental consent; retrospective data may be used with appropriate privacy approvals.

Why it matters

Potential benefit: Better characterizations of dysregulation profiles could inform future tailored approaches for preschoolers with these disorders.

How similar studies have gone: Similar work has used translatable dysregulation instruments to describe phenotypes, supporting feasibility in this age group.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • IRCCS Stella Maris
    Pisa, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.