ClinConnect ClinConnect Logo
Search / Trial NCT05004090

Emotional Regulation in Children With ND: the Role of Genomic Variation, Proteomic Patterns, and Early Experience

Launched by IRCCS EUGENIO MEDEA · Aug 12, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how both biological factors (like DNA and proteins) and early life experiences affect emotional regulation in children with neurodevelopmental disabilities (ND). ND includes a variety of conditions such as cerebral palsy and sensory impairments. Researchers want to understand why some children with ND may struggle more with emotions and social skills than others. They hope that by examining these factors, they can identify ways to support these children's emotional development better.

If you have a child aged 3 to 24 months with mild to moderate developmental delays or a typically developing child in the same age range, they may be eligible to participate in this study. Mothers of the children must be over 18, speak Italian well, and have no significant cognitive or psychiatric issues. Participants will undergo assessments to measure development and emotional behavior, aiming to shed light on how both genetic and environmental influences contribute to emotional regulation in young children. This research could lead to improved strategies for helping children with ND thrive emotionally.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children with ND:
  • Age between 3 and 24 months (chronologically or corrected in the case of children born preterm);
  • mild to moderate developmental delay documented by clinical signs (e.g., symptoms of brain injury on neurological examination or neuroimaging) or by developmental scales (i.e., Griffiths III scales) associated with various diagnoses (e.g., cerebral palsy, prematurity);
  • absence of genetic syndromes. The Griffiths III scale will be used to assess the child's overall level of development.
  • Typical developmental children:
  • birth to term;
  • age between 3 and 24 months (chronological);
  • absence of peri- or postnatal pathology.
  • Inclusion criteria for mothers (DN and typical development):
  • age above 18 years;
  • good understanding of the Italian language;
  • absence of cognitive difficulties and/or psychiatric disorders;
  • no intake of psychotropic medications;
  • not part of a single-parent family.
  • Exclusion Criteria: refer to the inclusion criteria.

About Irccs Eugenio Medea

IRCCS Eugenio Medea is a leading clinical research institute based in Italy, dedicated to advancing pediatric healthcare through innovative research and evidence-based practices. As a recognized center of excellence, it focuses on multidisciplinary approaches to address complex health challenges in children and adolescents, particularly in the fields of neurodevelopmental disorders, mental health, and rehabilitation. The institute collaborates with national and international partners to conduct rigorous clinical trials, aiming to translate scientific discoveries into effective therapeutic interventions. Committed to enhancing patient outcomes, IRCCS Eugenio Medea prioritizes ethical standards and patient safety in all its research endeavors.

Locations

Bosisio Parini, Lecco, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials