Exploring emotional regulation in young children with neurodevelopmental disabilities
Emotional-behavioral Regulation in Children With Neurodevelopmental Disabilities: an Exploratory Investigation of the Role of Genomic Variation, Proteomic Patterns, and Quality of Early Experience
This study looks at how genes and early experiences affect the way young children with neurodevelopmental disabilities manage their emotions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 248 (estimated) |
| Ages | 3 Months to 24 Months |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea Academic / other |
| Locations | 1 site (Bosisio Parini, Lecco) |
| Trial ID | NCT05004090 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the emotional regulation of children aged 3 to 24 months with neurodevelopmental disabilities (ND) by examining the roles of genomic variations, proteomic patterns, and early environmental experiences. The study aims to understand how factors such as DNA methylation, genetic polymorphisms, and parental behaviors contribute to emotional-behavioral regulation in these children. By analyzing biological and environmental influences, the research seeks to uncover the underlying mechanisms that affect developmental trajectories in children with ND.
Who should consider this trial
Good fit: Ideal candidates include children aged 3 to 24 months with mild to moderate developmental delays due to neurodevelopmental disabilities.
Not a fit: Patients with genetic syndromes or those who do not meet the specified developmental criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and interventions for emotional regulation in children with neurodevelopmental disabilities.
How similar studies have performed: While some studies have explored emotional regulation in typically developing children, this approach focusing on genomic and proteomic factors in children with ND is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bosisio Parini, Lecco
- IRCCS E. Medea — Bosisio Parini, Lecco, Italy (Recruiting)
Study contacts
- Study coordinator: Rosario Montirosso
- Email: rosario.montirosso@lanostrafamiglia.it
- Phone: +39031877494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.