Clinical trial NCT06109090: Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children
Official title: Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adoption
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who have had the experience of adoption in the early years of life

Brief summary: The neuro-psychomotor development of children is influenced by multiple factors that play a crucial role in determining normal development or the onset of difficulties and atypicalities. Among these, the environmental context plays a fundamentally relevant role in modulating the child's abilities. Previous studies have compared children who have lived in foster care for at least 8 months with children who have always been within their own family nucleus, highlighting deficits in growth, development, and cognitive and behavioral skills in the former.

The aim of this project is to assess the effect of the environmental context on the development of executive functions and adaptive abilities in adopted children. Executive functions involve cognitive processes such as initiation, planning, organization, and regulation of behavior, while adaptive abilities include skills that allow the child to respond to demands from the external environment.

The project is conducted in two phases: a retrospective and a parallel prospective phase. The retrospective phase involves the analysis of the clinical records of adopted children in school age at the Pediatric, Child Neuropsychiatry, and Clinical Psychology units of the Fondazione Policlinico A. Gemelli IRCCS. The prospective phase consists of evaluating executive functions and adaptive abilities using specific tools recommended by the Italian Society of Child Neuropsychiatry, including the Vineland Adaptive Behavior Scales for adaptive abilities and a series of specific tests for executive functions, included in the document "Assessment of attention and executive functions in developmental age: review of Italian instruments and proposal of a battery for in-depth analysis." Additionally, to assess internalizing or externalizing behavioral aspects, parents will complete the Child Behavior Checklist (CBCL) questionnaire.

Through this study, the investigators aim to deepen the understanding of the role of the environmental context in the neuro-psychomotor development of adopted children, with particular attention to executive functions and adaptive abilities. The results obtained may provide valuable information for a better understanding of the underlying mechanisms and for the implementation of targeted interventions aimed at the optimal support of these children during their growth and development journey.


Eligibility criteria: Inclusion Criteria:

* Signing the informed consent
* Age between 6 and 10 years
* Adopted after the first year of life

Exclusion Criteria:

* Comorbidity with other pathologies
* Children adopted from birth
* Cognitive impairment (IQ\<85)

Primary outcomes:
measure: Trial making test
timeFrame: 10 minutes
measure: Wisconsin Card Sorting Test
timeFrame: 10 minutes
measure: Italian battery for ADHD (BIA)
timeFrame: 15 minutes
measure: Luria's motor tasks
timeFrame: 15 minutes
measure: London's tower test
timeFrame: 15 minutes
Secondary outcomes:
measure: Vineland Adaptive Behavior Scale
timeFrame: 10 minutes
measure: Child Behavior Checklist (CBCL) questionnaire
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Giorgia Coratti
role: PRINCIPAL_INVESTIGATOR
References: