NCT06109090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

October 26, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2024

Completed
Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

October 13, 2023

Last Update Submit

March 14, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Trial making test

    This test assesses various cognitive skills, including attention, visuo-motor planning, sustained attention, and working memory. Participants are given an A4 sheet with numbered circles and instructed to quickly connect them in ascending order. There are two TMT forms: TMT A with only numbers (1 to 25) and TMT B with alternating numbers and letters (1, A; 2, B; … to 13). Scarpa et al. introduced a new 'A/B' form between A and B, using only letters (A to Z), where participants connect letters in alphabetical order. This aims to ensure that children, especially younger ones, possess the alphabetical knowledge needed for part B. Scarpa, P et al. doi:10.1007/s10072-006-0717-5

    10 minutes

  • Wisconsin Card Sorting Test

    The Wisconsin Card Sorting Test (WCST) is a neuropsychological assessment of set-shifting, measuring one's ability to demonstrate flexibility in response to changes in reinforcement. Participants are presented with stimulus cards and instructed to match them. Crucially, they are not provided with explicit instructions on how to make the matches but receive feedback indicating whether their choices are correct or incorrect. In its initial release, the test involved an evaluator using paper cards, positioned on one side of the desk while the participant faced them on the other side.

    10 minutes

  • Italian battery for ADHD (BIA)

    Sub-test used: Stroop test/ Alternative sentence completion/ Test for the assessment of impulsive behavior

    15 minutes

  • Luria's motor tasks

    Motor planning and executive action control were investigated using Luria's motor tasks. In the 'contrast' task, which assessed the ability to prevent interference effects, participants were required to execute an action opposite to that performed by the examiner, resisting the inclination to imitate the examiner's action. Inhibition of control was assessed through a 'Go-No-Go' task. Scores for each subtest ranged from 0 (no correct responses) to 3 (all correct responses). The total score was the sum of the three subtest scores, with a range of 0 to 9. Scarpa, P et al. doi:10.1007/s10072-006-0717-5

    15 minutes

  • London's tower test

    The Tower of London (TOL) test, developed by Shallice in 1982 and further refined by Norman and Shallice in 1986, is one of the most widely used tools to assess strategic decision-making and problem-solving skills in children and adolescents aged 4 to 13. It serves both clinical and research purposes. The test involves a set-up with three pegs of varying lengths and three balls-red, green, and blue-that must be moved to achieve a configuration specified by the examiner. This test is instrumental in studying and measuring planning and monitoring abilities in task execution.

    15 minutes

Secondary Outcomes (2)

  • Vineland Adaptive Behavior Scale

    10 minutes

  • Child Behavior Checklist (CBCL) questionnaire

    10 minutes

Study Arms (1)

Adopted children

Patients included in the study must meet the following inclusion criteria: * Signing the informed consent * Age between 6 and 10 years * Adopted after the first year of life The exclusion criteria for this study are: * Comorbidity with other pathologies * Children adopted from birth * Cognitive impairment (IQ\<85)

Other: Neuropsychological testing

Interventions

In this study, the Vineland Adaptive Behavior Scale is administered, which evaluates the child's adaptive functioning, particularly in four areas: communication, socialization, daily living skills, and motor activities. The Child Behavior Checklist (CBCL) questionnaire is also administered, which is a questionnaire given to parents that highlights elements related to internalizing and externalizing behavioral disorders. For the assessment of executive functions, a series of tests are administered to evaluate specific functions. These tests are chosen from a list of available tests according to the document from the Italian Society of Child Neuropsychiatry, titled "Assessment of attention and executive functions in developmental age: review of Italian instruments and proposal of a battery for in-depth analysis."

Adopted children

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children who have had the experience of adoption in the early years of life

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Giorgia Coratti

    Fondazione Policlinico Universitario A. Gemelli, IRCCS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 31, 2023

Study Start

October 26, 2023

Primary Completion

October 26, 2024

Study Completion

October 26, 2024

Last Updated

March 18, 2025

Record last verified: 2025-03

Locations