Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children

Adoption Clinical Trial

— ADOPT_TNPEE  

Official title:

Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06109090
• Other study ID #: 6051
• Status: Recruiting
• Start date: October 26, 2023
• Est. completion date: October 26, 2024

Study information

• Verified date: October 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 26, 2024
• Est. primary completion date: October 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adoption

Intervention

Other:
• Neuropsychological testing
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."

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Italian battery for ADHD (BIA)	Sub-test used: Stroop test/ Alternative sentence completion/ Test for the assessment of impulsive behavior	15 minutes
Primary	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
Primary	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	Vineland Adaptive Behavior Scale	The Vineland assesses adaptive behavior across a wide age range, from birth to 90 years old. It comprises five main domains, each with 2-3 subdomains: Communication, Daily Living Skills, Socialization, Motor Skills, and optionally, Maladaptive Behavior. Administered individually, it features 11 general subdomains grouped into Communication, Daily Living Skills, Socialization, and Motor Skills. Subdomain scores contribute to domain composite scores, and these, in turn, combine to form adaptive behavior composites. For individuals aged 0 to 6 years 11 months, four domain composite scores are calculated, while those aged 7 to 90 have a composite based on three domains: communication, daily living skills, and socialization.	10 minutes
Secondary	Child Behavior Checklist (CBCL) questionnaire	The Child Behavior Checklist (CBCL) is a segment of the Achenbach System of Empirically Based Assessment (ASEBA), a tool employed for identifying behavioral and emotional issues in children and adolescents. Administered by parents, the CBCL involves responding to 113 questions, with scores assigned on a three-point Likert scale (0=absent, 1=occurs sometimes, 2=occurs often).	10 minutes