AdoptionADOPT_TNPEENCT06109090
Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children
An observational study of Adoption, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Adoption
- What is being tested?
- Neuropsychological testing
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2023to 26 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children who have had the experience of adoption in the early years of life
Who may be able to join
- Signing the informed consent
- Age between 6 and 10 years
- Adopted after the first year of life
Who cannot join
- Comorbidity with other pathologies
- Children adopted from birth
- Cognitive impairment (IQ<85)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
About this study
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.
Read more
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.
- Conditions
- Adoption
- Being tested
- Neuropsychological testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological testingOther
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."
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Neuropsychological testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 10 minutes
Italian battery for ADHD (BIA)
Sub-test used: Stroop test/ Alternative sentence completion/ Test for the assessment of impulsive behavior
Measured: 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
Measured: 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.
Measured: 15 minutes
Secondary outcomes (2)
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.
Measured: 10 minutes
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).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start26 Oct 2023
- Primary completion26 Oct 2024
- Study completion26 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdoptionStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgia Coratti, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109090
- Sponsor's protocol ID
- 6051
- Acronym
- ADOPT_TNPEE
- Status last verified
- Mar 2025
- First submitted
- 13 Oct 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Environmental Context on Neuro-psychomotor Development in Adopted Children
- ClinicalTrials.gov ID
- NCT06109090
- Acronym / sponsor ID
- ADOPT_TNPEE / 6051
- Conditions
- Adoption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 26 Oct 2024 (actual)
- Study completion
- 26 Oct 2024 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adopted children | – | Other: Neuropsychological testingPatients 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) |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children who have had the experience of adoption in the early years of life
Key inclusion criteria (3 listed)
- Signing the informed consent
- Age between 6 and 10 years
- Adopted after the first year of life
Key exclusion criteria (3 listed)
- Comorbidity with other pathologies
- Children adopted from birth
- Cognitive impairment (IQ<85)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological testingIn 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." | Other | Adopted children |
Primary outcome
Trial making test
Time frame: 10 minutes
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
Wisconsin Card Sorting Test
Time frame: 10 minutes
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.
Italian battery for ADHD (BIA)
Time frame: 15 minutes
Sub-test used: Stroop test/ Alternative sentence completion/ Test for the assessment of impulsive behavior
Luria's motor tasks
Time frame: 15 minutes
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
London's tower test
Time frame: 15 minutes
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.
2 secondary outcomes
Vineland Adaptive Behavior Scale
Time frame: 10 minutes
Child Behavior Checklist (CBCL) questionnaire
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgia Coratti principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adoption, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial making test (time frame: 10 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.