ChildrenQUADOPNCT02553486
Internationally Adopted Children Quality of Life
An observational study of Children and Quality of Life, run by Nantes University Hospital at 1 site in France.
Trial summary
This study evaluates the global quality of life of foreign born adopted children, one to seven years following their arrival in France. Investigators will assess global health, behavior, school integration for each child who arrived in France between 2008 and 2013, through an online anonymous survey. Read more about this study
- Who is it for?
- Ages 1 month to 25 years
- Conditions the study is for
- Children, Quality of Life
- What is being tested?
- quality of life evaluation
- How many people
- 756 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Mar 2016
- 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 1 month to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All international adopted children, who arrived in France between 2008 and 2013, living in four French districts (Loire-Atlantique, Ille-et-vilaine, Maine et Loire and Finistère)
Who may be able to join
- All international adopted children, who arrived in France between 2008 and 2013, living in four French districts (Loire-Atlantique, Ille et vilaine, Maine et Loire and Finistère) and accepting to fill the on-line questionnaire of the study
Who cannot join
- Children born in France.
- Children or adoptive parents refusing to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internationally Adopted Children Quality of Life Study (QUADOP)
This study evaluates the global quality of life of foreign born adopted children, one to seven years following their arrival in France. Investigators will assess global health, behavior, school integration for each child who arrived in France between 2008 and 2013, through an online anonymous survey. Investigators, then, will identify variables associated with a lower quality of life in order to improve the support offered to the children.
Read the detailed description
Investigators will use a known and official quality of life score: the PedsQL®. This score has never been used in this population so investigators will first have to test its internal validity, so that investigators cannot use it in their global evaluation. The second stage will consist of identifying variables associated with a lower quality of life, as previously determined. Investigators will send letters to each family through the adoption department of each area enrolled in our study, to ensure data. Parents and children will be required to login to a safe, anonymous, controlled website in order to input their data. The data will be recorded on the internal server of Nantes University Hospital. This study has been accepted by both the Computing and Liberties Commission (CNIL) and Nantes University Hospital's Ethics group in the field of Health (GNEDS) comities.
- Conditions
- Children, Quality of Life
- Being tested
- quality of life evaluation
- Keywords
- adoption, children, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Internationally adopted children | All internationally adopted children, who arrived in France between 2008 and 2013, living in four French districts Receives: Other: quality of life evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
International adopted children global quality of life evaluation
Global international adopted children quality of life score one to seven years after arrival in France, using a quality of life score : PedsQL®.
Measured: up to 9 months
Secondary outcomes (1)
Identification of Quality of life low score risk factors
Validation of the questionnaire in our population; Highlight the determiners of a bad quality of life (after dichotomization of the population, investigators will compare participants who have a score under one standard deviation to those who have a better score).
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553486
- Sponsor's protocol ID
- RC15_0062
- Acronym
- QUADOP
- Status last verified
- May 2016
- First submitted
- 15 Sep 2015
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Upton P, Eiser C, Cheung I, Hutchings HA, Jenney M, Maddocks A, Russell IT, Williams JG. Measurement properties of the UK-English version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health Qual Life Outcomes. 2005 Apr 1;3:22. doi: 10.1186/1477-7525-3-22.
PubMed 15804349Hjern A, Lindblad F, Vinnerljung B. Suicide, psychiatric illness, and social maladjustment in intercountry adoptees in Sweden: a cohort study. Lancet. 2002 Aug 10;360(9331):443-8. doi: 10.1016/S0140-6736(02)09674-5.
PubMed 12241716de Monleon JV, Huet F. [Usefulness of management of adopted children born in foreign countries]. Arch Pediatr. 2000 Oct;7(10):1039-40. doi: 10.1016/s0929-693x(00)00310-9. No abstract available. French.
PubMed 11075257
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internationally Adopted Children Quality of Life Study (QUADOP)
- ClinicalTrials.gov ID
- NCT02553486
- Acronym / sponsor ID
- QUADOP / RC15_0062
- Conditions
- Children, Quality of Life
- Keywords
- adoption, children, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 756 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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.
This study evaluates the global quality of life of foreign born adopted children, one to seven years following their arrival in France. Investigators will assess global health, behavior, school integration for each child who arrived in France between 2008 and 2013, through an online anonymous survey. Investigators, then, will identify variables associated with a lower quality of life in order to improve the support offered to the children.
Detailed description
Investigators will use a known and official quality of life score: the PedsQL®. This score has never been used in this population so investigators will first have to test its internal validity, so that investigators cannot use it in their global evaluation. The second stage will consist of identifying variables associated with a lower quality of life, as previously determined. Investigators will send letters to each family through the adoption department of each area enrolled in our study, to ensure data. Parents and children will be required to login to a safe, anonymous, controlled website in order to input their data. The data will be recorded on the internal server of Nantes University Hospital. This study has been accepted by both the Computing and Liberties Commission (CNIL) and Nantes University Hospital's Ethics group in the field of Health (GNEDS) comities.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internationally adopted children | – | Other: quality of life evaluationAll internationally adopted children, who arrived in France between 2008 and 2013, living in four French districts |
Who may qualify
- Ages
- 1 month to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All international adopted children, who arrived in France between 2008 and 2013, living in four French districts (Loire-Atlantique, Ille-et-vilaine, Maine et Loire and Finistère)
Key inclusion criteria (1 listed)
- All international adopted children, who arrived in France between 2008 and 2013, living in four French districts (Loire-Atlantique, Ille et vilaine, Maine et Loire and Finistère) and accepting to fill the on-line questionnaire of the study
Key exclusion criteria (2 listed)
- Children born in France.
- Children or adoptive parents refusing to participate.
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 |
|---|---|---|
| quality of life evaluation | Other | Internationally adopted children |
Primary outcome
International adopted children global quality of life evaluation
Time frame: up to 9 months
Global international adopted children quality of life score one to seven years after arrival in France, using a quality of life score : PedsQL®.
1 secondary outcome
Identification of Quality of life low score risk factors
Time frame: up to 9 months
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 24 Jun 2026.
- Background: PubMed 15804349Upton P, Eiser C, Cheung I, Hutchings HA, Jenney M, Maddocks A, Russell IT, Williams JG. Measurement properties of the UK-English version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health Qual Life Outcomes. 2005 Apr 1;3:22. doi: 10.1186/1477-7525-3-22.
- Background: PubMed 12241716Hjern A, Lindblad F, Vinnerljung B. Suicide, psychiatric illness, and social maladjustment in intercountry adoptees in Sweden: a cohort study. Lancet. 2002 Aug 10;360(9331):443-8. doi: 10.1016/S0140-6736(02)09674-5.
- Background: PubMed 11075257de Monleon JV, Huet F. [Usefulness of management of adopted children born in foreign countries]. Arch Pediatr. 2000 Oct;7(10):1039-40. doi: 10.1016/s0929-693x(00)00310-9. No abstract available. French.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Children and Quality of Life, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 2 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 24 Jun 2026. 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 France. 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?
International adopted children global quality of life evaluation (time frame: up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02553486, which also lists 3 linked publications.
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 24 Jun 2026.