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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02553486
Other study ID # RC15_0062
Secondary ID
Status Completed
Phase N/A
First received September 15, 2015
Last updated May 4, 2016
Start date September 2015
Est. completion date March 2016

Study information

Verified date May 2016
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical 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. Investigators, then, will identify variables associated with a lower quality of life in order to improve the support offered to the children.


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.


Recruitment information / eligibility

Status Completed
Enrollment 756
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 25 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Children born in France.

- Children or adoptive parents refusing to participate.

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
quality of life evaluation


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

References & Publications (3)

de Monléon JV, Huet F. [Usefulness of management of adopted children born in foreign countries]. Arch Pediatr. 2000 Oct;7(10):1039-40. French. — View Citation

Hjern 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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®. up to 9 months No
Secondary 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). up to 9 months No
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