Internationally Adopted Children Quality of Life

Quality of Life Clinical Trial

— QUADOP  

Official title:

Internationally Adopted Children Quality of Life Study (QUADOP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553486
• Other study ID #: RC15_0062
• 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

• Children
• Quality of Life

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