Internationally Adopted Children Quality of Life (QUADOP)

May 4, 2016 updated by: Nantes University Hospital

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

756

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Internationally adopted children
All internationally adopted children, who arrived in France between 2008 and 2013, living in four French districts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®.
up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Quality of life low score risk factors
Time Frame: up to 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Estimate)

May 5, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • RC15_0062

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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