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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03872895
Other study ID # D18-PO16
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2019

Study information

Verified date January 2019
Source Centre Hospitalier St Anne
Contact Laurie Miller, MD
Phone 33612222628
Email laurie.miller@tufts.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The adjustment of adopted adolescents has been studied in the U.S. and England, but few other European countries have conducted research into this topic. As countries differ greatly in their cultural practices, a comparative study of the adjustment of internationally adopted teenagers in 4 European countries (France, Italy, Spain, Norway) is planned. The adjustment of teens and their families will be studied in relation to the openness of communication related to adoption within the families.


Description:

The aim of the study is to evaluate the status of internationally adopted adolescents in relation to the characteristics of their families, and to explore the similarities and differences in 4 different European countries. Parents and adolescents will complete questionnaires which incorporate and adapt many standard measures. The parent questionnaire includes components of : a) Family Adjustment and Cohesion Scale (FACES), b) Strengths and Difficulties Questionnaire for parents (SDQ-parent), c) Parent Stress Index (PSI), d) Adoption Satisfaction Questionnaire (ASQ), d) Brodzinsky Scale (openness in family communication related to adoption), and e) basic demographic information.

The adolescent questionnaire includes elements of : a) SDQ-adolescent, b) Health Behavior in School Children questionnaire (HBSC), c) Life Orientation Test-Revised (LOT-R), d) Lee Scale (Discrimination Scale for Adoptees).

It is hoped that the study will permit a better understanding of the experiences of families and their children after international adoption. This knowledge will help potential adoptive families as well as families who have already adopted. This information is not yet available in a European context. In addition, the information will be valuable to adoption professionals. Moreover, the opportunity to compare outcomes and experiences of families and adolescents in 4 European countries will allow a better understanding of the contribution of different cultural contexts to these outcomes. It is hypothesized that different cultural practices and beliefs about adoption likely impact the experience of adoption by adolescents and parents. A better understanding of this dynamic will be useful clinically as well as at the community level and beyond.


Recruitment information / eligibility

Status Recruiting
Enrollment 800
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years and older
Eligibility Inclusion Criteria:

- Parents: have an internationally adopted adolescent between ages of 11-17 years child arrived in the family at least 6 months ago Adolescents: internationally adopted, between ages of 11-17 years arrived in the family at least 6 months ago

Exclusion Criteria:

- Parents: unwilling or unable to complete questionnaire Adolescent: unwilling or unable to complete questionnaire

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hospital SAINTE ANNE Paris

Sponsors (4)

Lead Sponsor Collaborator
Centre Hospitalier St Anne Catholic University, Italy, University of Oslo, University of Seville, Spain

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Openness of family communication related to adoption (standardized scale developed by David Brodzinsky) Openness to family communication about the subject of adoption will be assessed using the Brodzinsky standardized scale. This will be correlated to adolescent outcomes (adjustment to family, school, and community) using constructed variables drawn from the Health Behavior in School Children questionnaire past 30 days
Secondary Parent Stress (using PSI, Parent Stress Index) Parent Stress will be measured using the widely-used Parent Stress Index. This scale contains 36 items which are completed by parent self-report. The items are combined to form a Total Stress scale. Scoring results in a percentile profile. The normal range=15th-80th percentile. Scores at or above the 85th percentile are considered high (more stress) and Defensive Reponding scores at 10 or below are considered extremely low. Cronbach's alpha for internal consistency: minimum =0.8, max=.91, and average=.85. This scale (first published in 1990 by Abdin) has been used and cited in over 4900 scientific papers. past year
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