Adjustment of Adopted Adolescents in Their Families (EEAA)

March 11, 2019 updated by: Centre Hospitalier St Anne
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parents who have an internationally adopted adolescent between ages of 11-17 years, and whose child arrived in the family at least 6 months ago, as well as internationally adopted adolescents between ages of 11-17 years who arrived in the family at least 6 months ago

Description

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 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Openness of family communication related to adoption (standardized scale developed by David Brodzinsky)
Time Frame: past 30 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Parent Stress (using PSI, Parent Stress Index)
Time Frame: past year
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

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier St Anne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Catholic University, Italy
University of Seville, Spain

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Laurie Miller, MD, GHU Ste Anne

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D18-PO16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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