AdoptionEEAANCT03872895
Adjustment of Adopted Adolescents in Their Families
An observational study of Adoption and Adolescent Behavior, run by Centre Hospitalier St Anne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 11 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adoption, Adolescent Behavior, Family Relations
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Parents: unwilling or unable to complete questionnaire Adolescent: unwilling or unable to complete questionnaire
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospital SAINTE ANNE
Paris, 75014
Marie Odile MD PEROUSE DE MONTCLOS, perousedemontclos@ch-sainte-anne.fr
Laurie MD MILLER
About this study
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.
Read the 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.
- Conditions
- Adoption, Adolescent Behavior, Family Relations
- Medical subject headings
- Adolescent Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: past 30 days
Secondary outcomes (1)
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.
Measured: past year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start1 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdoptionStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University, Italy, University of Oslo, University of Seville
- Responsible party
- Sponsor
- Investigators
- Laurie Miller, MD, Study chair, GHU Ste Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872895
- Sponsor's protocol ID
- D18-PO16
- Acronym
- EEAA
- Status last verified
- Jan 2019
- First submitted
- 25 Jan 2019
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment of Adopted Adolescents in Their Families
- ClinicalTrials.gov ID
- NCT03872895
- Acronym / sponsor ID
- EEAA / D18-PO16
- Conditions
- Adoption, Adolescent Behavior, Family Relations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Collaborators
- Catholic University, Italy, University of Oslo, University of Seville
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Parents: unwilling or unable to complete questionnaire Adolescent: unwilling or unable to complete questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Parent Stress (using PSI, Parent Stress Index)
Time frame: past year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurie Miller, MD study chair
GHU Ste Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adoption and Adolescent Behavior, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laurie Miller, MD (33612222628, laurie.miller@tufts.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Openness of family communication related to adoption (standardized scale developed by David Brodzinsky) (time frame: past 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.