Affective Spectrum SymptomsGiGANCT05716412
Gene-environment Interactions in Families With Adolescents (Gen-omgevingsinteracties in Gezinnen Met Adolescenten)
An observational study of Affective Spectrum Symptoms, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
Trial summary
English: The main purpose of this study is to investigate the developmental trajectories of parents and adolescents in the Flemish region of Belgium. The investigators will focus on the role of genetic factors, environmental factors (e.g. parental rearing styles), and the interaction between these factors. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Affective Spectrum Symptoms
- How many people
- 1,326 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2014to Feb 2017
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adopted adolescents and their parents, adolescents with their biological parents, and an additional community sample.
Who may be able to join
- Adolescents adopted before the age of one and currently 12 to 18 years old (from international adoption) and their adoptive parents
- Matched community sample of adolescents between the age of 12 and 18 years old and their biological related parents
Who cannot join
- Major medical or psychiatric disease
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University of Gent - Faculty of Psychology and Educational Sciences - Department of Developmental-, Personality- and Social Psychology
Ghent, Oost-Vlaanderen, 9000
KU Leuven - Department of Psychology and Educational Sciences - Clinical Psychology Research Unit
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Personality and Vulnerability for Affective Spectrum Disorders and Complaints: The Role of Gene-Environment Correlations (rGE) and Interactions (GxE)
English:
The main purpose of this study is to investigate the developmental trajectories of parents and adolescents in the Flemish region of Belgium. The investigators will focus on the role of genetic factors, environmental factors (e.g. parental rearing styles), and the interaction between these factors. Specifically, it will be investigated were difficulties or strengths in the development of adolescents can be attributed to. How an individual's genetic characteristics and his/her family environment can interact, will also be monitored. This study is closely related to the Leuvense Adoption Study (http://leuvenseadoptiestudie.be/). Just like this research, the investigators will take child and parent factors in account, as well as their interaction. The investigators will not only focus on vulnerability, but also on protective factors that can give resilience to both parents and children. The theoretical framework of this study is twofold. (1) In the development of children, genes and environment are interwoven in a dynamical relation. Neither genes or environment alone can explain how a child will develop over time. (2) The relation between genetic and environmental factors can be expressed in different ways. On the one hand, a certain genetic contribution can impact the way parents will uphold a certain parental rearing style. On the other hand, having certain genetic characteristics will have consequences for how adolescents will react to their environment. For example, a certain parental rearing style will strengthen some adolescents resilience, but for other adolescents this could equally lead to a more maladaptive development. Thus, depending on his or her genetic endowment, a child will develop differently given a certain family environment.
- Conditions
- Affective Spectrum Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adopted adolescents and their adoptive parents | Adopted before the age of one, currently between 12 to 18 years old | |
| Adolescents and their biological related parents | Matched to adoptive adolescents | |
| Additional community sample | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck's Depression Inventory / Children's Depression Inventory
Dimensional assessment and cut-off scores using Beck's Depression Inventory for the adults and Kovacs' Children's Depression Inventory for the adolescents.
Measured: current symptoms, measured once after enrollment
Secondary outcomes (2)
Somatic Symptoms Questionnaire
Pain and fatigue related complaints. Sometimes referred to as somatic complaints.
Measured: current complaints, measured once after enrollment
Depressive Experiences Questionnaire: self-criticism and dependency
Personality assessment by Blatt's polarities of experience model. Blatt's model is a two-polarity model: relatedness (dependency) and self-definition (self-criticism).
Measured: measured once after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study startSep 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affective Spectrum SymptomsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 1,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Sponsor
- Investigators
- Patrick Luyten, Prof. Dr., Principal investigator, KU Leuven - Faculty of Psychology and Educational Sciences - Clinical Psychology Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716412
- Sponsor's protocol ID
- S56106
- Acronym
- GiGA
- Status last verified
- May 2016
- First submitted
- 19 May 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality and Vulnerability for Affective Spectrum Disorders and Complaints: The Role of Gene-Environment Correlations (rGE) and Interactions (GxE)
- ClinicalTrials.gov ID
- NCT05716412
- Acronym / sponsor ID
- GiGA / S56106
- Conditions
- Affective Spectrum Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,326 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Sep 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Feb 2023 (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.
English:
The main purpose of this study is to investigate the developmental trajectories of parents and adolescents in the Flemish region of Belgium. The investigators will focus on the role of genetic factors, environmental factors (e.g. parental rearing styles), and the interaction between these factors. Specifically, it will be investigated were difficulties or strengths in the development of adolescents can be attributed to. How an individual's genetic characteristics and his/her family environment can interact, will also be monitored. This study is closely related to the Leuvense Adoption Study (http://leuvenseadoptiestudie.be/). Just like this research, the investigators will take child and parent factors in account, as well as their interaction. The investigators will not only focus on vulnerability, but also on protective factors that can give resilience to both parents and children. The theoretical framework of this study is twofold. (1) In the development of children, genes and environment are interwoven in a dynamical relation. Neither genes or environment alone can explain how a child will develop over time. (2) The relation between genetic and environmental factors can be expressed in different ways. On the one hand, a certain genetic contribution can impact the way parents will uphold a certain parental rearing style. On the other hand, having certain genetic characteristics will have consequences for how adolescents will react to their environment. For example, a certain parental rearing style will strengthen some adolescents resilience, but for other adolescents this could equally lead to a more maladaptive development. Thus, depending on his or her genetic endowment, a child will develop differently given a certain family environment.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adopted adolescents and their adoptive parents | – | –Adopted before the age of one, currently between 12 to 18 years old |
| Adolescents and their biological related parents | – | –Matched to adoptive adolescents |
| Additional community sample | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adopted adolescents and their parents, adolescents with their biological parents, and an additional community sample.
Key inclusion criteria (2 listed)
- Adolescents adopted before the age of one and currently 12 to 18 years old (from international adoption) and their adoptive parents
- Matched community sample of adolescents between the age of 12 and 18 years old and their biological related parents
Key exclusion criteria (1 listed)
- Major medical or psychiatric disease
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
Beck's Depression Inventory / Children's Depression Inventory
Time frame: current symptoms, measured once after enrollment
Dimensional assessment and cut-off scores using Beck's Depression Inventory for the adults and Kovacs' Children's Depression Inventory for the adolescents.
2 secondary outcomes
Somatic Symptoms Questionnaire
Time frame: current complaints, measured once after enrollment
Depressive Experiences Questionnaire: self-criticism and dependency
Time frame: measured once after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Patrick Luyten, Prof. Dr. principal investigator
KU Leuven - Faculty of Psychology and Educational Sciences - Clinical Psychology Research Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Affective Spectrum Symptoms, run by Universitaire Ziekenhuizen KU Leuven at 2 sites in Belgium.
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 2 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck's Depression Inventory / Children's Depression Inventory (time frame: current symptoms, measured once after enrollment). 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 8 Feb 2023.