- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05126134
Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study (VATED)
July 26, 2022 updated by: University Hospital, Toulouse
The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade.
However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France.
The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents.
This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life.
A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers.
This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process.
transition process.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Toulouse, France
- CHU Toulouse
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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
12 years to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
adolescents receiving follow-up in a specialized consultation on gender dysphoria
Description
Inclusion Criteria:
- Be between 12 and 18 years old
- Be followed up at the gender consultation of the Toulouse University Hospital
Exclusion Criteria:
- Have not yet completed the first consultation on gender issues at the time of selection.
- Have only one last appointment with the gender consultation at the time of selection
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 |
|---|---|
|
adolescents followed for gender dysphoria
The data collection by the examiner takes place during a single interview centered around the child's completion of a semi-structured questionnaire: the Kiddie Schedule for Affective Disorders and Schizophrenia.
The child is interviewed alone and then with an accompanying parent.
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completion of the semi-structured questionnaire: the KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia).
The duration is 1h30 to 2h
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
list of diagnoses of mental disorders
Time Frame: enrollment
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description of the prevalence of psychiatric comorbidities present in adolescents receiving follow-up in a specialized consultation on gender dysphoria using Diagnostic and Statistical Manual of Mental Disorders 5
|
enrollment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sophie Çabal-Berthoumieu, MD, University Hospital, Toulouse
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)
November 26, 2021
Primary Completion (ACTUAL)
June 3, 2022
Study Completion (ACTUAL)
June 3, 2022
Study Registration Dates
First Submitted
November 3, 2021
First Submitted That Met QC Criteria
November 16, 2021
First Posted (ACTUAL)
November 18, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2022
Last Update Submitted That Met QC Criteria
July 26, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/21/0385
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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