Gender Dysphoria, AdolescentVATEDNCT05126134
Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
An observational study of Gender Dysphoria, Adolescent, run by University Hospital, Toulouse at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Gender Dysphoria, Adolescent
- What is being tested?
- KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2021to 3 Jun 2022
- 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 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: adolescents receiving follow-up in a specialized consultation on gender dysphoria
Who may be able to join
- Be between 12 and 18 years old
- Be followed up at the gender consultation of the Toulouse University Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gender Dysphoria, Adolescent
- Being tested
- KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)
- Keywords
- mental disorders
- Medical subject headings
- Gender Dysphoria, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)Diagnostic test
completion of the semi-structured questionnaire: the KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia). The duration is 1h30 to 2h
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia) |
What is being measured
The primary outcome is the main question the study is designed to answer.
list of diagnoses of mental disorders
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
Measured: enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start26 Nov 2021
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender Dysphoria, AdolescentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Çabal-Berthoumieu, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126134
- Sponsor's protocol ID
- RC31/21/0385
- Acronym
- VATED
- Status last verified
- Jul 2022
- First submitted
- 3 Nov 2021
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
- ClinicalTrials.gov ID
- NCT05126134
- Acronym / sponsor ID
- VATED / RC31/21/0385
- Conditions
- Gender Dysphoria, Adolescent
- Keywords
- mental disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 18 Nov 2021 (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 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents followed for gender dysphoria | – | Diagnostic Test: KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- adolescents receiving follow-up in a specialized consultation on gender dysphoria
Key inclusion criteria (2 listed)
- Be between 12 and 18 years old
- Be followed up at the gender consultation of the Toulouse University Hospital
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)completion of the semi-structured questionnaire: the KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia). The duration is 1h30 to 2h | Diagnostic test | adolescents followed for gender dysphoria |
Primary outcome
list of diagnoses of mental disorders
Time frame: enrollment
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
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Sophie Çabal-Berthoumieu, MD principal investigator
University Hospital, Toulouse
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 Gender Dysphoria, Adolescent, run by University Hospital, Toulouse 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 2 inclusion and 2 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 29 Jul 2022. 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?
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?
list of diagnoses of mental disorders (time frame: 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 29 Jul 2022.