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Gender Dysphoria in Children and Adolescents : Parents' Perspectives (GeDyPar)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04160364
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

Gender dysphoria is defined as a persistent incongruence between an experienced gender and the assigned sex at birth Transgender and gender nonconforming persons desire to modify their appearance to be consistent with their self-identified gender identities. In non-binary people, contrary to binary transgender persons, self-identified gender identities do not fit the classical pattern male/female.

During the last decennium, an increase in the number of young subjects, especially children and adolescents, referred to gender identity centres has been observed. A new nosological entity "rapid-onset gender dysphoria in adolescents and young adults" has recently been described in the literature, whose etiology has not been well understood.

This growing demand of adolescents and young adults observed in the recent years is not well understood.


Condition or disease Intervention/treatment
Gender Dysphoria Other: qualitative study

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Gender Dysphoria in Children and Adolescents : Parents' Perspectives
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Intervention Details:
  • Other: qualitative study
    qualitative research via guided interview


Primary Outcome Measures :
  1. thematic analysis [ Time Frame: one year ]

    The recorde material will be coded using descriptive codes. Conceptual notes will be written, through processes of condensation, comparison and abstracting the initial notes.

    Connections between notes will be noted and synthesized, and emergent themes will be developed.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study will be proposed to parents of transgender children <18 years of age followed in the endocrinology, diabetology and nutrition department of the University Hospital of Nancy on the occasion of the regular follow-up visit at the outpatient clinic ( consecutive recruitment).
Criteria

Inclusion Criteria:

  • be a parent of a child <18 years followed in the endocrinology department of the University Hospital of Nancy for gender dysphoria
  • be in stable couple
  • both parents agree to participate
  • capacity to communicate in French
  • Person who has received complete information on the organization of the research and who agreed to the exploitation of the data

Exclusion Criteria:

  • Refusal to participate
  • Inability to be physically, psychologically or linguistically involved in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04160364


Contacts
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Contact: Eva Feigerlova, MD, PhD 00330383153412 e.feigerlova@chru-nancy.Fr

Locations
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France
University Hospital of Nancy
Vandœuvre-lès-Nancy, France, 54511
Contact: Eva Feigerlova, MD, PhD    00330670204634      
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Eva Feigerlova, MD,PhD University Hospital of Nancy, France

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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04160364    
Other Study ID Numbers: 2019PI204
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not planned

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
children
adolescents
parents
Additional relevant MeSH terms:
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Depressive Disorder, Major
Gender Dysphoria
Depressive Disorder
Mood Disorders
Mental Disorders
Sexual Dysfunctions, Psychological