Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573177
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-18
Brief Title:
Optimizing Individual Health Care for Young People With Gender Incongruence
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gender Incongruence in Danish Youth GenDa An Observational Cohort Study of Danish Children and Adolescents Referred to a National Gender Identity Service
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This observational study focuses on evaluating the effect of the current health care program for Danish children and adolescents with gender incongruence which was established in January 2016 Somatic outcome parameters include growth bone health body composition metabolic parameters hormone levels and concurrent diseases Psychosocial parameters include the trajectory of gender incongruence development mental health ie autism spectrum disorders behavioural problems self-harm suicidal ideation and psychiatric diagnoses and social context ie family demographics education minority stress
This study aims to
1 Characterise the psychosocial profile of all children and adolescents referred for treatment as well as the history of gender identity development and treatment trajectories
2 Systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone GnRH analogues and cross-sex hormones and to establish a biobank for those in hormone treatment
The investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters The overall aim is to provide data for improving future family counselling clinical care patient satisfaction patient safety and ultimately quality-of-life
This study aims to
1 Characterise the psychosocial profile of all children and adolescents referred for treatment as well as the history of gender identity development and treatment trajectories
2 Systematically evaluate biological parameters before and during hormonal treatment with gonadotropin-releasing hormone GnRH analogues and cross-sex hormones and to establish a biobank for those in hormone treatment
The investigators hypothesise that intervention with counselling and hormonal treatment is safe and has a positive impact on psychosocial well-being of transgender youngsters The overall aim is to provide data for improving future family counselling clinical care patient satisfaction patient safety and ultimately quality-of-life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None