Optimizing Individual Health Care for Young People With Gender Incongruence

Gender Incongruence in Danish Youth (GenDa): An Observational Cohort Study of Danish Children and Adolescents Referred to a National Gender Identity Service

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, i.e. autism spectrum disorders, behavioural problems, self-harm, suicidal ideation and psychiatric diagnoses, and social context, i.e. 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.

Study Overview

• Status: Recruiting
• Conditions: Gender Incongruence
• Intervention / Treatment: Other: Referral to the gender identity service.

• Study Type: Observational
• Enrollment (Estimated): 1300

Contacts and Locations

• Study Contact: Name: Katharina M Main; Phone Number: +4535455085; Email: katharina.main@regionh.dk
• Study Contact Backup: Name: Annamaria GE Giraldi; Email: annamaria.giraldi@regionh.dk

Study Locations

• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Recruiting
      • Department of Growth and Reproduction, Rigshospitalet
      • Contact: Katharina M Main; Phone Number: +4535455085; Email: katharina.main@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

All children and youngsters under the age of 18 years referred to the gender identity service in Denmark.

Description

Inclusion Criteria:

• Accepted referral to the gender identity service.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	BMI will be calculated from height and weight (kg/m^2) measurements	8 years
Puberty	Tanner stages of puberty (1-5) are obtained by clinical examination	8 years
Bone mineral content (BMD)	Whole body dual-energy x-ray absorptiometry (DXA) will determine BMD Z-score for age and sex	8 years
Body fat	Whole body dual-energy x-ray absorptiometry (DXA) will measure body fat percentage (%)	8 years
Lean body mass	Whole body dual-energy x-ray absorptiometry (DXA) will measure lean mass (kg)	8 years
Reproductive serum hormone levels	Changes in reproductive hormone levels (%)	8 years
Adrenal serum hormone levels	Changes in adrenal hormone levels (%)	8 years
Blood pressure	Changes in blood pressure measurement (mm Hg)	8 years
Transabdominal ultrasound of uterus	Changes of endometrium (thickness in mm) during testosterone treatment	8 years
Transabdominal ultrasound of ovaries	Change in number of follicles (n) during testosterone treatment	8 years
Sperm count	Sperm Count (at cryopreservation)	8 years
Sperm motility	Sperm motility (at cryopreservation)	8 years
Morbidity	Number of participants with registered ICD10 diagnoses	8 years
Demographic characteristics	eg. socioeconomic status	8 years
Prevalence of psychiatric disorders	Based on screening for psychopathology using validated tests, as indicated: Schedule for Affective Disorders and Schizophrenia for School-age children (K-SADS): A diagnostic tool used to assess psychiatric disorders in children and adolescents. It is a semi-structured interview guide used to identify psychiatric conditions. Wechsler Intelligence Scale for Children (WISC 4/5) or Wechsler Adult Intelligence Scale (WAIS 4): General cognitive function is measured on a scale from 40-160 which is used as an intelligence quotient. A higher score: A higher cognitive function. Rorschach: A projective psychological test. The test uses a series of ink blots to evaluate a person's mental functions and emotional state by analysing their perceptions of the figures. The test is based on complex and subjective scoring and interpretation.	8 years
Prevalence of Attention Deficit Hyperactive Disorder (ADHD)	Screening using validated tests: Behavior Rating Inventory of Executive Function (BRIEF): General executive function is measured on a normative scale with T-scores from 20-80. A higher score: more executive difficulties. Attention Deficit/Hyperactive Disorder-Rating Scale (ADHD-RS): Attention Deficit Hyperactive Disorder traits measured on a normative scale with T-scores from 0-78. A higher score: More Attention Deficit Hyperactive Disorder traits	8 years
Prevalence of autism spectrum disorder	Screening using validated tests: Social Responsiveness Scale (SRS): Autism spectrum disorder (ASD) traits measured on a scale with T-scores from 0-76+. A higher score: More autistic traits. Autism Diagnostic Observation Schedule (ADOS): A structured observational tool to assess ASD. A trait is rated on a scale from 0 to 3. 0 indicates absence of a behaviour and 3 indicates severe occurrence of a behaviour. The total score determines the presence and severity of ASD. The cut-off scores are 10 for autism and 7 for ASD traits. Autism Diagnostic Interview-Revised (ADI-R): A structured interview used to assess ASD traits. Interview questions are scored on a scale from 0-3. 0 indicates absence of a behaviour and 3 indicates severe occurrence of a behaviour. The scores compared with cut-off values determine the presence of ASD. Cut-off values for each trait: Social interaction: cut-off 10; Communication skills: cut-off 8; Restrictive and repetitive behaviour patterns: cut-off 3.	8 years
Global level of functioning	Children's Global Assessment Scale (C-GAS, range 1-100)	8 years
Psychosocial Disability	Global Assessment of Psychosocial Disability (GAPD, range 0-8)	8 years
Suicide risk	Number of participants with self-reported suicide thoughts or attempts (interview)	8 years
Substance abuse.	Number participants with self-reported abuse of alcohol, drugs or medications (interview)	8 years
Personal history of gender incongruence (GI)	Age at onset of GI and social transitioning (interview)	8 years
Cultural measures	Interviews with youngsters and their families to explore: 1) The experiences that are influential in the process of seeking gender-affirming treatment. 2) Treatment expectations and wishes. 3) The cultural understandings of gender, sex, body and identity that inform the decision to seek treatment. 4) The role of the family in the decision to seek treatment.	8 years
Establishment of biobank	Serum, plasma, DNA at -20 and -80 degrees Celsius.	8 years.

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Katharina M Main, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: August 25, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria
• Other Study ID Numbers: H-18050607

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