Optimizing Individual Health Care for Young People With Gender Incongruence
NCT Number: NCT06573177
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gender Incongruence
Interventions: OTHER: Referral to the gender identity service.
Sponsor: Rigshospitalet, Denmark
Sex: ALL
Age: CHILD, ADULT
Enrollment: 1300
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-01-01
Completion Date: 2030-12
Locations: Department of Growth and Reproduction, Rigshospitalet, Copenhagen, Capital Region, 2100, Denmark

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, 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.

Primary Outcome Measures: 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.