Optimizing Individual Health Care for Young People With Gender Incongruence

Primary outcomes

1. Body Mass Index (BMI)

   Time frame: 8 years

   BMI will be calculated from height and weight (kg/m^2) measurements

2. Puberty

   Time frame: 8 years

   Tanner stages of puberty (1-5) are obtained by clinical examination

3. Bone mineral content (BMD)

   Time frame: 8 years

   Whole body dual-energy x-ray absorptiometry (DXA) will determine BMD Z-score for age and sex

4. Body fat

   Time frame: 8 years

   Whole body dual-energy x-ray absorptiometry (DXA) will measure body fat percentage (%)

5. Lean body mass

   Time frame: 8 years

   Whole body dual-energy x-ray absorptiometry (DXA) will measure lean mass (kg)

6. Reproductive serum hormone levels

   Time frame: 8 years

   Changes in reproductive hormone levels (%)

7. Adrenal serum hormone levels

   Time frame: 8 years

   Changes in adrenal hormone levels (%)

8. Blood pressure

   Time frame: 8 years

   Changes in blood pressure measurement (mm Hg)

9. Transabdominal ultrasound of uterus

   Time frame: 8 years

   Changes of endometrium (thickness in mm) during testosterone treatment

10. Transabdominal ultrasound of ovaries

    Time frame: 8 years

    Change in number of follicles (n) during testosterone treatment

11. Sperm count

    Time frame: 8 years

    Sperm Count (at cryopreservation)

12. Sperm motility

    Time frame: 8 years

    Sperm motility (at cryopreservation)

13. Morbidity

    Time frame: 8 years

    Number of participants with registered ICD10 diagnoses

14. Demographic characteristics

    Time frame: 8 years

    eg. socioeconomic status

15. Prevalence of psychiatric disorders

    Time frame: 8 years

    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.

16. Prevalence of Attention Deficit Hyperactive Disorder (ADHD)

    Time frame: 8 years

    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

17. Prevalence of autism spectrum disorder

    Time frame: 8 years

    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.

18. Global level of functioning

    Time frame: 8 years

    Children's Global Assessment Scale (C-GAS, range 1-100)

19. Psychosocial Disability

    Time frame: 8 years

    Global Assessment of Psychosocial Disability (GAPD, range 0-8)

20. Suicide risk

    Time frame: 8 years

    Number of participants with self-reported suicide thoughts or attempts (interview)

21. Substance abuse.

    Time frame: 8 years

    Number participants with self-reported abuse of alcohol, drugs or medications (interview)

22. Personal history of gender incongruence (GI)

    Time frame: 8 years

    Age at onset of GI and social transitioning (interview)

23. Cultural measures

    Time frame: 8 years

    Interviews with youngsters and their families to explore:

    • 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.

24. Establishment of biobank

    Time frame: 8 years.

    Serum, plasma, DNA at -20 and -80 degrees Celsius.