Optimizing Individual Health Care for Young People With Gender Incongruence

NCT06573177 | Recruiting DMC

• 1 other identifier: H-18050607
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

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, 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. 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. 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.

Conditions

Gender Incongruence

Outcome Measures

Primary Outcomes (24)

• 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.

Interventions

Referral to the gender identity service. OTHER

Referral to the national gender identity service consisting of the Sexological Clinic, Child and Adolescent Mental Health Center, and Department of Growth and Reproduction in the Capital Region of Denmark.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Accepted referral to the gender identity service.

You may not qualify if:

• None.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Department of Growth and Reproduction, Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, DNA.

MeSH Terms

Conditions

Gender Dysphoria

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Katharina M Main

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharina M Main

CONTACT

+4535455085; katharina.main@regionh.dk

Annamaria GE Giraldi

CONTACT

annamaria.giraldi@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, Ph.d.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)