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临床试验/NCT06573177
NCT06573177招募中不适用

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

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,300
试验地点
1
主要终点
Puberty

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Accepted referral to the gender identity service.

排除标准

  • 未提供

结局指标

主要结局

Puberty

时间窗: 8 years

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

Body fat

时间窗: 8 years

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

Reproductive serum hormone levels

时间窗: 8 years

Changes in reproductive hormone levels (%)

Adrenal serum hormone levels

时间窗: 8 years

Changes in adrenal hormone levels (%)

Transabdominal ultrasound of ovaries

时间窗: 8 years

Change in number of follicles (n) during testosterone treatment

Morbidity

时间窗: 8 years

Number of participants with registered ICD10 diagnoses

Substance abuse.

时间窗: 8 years

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

Lean body mass

时间窗: 8 years

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

Blood pressure

时间窗: 8 years

Changes in blood pressure measurement (mm Hg)

Transabdominal ultrasound of uterus

时间窗: 8 years

Changes of endometrium (thickness in mm) during testosterone treatment

Sperm motility

时间窗: 8 years

Sperm motility (at cryopreservation)

Psychosocial Disability

时间窗: 8 years

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

Suicide risk

时间窗: 8 years

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

Body Mass Index (BMI)

时间窗: 8 years

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

Bone mineral content (BMD)

时间窗: 8 years

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

Sperm count

时间窗: 8 years

Sperm Count (at cryopreservation)

Demographic characteristics

时间窗: 8 years

eg. socioeconomic status

Prevalence of Attention Deficit Hyperactive Disorder (ADHD)

时间窗: 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

Global level of functioning

时间窗: 8 years

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

Prevalence of psychiatric disorders

时间窗: 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.

Prevalence of autism spectrum disorder

时间窗: 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.

Cultural measures

时间窗: 8 years

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.

Personal history of gender incongruence (GI)

时间窗: 8 years

Age at onset of GI and social transitioning (interview)

Establishment of biobank

时间窗: 8 years.

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katharina Maria Main

Prof. MD, Ph.d.

Rigshospitalet, Denmark

研究点 (1)

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