Optimizing Individual Health Care for Young People With Gender Incongruence

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Accepted referral to the gender identity service.

Disqualifiers

None.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Referral to the gender identity service.

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Body Mass Index (BMI)

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

Time frame
8 years
2

Puberty

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

Time frame
8 years
3

Bone mineral content (BMD)

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

Time frame
8 years
4

Body fat

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

Time frame
8 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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