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Gender DysphoriaNCT03643120

Gender Dysphoria Among Adolescents (Norwegian Title: Kjønnsdysfori Blant Ungdom)

A study testing Qualitative interview in people with Gender Dysphoria, run by Oslo University Hospital at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to explore how gender dysphoria is experienced among adolescents aged 13 - 18 from a clinical population. The method is qualitative, with a phenomenological approach. Read more about this study

Who is it for?
Ages 13 to 18 years
Conditions the study is for
Gender Dysphoria
What is being tested?
Qualitative interview
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteNorway
Study dates
20 Aug 2018to 1 Sep 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Referred to the National Treatment Unit for Transsexuality/Gender dysphoria

Who cannot join

  • Not referred to the National Treatment Unit for Transsexuality/Gender dysphoria

Trial locations and contacts

1 site in 1 country.

Reidar Schei Jessen, Master of science contact

004745222800

reijes@ous-hf.no

Norway1 site, 1 recruiting
  • Oslo university hospital

    Oslo, 0424

    Reidar Schei Jessen, Master of science, 004745222800, reijes@ous-hf.no

    Ira Haraldsen, MD, 92011533, ira.haraldsen@ouf-hf.no

    Recruiting

Other trials in Norway

About this study

Official title: Gender Dysphoria Among Adolescents

The aim of this study is to explore how gender dysphoria is experienced among adolescents aged 13 - 18 from a clinical population. The method is qualitative, with a phenomenological approach. Qualitative in-depth data on how gender dysphoria is experienced by the adolescents themselves is lacking in the research literature. As a consequence the within perspective from the clients is lacking. In addition, one aim is to help develop further hypothesis and clinical theory and rationale.

Read the detailed description

For some children and adolescents their ascribed gender at birth do not match with their gender expression or how they identify later in life. If the mismatch between ascribed gender at birth and gender identity and expression and how the body looks like is associated With distress or discomfort of any kind, this is referred to as gender dysphoria in the Research literature and DSM-V (DSM-V, 2014; Kreukels et al., 2012; Wren, 2014). After initial attempts with so called reparative therapy at changing clients' gender identity in accordance with their ascribed gender at birth, sex reassignment became the treatment of choice to gender dysphoria (Wierckx et al., 2014; Wren, 2014). Since the advent of sophisticated physical treatment like hormonal therapy and surgical techniques, capable of removing certain characteristics of the sexual body, an increasing number of clinics globally have started to offer puberty suppression to pubertal adolescents with gender dysphoria, in order to allow more time before making decisions regarding gender identity. This is referred to as the Dutch model, and the clinical aim is to reduce the pressure the youth are experiencing when the body is developing in a way that creates a lot of distress. Many countries have established special clinics, which focus on development of treatment programs, and there has been a steep increase in number of referrals the last years (Kaltiala-Heino, Sumia, Työläjärvi, \& Lindberg, 2015). In Norway, 450 clients were referred to the Norwegian National Unit for Gender Dysphoria and Transsexualism (Nasjonal behandlingstjeneste for transseksualisme, NBTS) in 2016. Half of them were under 18, and the number has been multiplied the last years (Nasjonal behandlingstjeneste for transseksualisme, årsrapport 2016). However, clinical treatment has been initiated without clarifying what gender dysphoria is, how it is experienced by those suffering from it and how it should be understood theoretically. A common concern in the research literature and among clinicians has been that important medical interventions have been utilized while the understanding of gender dysphoria among adolescents and Young adults and its psychological implications could be better understood (Kaltiala-Heino et al., 2015; Wren, 2014). In addition, activists and clients have claimed that their perspectives have been overseen by researchers and clinicians (Wren, 2014). Furthermore, there has been increased attention toward gender dysphoria both nationally and internationally. The aim of this project is to do an interview study in collaboration with chief physician at the NBTS, Ira Haraldsen and a reference group with former clients, in order to produce knowledge on how clients between the ages of 13 and 18 years that are being treated at the NBTS experience the gender dysphoria, how they understand the condition and make sense of their experiences and how it affects their lives. Much of the research on gender dysphoria has been quantitative, based on self report from the clients themselves or reports from health professionals (Drescher \& Byne, 2012). This means that the research has focused on predictors of good outcome, and delivered important knowledge on the treatment of gender dysphoria. However, there has not been done much research on the psychological nature of gender dysphoria, what psychosocial consequences this has for the development of gender identity and identity in general and how this is experienced by the young people themselves. There is also a lack of theoretical incorporation of gender dysphoria within the clinical and developmental psychological literature, and a psychological approach to it. Furthermore, studies on the outcome of puberty suppression and sex reassignment have demonstrated that although many adolescents improve mentally after transitioning into an other gender and gender dysphoria ameliorate, many are still suffering from severe psychiatric conditions and psychosocial adjustment (Kaltiala-Heinoet al., 2015). Studies have also demonstrated that adolescents undergoing this treatment is in need of psychological monitoring, but the research on how this should be implemented is lacking (de Vries et al., 2014).

NBTS has been at the forefront internationally implementing the Dutch model. The plan is to interview participants that have been referred to NBTS, consisting of clients that are in different phases of the treatment. The methodological approach will be qualitative and phenomenological, aiming to shed light on how gender dysphoria is experienced subjectively, and focusing on the diversity of presentations rather than searching for general principles. An other important aim is to contribute to theory development, drawing on clinical psychological theories as well as biological and medical knowledge and concepts from gender studies. In relation to this, an aim is to generate hypothesis and stimulate further studies. The collaboration between NBTS and the reference group is an opportunity to fill a gap in the international research between clients and activists one the one hand and researchers and clinicians on the other, and contribute to improved understanding of adolescents suffering from gender dysphoria and how clinicians can help them. This is in line with Standards of Care, the recommendations for treatment of gender dysphoria published by the World Professional Association for Transgender Health. According to this report, the perspectives of people having gender dysphoria are essential to ensure good health care, given the discrimination many are experiencing. Besides, in 2015, the Norwegian Directorate of Health published a report on the health services offered to people with gender dysphoria, named Rett til rett kjønn - helse til alle kjønn, based on the work of an expert group consisting of clinicians, activist and clients. The report concludes that there is a need to do more Research on how gender dysphoria is experienced and what consequences it has for young People living with it. Furthermore, the expert group concludes that there is a need for increased knowledge and awareness of gender dysphoria and how young people living with it should be helped among health professionals working in both specialist and primary health care.

Being tested
Qualitative interview
Medical subject headings
Gender Dysphoria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Qualitative interviewOther

    Explorative study of gender dysphoria.

Study groups in NCT03643120
Study groupRoleWhat they receive
Development of diagnostic typologyOtherOne main goal is to Development a typology of sub-types of gender dysphoria.
Receives: Other: Qualitative interview

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical sub-types

    The aim is to develop a typology to describe gender dysphoria.

    Measured: 2021

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start20 Aug 2018
  3. Primary completion1 May 2019 (estimated)
  4. Study completion1 Sep 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Qualitative interviews, 15 - 20 participants.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643120
Sponsor's protocol ID
2018/1088/REK sør-øst C
Status last verified
Aug 2018
First submitted
21 Aug 2018
Last updated
22 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The interviews will we transcribed. Not yet decided whether the transcribed material will be made available.

Questions about this trial

What is this clinical trial studying?

A study testing Qualitative interview in people with Gender Dysphoria, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Reidar Schei Jessen, Master of science (004745222800, reijes@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical sub-types (time frame: 2021). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.

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