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.
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.
Norway1 site, 1 recruiting
- 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
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.
- Conditions
- Gender Dysphoria
- 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 group | Role | What they receive |
|---|---|---|
| Development of diagnostic typology | Other | One 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.
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.
- First posted22 Aug 2018
- Study start20 Aug 2018
- Primary completion1 May 2019 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reidar Schei Jessen, Oslo University Hospital
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Dysphoria Among Adolescents
- ClinicalTrials.gov ID
- NCT03643120
- Acronym / sponsor ID
- 2018/1088/REK sør-øst C
- Conditions
- Gender Dysphoria
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Qualitative interviews, 15 - 20 participants.
| Arm | Type | Receives |
|---|---|---|
| Development of diagnostic typology | Other | Other: Qualitative interviewOne main goal is to Development a typology of sub-types of gender dysphoria. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Referred to the National Treatment Unit for Transsexuality/Gender dysphoria
Key exclusion criteria (1 listed)
- Not referred to the National Treatment Unit for Transsexuality/Gender dysphoria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative interviewExplorative study of gender dysphoria. | Other | Development of diagnostic typology |
Primary outcome
Clinical sub-types
Time frame: 2021
The aim is to develop a typology to describe gender dysphoria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Undecided. The interviews will we transcribed. Not yet decided whether the transcribed material will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.