We know that hearing that the research protocol for the blocker trial has been published might make a lot of trans young people worried or upset.
It’s important that you have access to reliable info on what the protocol does (and doesn’t say). This is why we’ve quickly made this info page. We will work with other orgs to make a better version later, but we wanted to have something you could look at right away.
There will be a maximum of 226 participants on the parts of the trial that provide access to blockers (called the PATHWAYS Trial.
PATHWAYS Trial
People that are accepted onto the trial that involves taking blockers will be randomly split into two groups:
- The ‘immediate start’ group will be assessed as suitable for blockers and given them upon recommendation for them.
- The ‘delayed start’ group will be assessed as suitable for blockers and then will wait a year before being given access to them.
PATHWAYS Horizon Intensive
There will be another research project called PATHWAYS Horizon intensive:
- People who couldn’t take part in the PATHWAYS trial or didn’t want to access puberty blockers can sign up to be part of this.
- This research project doesn’t involve puberty blockers.
- People taking part in this project will take part in many similar activities to the people on the PATHWAYS Trial – for example answering questions about their gender, tests about memory and thinking, and some blood tests.
People will be able to take part in the PATHWAYS trial if…
Professionals at the gender service agree that:
- they meet the diagnostic criteria for gender incongruence
- puberty blockers will be helpful for the person
- they have taken part enough in the care offered to them by the gender clinic up to that point
And if they:
- want to be able to take puberty blockers
- are younger than 15 years and 11 months when they sign the consent form for the trial
- are in at least Tanner Stage 2 of puberty
- show that they understand the risks and benefits of taking blockers and how it will impact their body and their life
- have talked to staff at the gender clinic about fertility and if they want to preserve their eggs or sperm
- are willing to be in either the “immediate treatment” or “delayed treatment” group
And if at least one parent or carer:
- understands the risks and benefits of taking blockers and how it will impact the young person’s body and their life
- understands what fertility related options are available to their child
- is able to understand and remember enough information to be able to consent to their child taking part in the research trial
- is willing for their child to be in either the “immediate treatment” or “delayed treatment” group
People won’t be able to take part in the PATHWAYS trial if they have:
- severe mental health difficulties. The examples given are:
- “Severe or profound depression with significant effects on the ability to accurately evaluate choices and future outcomes”
- “Severe body dysmorphic disorder that is confounded with secondary sexual characteristics or physique not conforming to the desired gender” (confounded means confused)
- “Active psychotic symptoms” (for example, if someone experiences hallucinations)
- “Significant risk of harm to self or others as exemplified by consistent suicidal thoughts, repeated and ongoing acts of self-harm and/or the need for emergency plans with the child or young person and family”
- very high or very low BMI or if their BMI changes very quickly
- a medical condition that means they won’t start puberty anyway
- a medical condition that is not well controlled (for example if someone has epilepsy but their doctor hasn’t found the medication that works best for them yet)
- issues with the health of their bones
- certain issues with their heart
Or if they:
- are currently taking or have taken hormone blockers in the past
- are currently taking HRT or have taken it in the past
- are taking part in certain types of medical research as well as the PATHWAYS trial
- will struggle to go to follow up appointments because of a situation with their family (for example, if nobody can take them to their appointments)
- are taking certain types of medication that…
- have an impact on bone health (for example, some types of epilepsy medication like phenytoin, phenobarbital, carbamazepine, valproic acid)
- can impact heart rate (for example, quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone)
- are assigned female at birth and..
- are having the type of sex that could get them pregnant and they don’t want to use contraception
- are pregnant or chest feeding
- have bleeding from their vagina that isn’t a period and isn’t something their doctor has found a cause for
Or if professionals:
- are looking into a safeguarding concern about the young person. A safeguarding concern is when professionals are worried that a child or young person might be being hurt, might not be looked after properly or might be hurting themselves.
- don’t think you are are able to consent to treatment.
This means they don’t think you have a good understanding of the risks and benefits, aren’t in a headspace where you can make decisions about your future, or can’t remember the info long enough to be able to make a decision for yourself. - don’t think you understand the PATHWAYS trial well enough.
This means that they want to check you understand what will be involved in taking part and what the trial is for. Don’t worry, they aren’t expecting you to understand the research protocol or anything like that!
For a start, being part of the PATHWAYS trial will involve answering lots of questions. The young people taking part will be asked lots of questions and so will their parent(s) or carer(s).
The way young people answer these questions isn’t normally going to mean that they can’t be on the trial any more – it isn’t a pass or fail situation.
Remember: the questions we are talking about here are things that will take place once gender clinic staff think you should be able to take part in the trial and once you’ve agreed to it.
Questions that they’ll ask young people and their parents and carers:
- questions about the young person and their hobbies, their family life, their health, their feelings, money, friends, school, and experiences of bullying
- what their priorities for the young person’s care from the gender clinic are
- questions to help them understand whether the young people has experienced trauma
- questions about the young person’s mood and anxiety
- questions about the young person’s behaviour and emotions
- questions about the young person’s eating habits
Questions that they’ll ask parents and carers but not young people:
- questions related to finding out if the young person taking part might have ADHD
- questions related to finding out if the young person taking part might be autistic
- questions about their own gender identity
Questions they’ll ask young people but not parents and carers:
- their gender and how they identify
- their experiences of gender dysphoria
- questions about their body parts and how they feel about them
- whether they have socially transitioned and in what parts of their life
- how supportive you feel your parent(s) or carer(s) are
- what their sexual orientation is
- whether they have sex, and if they do – what type of sex
Tests they’ll ask young people to take to do with things like:
- Language understanding
- Solving puzzles and problems
- Decision making and planning
- Memory
- Creativity
(don’t worry, they’re not pass or fail tests)
People taking part in the trial will be asked the same (or similar) questions a few times during the course of the trial.
There are quite a few physical tests involved in the PATHWAYS trial. Like with the questions, the tests will be done a few times over the course of the trial.
Physical tests include:
- Checking the young person’s general health, especially their heart, lungs and abdomen (tummy)
- Measuring height and weight of the young person
- Using some fancy scales (Tanita scales) to look at how much of the young person’s body is muscle, fat, bones and water.
- Taking the young person’s blood pressure and checking their blood oxygen levels (with the thing that clips to your finger)
- An ECG – this is a test that checks your heart is working properly
- A doctor looking at the young person’s body to find out what stage of puberty they’re at (the Tanner Stage)
- Hip and spine scans (DEXA scans) to check the young person’s bones
- X-rays to check the young person’s bones
- Blood tests to check the young person’s hormones, liver, lipids (fats in the blood), vitamin D
- Urine (wee) tests to look for any signs there might be a problem with your health
- For young people assigned female at birth who are having the sort of sex that can result in pregnancy: pregnancy tests
There’s also a research project called PATHWAYS Connect. Young people taking part in the PATHWAYS Trial can choose whether or not to take part in it. If they do, they will have some extra tests done – these will involve having an MRI scan of their brain
The part of the PATHWAYS trial involving puberty blockers will go on for 2 years.
The part of the trial looking at the impact of puberty blockers will go on for at least 5 and a half years.
The research protocol says that young people who were given puberty blockers as part of the trial will be likely to be able to keep taking them after the trial ends. If it’s still right for them and if the researchers haven’t found anything to worry about.
If you’re struggling with your feelings about this news (or anything else), there are organisations there to support you:
Info from the research team
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