New children's gender identity clinic, clinical trials and Cass

[VegasVagabond]

I'm a regular here but have named changed.

I have come across an advert for a psychologist at the new GI clinic for children in Nottingham. I am concerned that the advert says that the psychologist would be supporting children on 'gender affirming pathways' for children receiving hormones under endocrinologists.

My understanding had been that children should no longer be 'gender affirmed' or given puberty blockers and that psychological support should be exploratory to understand the child's context and wider needs?

I also thought clinical trials had not been agreed and were unlikely to be agreed?

Does anyone have any clarity on the current situation in terms of medical pathways, the new clinics, psychological support and the clinical trials?

Here is an extract from the job advert:

Job overview

Due to the development of a new young people’s gender service, there is an exciting opportunity for a Clinical Psychologist (Band 8a) to join The Nottingham Young people’s Gender Service (NYGS) at the forefront of delivering care and support to young patients. You will receive in-depth training and clinical supervision whilst working with our experienced nurses and MDT within a forward thinking and supportive NHS Trust.

NYGS are recruiting to a new team comprising Consultant Psychiatrist, Paediatrics, Advanced Clinical Practitioners, Clinical Nurse Specialists, Psychologists and Research assistants. You will have the opportunity to work with a progressive team leading the way nationally and international in children and young people’s Transgender Health.

NYGS is a multi-disciplinary service offering psychological support to young people on the gender affirming medical pathway and looked after by the adolescent endocrinologist service, some of them will be awaiting to or prescribed hormone blockers or hormones by the NHS following an assessment by the Gender Identity Development Service.

Main duties of the job

The new service will provide multi-disciplinary care and support to young people aged from 11 to (and including) 17 years old who are about to receive or currently receiving gender affirming medical treatment from the Specialist Paediatric Endocrinology services (SPES) which is the endocrinology arm of the Gender Identity Development Service (GIDs) which will be closing on the 31st of March 2024.
This new service (NYGS) service will work to NHS England’s published interim service specification for specialist gender incongruence services for children and young people (Interim Service Specification).
NYGS will sit within the established NCTH Network which provides the Nottingham Centre for Transgender Health Adult Service, the East of England Gender Service, the Linked Clinic activity with Indigo Gender Service and the Linked Clinic activity with the Sussex Gender Service.

There is scheduled to be a clinical trial with the sign-off this year and recruiting from Feb. 2025.

The study into the potential benefits and harms of puberty suppressing hormones as a treatment option for children and young people with gender incongruence is being developed through the National Research Collaboration Programme (NCRP) in place between NHS England and the National Institute for Health and Care Research (NIHR). The NRCP joint programme provides a collaborative approach to study development; studies being progressed through this route still have to demonstrate that they can materially build the evidence base for potential future NHS treatment options, while meeting a high scientific bar in terms of research methodology, as well as securing other important research approvals, including ethics committee approval.
It is envisaged that children and young people in both England and Wales will be able to participate in the study with access through NHS children and young people’s gender services. A multi-disciplinary team approach will be taken to identify those children who, with the consent of their parents, may be deemed clinically suitable for consideration of puberty suppressing hormones through the study. Children participating in the study will also continue to receive comprehensive psychosocial support.
The study will measure a range of potential treatment benefits and harms (for example whether puberty suppressing hormones impact in a meaningful way on levels of anxiety or depression, on body image, or brain development) using a range of validated tools, questionnaires and user feedback. Key measures included in the study, and the way data are collected, will aim to bridge gaps in existing research and will also be shaped by engagement with a range of stakeholders, including children and young people referred into NHS gender services and their families or carers.

https://www.england.nhs.uk/commissioning/spec-services/npc-crg/gender-dysphoria-clinical-programme/implementing-advice-from-the-cass-review/cyp-gender-dysphoria-research-oversight-board/

Thank you!

So has the study been agreed?
Do we know numbers of children?

How is any study on children in this area ethical? Surely resrach on children which we know may have negative outcomes should only be conducted if there is a demonstarted need to avoid a negative outcome if there was no treatment?
There is no evidence that children not given puberty blockers have negative outcomes so how can trialling them on children be justified?

Protocol hasn't been published, so many of the answers aren't available.

In a recent Woman's Hour interview, Dame Hilary Cass indicated that there is no upper limit to the number of children who can be recruited to the trial. (I'm genuinely surprised by this and need to see the protocol to understand.)

An ethics review committee will be considering this study very shortly. They may ask for an amended protocol. This is all opaque until there is ethics agreement and a published protocol. NB: there must have been some prior ethical agreement back when the HRA et al. agreed to this study.

I note that all the official documents, reports etc refer to this as a study rather than clinical trial and on Womens Hour the other day Hilary Cass also referred to it as a study initially when talking about no limit to the number of children recruited.
I don't know how significant the difference is between a study and trial is in this setting but it made me wonder if there will be a study of which only part will be a clinical trial.

When Hilary Cass says that there is no upper limit to the number of children that can be recruited is she perhaps saying that there is no upper limit for children to be included in the study as a whole rather than specifically for the clinical trial.

Please could you link the advertisement?

I also thought clinical trials had not been agreed and were unlikely to be agreed?

I’d put money on these trials getting ethical approval. Both the Government and Cass talk about the trials as if they are definitely going ahead. They never say “subject to ethics approval”. I think there will be immense pressure for the ethics committee to approve this in some form or another and of course ethics are as likely to be as ideologically captured as any other process / organisation. Also there was approval for previous trials.

Don’t worry I found it…

https://www.nhsjobs.com/job/UK/Nottinghamshire/Nottingham/Nottinghamshire_Healthcare_NHS_Foundation_Trust/Psychology/Psychology-v6422172

Are they having a control group?

Are they also having a group of children who receive the same amount of contact with interested professionals in meetings with their parents, but no hormones?

Lots of scheduled meetings with kind professionals who are interested in your life, regular scheduled time where your parents have to attend and no siblings allowed; it's obvious that this is going to go some way towards answering the needs of some of these children.

But presumably any gains would be attributed to hormones unless they are also studying other groups.

Are they having a control group?

They won't be having a control group no. This would be considered to be unethical and unworkable. Sterilising future gay adults however will be considered to be perfectly ethically acceptable.

How can they evaluate the outcomes without a control group?

Surely any found benefits or harm would need to be measured against the outcomes for children with the same diffiulcties who didn't receive the intervention?

This does suond like it's going to be the case in the way it's being discussed.

I see Cass is on the oversight board for the 'study'.

If normal medcial ethis are not applied and there are no limits to the numver of children on thr trial...then basically puberty blockers fpr kids is back to jsut the same position it was previously, but with more data collection?

I wonedr if that is the differnec between a clinical trial and a 'study'? A study collects data but doesn't require the rigour of a clinical trial.

Will the ethics board submission and comments be made public for scrutiny?

How can they evaluate the outcomes without a control group?

They can't. But a control just wouldn't be workable. A control group would require that a group of children who desperately want to go on PBs are given a placebo. What child would agree to be in the control group. In a normal trial neither group would know whether or not they are given the drug or the placebo but obviously it wouldn't take long for them to realise that they had not been given the PB (because puberty would continue) and this would likely result in them either refusing to take part any longer or attempting to access the drugs elsewhere.

I reckon some parents (surely they consent on behalf of their children?) might consent to being in a group that received exactly the same amount of professional attention, but no medication.

People are often reassured and encouraged to receive regular attention from trained professionals.

I found this explanation of the difference between a study and a trial. In brief a clinical trial is a specific type of clinical study but not all studies are trials

For considerations around study | trial design, I always suggest reading Testing Treatments, a book that is free to download.

www.testingtreatments.org/

Ethics in UK studies etc: https://www.ukri.org/publications/mrc-guidance-for-applicants/ethics-and-approvals/

https://www.ukri.org/councils/mrc/facilities-and-resources/find-an-mrc-facility-or-resource/mrc-regulatory-support-centre/understanding-health-research/ethical-approval/

It's not common for ethics' discussions to be published beyond the outcomes of the decision-making. I would expect the protocol to be published near the end of the year. I may be wrong on both counts given the amount of interest in this work.

Thank you. That makes sense.

Will they instead compare to a group who didn't receive the intervention and received a different intervention: wait, with psychologial support?

Would the study then have to reflect the flaws in this design when making comparisons?

It all seems a pretty depressing outcome after Cass.

Gender confused kids are still going to be medical guinea pigs without anything to safeguard them against that beyond calling it 'a study'.

If that 'study' shows over time they regret being sterilised then we won't do it to the next generation of kids??

I agree you can’t have a control group who are given a placebo. Surely not all children will be given PB, so why would collecting data on those not given PB not provide a reasonable level of comparison? It would not be as good quality but still valuable data.

I still think there is a big issue around informed consent.

I don’t see why you couldn’t or wouldn’t have a group that get “only” psychological support - otherwise you’ve no way of knowing if your trial group has had a better outcome than no intervention at all surely ?

Re the job advert - it talks about children on existing puberty blockers as well.

Also, Cass talked about all modalities of treatment of gender care requiring study - including psychotherapy. So the 'no upper limit' may not refer purely to the puberty blocker arm, if there is one, but to the whole model of gender care.

There are do many areas that require longitudinal research - social transition, the effect of therapeutic affirmation, the effect of treating comorbidites, different forms of therapeutic intervention.... these will not all fit into the RCT model. I think we can only wait for the protocol. I don't think it will be a free for all on puberty blockers.

The reference to WPATH SOC 8 is concerning. How can they be following WPATH SOC 8 but also implement Cass?

Dr Walter Bouman has worked at the Nottingham gender identity clinic since 2007, he is a past president of WPATH and played a role in the creation of SOC8 (WPATH's latest Standards of Care published September 2022)

https://x.com/BayswaterSG/status/1765128386433978406

https://uk.linkedin.com/in/walter-pierre-bouman-87725a21

www.economist.com/united-states/2024/06/27/research-into-trans-medicine-has-been-manipulated

Jon Arcelus is at Nottingham, too.

Nottingham is often discussed as being the most favourable of the adult GICs as it’s less gatekeepy/ more compatible with gender identity ideology than say, London, which is still as far as I’m aware, run by James Barrett, who is one of the more old fashioned, paternalistic, doctor-decided-if-you-are-woman psychiatrists still working in Gender services. (The wildly differing reviews on his book seem to split perfectly between HCP and patient, with the low ratings all from the latter)

As a charitable interpretation of the advert perhaps the new service is going to be split so that it’s more experienced clinicians doing exploratory work/differential diagnosis in the early stages and then the ones who are approved for medical intervention are referred to a different psychology team, who are tasked with supporting them via that process/making sure they are still seen in clinic/supervised? One of Cass’
criticisms was the lack of consistency between clinicians so it would sort of make sense to divvy the skeptical staff and the gushy staff into two different sections of a pathway protocol (and some kids will never be referred to the gender cheerleaders?)

Found this on the T UK subreddit - dunno where the op over there found it, but it looks like it’s the data finding research that Cass tasked to York University and that the adult GICs subsequently refused to engage with (leading to the new Cass style review of adult services now being undertaken by Dr David Levy).

There is lots of muttering about all the ‘transphobes’ on the Paediatric Gender Dysphoria Research Oversight Board but I must admit, the sheer volume of experienced clinicians involved makes me feel fairly positive that nothing like the GIDS @ Tavistock debacle will be allowed to happen again - it won’t be a shadowy team of Gender Ideologues in an isolated office building doing whatever the WPATH they fancy and answering to no-one (with an ever expanding NHSE funding pot keeping the whole trust afloat).

www.england.nhs.uk/commissioning/spec-services/npc-crg/gender-dysphoria-clinical-programme/implementing-advice-from-the-cass-review/cyp-gender-dysphoria-research-oversight-board/