King's College London

PATHWAYS CONNECT is a research study that will explore brain development and changes over time in young people with gender incongruence who are attending the NHS Gender Service.

The study will follow and compare young people enrolled in the PATHWAYS TRIAL, who are offered puberty suppressing hormones either immediately or after one year, and young people from PATHWAYS HORIZON INTENSIVE, who are not receiving puberty suppressing hormones. It will not follow everyone in these studies but a group from each.

Why is this important?

Gender incongruence is when someone’s gender doesn’t match the sex they were registered at birth. Young people with gender incongruence often feel especially distressed during puberty, because their body starts to change in ways that don’t match how they feel inside.

Puberty suppressing hormones may reduce this feeling of strong dislike of the person’s body and help young people with gender incongruence explore their gender identity more comfortably without feeling rushed or distressed by changes in their body.

However, doctors and researchers don’t yet know for sure what the benefits or risks of this treatment are. One of the main concerns is that puberty suppressing hormones might affect brain development, thinking and learning.

There is not enough research to understand whether any changes happen, how big they might be, or if they return to normal after treatment stops. This is especially important because adolescence and puberty is a time of rapid brain development with big gains in memory, organisation, and abstract thinking.

To understand whether puberty suppressing hormones affect brain development, a research study needs to be done to compare young people receiving puberty blockers to those who do not. PATHWAYS CONNECT is the first study to explore this among young people with gender incongruence.

How will PATHWAYS CONNECT be done?

PATHWAYS CONNECT will recruit young people from two other PATHWAYS studies: TRIAL and HORIZON INTENSIVE.

In the TRIAL study, half of the participants start puberty suppression treatment straight away, while the other half begin after 12 months. PATHWAYS CONNECT will include an equal number of young people from each of these two groups. It will also recruit a subgroup of young people who are not receiving puberty blockers, from PATHWAYS HORIZON INTENSIVE.

PATHWAYS CONNECT participants will have brain scans (magnetic resonance imaging, MRI) so that researchers can understand how the brain develops and whether it changes over time. To spot these changes, young people participating in both the PATHWAYS TRIAL and CONNECT will have the scans three times — at the start of the study, one year later, and again after two years.

Young people participating in both HORIZON INTENSIVE and CONNECT will take part in brain scans twice — at the start of the study and after two years.

Funding

The research is funded by the National Research Collaboration Programme (NRCP), a partnership between NHS England and the National Institute for Health and Care Research (NIHR).

Oversight

The research is led by King’s College London and co-sponsored by King’s College London and the South London and Maudsley NHS Foundation Trust.

The study has been carefully checked by independent scientists who advise the National Institute for Health and Care Research (NIHR). These include independent academic peer reviewers and NIHR funding committee consideration.

It has also been carefully checked by the Medicines and Healthcare products Regulatory Agency and received approval from a Research Ethics Committee.

The research is overseen by two groups of people who are independent from the research team and the funders. A Data Monitoring Committee will check the data and highlight any concerns they have about the quality of the data (such as the amount of missing information) and any concerns about the safety or wellbeing of people taking part.

The Programme Steering Committee will include at least two people with lived experience of being a gender diverse young person, or a parent/caregiver of a gender diverse young person, as well as scientists. The Programme Steering Committee will advise on the study’s progress overall.

Documents

PATHWAYS CONNECT Easy Read Study Description (PDF)

PATHWAYS TRIAL & CONNECT FAQs (PDF)