Condition category
Not Applicable
Date applied
16/11/2018
Date assigned
30/11/2018
Last edited
30/11/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Gender identity clinics provide specialist services for people who feel that their gender is different from the sex on their birth certificate. Demand for gender identity clinics is increasing; the Tavistock and Portman Gender Identity Development Service for young people has an estimated waiting list of 1400 people. This can mean lengthy waits for young people and their families who are likely to have questions, concerns and support needs during this period. Finding balanced online information can be challenging, as views about transgender issues vary widely. Little is known about the experiences, information and support needs of young people waiting for gender identity clinic services. This research aims to improve the care and support of gender-questioning people, and their families, by identifying possible improvements to care and by providing resources, information and support for self-management.
The interviews will be used to develop two new online resources (which will be published on the well-established, public facing website Healthtalk.org). They will feature analyses and balanced video and audio extracts from the interviews, to support young people and their families. The material will also be made available to train staff, inform service improvements and develop resources for relationship and sex education (RSE) in schools. The resources will be evaluated with young people and their families on the waiting list for specialist services.

Who can participate?
Gender-questioning young people and adults (aged over 12 years), non-paired families, GPs and Child and Adolescent Mental Health Service (CAMHS) professionals (and other ‘gateway’ health professionals)

What does the study involve?
Interviews with the participants will be recorded by audio and video. The interviewers will aim to find out the participant's views and experience of gender identity health services, as well as their broader experiences of living trans, non-binary and/or gender diverse. The participant interviews will be used to inform development of two new sections of Healthtalk.org, a website that provides personal perspectives on different health issues. The participants will also be asked for their feedback on the new Healthtalk sections using interviews and a survey.

What are the possible benefits and risks of participating?
Given the nature of this study, it is unlikely that participants will suffer harm by taking part. However, the impact of being interviewed can differ for each person. Therefore, each interview participant will be offered further sources of help and information after the interview should they require this – this list will likely include the Mermaids helpline, and Mindline Trans+ support helpline – further sources of help will be decided in collaboration with the Advisory Group. The main beneficiaries of the research are likely to be the children and young people (and families) preparing to attend specialist services and/or those who are questioning their gender identity.

Where is the study run from?
University of Oxford (UK)

When is the study starting and how long is it expected to run for?
June 2018 to June 2021

Who is funding the study?
National Institute for Health Research

Who is the main contact?
Dr Angela Martin, angela.martin@phc.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Melissa Stepney

ORCID ID

http://orcid.org/0000-0001-8743-9443

Contact details

Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Type

Public

Additional contact

Dr Angela Martin

ORCID ID

http://orcid.org/0000-0001-6196-0409

Contact details

Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom

Additional identifiers

EudraCT number

N/A

ClinicalTrials.gov number

N/A

Protocol/serial number

17/51/07, IRAS 112111, CPMS 13550

Study information

Scientific title

Meeting the transgender challenge: improving the experience of health services for gender-diverse young people and their families.

Acronym

N/A

Study hypothesis

Our aim is to improve the care and support for young people and their families before and after referral to specialist gender identity services.

Ethics approval

NRES Committee South Central – Berkshire, 11/09/2012, ref: 12/SC/0495)
Our studies do not require NHS sites to act as 'Research Sites' (under the new National Research Ethics service guidelines), but only as 'Participant Identification Centres (PICS)'. Research that is conducted using these methods and for dissemination on Healthtalk is included on the National Institute for Health Research Network (NIHR CRN) Portfolio (IRAS Ref: 112111. Study ID: 13550).

Study design

Qualitative observational study

Primary study design

Observational

Secondary study design

Qualitative

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participation information sheet.

Condition

Gender identity/variance

Intervention

We will conduct video and audio recorded in-depth narrative interviews with a diverse nationwide sample of 40 gender-questioning young people (aged 12-25 years), 10 adults over the age of 25 years, and 20 (non-paired) family members. We will audio record interviews with 20 “gateway” professionals (GPs, CAMHS professionals). Interviews will take place in people’s own homes, or another location if the participant prefers, using methods that have already been approved for national studies by an NHS ethics committee. The interviews will be video or audio recorded (according to the participant’s preference) and will invite people to talk about their experiences of health and healthcare including perceptions of current service provision. The interviews we conduct for this project will cover a broad range of experiences and perspectives, not just of healthcare experiences but also wider experiences of living transgender, including schooling, work and careers; friends and family relationships; leisure; sense of self and body image; planning for the future; sources of support and information. We want to find out about the experiences and priorities of the transgender community and the interviews will therefore resemble a guided conversation in which the researcher has a list of possible topics and prompts rather than structured questions. The researcher will conduct the interview either in one session or two, depending on the preferences and energy levels of the participant and how long they would like to talk. Interviews are anticipated to be between 45 minutes to several hours.

The impact of HealthTalk resources will be measured through the e-HIQ evaluation tool with 50 young people to explore how useful they found the resources. Participants will be asked to complete a set of questions about their general attitudes towards online health experiences and provide a contact email address. They will then be given a link to access the ‘draft’ site which they will be able to use for as long and as frequently as they like during a two-week period. Finally, they will be asked to complete part two of the eHIQ which explores attitudes towards various aspects of the site, including relevance, presentation, trust, community and support, managing health and distress. Short telephone interviews will also be used with a purposive sample of 15 eHIQ respondents/young people to explore the extent to which we have achieved our aim of data saturation.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Understand the perspectives and experiences of young people, families and 'gateway' professionals (GPs, child and adolescent mental health professionals, gender identity clinic clinicians) in gender identity health services
2. Identify ways in which specialist gender identity services can be improved and develop resources to help achieve these improvements

Secondary outcome measures

1. Conduct a mixed methods formative evaluation of the two new Healthtalk sections, using a validated questionnaire, to assess their role as a source of information and emotional support for people waiting for specialist services.

Overall trial start date

19/06/2018

Overall trial end date

30/06/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Gender-questioning young people:
1. Aged 12-25 years

Gender-questioning adults:
2. Aged over 25 years

Non-paired family members:
3. Siblings or parents of gender-questioning young people

Health professionals:
4. Practising GPs and Child and Adolescent Mental Health Service (CAMHS) professionals

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

90

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/04/2019

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford
Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road
Oxford
OX2 6GG
United Kingdom

Trial participating centre

Gender Identity Development Service, Tavistock and Portman NHS Foundation Trust
120 Belsize Lane
London
NW3 5BA
United Kingdom

Sponsor information

Organisation

University of Oxford / Clinical Trials and Research Governance

Sponsor details

Joint Research Office
1st Floor
Boundary Brook House
Churchill Drive
Headington
Oxford
Oxford
OX3 7GB
United Kingdom
00000 000000
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Dissemination routes will include two new Healthtalk sections - which had 5.7 million visitors in 2017 - and other social media platforms including Twitter and Facebook, specialist clinics and more traditional academic publications and conference presentations. Co-applicants and participants in the national networking event will help to co-produce recommendations and resources to help health and care staff to respond effectively to young people and their families. Dissemination activities are scheduled March to June 2021.

IPD sharing statement:
The interview transcripts will be available indefinitely upon request from Sue Ziebland (sue.ziebland@phc.ox.ac.uk) after completion of the study to bona fide researchers for secondary analyses of the interview data. Applicants will be required to sign a data sharing agreement. Consent from participants was obtained in the consent and copyright process. All participants assign copyright in their interview to the University of Oxford and agree to their interview being used for teaching, publication, broadcasting and secondary analysis for research. All transcripts will be checked and identifying information removed.

Intention to publish date

14/07/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes