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PATHWAYS HORIZON: A longitudinal observational study

Puberty suppression And Transitional Healthcare with Adaptive Youth Services (PATHWAYS): a longitudinal observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN69296987
Enrollment
3600
Registered
2025-08-13
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender incongruence Other

Interventions

Participants are recruited from the NHS Children & Young People’s Gender Services (CYP-GS). They can consent to the study in clinic or remotely from home. The CYP’s parent/caregiver may also consent t

Sponsors

South London and Maudsley NHS Foundation Trust
Lead Sponsor
King's College London
Collaborator

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 06/10/2025: 1. The Child or young-person (CYP) has an accepted referral to CYP-Gender Services (CYPGS), or has already attended an appointment at a CYPGS. 2. The CYP is awaiting or has received their first appointment with the service at the time of completing baseline measures. 3. Valid assent/consent has been obtained: - For CYP under the age of 16 at recruitment providing self-reports: --Parent/legal guardian gives consent for them to participate AND --CYP gives assent to participate OR --CYP is deemed to have capacity to consent by their clinician and gives consent to participate. - For CYP 16 years and above at recruitment providing self-report information: --CYP gives consent to participate. OR --Personal Consultee gives consent for the CYP to participate if the CYP lacks capacity to consent. -For parent-reported measures for CYP under the age of 16 at recruitment: -- Parent/legal guardian consents to their own participation to provide parent-reported measures. For parent-reported measures for CYP 16 years and over at recruitment: -- Parent/legal guardian consents to their own participation to provide parent-reported measures and CYP consents to parent/legal guardian completing measures. Previous inclusion criteria: 1. The Child or young-person (CYP) has an accepted referral to CYP-Gender Services (CYPGS), or has already attended an appointment at a CYPGS. 2. The CYP is awaiting or has received their first appointment with the service at the time of completing baseline measures. 3. Valid assent/consent has been obtained: - For CYP under the age of 16 at recruitment providing self-reports: --Parent/legal guardian gives consent for them to participate AND --CYP gives assent to participate. CYP is deemed to have capacity to consent by their clinician and gives consent to participate. - For CYP 16 years and above providing self-report information: --CYP gives consent to participate. OR --Personal Consultee gives consent for the CYP to participate if the CYP lacks capacity to consent. -For parent-reported measures for CYP under the age of 16 at recruitment: -- Parent/legal guardian consents to their own participation to provide parent-reported measures. For parent-reported measures for CYP 16 years and over at recruitment: -- Parent/legal guardian consents to their own participation to provide parent-reported measures and CYP consents to parent/legal guardian completing measures.

Exclusion criteria

Exclusion criteria: 1. Child or young-person (CYP) did not attend a first appointment at CYP gender services. 2. CYP is deemed unsuitable in the opinion of the investigator for clinical or other reasons.

Design outcomes

Primary

MeasureTime frame
Mental health status and well-being quantitatively assessed using the KIDSCREEN-10 questionnaire at baseline and annually for up to 5.5 years

Secondary

MeasureTime frame
Current secondary outcome measures as of 03/09/2025: 1. Quality of life is measured using the KIDSCREEN-52 at baseline and annual follow-up assessments for up to 5.5 years 2. Severity of gender-related distress is measured using the Utrecht Gender Dysphoria Scale – Gender Spectrum (UGDS-GS) at baseline and annual follow-up assessments for up to 5.5 years 3. Anxiety and depression symptoms are measured using the Revised Children’s Anxiety and Depression Scale (RCADS) at baseline and annual follow-up assessments for up to 5.5 years 4. Suicidal ideation and non-suicidal self-injury are measured using the Ask Suicide-Screening Questions (ASQ) at baseline and annual follow-up assessments for up to 5.5 years 5. Post-traumatic stress disorder (PTSD) symptoms are measured using the Adolescent Primary Care Traumatic Stress Screen (APCTSS) at baseline and annual follow-up assessments for up to 5.5 years 6. Behavioural and functional difficulties are measured using the Child Behavior Checklist (CBCL) and the Youth Self-Report (YSR) at baseline and annual follow-up assessments for up to 5.5 years 7. Body image dysphoria is measured using the Body Image Dysphoria Scale (BIS-GS) at baseline and annual follow-up assessments for up to 5.5 years 8. Emotional dysregulation is measured using the Difficulties in Emotional Regulation Scale (DERS-18 for CYP and DERS-29 for parents) at baseline and annual follow-up assessments for up to 5.5 years 9. Eating problems are measured using the SCOFF at baseline and annual follow-up assessments for up to 5.5 years 10. Sexual attraction and sexual behaviours are measured using items from the Avon Longitudinal Study of Parents and Children (ALSPAC) at baseline and annual follow-up assessments for up to 5.5 years 11. Hospitalisations are measured using hospital records at baseline and annual follow-up assessments for up to 5.5 years 12. Social transition status is measured using the Social Transition Status form developed for the PATHWAYS-HORIZON s

Countries

England, United Kingdom

Contacts

Public ContactEmily Simonoff
PATHWAYSEnquiries@kcl.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026