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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Apr 22, 2019
Open Peer Review Period: Apr 23, 2019 - Apr 29, 2019
Date Accepted: Jun 9, 2019
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Impact of Early Medical Treatment for Transgender Youth: Protocol for the Longitudinal, Observational Trans Youth Care Study

Olson-Kennedy J, Chan YM, Garofalo R, Spack N, Chen D, Clark L, Ehrensaft D, Hidalgo M, Tishelman A, Rosenthal S

Impact of Early Medical Treatment for Transgender Youth: Protocol for the Longitudinal, Observational Trans Youth Care Study

JMIR Res Protoc 2019;8(7):e14434

DOI: 10.2196/14434

PMID: 31290407

PMCID: 6647755

The Impact of Early Medical Treatment in Transgender Youth: The Trans Youth Care Study

  • Johanna Olson-Kennedy; 
  • Yee-Ming Chan; 
  • Robert Garofalo; 
  • Norman Spack; 
  • Diane Chen; 
  • Leslie Clark; 
  • Diane Ehrensaft; 
  • Marco Hidalgo; 
  • Amy Tishelman; 
  • Stephen Rosenthal

ABSTRACT

Background:

Transgender children and adolescents, those who experience incongruence between assigned sex at birth and internal gender identity, are a poorly understood and understudied population in the United States. Since 2008, medical care for transgender youth has generally followed guidelines developed by professional consensus given the paucity of empirical research, particularly in a U.S. setting.

Objective:

The objective of this research is to provide evidence-based data to inform clinical care for transgender youth. The study aims to: 1) evaluate the impact of gonadotropin-releasing hormone (GnRH) agonists administered for puberty suppression on mental health, psychological well-being, and metabolic and physiologic parameters including bone health in a cohort of children and adolescents (Tanner stages 2-4) with gender dysphoria, comparing baseline and follow-up assessments; and 2) evaluate the impact of gender-affirming hormones (e.g. estradiol, testosterone, etc.) administered for phenotypic gender transition on mental health, psychological well-being, and metabolic and physiologic parameters in a cohort of adolescents with gender dysphoria, comparing baseline and follow-up assessments.

Methods:

The study uses a longitudinal observational design to examine the outcomes of existing medical treatment protocols for gender dysphoria in two distinct cohorts: youth initiating puberty suppression and youth pursuing a phenotypic gender transition. Routine anthropometric and physiologic parameters are collected through chart abstraction, questionnaires, and research interviews throughout the 24-month study period. Audio computer-assisted self-interview (ACASI) and individual interview survey instruments are used to collect demographic, mental health, psychosocial, and behavioral data from parents and youth in the blocker cohort and only from youth in the gender-affirming hormone cohort at baseline, 6, 12, 18, and 24 months.

Results:

Participant recruitment commenced in July 2016 and enrollment was completed in September 2018. Ninety participants were enrolled in the blocker cohort, and 301 participants in the gender affirming hormone cohort. Findings based on baseline data are expected to be submitted for publication in 2019.

Results:

Participant recruitment commenced in July 2016 and enrollment was completed in September 2018. Ninety participants were enrolled in the blocker cohort, and 301 participants in the gender affirming hormone cohort. Findings based on baseline data are expected to be submitted for publication in 2019.

Conclusions:

This longitudinal, observational study is collecting critical data on the existing models of care for transgender youth that have been used in clinical settings for close to a decade, though with limited empirical research to support them. This research is a direct response to the Institute of Medicine report calling for such studies, as well as the needs of clinicians and patients. Results from this study have the potential to significantly impact the medical and mental health services provided to transgender youth by making available rigorous scientific evidence describing the impact and safety of early treatment based on sexual development stage. Ultimately, we aim to understand if early medical intervention reduces the health disparities well-known to disproportionately affect transgender individuals across the lifespan.


 Citation

Please cite as:

Olson-Kennedy J, Chan YM, Garofalo R, Spack N, Chen D, Clark L, Ehrensaft D, Hidalgo M, Tishelman A, Rosenthal S

Impact of Early Medical Treatment for Transgender Youth: Protocol for the Longitudinal, Observational Trans Youth Care Study

JMIR Res Protoc 2019;8(7):e14434

DOI: 10.2196/14434

PMID: 31290407

PMCID: 6647755

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