Evaluation of the Effectiveness of Hormonal Treatment in Adolescents Suffering From Gender Dysphoria
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Global functionning using the Children's Global Assessment Scale (CGAS)
研究概览
简要总结
Gender dysphoria (GD) is a significant suffering lasting more than 6 months in a subject, with regard to the discrepancy felt between his or her gender identity and his or her birth sex. From the onset of puberty, most of these self-identified transgender adolescents will persist in their transgender identity and will undergo hormonal and surgical reassignment when the time comes. International best practice guidelines recommend early treatment from the start of pubertal development to block pubertal progression, with the possibility of hormonal transition by administering sex hormones of the desired sex usually around the age of 15.5. However, in order to reduce the psychosocial consequences of GD, more and more referral teams are carrying out this transition from the age of 13.5, although no study has been published to show its benefit compared with a transition at the age of 15.5. In the absence of treatment, co-morbidity among adolescents suffering from gender dysphoria is very high, with anxiety-depressive states, suicidal risk and dropping out of school in the forefront. Our hypothesis is that hormonal transition started at an age closer to physiological puberty can significantly reduce this comorbidity and improve quality of life for these adolescents. This is the first therapeutic trial to be conducted in France in the transgender adolescent population, in an area where international recommendations based on the principles of Evidence Based Medicine are essentially derived from the clinical expertise of teams who have specialized in the care of transgender people for over forty years, while clinical data derived from structured research are still very scarce.
The results of this study will guide the care of transgender adolescents, allowing them, if the study is positive, to access hormonal treatments earlier and thus more quickly improve their overall functioning, anxiety-depressive symptoms and their quality of life.
详细描述
Multicenter, controlled, randomized, open trial with blinded evaluation of the primary endpoint (Prospective Open Blinding Endpoint PROBE study). Randomization will be stratified by sex assigned at birth and the investigating center. The primary analysis will be intention-to-treat and multiple imputation methods will be used to handle missing data. After verification of the inclusion criteria by the child psychiatrist (selection visit), then the pediatric endocrinologist (inclusion visit), the adolescent will be included in the study and will benefit from an initial evaluation (T0) by a psychologist trained for the primary criterion (CGAS) and secondary psycho-affective criteria.The patients will then be sent again to the pediatric endocrinologist who will randomize the patient (via an IT platform) and give them the treatment corresponding to their assigned group. Adolescents in both groups will be reassessed at 15.5 years +/- 6 months (T1). At the end of this evaluation, patients in the control group will begin their hormonal treatment. Adolescents will undergo a final evaluation at 17.5 years +/- 6 months (T2), at which time the same criteria as at T0 and T1 will be collected.
Main objective: To evaluate, in gender dysphoric adolescents, having completed their social transition, having or not undergone prior pubertal suppression, the effectiveness of hormonal treatment with estrogens or testosterone initiated at 13.5 years +/- 6 months of age on the overall functioning of the teenager at 15.5 years +/- 6 months old.
Primary endpoint: Children's Global Assesment Scale (CGAS) score at age 15.5 +/- 6 months
Secondary objectives : Evaluate, in gender dysphoric adolescents who have completed their social transition, whether or not they have benefited from prior pubertal suppression:
- the effectiveness of hormonal treatment started at 13.5 years old +/- 6 months vs. 15.5 years old +/- 6 months on the overall functioning of the adolescent at 17.5 years old+/- 6 months,
- the safety (side effects) of hormonal treatment started at age 13.5 +/- 6 months,
- and the relevance of hormonal treatment started at 13.5 years old +/- 6 months on other parameters assessed at 15.5 +/- 6 months and 17.5 +/- 6 months years old (gender identity, depression, anxiety, emotional, behavioral disorders and other comorbidities, objective and subjective quality of life, body image, height, waist/hip ratio, bone mineral density, BMI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of the primary criteria will be carried out by a psychologist who will have no knowledge of the teenager's allocation group and will not have been involved in his or her care. At T1, the assessment will be based on key elements of the patient's file provided to him or her without any element that could indicate his or her allocation group or original gender, and a telephone interview with the teenager and his or her parents in which they will have been told in advance not to reveal the allocation group or gender. The psychologist who assesses a 15.5-year-old will be different from the one who assesses a 13.5-year-old. Psychological assessments other than the primary criterion, and the assessment by the pediatric endocrinologist, will take place at the site of the patient's usual care. Adolescents will be monitored as part of their usual care.
入排标准
- 年龄范围
- 156 Months 至 168 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 13.5 years +/- 6 months,
- •Having initiated puberty: tanner score ≥2 for transgender boys; tanner score ≥2 for ; (clinic and/or testosterone >0.3 ng/mL) for transgender girls
- •Presenting the criteria for gender dysphoria according to the DSM5 assessed by at least two child psychiatric interviews at least six months apart where the diagnosis of gender dysphoria was clinically established and that of associated autism spectrum disorder refuted and/or associated cognitive impairment, confirmed by specific scales (Gender Identity / Gender Dysphoria Questionnaire for Adults and Adolescents (GIDYQ-AA) and Utrecht Gender Dysphoria Scale (UGDS))
- •Whose indication for hormonal transition has been validated in a multidisciplinary consultation meeting after at least one consultation with the pediatric endocrinologist with clinical examination, blood pressure measurement, and information on hormonal treatments in the context of gender dysphoria.
排除标准
- •Contraindication to hormonal treatment (see paragraph 1.5)
- •Hormonal treatment needs to be adjusted (transgender boys patients treated with anti-coagulants or with thrombophilia).
- •Patients with risk of aggravation of certain diseases under oestrogen treatment (transgender girls patients with uncontrolled diabetes with HBA1C > 8%, patients with cholelithiasis, biliary lithiasis, systemic lupus erythematosus, severe asthma, severe arterial hypertension, severe migraines, otosclerosis, epilepsy not controlled by treatment).
- •Patients with cancer with a risk of hypercalcemia (and associated hypercalciuria), linked to bone metastases.
- •Severe cardiac, hepatic or renal failure or ischemic heart disease, due to the risk of severe complications characterized by edema, with or without congestive heart failure.
- •Uncontrolled high blood pressure.
- •Patients with epilepsy and migraine.
- •Patients with current or history of thromboembolic events.
- •Severe untreated chronic depression clinically assessed and documented using the Beck Depression Inventory (BDI).
- •Diagnosed schizophrenia that is unstable or progressive
- •Diagnosed bipolar disorder that is unstable or progressive
- •Suicidal ideation identified through the MINI with a Columbia C-SSRS score > 4, until the clinical condition has stabilized
- •Current anticoagulant treatment
- •Severe autism Spectrum Disorder (clinical screening, confirmed in cases of doubt by the Social Responsiveness Scale (SRS) Raw-score > 76, carried out as part of usual care in cases of clinical evidence,
- •Cognitive deficit (clinical screening, confirmed by an QI < 80 on the Weschler scale (WISC V), carried out as part of the usual treatment in the event of clinical evidence.
- •Refusal to participate in the study on the part of the adolescent or one of the holders of parental authority (both holders and the adolescent must sign a written consent after receiving appropriate information).
- •No social security cover
- •Participation in other intervention research
- •Pregnancy in progress
- •Insufficient knowledge of French
研究组 & 干预措施
early hormonal treatment
early hormonal treatment initiated at 13.5 years +/- 6 months, in addition to usual care
干预措施: hormonal treatment with cross sex hormones (testosterone or oestrogenes) started at 14 years old +/- 6 months (Drug)
usual treatment
Usual care between 13.5 and 15.5 years +/- 6 months : child psychiatric consultations, endocrinological consultations and consultations with a psychologist, family interviews, network work with local health partners and national education.
Then hormonal treatment initiated at 15.5 years +/- 6 months, in addition to usual care.
干预措施: Cross sex hormones ( œstrogenes or testosterone) started at 15.5 years old +/- 6 months (Drug)
结局指标
主要结局
Global functionning using the Children's Global Assessment Scale (CGAS)
时间窗: 15.5 years old +/- 6 months
The Children's Global Assessment Scale (CGAS), adapted from the Global Assessment Scale for adults, is a rating of general functioning for children and young people until 16 years old. The clinician assesses a range of aspects of psychological and social functioning and gives the child or young person a single score between 1 and 100, based on their lowest level of functioning. The score puts them in one of ten categories that range from "needs constant supervision" (1-10) to "superior functioning" (91-100). The measure can be used by clinicians as well as researchers to complement other scales measuring more specific symptoms.
次要结局
- Drug use (DEP-ADO)(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- WISC-V (weschler Test)(T0 (13.5 years old +/-6 months); T2 ( 17.5 years old +/-6 months))
- School drop-out / family breakdown(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- UGDS (Utrecht Gender Dysphoria Scale ) and GIDYQ-AA (Gender Identity/ Gender Dysphoria Questionnaire for Adolescents and Adults scale )(selection visit ; T1 (15.5 years old +/-6 months) ; T2 (17.5 years old +/-6 months))
- Beck Depression Inventory (BDI)(T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months))
- Body Image Scale (BIS)(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- State and Anxiety Inventory for Children (STAI-C)(T0 (13.5 years old +/-6 mois); T1 (15.5 years old+/-6 monhs); T2 ( 17.5 years old +/-6 months))
- The emotional and sexual relationship(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- World Health Organization Quality Of Life - BREF (WHOQOL-BREF)(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Satisfaction With Life Scale (SWLS)(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Height, bone mineral density, BMI, waist to hip ratio(inclusion visit (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Mini International Neuropsychiatric Interview (MINI)(selection visit ; T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Global Assesment Scale (GAS)(T2 : 17.5 years old +/-6 months)
- Potential side-effects(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Child Behaviour Checklist (CBCL) scale(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Youth Self Report (YSR) scale(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))
- Suicidal risk(T0 (13.5 years old +/-6 months); T1 (15.5 years old+/-6 months); T2 ( 17.5 years old +/-6 months))