Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (PUPSY)
Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
GnRH agonists are used in the treatment of precocious puberty in order to improve adult height.However,the psychosocial impact of precocious puberty is often used by the clinician at diagnosis to justify treatment, but can not yet be properly assessed. It can not be considered as a rational neither for the indication to treatment, nor to assess its potential efficacy.
The overall objective of this work is to improve the conditions leading to the therapeutic decision and the procedures for monitoring girls with idiopathic central precocious puberty.
研究概览
地位
条件
详细说明
During the day hospital, the diagnostic workup for precocious puberty will be performed and include:
- A clinical examination with pubertal stage assessment.
- A GnRH test
- A Pelvic ultrasound
- An MRI will be performed later after the results of GnRH test confirming precocious central puberty.
These reviews are conducted as part of usual care and are required to validate the inclusion criteria of patients.
The CBCL questionnaire will be completed by patient's parents and the first semi-structured interview will be conducted by a sociologist assisted by the psychologist, dedicated to the study.
Patient's follow-up will be planned 6 months after inclusion, including similar investigations (except MRI).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Paris、法国、75019
- Assistance Publique - Hôpitaux de Paris
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
6 to 8 years old girls, with idiopathic central precocious puberty defined as:
- Onset of clinical signs between 6 and 8 years excluded: breast development (Tanner stage S2 or more), possibly with pubic hair or accelerated growth rate.
- The GnRH test: LH peak> 5 IU / l during the test.
- Pelvic ultrasound: uterine length> 34 mm
- The normality of the hypothalamic-pituitary region assessed by magnetic resonance imaging (MRI).
- Parental Informed and written consent
Exclusion Criteria:
- Parents and / or children do not speak French
- Other chronic disease
- The child does not benefit of the French social security cover
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Psychosocial characteristics
大体时间：1 day
|
|
1 day
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Child Behavior Checklist
大体时间：1 day
|
Quantitative data on the psychosocial status of patients will be collected as a self-administered questionnaire: the Child Behavior Checklist (CBCL) that is validated.
|
1 day
|
|
Evolution at 6 months
大体时间：6 months
|
Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
|
6 months
|
合作者和调查者
调查人员
- 首席研究员：Dominique SIMON, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.