Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Psychosocial characteristics
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Parents and / or children do not speak French
- •Other chronic disease
- •The child does not benefit of the French social security cover
结局指标
主要结局
Psychosocial characteristics
时间窗: 1 day
* The thematic content related to the perception of early puberty, the factors motivating the consultation, the concerns of families and children, psychosocial characteristics of the subjects received in consultation. * The thematic content related to the perception of hormone therapy: identifying the knowledge, concerns and expectations regarding the treatment of precocious puberty.
次要结局
- Child Behavior Checklist(1 day)
- Evolution at 6 months(6 months)