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.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Paris、フランス、75019
- Assistance Publique - Hôpitaux de Paris
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychosocial characteristics
時間枠：1 day
|
|
1 day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Child Behavior Checklist
時間枠：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
時間枠：6 months
|
Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
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6 months
|
協力者と研究者
捜査官
- 主任研究者：Dominique SIMON, MD, PhD、Assistance Publique - Hôpitaux de Paris
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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