Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (PUPSY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01679925|
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : March 26, 2015
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.
|Condition or disease|
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).
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years|
|Study Start Date :||October 2012|
|Primary Completion Date :||July 2014|
|Study Completion Date :||February 2015|
- Psychosocial characteristics [ Time Frame: 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.
- Child Behavior Checklist [ Time Frame: 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.
- Evolution at 6 months [ Time Frame: 6 months ]Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679925
|Assistance Publique - Hôpitaux de Paris|
|Paris, France, 75019|
|Principal Investigator:||Dominique SIMON, MD, PhD||Assistance Publique - Hôpitaux de Paris|