Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years (PUPSY)
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years|
- Psychosocial characteristics [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||January 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679925
|Assistance Publique - Hôpitaux de Paris|
|Paris, France, 75019|
|Principal Investigator:||Dominique SIMON, MD, PhD||Assistance Publique - Hôpitaux de Paris|