Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years

Completed

• Conditions: Early Puberty

• Registration Number: NCT01679925
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2012-07
• Study First Submitted: 2012-07-25
• Study First Submitted QC: 2012-09-03
• Study First Posted: 2012-09-06
• Study Start: 2012-10
• Primary Completion: 2014-07
• Study Completion: 2015-02
• Last Update Submitted: 2015-03-25
• Last Update Posted: 2015-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychosocial characteristics	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.

Secondary Outcome Measures

Name	Time	Method
Child Behavior Checklist	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	6 months	Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France