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

Early Puberty Clinical Trial

— PUPSY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679925
• Other study ID #: P111010
• Status: Completed
• Phase: N/A
• First received: July 25, 2012
• Last updated: March 25, 2015
• Start date: October 2012
• Est. completion date: February 2015

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 6 Years to 8 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Puberty
• Puberty, Precocious

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychosocial characteristics	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.	1 day	No
Secondary	Child Behavior Checklist	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	No
Secondary	Evolution at 6 months	Changing views of qualitative and quantitative data will be followed six months after the diagnosis of precocious puberty, with or without treatment.	6 months	No