Clinical trial NCT01679925: Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
Official title: Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Puberty
Keywords: Early puberty
Psychosocial impact
Qualitative assessment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 30
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be offered to all children and families who visit in a day hospital in the pediatric endocrinology department of Robert Debré Hospital for further assessment of early puberty.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Psychosocial characteristics
timeFrame: 1 day
Secondary outcomes:
measure: Child Behavior Checklist
timeFrame: 1 day
measure: Evolution at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique SIMON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: