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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Completed
CT.gov ID
NCT01679925
Collaborator
(none)
30
Enrollment
1
Location
28
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Qualitative Assessment of the Psychosocial Impact of Early Puberty in Girls Aged 6 to 8 Years
    Study Start Date :
    Oct 1, 2012
    Actual Primary Completion Date :
    Jul 1, 2014
    Actual Study Completion Date :
    Feb 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 8 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assistance Publique - Hôpitaux de Paris Paris France 75019

    Sponsors and Collaborators

    • Assistance Publique - Hôpitaux de Paris

    Investigators

    • Principal Investigator: Dominique SIMON, MD, PhD, Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Assistance Publique - Hôpitaux de Paris
    ClinicalTrials.gov Identifier:
    NCT01679925
    Other Study ID Numbers:
    • P111010
    First Posted:
    Sep 6, 2012
    Last Update Posted:
    Mar 26, 2015
    Last Verified:
    Jul 1, 2012
    Keywords provided by Assistance Publique - Hôpitaux de Paris
    Early puberty
    Psychosocial impact
    Qualitative assessment
    Additional relevant MeSH terms:
    Puberty, Precocious

    Study Results

    No Results Posted as of Mar 26, 2015