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

This study is currently recruiting participants.
Verified July 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01679925
First received: July 25, 2012
Last updated: November 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Early Puberty

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Puberty
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679925

Contacts
Contact: Dominique SIMON, PhD (0)140033634 ext +33 dominique.simon@rdb.aphp.fr

Locations
France
Assistance Publique - Hôpitaux de Paris Recruiting
Paris, France, 75019
Contact: Dominique SIMON, MD, PhD     (0)140033634 ext +33     dominique.simon@rdb.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Dominique SIMON, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01679925     History of Changes
Other Study ID Numbers: P111010
Study First Received: July 25, 2012
Last Updated: November 19, 2012
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Early puberty
Psychosocial impact
Qualitative assessment

Additional relevant MeSH terms:
Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 21, 2013