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

• ClinicalTrials.gov Identifier: NCT01679925
• Recruitment Status: Completed
• First Posted: September 6, 2012
• Last Update Posted: March 26, 2015
• Sponsor: Assistance Publique - Hôpitaux de Paris
• Information provided by (Responsible Party): Assistance Publique - Hôpitaux de Paris

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
Early 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 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: October 2012
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: February 2015

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Psychosocial characteristics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

• Ages Eligible for Study: 6 Years to 8 Years (Child)
• Sexes 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

Locations

France

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

More Information

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT01679925
• Other Study ID Numbers: P111010
• First Posted: September 6, 2012
• Last Update Posted: March 26, 2015
• Last Verified: July 2012

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