Clinical trial NCT02287805: Qualitative and Quantitative Study Which Aims to Determine the Specifics of the Announcement for the Diagnosis of Patients With Craniosynostosis and Their Parents to Better Support Them in Their Care
Official title: Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniosynostosis
Keywords: craniosynostosis
simple form
complex form
diagnostic
announcement
impacts
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Université de Cergy Pontoise
First posted: 2014-11-11
Enrollment: 574
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.

Brief summary: The purposes of this study are:

* to better understand the experience of the announcement for the diagnostic of craniosynostosis to patients and their families to improve the understanding of it and it modes of appropriation
* to compare the announcement process concerning "simple" and "complex" forms.
* to identify the intra-family issues at the announcement of a genetic mutation.
* to reconstruct the care course of patients by analyzing the time of the announcement and the post-operative period.

Detailed description: The supported hypothesis is that the diagnosis of craniosynostosis disturbs the initial family pattern. The different forms of the disease will have different repercussions on intra-family relationships.

The quality of the announcement done by the doctor influences the way how the subjects (parents and patients themselves) appropriate and incorporate it at short, medium and long term.

This research will contribute to the knowledge of this rare disease by different scientific communities: social sciences, medicine and neuropsychology. The originality of this research lies in interdisciplinary teams involved and the cross looks between professional and associative fields.

To better understand the impact of congenital malformations and specifically those related to craniosynostosis, the experiences of children and their families at short, medium and long term, the research will take place in the center of reference "Dysostoses craniofacial", Pediatric Neurosurgery Service at the Necker Hospital in Paris.

Prior to fieldwork, a thorough literature search will be conducted on issues related to our subject: the announcement, psychological, identity, family and social impacts, as well as the specifics of the disease and its manifestations.

The fieldwork will be included in a longitudinal approach which will be located at the intersection of quantitative and qualitative methods.

Eligibility criteria: Inclusion Criteria :

Group 1 :

Parents of operated children with a clinical diagnosis of craniosynostosis

Group 2 :

* Parents of newly diagnosed children for a craniosynostosis who will be operated
* Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Group 3 :

* Parents of newly diagnosed children for a craniosynostosis who will be operated
* Children aged 15 who were operated for a craniosynostosis at least 10 years ago

Exclusion Criteria:

* nothing to declare

Primary outcomes:
measure: measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
timeFrame: 5 months
Secondary outcomes:
measure: measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview
timeFrame: 16 months
measure: measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades
Study officials:
affiliation: Cergy University
name: Séverine Colinet, PhD
role: STUDY_CHAIR
References: