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 (AmAc)

August 25, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

574

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
quantitative survey 1
parents of 300 patients with craniosynostosis diagnostic
Other: quantitative survey
qualitative survey
  • parents of 12 newly diagnosed patients, they will be seen 3 times (after the diagnosis, 3 months after surgery, 1 year after surgery
  • 12 patients aged over 15 years, operated more than 10 years before
Other: qualitative survey
quantitative survey 2
  • 100 parents of patients 1 year after surgery
  • 100 parents of patients, 5 years after the operation
  • 100 patients aged over 15 years and operated over 10 years ago
Other: quantitative survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
Time Frame: 5 months
Analysis of the questionnaires will permit us to learn more about the conditions and experiences of the announcement concerning different profiles families whose experience has been received differently depending on the type of craniosynostosis (simple or complex), the medical history or sociodemographic characteristics.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview
Time Frame: 16 months
In a longitudinal perspective, we will develop interview guides. For conducting interviews, we will use the life story method. The interest of the life story is that it provides a method to study the modes of appropriation of the announcement and the way in which subjects incorporate it into their life history.
16 months
measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
Time Frame: 6 months
From the results of all the interviews (from qualitative survey) and the analysis of questionnaires from the quantitative survey 1, we will develop questionnaires for themes and issues that have emerged from those analyses (accompanying the announcement of genetic mutation in the family, aesthetics, education ...). It will then develop targeted questionnaires, based on the analysis of interviews and questionnaires from the quantitative survey. The goal will be a deepening of themes.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Université de Cergy Pontoise

Investigators

  • Study Chair: Séverine Colinet, PhD, Cergy University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URC 1073

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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