CraniosynostosisAmAcNCT02287805
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
An observational study of Craniosynostosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Craniosynostosis
- What is being tested?
- qualitative survey and quantitative survey
- How many people
- 574 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.
Who may be able to join
- 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
Who cannot join
- nothing to declare
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des dysostoses craniofaciales, Hôpital Necker Enfants Malades
Paris, 75015
About this study
Official title: 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.
Read the 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.
- Conditions
- Craniosynostosis
- Being tested
- qualitative survey, quantitative survey
- Keywords
- craniosynostosis, simple form, complex form, diagnostic, announcement, impacts
- Medical subject headings
- Craniosynostoses, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative surveyOther
quantitative surveyOther
| Study group | Role | What they receive |
|---|---|---|
| quantitative survey 1 | parents of 300 patients with craniosynostosis diagnostic Receives: 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 Receives: 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 Receives: Other: quantitative survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
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.
Measured: 5 months
Secondary outcomes (2)
measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview
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.
Measured: 16 months
measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniosynostosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 574 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Cergy Pontoise, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Séverine Colinet, PhD, Study chair, Cergy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287805
- Sponsor's protocol ID
- URC 1073
- Acronym
- AmAc
- Status last verified
- Mar 2026
- First submitted
- 10 Oct 2014
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Craniosynostosis: How to Improve the Diagnosis and Assist Patients and Their Families?
- ClinicalTrials.gov ID
- NCT02287805
- Acronym / sponsor ID
- AmAc / URC 1073
- Conditions
- Craniosynostosis
- Keywords
- craniosynostosis, simple form, complex form, diagnostic, announcement, impacts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Université de Cergy Pontoise, URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| quantitative survey 1 | – | Other: quantitative surveyparents of 300 patients with craniosynostosis diagnostic |
| qualitative survey | – | Other: 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 |
| quantitative survey 2 | – | Other: quantitative survey* 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children with craniosynostosis who are followed by the Reference Center "Dysostoses craniofaciales" and their parents.
Key inclusion criteria (8 listed)
- Parents of operated children with a clinical diagnosis of craniosynostosis
- 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
- 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
Key exclusion criteria (1 listed)
- nothing to declare
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative survey | Other | qualitative survey |
| quantitative survey | Other | quantitative survey 1, quantitative survey 2 |
Primary outcome
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.
2 secondary outcomes
measure by interview the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) interview
Time frame: 16 months
measure by an other questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Séverine Colinet, PhD study chair
Cergy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Craniosynostosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure by questionnaire the conditions and experiences of the announcement concerning craniosynostosis (simple or complex) (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.