Relational Development in Children With Cleft Lips and Palates: Influence of the Waiting Period Prior to the First Surgical Intervention and the Parents' Psychological Perception of the Abnormality
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Purpose
The treatment of patients suffering from cleft lip(s) with or without a cleft palate (CL/P) is multidisciplinary. The careful consideration of concerned families during the repetitive appointments required by these treatments show the importance of the psychological context and of the harmonious structuring of the parents-child relationships on the child's development. Yet the birth of a child affected by CL/P is a particularly stressing and traumatising event for the parents. The investigators' prospective, multidisciplinary and multi-centred research project aims to assess the psychological perceptions of parents of children affected by CL/P over the year following the birth and analyse the child's degree of psychological suffering as well as the parents-child relationships. The time of the first surgical intervention varies amongst the treatment centres. The investigators listed four centres that intervene at different times according to the more or less long waiting times between the child's birth and this first surgical intervention. The results obtained for each group will be compared to one another and according to two sub-groups: parents who found out about the CL/P through embryo diagnosis and those who found out at their child's birth. The mental and psychological dimension due to the malformation and its correction will be analysed in the parents group (importance of the prenatal diagnosis, relational development with the child, self-esteem, quality of life) but also in the child (likely distress and withdrawal symptoms).
| Condition |
|---|
|
Cleft Palate |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
- Assess the emotional state of withdrawal of any child carrying a CL/P based on the psychological state of their parents and time before the first surgery. We use ADBB scale for the child. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Learning about the psychological effects of this abnormality on parents from the time of diagnosis and of the therapeutic management. We use PSI scale for the parents. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Indices of psychological distress by Quebec Health Survey (IDPESQ) and the Edinburgh Postnatal Depression Scale (EPDS).The Family Impact Scale. The Dyadic Adjustment Scale Spanier of determining the marital context and questionnaires ad-hoc. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| group "early intervention" |
| group "late intervention" |
Eligibility| Ages Eligible for Study: | 4 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Primary care centers (France) Two referent centers Two competent centers
Inclusion Criteria:
- Children with Cleft Lip with or without Cleft Palate and their Parents
Exclusion Criteria:
- Children with Cleft Palate without Cleft Lip
- Children born the 35th week of d'amenorrhea
- Children with a birth weight inferior to 1800 g
- Children put under care by court order
- Parents under administrative supervision
- Parents who are not familiar with the french language and/or illiterate
Contacts and Locations| Contact: GROLLEMUND Bruno, MD | 33388365817 | bruno.grollemund@libertysurf.fr |
| France | |
| CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro | Recruiting |
| Lille, France, 59037 | |
| Contact: PELLEGRIN Philippe, MD 333 20 44 54 22 malface@chru-lille.fr | |
| Sub-Investigator: MARTINOT DUQUESNOY Véronique, MD | |
| CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central | Recruiting |
| Nancy, France, 54035 | |
| Contact: ETIENNE Simon, MD 333 83 85 12 88 e.simon@chu-nancy.fr | |
| Sub-Investigator: DAVROU Julien, MD | |
| APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale | Recruiting |
| Paris, France, 75571 | |
| Contact: VASQUEZ Marie-Paule, MD 331 44 73 69 35 marie-paule.vazquez@trs.aphp.fr | |
| Sub-Investigator: SOUPRE Véronique, MD | |
| Sub-Investigator: GALLIANI Eva, MD | |
| Sub-Investigator: PICARD Arnaud, MD | |
| CHRU, Service de Chirurgie Infantile | Recruiting |
| Strasbourg, France, 67098 | |
| Contact: KAUFMANN Isabelle, MD 333 88 12 73 07 isabelle.chevalier@chru-strasbourg.fr | |
| CSERD, Pôle d'odontologie | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: GROLLEMUND Bruno, MD 333 883 6 58 17 bruno.grollemund@libertysurf.fr | |
| CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1 | Recruiting |
| Strasbourg, France, 67091 | |
| Contact: BRUANT-RODIER Catherine, MD 333 88 11 66 92 catherine.bruant-rodier@chru-strasbourg.fr | |
| Principal Investigator: | GROLLEMUND Bruno, MD | not affiliated |
More Information
No publications provided by University Hospital, Strasbourg, France
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00993993 History of Changes |
| Other Study ID Numbers: | 2009-A00640-57 |
| Study First Received: | October 13, 2009 |
| Last Updated: | June 28, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Strasbourg, France:
|
cleft palate |
Additional relevant MeSH terms:
|
Cleft Palate Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities |
Musculoskeletal Abnormalities Stomatognathic Diseases Mouth Abnormalities Mouth Diseases Stomatognathic System Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 23, 2013