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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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ClinicalTrials.gov Identifier: NCT00993993
Recruitment Status : Completed
First Posted : October 14, 2009
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Cleft Palate

Study Design

Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : January 2010
Primary Completion Date : January 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
group "early intervention"
group "late intervention"


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care centers (France) Two referent centers Two competent centers
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993993


Locations
France
CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro
Lille, France, 59037
CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central
Nancy, France, 54035
APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale
Paris, France, 75571
CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1
Strasbourg, France, 67091
CSERD, Pôle d'odontologie
Strasbourg, France, 67091
CHRU, Service de Chirurgie Infantile
Strasbourg, France, 67098
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: GROLLEMUND Bruno, MD not affiliated
More Information

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
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2015

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