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

Cleft Palate Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993993
• Other study ID #: 4506
• Status: Completed
• Start date: April 27, 2010
• Est. completion date: January 7, 2013

Study information

• Verified date: September 2015
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 7, 2013
• Est. primary completion date: April 27, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Cleft Palate

Locations

Country	Name	City	State
France	CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro	Lille
France	CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central	Nancy
France	APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale	Paris
France	CHRU, Service de Chirurgie Infantile	Strasbourg
France	CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1	Strasbourg
France	CSERD, Pôle d'odontologie	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years
Primary	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.		2 years
Secondary	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.		2 years