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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

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Completed
CT.gov ID
NCT00993993
Collaborator
(none)
150
Enrollment
6
Locations
32.4
Actual Duration (Months)
25
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Actual Study Start Date :
    Apr 27, 2010
    Actual Primary Completion Date :
    Apr 27, 2010
    Actual Study Completion Date :
    Jan 7, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    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. [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. [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. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Months to 12 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro Lille France 59037
    2 CHU, Service de Chirurgie Maxillo-Faciale et Plastique de la Face Hôpital Central Nancy France 54035
    3 APHP Armand Trousseau, Centre de Référence des Malformations Rares de la Face et de la Cavité Buccale Paris France 75571
    4 CHRU, Service de Chirurgie Maxillo-Faciale Chirurgie B1 Strasbourg France 67091
    5 CSERD, Pôle d'odontologie Strasbourg France 67091
    6 CHRU, Service de Chirurgie Infantile Strasbourg France 67098

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: GROLLEMUND Bruno, MD, not affiliated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT00993993
    Other Study ID Numbers:
    • 4506
    First Posted:
    Oct 14, 2009
    Last Update Posted:
    Nov 10, 2020
    Last Verified:
    Sep 1, 2015
    Keywords provided by University Hospital, Strasbourg, France
    cleft palate
    Additional relevant MeSH terms:
    Cleft Palate

    Study Results

    No Results Posted as of Nov 10, 2020