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Completed

NCT Number: NCT00993993

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

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).

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Key information

Age range

4 month–12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU, Centre de référence des malformations Cranio Maxillo Faciales Rares, Hôpital Salengro, Lille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2013
First posted
Oct 14, 2009
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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