DANAO: Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "

Sponsor

University Hospital, Lille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04911036

Collaborator

(none)

240

Enrollment

Location

23.8

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational, national multicentre (34 centres involved), cross-sectional study in psychology whose objective is to describe and compare the levels of post-traumatic reactions of mothers to the announcement of their child's EA diagnosis.

An ancillary study will be carried out among the fathers present who agree to participate in the study.

Condition or Disease	Intervention/Treatment	Phase
Atresia, Esophageal	Other: Questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of the Effect of the Time of Diagnosis (Antenatal vs. Postnatal) on the Post-traumatic Reactions of Parents of Children Undergoing Oesophageal Atresia Surgery "

Actual Study Start Date :

May 6, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Mothers and/or fathers with an antenatal diagnosis	Other: Questionnaires Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire
Mothers and/or fathers with a postnatal diagnosis	Other: Questionnaires Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire

Arm

Intervention/Treatment

Mothers and/or fathers with an antenatal diagnosis

Other: Questionnaires

Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire

Mothers and/or fathers with a postnatal diagnosis

Other: Questionnaires

Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire

Outcome Measures

Primary Outcome Measures

Perinatal Posttraumatic Stress Disorder Questionnaire (score PPQ) [at 2 months]
The score PPQ derived from this instrument corresponds to the number of items (there are 14) to which the parent responded positively (theoretical spread: 0-14 points)

Secondary Outcome Measures

Percentage of mothers with Score PPQ >5 [at 2 months]
Questionnaire on early support [at 2 months]
This is a questionnaire co-constructed with the Association Française de l'Atresie de l'œsophage (AFAO) to collect information on the perception of support available or received upon suspicion of an abnormality in the child. It consists of 15 questions. The first eight explore satisfaction with various aspects of early support (information, support, professionals met...). The next seven address parental perceptions regarding information and support. Most of the questions are to be answered on a 5-point Likert scale (e.g., from "Not at all satisfied" to "Very satisfied" or "Never" to "Almost always"), the other questions are closed-ended. Time to complete the test: 5 to 10 minutes.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to mothers [at 2 months]
State-Trait Anxiety Inventory (STAI-TRAIT) SCORE: 20 items in the form of a 4-response Likert scale (from 1 : low anxiety to 4 : highest anxiety). The score goes from 20 to 80 depending of the degree of anxiety.
Correlation between STAI-Trait, Questionnaire on early support and Score PPQ evaluated to fathers [at 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be the mother and/or a father of a living child aged 12 to 24 months who has undergone neonatal surgery following the diagnosis of type 1 or type 3 EA;
Not to have objected to participating in the study (information and non-objection form signed by the investigator);
To be socially insured.

Exclusion Criteria:

Woman or man whose child with AO has a chromosomal abnormality;
Woman or man whose child with AO has a polymalformative syndrome;
Female or male minor ;
Pregnant woman;
Woman or man who does not speak French;
Woman or man unable to consent, or benefiting from a legal protection regime (guardianship or curatorship);
Woman or man deprived of liberty.