The Visiting Child and His Family in ICU (ENVIFAR)

Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU

According to literature, it's difficult to evaluate the impact of the visit of the child in ICU. Currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in ICU. Collaboration between humanities and medical sciences brings to this question a complementary look. Majority of studies investigated the question of the impact of young child ICU visit in a unidirectional linear causality scheme visit = psychopathological impact. The visit of the child in ICU should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. Contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. The investigators hypothesize that children can overcome the visit of a kin hospitalized in ICU if accompanying people can support the child and contain, before and after the visit, the emotions of the child.

Study Overview

• Status: Unknown
• Conditions: Child; Post Traumatic Stress Disorder; Intensive Care; Acute Stress Disorder
• Intervention / Treatment: Other: interview

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphanie NGUYEN; Phone Number: 06.63.06.74.85; Email: stephanielaurent@gmx.fr
• Study Contact Backup: Name: Alexandra LAURENT; Email: Alexandra.Laurent@u-bourgogne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative
• family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit
• parent hospitalized in ICU is at least 18 years old
• informed consent of children, non-hospitalized and/or hospitalized relatives
• informed consent of the accompanying caregiver

Exclusion Criteria:

• moribund patient
• child unaccompanied by his/her parent/relative during the visit
• non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires)
• child benefiting from a psychological follow-up prior to the hospitalization of his/her parent
• non French-speaking child
• child under 6 years old or older than 14
• hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Expérimental; psychologist interview and psychometrics scales

Other: interview; Child = A clinical interview (recorded, duration approximately 30 min) and a scale of acute stress (IES child) will be performed at 2 times (during the 7 days following the first visit of hospitalized kin and 1 month after the kin was discharged from ICU) Accompanying parent/kin = Semi-directive interviews (recorded - duration approximately 30 min) will be performed at the same time as those of the child and will be recorded. The parent/kin will also complete a socio-demographic questionnaire of the family group and a depression anxiety scale (HADS) Nursing staff = A semi-directive interview (recorded - duration approximately 30 min) will be performed only once (during the 7 days following the first visit to the hospitalized kin). The caregiver will also complete a socio-demographic questionnaire and a Moral Distress Scale (MDS-R) Hospitalized parent = One month after ICU discharge, a depression anxiety scale (HADS) and an acute stress scale (IES) will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute psychotraumatic impact of the visit on the child	Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant	7 days
Chronic psychotraumatic impact of the visit on the child	Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant	1 month
Psychological experience of the visit for the child	semi directive interview	7 days
Parental, family and caregiver support provided to the child during and following the visit	semi directive interviews of caregiver/family	1 month
Psychological experience of the visit according the child age	semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: May 16, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; ICU; child; acute stress; parent hospitalized
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress Disorders, Traumatic, Acute
• Other Study ID Numbers: P/2018/354

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No