Clinical trial NCT04702386: Concerns of Children Whose Parents Have Cystic Fibrosis
Official title: Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis
parenthood
child with a severely ill parent
Psycho-social
Qualitative study
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Grégory Lemarchal Association
First posted: 2021-01-08
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is comprised of people, both minors and adults, who have a parent living with cystic fibrosis. These parents are participants in the study MUCOPAR.

Brief summary: As more and more patients with cystic fibrosis (CF) become parents, we have studied parenting concerns in this serious chronic disease in a first study (MucoPar) which is ongoing.

The current study (MucoKids) is an extension of the previous MucoPar study and aims to explore and collect the perceptions, expectations and needs of children whose one parent has CF.

This will be done in the context of individual interviews or in several small groups of children led by a psychologist who will encourage them to develop what constitutes to be the child of somebody with CF.

The collected information should make it possible to develop and propose adapted medico-psycho-social interventions, if necessary, in connection with patient associations.

Detailed description: Life expectancy has improved significantly in cystic fibrosis in recent years. From pediatric disease, it has become a disease of the adult, with the emergence of new issues, such as becoming a parent. Parent patients still face the risk of complications and death while their child is still young. However, there is very little data in the literature on parenting in cystic fibrosis. In a first study which is ongoing (43 patients out of the 50 planned have been included), we intended to study parenting, considering the sick parent's point of view.

However, this question does not only concern parents and their spouses. It is also fundamental to take into account the experience of the children, to understand their experiences and their own needs in this context of serious illness of a parent with limited life expectancy.

Therefore, the purpose of this study is to explore and collect the perceptions, expectations and needs of children whose one parent has CF. Children are eligible from the age of 6 if their parents agree.

Children will have semi-structured individual interviews or will participate in focus groups with the study psychologist in order to express their feelings, difficulties, expectations and needs in living with a parent who has CF.

Thematic analysis of the content will first be done separately for individual interviews and focus groups, and a global synthesis will be carried out.

Eligibility criteria: Inclusion Criteria:

* Have a parent with CF cared at one of the 2 adult CF centres participating into the study
* Have the authorization of the parent with CF if the child is an adult and of both parents for subjects less than 18 years old
* Be ay least 6 years old
* Have a good level of French and good speaking skills for adolescents and adults
* Have a level of French and oral expression skills adapted to their age group for the youngest

Exclusion Criteria:

* Psychiatric pathology (borderline state, bipolarity and other psychotic disorders) in their parents or themselves
* Serious somatic disease not related to cystic fibrosis in their parents or themselves

Primary outcomes:
measure: Identification of themes about being the child of a parent with CF
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of themes
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
city: Suresnes
country: France
facility: Foch Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Cécile FLAHAULT, PhD
role: STUDY_CHAIR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Dominique HUBERT, MD
role: PRINCIPAL_INVESTIGATOR
References: