Concerns of Children Whose Parents Have Cystic Fibrosis (MUCOKIDS)

Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Focus groups; Behavioral: Individual interviews

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.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin Hospital
  • Suresnes, France, 92150
    • Foch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Focus groups; Children aged 8 years or more participating in a focus group with the study psychologist	Behavioral: Focus groups; Groups of 3 to 8 children led by the study psychologist lasting 1 hour for the 8-11-year-old children and up to 2 hours for the children of at least 12 years old, about being the child of a parent with CF; Behavioral: Individual interviews; Interview led by the psychologist about being the child of a parent with CF
Individual interviews; All children who have an individual interview with the study psychologist	Behavioral: Focus groups; Groups of 3 to 8 children led by the study psychologist lasting 1 hour for the 8-11-year-old children and up to 2 hours for the children of at least 12 years old, about being the child of a parent with CF; Behavioral: Individual interviews; Interview led by the psychologist about being the child of a parent with CF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of themes about being the child of a parent with CF	Content of groups and individual interviews analysed by thematic analysis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of themes	The number of appearances of each theme, in focus groups and in individual interviews will provide information on the importance of each theme.	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Grégory Lemarchal Association
• Investigators: Study Chair: Cécile FLAHAULT, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2021
• Primary Completion (Actual): February 18, 2022
• Study Completion (Actual): February 18, 2022

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cystic fibrosis; parenthood; Qualitative study; Psycho-social; child with a severely ill parent
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: APHP190326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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