NCT04702386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

February 18, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2022

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1 year

First QC Date

January 7, 2021

Last Update Submit

November 17, 2025

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisparenthoodchild with a severely ill parentPsycho-socialQualitative study

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Occurrence of themes

    2 years

Study Arms (2)

Focus groups

Children aged 8 years or more participating in a focus group with the study psychologist

Behavioral: Focus groupsBehavioral: Individual interviews

Individual interviews

All children who have an individual interview with the study psychologist

Behavioral: Focus groupsBehavioral: Individual interviews

Interventions

Focus groupsBEHAVIORAL

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

Focus groupsIndividual interviews
Individual interviewsBEHAVIORAL

Interview led by the psychologist about being the child of a parent with CF

Focus groupsIndividual interviews

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cochin Hospital

Paris, 75014, France

Location

Foch Hospital

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Cécile FLAHAULT, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY CHAIR

  • Dominique HUBERT, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 8, 2021

Study Start

February 18, 2021

Primary Completion

February 18, 2022

Study Completion

February 18, 2022

Last Updated

November 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)