Cystic FibrosisMUCOKIDSNCT04702386
Concerns of Children Whose Parents Have Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Focus groups and Individual interviews
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Feb 2021to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Focus groups, Individual interviews
- Keywords
- Cystic fibrosis, parenthood, child with a severely ill parent, Psycho-social, Qualitative study
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus groupsBehavioural
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
Individual interviewsBehavioural
Interview led by the psychologist about being the child of a parent with CF
| Study group | Role | What they receive |
|---|---|---|
| Focus groups | Children aged 8 years or more participating in a focus group with the study psychologist Receives: Behavioral: Focus groups; Behavioral: Individual interviews | |
| Individual interviews | All children who have an individual interview with the study psychologist Receives: Behavioral: Focus groups; Behavioral: Individual interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of themes about being the child of a parent with CF
Content of groups and individual interviews analysed by thematic analysis
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start18 Feb 2021
- Primary completion18 Feb 2022
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Grégory Lemarchal Association, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Cécile FLAHAULT, PhD, Study chair, Assistance Publique - Hôpitaux de ParisDominique HUBERT, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702386
- Sponsor's protocol ID
- APHP190326
- Acronym
- MUCOKIDS
- Status last verified
- Oct 2025
- First submitted
- 7 Jan 2021
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences, Expectations and Needs of Children Whose Parents Have Cystic Fibrosis - Exploratory Study
- ClinicalTrials.gov ID
- NCT04702386
- Acronym / sponsor ID
- MUCOKIDS / APHP190326
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, parenthood, child with a severely ill parent, Psycho-social, Qualitative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Grégory Lemarchal Association, URC-CIC Paris Descartes Necker Cochin
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 18 Feb 2022 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus groups | – | Behavioral: Focus groups, Behavioral: Individual interviewsChildren aged 8 years or more participating in a focus group with the study psychologist |
| Individual interviews | – | Behavioral: Focus groups, Behavioral: Individual interviewsAll children who have an individual interview with the study psychologist |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus groupsGroups 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 | Behavioural | Focus groups, Individual interviews |
| Individual interviewsInterview led by the psychologist about being the child of a parent with CF | Behavioural | Focus groups, Individual interviews |
Primary outcome
Identification of themes about being the child of a parent with CF
Time frame: 2 years
Content of groups and individual interviews analysed by thematic analysis
1 secondary outcome
Occurrence of themes
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile FLAHAULT, PhD study chair
Assistance Publique - Hôpitaux de Paris
Dominique HUBERT, MD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of themes about being the child of a parent with CF (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.