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Concerns of Children Whose Parents Have Cystic Fibrosis (MUCOKIDS)

28 oktober 2022 uppdaterad av: Assistance Publique - Hôpitaux de Paris

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

27

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Frankrike
      • Paris, Frankrike, 75014
        • Cochin Hospital
      • Suresnes, Frankrike, 92150
        • Foch hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Focus groups
Children aged 8 years or more participating in a focus group with the study psychologist
Beteende: 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
Beteende: 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
Beteende: 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
Beteende: Individual interviews
Interview led by the psychologist about being the child of a parent with CF

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Identification of themes about being the child of a parent with CF
Tidsram: 2 years
Content of groups and individual interviews analysed by thematic analysis
2 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of themes
Tidsram: 2 years
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Samarbetspartners

Grégory Lemarchal Association

Utredare

  • Studiestol: Cécile FLAHAULT, PhD, Assistance Publique - Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

18 februari 2021

Primärt slutförande (Faktisk)

18 februari 2022

Avslutad studie (Faktisk)

18 februari 2022

Studieregistreringsdatum

Först inskickad

7 januari 2021

Först inskickad som uppfyllde QC-kriterierna

7 januari 2021

Första postat (Faktisk)

8 januari 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

31 oktober 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2022

Senast verifierad

1 oktober 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • APHP190326

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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