- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00955370
The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition
30 giugno 2017 aggiornato da: National Human Genome Research Institute (NHGRI)
Background:
- Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting different organ systems at various levels of severity. Perhaps the most challenging feature of an undiagnosed medical condition that has lasted 2 or more years is its characteristic uncertainty. In the absence of a diagnosis, health care professionals can provide only limited treatment and prognostic information.
- In the case of a child with an undiagnosed condition, the uncertainty that accompanies what is often a chronic, debilitating medical condition and an undefined prognosis may have physical, psychological, social, and spiritual implications for the entire family. Research suggests that parents of a child with an undiagnosed medical condition may be at significantly increased risk of anxiety, depression, poor health, and overall lower quality of life.
- It is not well understood how individuals cope with and adapt to chronic uncertainty, and the factors that influence this process. To design future interventions, descriptive studies are needed to reveal predictors that can be manipulated to improve outcomes.
Objectives:
- To examine whether perceptions of uncertainty, and perceived personal control, are associated with coping and adaptation.
- To examine how the length of time elapsed since child was identified as sick and perceptions of uncertainty affect coping and adaptation.
- To assess how perceptions of uncertainty, time elapsed since child became sick, optimism, and perceived personal control affect coping and adaptation.
Eligibility:
- Parents (older than 18 years of age) of children who have an undiagnosed medical condition.
- Participants must have a working e-mail address or fixed postal address.
Design:
- Parents will be recruited from Web-based support networks for parents of undiagnosed children through Web site postings, electronic mailing lists, and printed newsletter postings.
- Participants will be asked to complete a questionnaire about their experiences in living with a child who has an undiagnosed but chronic medical condition. The main outcome variable is adaptation to living with one's child's undiagnosed medical condition.
- Participants have the option to complete an online or paper version of the questionnaire. The questionnaire should take between 20 and 30 minutes to complete.
- No medical treatments are specifically offered as a part of this study.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
This study aims to understand the impact on parents of having a child with an undiagnosed medical condition and the factors that contribute to their adaptation.
Rare and undiagnosed conditions are often chronic and disabling, with symptoms affecting different organ systems at various levels of severity.
Perhaps the most challenging feature of an undiagnosed medical condition that has lasted two or more years, however, is its characteristic uncertainty.
In the absence of a diagnosis, health care professionals can provide only limited treatment and prognostic information.
It is not well understood how individuals cope with and adapt to chronic uncertainty, and the factors that influence this process.
To design future interventions, descriptive studies are needed to reveal predictors that can be manipulated to improve outcomes.
In this study, Lazarus and Folkman's Transactional Model of Stress and Coping provides a framework to examine coping and adaptation in the parents of children who have had a chronic, undiagnosed medical condition for two or more years.
A cross-sectional research design using a mixed methods survey will be used to examine the relationships among appraisals (perceptions of uncertainty and perceived personal control), time elapsed since parents first realized their child was sick, coping and adaptation.
Parents will be recruited from web-based support networks for parents of undiagnosed children via website postings, email listservs and printed newsletter postings.
Participants will have the option to complete an online or paper version of the questionnaire.
The main outcome variable is adaptation to living with one's child's undiagnosed medical condition.
Tipo di studio
Osservativo
Iscrizione (Anticipato)
500
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Maryland
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Bethesda, Maryland, Stati Uniti, 20892
- National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 100 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
- INCLUSION CRITERIA:
- Men and women 18 years or older
- Biological or adoptive parent
- At least one child of participants has a medical problem or problems that have remained undiagnosed for > 2 years
- The child with an undiagnosed medical problem must reside with the parent
- Read and write in English
EXCLUSION CRITERIA:
-One parent/household may participate
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Guillem P, Cans C, Robert-Gnansia E, Ayme S, Jouk PS. Rare diseases in disabled children: an epidemiological survey. Arch Dis Child. 2008 Feb;93(2):115-8. doi: 10.1136/adc.2006.104455. Epub 2007 Oct 17.
- Lenhard W, Breitenbach E, Ebert H, Schindelhauer-Deutscher HJ, Henn W. Psychological benefit of diagnostic certainty for mothers of children with disabilities: lessons from Down syndrome. Am J Med Genet A. 2005 Mar 1;133A(2):170-5. doi: 10.1002/ajmg.a.30571.
- Rosenthal ET, Biesecker LG, Biesecker BB. Parental attitudes toward a diagnosis in children with unidentified multiple congenital anomaly syndromes. Am J Med Genet. 2001 Oct 1;103(2):106-14. doi: 10.1002/ajmg.1527.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
4 agosto 2009
Completamento dello studio
10 aprile 2012
Date di iscrizione allo studio
Primo inviato
7 agosto 2009
Primo inviato che soddisfa i criteri di controllo qualità
7 agosto 2009
Primo Inserito (Stima)
10 agosto 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
2 luglio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 giugno 2017
Ultimo verificato
10 aprile 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 999909206
- 09-HG-N206
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .