The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00955370
First received: August 7, 2009
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.

Condition
Multiple Abnormalities

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: August 2009
Estimated Study Completion Date: April 2012
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955370

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara B Biesecker National Human Genome Research Institute (NHGRI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00955370     History of Changes
Other Study ID Numbers: 999909206, 09-HG-N206
Study First Received: August 7, 2009
Last Updated: April 11, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Uncertainty
Undiagnosed
Rare Diseases
Parents
Multiple Abnormalities

Additional relevant MeSH terms:
Abnormalities, Multiple
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 23, 2014