Ignite Creation Date:
2024-05-05 @ 9:44 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00955370
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2009-08-07
Brief Title:
The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Experience of Uncertainty in Parents of Children With an Undiagnosed Medical Condition
Status:
COMPLETED
Status Verified Date:
2012-04-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ones childs 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
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 ones childs 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
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 Folkmans 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 ones childs undiagnosed medical condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 09-HG-N206 | None | None | None |