Undiagnosed DiseaseNCT01905865
The Role of Uncertainty in Coping: The Experience of Parents of Children With Undiagnosed Medical Conditions
An observational study of Undiagnosed Disease, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They may not know how to take care of their child or how the illness will affect their family life. Researchers want to study how these parents cope with and adapt to their child s condition in light of this uncertainty. Read more about this study
- Who is it for?
- Ages 18 to 115 years
- Conditions the study is for
- Undiagnosed Disease
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2013to 12 Jun 2013
- 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 18 to 115 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants for this study will be English speaking men and women ages 18 years or older who have a child with an undiagnosed medical condition, who have applied to the Undiagnosed Diseases Network, and have been assigned to the NIH.
- Participants for this study will be English speaking men and women ages 18 years or older who have a child with an undiagnosed medical condition who have applied to the Undiagnosed Diseases Network, and have been assigned to the NIH.
The participant may be the adoptive or biological parent.
Parents may decide between themselves who will complete the survey as only one survey per household will be allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: The Role of Uncertainty in Coping Efficacy: The Experience of Parents of Children With Undiagnosed Medical Conditions
Background:
- Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They may not know how to take care of their child or how the illness will affect their family life. Researchers want to study how these parents cope with and adapt to their child s condition in light of this uncertainty. Being uncertain can make it hard for parents to adapt. But it also might give them hope. Researchers want to study how uncertain the parents think their situation is and how that affects the way they think they can cope. Personality traits, like being able to handle uncertainty and being resilient, might also affect coping.
Read more
Objectives:
- To understand how having a child with an undiagnosed illness affects the way their parents think they can cope.
Eligibility:
- Adults with a child who has a medical condition that has not been diagnosed for at least 2 years and involves at least 2 parts of the body.
Design:
- Participants will answer survey questions for about 30 minutes. The questions are about their thoughts and feelings about having a child with an undisclosed illness.
- Participants can take the survey on paper or online.
Read the detailed description
The proposed study aims to test the effect of the degree of perceived uncertainty on coping efficacy among parents of children with undiagnosed medical conditions. There are many dimensions to uncertainty when there is no identified cause for a condition that affects one s child. They include illness identity, management, longevity and life planning, the meaning of the child s condition for the family and both the child s and the family s social connections. How parents of children with undiagnosed medical conditions appraise, cope and ultimately adapt to their child s condition in light of this uncertainty is largely unexplored. While high levels of perceived uncertainty may be seen as a threat to adaptation, there is evidence that parents find hope and opportunity in the uncertainty. The literature suggests that many factors affect how uncertainty is appraised, and higher levels of coping self-efficacy are associated with more effective coping and ultimately better adaptation. There is no research that systematically assesses the dimensions of uncertainty perceived by parents and whether overall perceptions of uncertainty or particular subsets are associated with coping efficacy. Further, personality traits, such as tolerance of uncertainty and resilience, may moderate these unexplored relationships. This study s conceptual framework is based on Lazarus and Folkman s Transactional Model of Stress and Coping and Mishel s Perceived Uncertainty in Illness Theory. A cross-sectional survey design will be used to quantitatively assess the relationships between dimensions of uncertainty and coping efficacy. Participants will be recruited through online support groups, website postings, and listservs. They will have the option of completing either a paper or online version of the survey.
- Conditions
- Undiagnosed Disease
- Keywords
- Undiagnosed Medical Conditions, Natural History
- Medical subject headings
- Undiagnosed Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parent | Persons aged 18 years or older who have a child with an undiagnosed medical condition, who have applied to the Undiagnosed Diseases Network, and have been assigned to the NIH. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A
To assess the dimensions of perceived uncertainty and their relative importance among parents of children with undiagnosed medicalconditions.
Measured: Enrollment
B
To assess the role of uncertainty in predicting coping efficacy among parents of children with undiagnosed medical conditions.
Measured: Enrollment
C
To determine whether tolerance for uncertainty and optimism moderate the relationship between uncertainty and coping efficacy.
Measured: Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start12 Jun 2013
- Primary completion12 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undiagnosed DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Ellen F Macnamara, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905865
- Sponsor's protocol ID
- 999913162
- Other IDs
- 13-HG-N162
- Status last verified
- 12 May 2026
- First submitted
- 18 Jul 2013
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Uncertainty in Coping Efficacy: The Experience of Parents of Children With Undiagnosed Medical Conditions
- ClinicalTrials.gov ID
- NCT01905865
- Acronym / sponsor ID
- 999913162
- Conditions
- Undiagnosed Disease
- Keywords
- Undiagnosed Medical Conditions, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Collaborators
- University of Virginia
- Study start
- 12 Jun 2013
- Primary completion
- 12 Jun 2013 (actual)
- First posted
- 23 Jul 2013 (estimated)
- 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.
Background:
- Parents of a child with an undiagnosed medical condition face a lot of uncertainty. They may not know how to take care of their child or how the illness will affect their family life. Researchers want to study how these parents cope with and adapt to their child s condition in light of this uncertainty. Being uncertain can make it hard for parents to adapt. But it also might give them hope. Researchers want to study how uncertain the parents think their situation is and how that affects the way they think they can cope. Personality traits, like being able to handle uncertainty and being resilient, might also affect coping.
Objectives:
- To understand how having a child with an undiagnosed illness affects the way their parents think they can cope.
Eligibility:
- Adults with a child who has a medical condition that has not been diagnosed for at least 2 years and involves at least 2 parts of the body.
Design:
- Participants will answer survey questions for about 30 minutes. The questions are about their thoughts and feelings about having a child with an undisclosed illness.
- Participants can take the survey on paper or online.
Detailed description
The proposed study aims to test the effect of the degree of perceived uncertainty on coping efficacy among parents of children with undiagnosed medical conditions. There are many dimensions to uncertainty when there is no identified cause for a condition that affects one s child. They include illness identity, management, longevity and life planning, the meaning of the child s condition for the family and both the child s and the family s social connections. How parents of children with undiagnosed medical conditions appraise, cope and ultimately adapt to their child s condition in light of this uncertainty is largely unexplored. While high levels of perceived uncertainty may be seen as a threat to adaptation, there is evidence that parents find hope and opportunity in the uncertainty. The literature suggests that many factors affect how uncertainty is appraised, and higher levels of coping self-efficacy are associated with more effective coping and ultimately better adaptation. There is no research that systematically assesses the dimensions of uncertainty perceived by parents and whether overall perceptions of uncertainty or particular subsets are associated with coping efficacy. Further, personality traits, such as tolerance of uncertainty and resilience, may moderate these unexplored relationships. This study s conceptual framework is based on Lazarus and Folkman s Transactional Model of Stress and Coping and Mishel s Perceived Uncertainty in Illness Theory. A cross-sectional survey design will be used to quantitatively assess the relationships between dimensions of uncertainty and coping efficacy. Participants will be recruited through online support groups, website postings, and listservs. They will have the option of completing either a paper or online version of the survey.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent | – | –Persons aged 18 years or older who have a child with an undiagnosed medical condition, who have applied to the Undiagnosed Diseases Network, and have been assigned to the NIH. |
Who may qualify
- Ages
- 18 to 115 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants for this study will be English speaking men and women ages 18 years or older who have a child with an undiagnosed medical condition, who have applied to the Undiagnosed Diseases Network, and have been assigned to the NIH.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A
Time frame: Enrollment
To assess the dimensions of perceived uncertainty and their relative importance among parents of children with undiagnosed medicalconditions.
B
Time frame: Enrollment
To assess the role of uncertainty in predicting coping efficacy among parents of children with undiagnosed medical conditions.
C
Time frame: Enrollment
To determine whether tolerance for uncertainty and optimism moderate the relationship between uncertainty and coping efficacy.
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 8 Oct 2026.
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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.
Ellen F Macnamara principal investigator
National Human Genome Research Institute (NHGRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Undiagnosed Disease, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
A (time frame: Enrollment). The study lists 3 primary outcomes in all. 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 8 Oct 2026.