Down SyndromeNCT00695695
The Experience of Caregivers of Children With Down Syndrome
An observational study of Down Syndrome, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will explore how caregivers adjust to having a child with Down syndrome. Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible for this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Down Syndrome
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2008to 3 Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be men and women ages 18 or older who are the primary caregivers of a child with Down syndrome. The parent may be a biological or adoptive parent or other primary caregiver and the child must reside with the primary caregiver.
Who cannot join
- None
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 Hope in Adaptation to Uncertainty: The Experience of Caregivers of Children With Down Syndrome
This study will explore how caregivers adjust to having a child with Down syndrome.
Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible for this study. Participants complete a 20- to 30-minute survey that explores the subject s thoughts and feelings about being a caregiver to a child with Down syndrome. Questions explore the impact on the subject of being a caregiver for a child with Down syndrome, the subject s uncertainties related to the child s condition and goals for the child related to social skills, behavior, learning and education, physical and mental health, independence, and other goals. It also asks questions about the caregiver, the family and the child with Down syndrome.
...
Read the detailed description
The proposed study aims to explore the relationships between perceived uncertainty, hope and adaptation in caregivers of children with Down Syndrome (DS). There are often uncertainties surrounding the prognosis of DS which extend into various aspects of the child s life. In addition to the possibility of chronic medical conditions associated with the syndrome, there is also uncertainty related to the level of independence and cognitive, social and behavioral functioning that the child will achieve. It is not fully understood how caregivers adapt to having a child with DS in light of the uncertainty and the particular challenges associated with this condition. While a high level of perceived uncertainty may be seen as a threat to adaptation, there is also evidence that caregivers may find benefits in uncertainty. Literature suggests that a person s level of hope influences how the perceived uncertainty is appraised and that hope is also related to the process of adaptation. There is no research that systematically explores the relationship between perceived uncertainty, hope, and adaptation. This study s conceptual framework is based on Lazarus \& Folkman s Transactional Model of Stress and Coping and is also informed by Snyder s conceptualization of hope and Mishel s theory of perceived uncertainty in illness. A cross-sectional research design will quantitatively explore the relationships between perceived uncertainty, hope, and adaptation. In addition, an open-ended section will be included to qualitatively describe the focus of caregivers hope for their child and how the focus of hope relates to the degree of hope. Participants will be recruited from DS support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey, or completing the survey by phone. The main outcome variable is psychological adaptation to being a care giver for a child with DS.
- Conditions
- Down Syndrome
- Keywords
- Parents, Down Syndrome, Hope, Uncertainty, Adaptation, DS, Survey
- Medical subject headings
- Down Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2008 (estimated)
- Study start14 May 2008
- Study completion3 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies 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
- Time perspective
- Prospective
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695695
- Sponsor's protocol ID
- 999908142
- Other IDs
- 08-HG-N142
- Status last verified
- 3 Feb 2014
- First submitted
- 11 Jun 2008
- Last updated
- 17 Dec 2019
- Results posted
- No
Publications
Davis B. Mediators of the relationship between hope and well-being in older adults. Clin Nurs Res. 2005 Aug;14(3):253-72. doi: 10.1177/1054773805275520.
PubMed 15995154Folkman S, Greer S. Promoting psychological well-being in the face of serious illness: when theory, research and practice inform each other. Psychooncology. 2000 Jan-Feb;9(1):11-9. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-z.
PubMed 10668055Lipinski SE, Lipinski MJ, Biesecker LG, Biesecker BB. Uncertainty and perceived personal control among parents of children with rare chromosome conditions: the role of genetic counseling. Am J Med Genet C Semin Med Genet. 2006 Nov 15;142C(4):232-40. doi: 10.1002/ajmg.c.30107.
PubMed 17068805
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hope in Adaptation to Uncertainty: The Experience of Caregivers of Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT00695695
- Acronym / sponsor ID
- 999908142
- Conditions
- Down Syndrome
- Keywords
- Parents, Down Syndrome, Hope, Uncertainty, Adaptation, DS, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 14 May 2008
- Study completion
- 3 Feb 2014
- First posted
- 12 Jun 2008 (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.
This study will explore how caregivers adjust to having a child with Down syndrome.
Primary caregivers 18 years of age and older of a child with Down syndrome may be eligible for this study. Participants complete a 20- to 30-minute survey that explores the subject s thoughts and feelings about being a caregiver to a child with Down syndrome. Questions explore the impact on the subject of being a caregiver for a child with Down syndrome, the subject s uncertainties related to the child s condition and goals for the child related to social skills, behavior, learning and education, physical and mental health, independence, and other goals. It also asks questions about the caregiver, the family and the child with Down syndrome.
...
Detailed description
The proposed study aims to explore the relationships between perceived uncertainty, hope and adaptation in caregivers of children with Down Syndrome (DS). There are often uncertainties surrounding the prognosis of DS which extend into various aspects of the child s life. In addition to the possibility of chronic medical conditions associated with the syndrome, there is also uncertainty related to the level of independence and cognitive, social and behavioral functioning that the child will achieve. It is not fully understood how caregivers adapt to having a child with DS in light of the uncertainty and the particular challenges associated with this condition. While a high level of perceived uncertainty may be seen as a threat to adaptation, there is also evidence that caregivers may find benefits in uncertainty. Literature suggests that a person s level of hope influences how the perceived uncertainty is appraised and that hope is also related to the process of adaptation. There is no research that systematically explores the relationship between perceived uncertainty, hope, and adaptation. This study s conceptual framework is based on Lazarus \& Folkman s Transactional Model of Stress and Coping and is also informed by Snyder s conceptualization of hope and Mishel s theory of perceived uncertainty in illness. A cross-sectional research design will quantitatively explore the relationships between perceived uncertainty, hope, and adaptation. In addition, an open-ended section will be included to qualitatively describe the focus of caregivers hope for their child and how the focus of hope relates to the degree of hope. Participants will be recruited from DS support groups, website postings, listservs, and clinic patient lists. They will have the option of completing either a paper or online version of the survey, or completing the survey by phone. The main outcome variable is psychological adaptation to being a care giver for a child with DS.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be men and women ages 18 or older who are the primary caregivers of a child with Down syndrome. The parent may be a biological or adoptive parent or other primary caregiver and the child must reside with the primary caregiver.
Key exclusion criteria (1 listed)
- None
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
Not reported in the source record.
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 17 Dec 2019.
- Background: PubMed 15995154Davis B. Mediators of the relationship between hope and well-being in older adults. Clin Nurs Res. 2005 Aug;14(3):253-72. doi: 10.1177/1054773805275520.
- Background: PubMed 10668055Folkman S, Greer S. Promoting psychological well-being in the face of serious illness: when theory, research and practice inform each other. Psychooncology. 2000 Jan-Feb;9(1):11-9. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-z.
- Background: PubMed 17068805Lipinski SE, Lipinski MJ, Biesecker LG, Biesecker BB. Uncertainty and perceived personal control among parents of children with rare chromosome conditions: the role of genetic counseling. Am J Med Genet C Semin Med Genet. 2006 Nov 15;142C(4):232-40. doi: 10.1002/ajmg.c.30107.
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Down Syndrome
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.
Barbara B Biesecker 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 Down Syndrome, 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 17 Dec 2019. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00695695, which also lists 3 linked publications.
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 17 Dec 2019.