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Trial record 59 of 167 for:    trisomy21 NOT prenatal

The Experience of Caregivers of Children With Down Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00695695
Recruitment Status : Completed
First Posted : June 12, 2008
Last Update Posted : July 18, 2019
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date June 11, 2008
First Posted Date June 12, 2008
Last Update Posted Date July 18, 2019
Study Start Date May 14, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00695695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Experience of Caregivers of Children With Down Syndrome
Official Title The Role of Hope in Adaptation to Uncertainty: The Experience of Caregivers of Children With Down Syndrome
Brief 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. 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.

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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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Down Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April¬†4,¬†2018)
546
Original Enrollment Not Provided
Study Completion Date February 3, 2014
Primary Completion Date Not Provided
Eligibility Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00695695
Other Study ID Numbers 999908142
08-HG-N142
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Barbara B Biesecker National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 3, 2014