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Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02194725
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date July 16, 2014
First Posted Date July 18, 2014
Last Update Posted Date April 5, 2018
Study Start Date July 6, 2014
Actual Primary Completion Date April 20, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2014)
Coping Efficacy [ Time Frame: Current ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 16, 2014)
  • Uncertainty [ Time Frame: Current ]
  • Adaptation [ Time Frame: Current ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy
Official Title Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy
Brief Summary

Background:

- Children with Duchenne/Becker Muscular Dystrophy (DBMD) slowly lose muscle function. They usually die at a young age. Some mothers adapt to the demands of caring for a child with this disease better than others. Studies show that a person s hope may positively affect how they cope and adapt. Researchers want to find out more about this. They want to develop ways to improve caregivers overall wellness.

Objective:

- To study the relationships between uncertainty, hope, and coping ability in mothers of children with DBMD.

Eligibility:

- Women in the United States 18 years and older. They must be biological mothers of a living child with DBMD and be able to answer a survey in English.

Design:

  • This study is part of a larger study that examines the well-being of mothers with sons who have DBMD.
  • Participants will take a questionnaire. The questionnaire can be done on paper or on a computer. It will take 30 45 minutes to complete.
  • The questionnaire will include basic demographic questions about the participant and the child. There will also be questions about how the participant copes with the stress and uncertainty of DBMD.
  • For most of the questions, participants will rate their feelings on a scale. There will also be four open-ended questions.
Detailed Description The proposed study aims to examine the relationships between maternal uncertainty, hope, and coping efficacy in mothers of children with Duchenne/Becker Muscular Dystrophy (DBMD). DBMD is described as a complex chronic condition causing challenges exemplified by both chronic and terminal illnesses. Parental adaptation to a child s DBMD diagnosis is multifaceted due to the evolution of the disease and uncertain timing of the progressive losses the child and family face. In addition to prognostic uncertainty associated with DBMD, there is uncertainty about the management of the condition, future and reproductive planning, the family s social connections, and the existential meaning of the child s life. It is not fully understood how mothers of children with DBMD appraise, cope with, and ultimately adapt to their child s condition in light of this uncertainty. While high degrees of perceived uncertainty may be seen as a threat to coping and adaptation, there is evidence that caregivers may find benefits in uncertainty. The theoretical literature suggests that a person s hope may influence the appraisal of uncertainty, as well as have therapeutic value in positively affecting coping and ultimately, adaptation. This study s conceptual framework is based on an integrated model from Lazarus and Folkman s Transactional Model of Stress and Coping, Mishel s Perceived Uncertainty in Illness Theory, and Dufault and Martocchio s Model of Hope. The proposed study uses a cross-sectional research design to explore the relationships between maternal uncertainty, hope, and coping efficacy and is nested within a larger longitudinal study designed to examine the predictors of wellbeing among mothers of boys with DBMD. In addition, open-ended questions will be used to describe the uncertainty the mothers perceive and the impact uncertainty has had on their life. Participants were recruited through the DuchenneConnect registry, Parent Project Muscular Dystrophy (PPMD), and Cincinnati Children s Hospital Medical Center Neuromuscular Clinic. Additional mothers will be recruited through the DuchenneConntect registry, PPMD, and the Muscular Dystrophy Association.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Stress
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)
228
Original Estimated Enrollment
 (submitted: July 16, 2014)
250
Actual Study Completion Date July 7, 2017
Actual Primary Completion Date April 20, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria
  • INCLUSION CRITERIA:

Participants will be biological mothers of a living child with Duchenne or Becker muscular dystrophy living in the United States, who are 18 years or older and able to answer a survey in English.

Participants will be asked to disclose their child's diagnosis but no screening evaluation will be required.

EXCLUSION CRITERIA:

Participants unable to answer a survey in English.

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02194725
Other Study ID Numbers 999914149
14-HG-N149
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
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 July 7, 2017