Trial record 3 of 191 for:    NHGRI

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT02194725
First received: July 16, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition
Stress

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Coping Efficacy [ Time Frame: Current ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uncertainty [ Time Frame: Current ] [ Designated as safety issue: No ]
  • Adaptation [ Time Frame: Current ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194725

Contacts
Contact: Megan E Bell (301) 435-6817 megan.bell@nih.gov
Contact: Barbara B Biesecker (301) 496-3979 barbarab@nhgri.nih.gov

Locations
United States, Maryland
National Human Genome Research Institute (NHGRI), 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Barbara B Biesecker National Human Genome Research Institute (NHGRI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier: NCT02194725     History of Changes
Other Study ID Numbers: 999914149, 14-HG-N149
Study First Received: July 16, 2014
Last Updated: July 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Stress and Coping Model
Coping

Additional relevant MeSH terms:
Muscular Dystrophy, Duchenne
Muscular Dystrophies
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 22, 2014