<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02194725</url>
  </required_header>
  <id_info>
    <org_study_id>999914149</org_study_id>
    <secondary_id>14-HG-N149</secondary_id>
    <nct_id>NCT02194725</nct_id>
  </id_info>
  <brief_title>Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy</brief_title>
  <official_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>
  <sponsors>
    <lead_sponsor>
      <agency>National Human Genome Research Institute (NHGRI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Children with Duchenne/Becker Muscular Dystrophy (DBMD) slowly lose muscle function. They&#xD;
      usually die at a young age. Some mothers adapt to the demands of caring for a child with this&#xD;
      disease better than others. Studies show that a person s hope may positively affect how they&#xD;
      cope and adapt. Researchers want to find out more about this. They want to develop ways to&#xD;
      improve caregivers overall wellness.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To study the relationships between uncertainty, hope, and coping ability in mothers of&#xD;
      children with DBMD.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Women in the United States 18 years and older. They must be biological mothers of a living&#xD;
      child with DBMD and be able to answer a survey in English.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  This study is part of a larger study that examines the well-being of mothers with sons&#xD;
           who have DBMD.&#xD;
&#xD;
        -  Participants will take a questionnaire. The questionnaire can be done on paper or on a&#xD;
           computer. It will take 30 45 minutes to complete.&#xD;
&#xD;
        -  The questionnaire will include basic demographic questions about the participant and the&#xD;
           child. There will also be questions about how the participant copes with the stress and&#xD;
           uncertainty of DBMD.&#xD;
&#xD;
        -  For most of the questions, participants will rate their feelings on a scale. There will&#xD;
           also be four open-ended questions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study aims to examine the relationships between maternal uncertainty, hope, and&#xD;
      coping efficacy in mothers of children with Duchenne/Becker Muscular Dystrophy (DBMD). DBMD&#xD;
      is described as a complex chronic condition causing challenges exemplified by both chronic&#xD;
      and terminal illnesses. Parental adaptation to a child s DBMD diagnosis is multifaceted due&#xD;
      to the evolution of the disease and uncertain timing of the progressive losses the child and&#xD;
      family face. In addition to prognostic uncertainty associated with DBMD, there is uncertainty&#xD;
      about the management of the condition, future and reproductive planning, the family s social&#xD;
      connections, and the existential meaning of the child s life. It is not fully understood how&#xD;
      mothers of children with DBMD appraise, cope with, and ultimately adapt to their child s&#xD;
      condition in light of this uncertainty. While high degrees of perceived uncertainty may be&#xD;
      seen as a threat to coping and adaptation, there is evidence that caregivers may find&#xD;
      benefits in uncertainty. The theoretical literature suggests that a person s hope may&#xD;
      influence the appraisal of uncertainty, as well as have therapeutic value in positively&#xD;
      affecting coping and ultimately, adaptation. This study s conceptual framework is based on an&#xD;
      integrated model from Lazarus and Folkman s Transactional Model of Stress and Coping, Mishel&#xD;
      s Perceived Uncertainty in Illness Theory, and Dufault and Martocchio s Model of Hope. The&#xD;
      proposed study uses a cross-sectional research design to explore the relationships between&#xD;
      maternal uncertainty, hope, and coping efficacy and is nested within a larger longitudinal&#xD;
      study designed to examine the predictors of wellbeing among mothers of boys with DBMD. In&#xD;
      addition, open-ended questions will be used to describe the uncertainty the mothers perceive&#xD;
      and the impact uncertainty has had on their life. Participants were recruited through the&#xD;
      DuchenneConnect registry, Parent Project Muscular Dystrophy (PPMD), and Cincinnati Children s&#xD;
      Hospital Medical Center Neuromuscular Clinic. Additional mothers will be recruited through&#xD;
      the DuchenneConntect registry, PPMD, and the Muscular Dystrophy Association.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 6, 2014</start_date>
  <completion_date type="Actual">July 7, 2017</completion_date>
  <primary_completion_date type="Actual">April 20, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Coping Efficacy</measure>
    <time_frame>Current</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uncertainty</measure>
    <time_frame>Current</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adaptation</measure>
    <time_frame>Current</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">228</enrollment>
  <condition>Stress</condition>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
        Participants will be biological mothers of a living child with Duchenne or Becker muscular&#xD;
        dystrophy living in the United States, who are 18 years or older and able to answer a&#xD;
        survey in English.&#xD;
&#xD;
        Participants will be asked to disclose their child's diagnosis but no screening evaluation&#xD;
        will be required.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
        Participants unable to answer a survey in English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara B Biesecker</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Human Genome Research Institute (NHGRI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Human Genome Research Institute (NHGRI), 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ballew SH, Hannum SM, Gaines JM, Marx KA, Parrish JM. The role of spiritual experiences and activities in the relationship between chronic illness and psychological well-being. J Relig Health. 2012 Dec;51(4):1386-96. doi: 10.1007/s10943-011-9498-0.</citation>
    <PMID>21604081</PMID>
  </reference>
  <reference>
    <citation>Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.</citation>
    <PMID>11574710</PMID>
  </reference>
  <reference>
    <citation>Biesecker BB, Erby LH, Woolford S, Adcock JY, Cohen JS, Lamb A, Lewis KV, Truitt M, Turriff A, Reeve BB. Development and validation of the Psychological Adaptation Scale (PAS): use in six studies of adaptation to a health condition or risk. Patient Educ Couns. 2013 Nov;93(2):248-54. doi: 10.1016/j.pec.2013.05.006. Epub 2013 Aug 28.</citation>
    <PMID>23993396</PMID>
  </reference>
  <verification_date>July 7, 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>April 4, 2018</last_update_submitted>
  <last_update_submitted_qc>April 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stress and Coping Model</keyword>
  <keyword>Coping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Dystrophies</mesh_term>
    <mesh_term>Muscular Dystrophy, Duchenne</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02194725
org study id: 999914149
secondary id: 14-HG-N149
nct id: NCT02194725
lead sponsor: 
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.
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.
observational model: Cohort
time perspective: Cross-Sectional
measure: Coping Efficacy
time frame: Current
measure: Uncertainty
time frame: Current
measure: Adaptation
time frame: Current
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barbara B Biesecker
role: Principal Investigator
affiliation: National Human Genome Research Institute (NHGRI)
facility: 
country: United States
citation: Ballew SH, Hannum SM, Gaines JM, Marx KA, Parrish JM. The role of spiritual experiences and activities in the relationship between chronic illness and psychological well-being. J Relig Health. 2012 Dec;51(4):1386-96. doi: 10.1007/s10943-011-9498-0.
PMID: 21604081
citation: Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.
PMID: 11574710
citation: Biesecker BB, Erby LH, Woolford S, Adcock JY, Cohen JS, Lamb A, Lewis KV, Truitt M, Turriff A, Reeve BB. Development and validation of the Psychological Adaptation Scale (PAS): use in six studies of adaptation to a health condition or risk. Patient Educ Couns. 2013 Nov;93(2):248-54. doi: 10.1016/j.pec.2013.05.006. Epub 2013 Aug 28.
PMID: 23993396
responsible party type: Sponsor
mesh term: Muscular Dystrophies
mesh term: Muscular Dystrophy, Duchenne