StressNCT02194725
Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy
An observational study of Stress, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2014to 7 Jul 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants unable to answer a survey in English.
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
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.
Read more
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.
Read the 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.
- Conditions
- Stress
- Keywords
- Stress and Coping Model, Coping
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping Efficacy
Measured: Current
Secondary outcomes (2)
Uncertainty
Measured: Current
Adaptation
Measured: Current
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start6 Jul 2014
- Primary completion20 Apr 2015
- Study completion7 Jul 2017
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 StressStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Barbara B Biesecker, Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194725
- Sponsor's protocol ID
- 999914149
- Other IDs
- 14-HG-N149
- Status last verified
- 7 Jul 2017
- First submitted
- 16 Jul 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
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.
PubMed 21604081Bedard 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.
PubMed 11574710Biesecker 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.
PubMed 23993396
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Where Does Hope Fit In? The Relationship Between Hope, Uncertainty, and Coping Efficacy in Mothers of Children With Duchenne/Becker Muscular Dystrophy
- ClinicalTrials.gov ID
- NCT02194725
- Acronym / sponsor ID
- 999914149
- Conditions
- Stress
- Keywords
- Stress and Coping Model, Coping
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 6 Jul 2014
- Primary completion
- 20 Apr 2015 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 18 Jul 2014 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants unable to answer a survey in English.
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
Coping Efficacy
Time frame: Current
2 secondary outcomes
Uncertainty
Time frame: Current
Adaptation
Time frame: Current
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 5 Apr 2018.
- Background: PubMed 21604081Ballew 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.
- Background: PubMed 11574710Bedard 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.
- Background: PubMed 23993396Biesecker 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.
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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 Stress, 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 2 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 5 Apr 2018. 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.
What does the primary outcome measure?
Coping Efficacy (time frame: Current). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02194725, 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 5 Apr 2018.