Genetic DiseaseNCT01386515
The Role of Family Functioning in Promoting Adaptation in Siblings of Individuals With Duchenne Muscular Dystrophy (DMD)
An observational study of Genetic Disease and Communication, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Background: We want to learn more about the relationship between the way families function and how children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will help us design better interventions for families. Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Disease, Communication
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2011to 7 Jan 2016
- 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 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents/Caregivers:
- Parent or caregiver of child with DMD and child without DMD
- Lives with child that does not have DMD
- 18 or older
- Reads/Writes English
- Siblings:
Show all 10Show fewer
- Sibling of child with DMD
- Lives in same household as individual with DMD
- 13-18 years of age
- Reads/Writes English
Who cannot join
None listed.
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:
We want to learn more about the relationship between the way families function and how children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will help us design better interventions for families.
Read more
Objective:
- To learn more about how families with an individual with DMD function.
- To learn how siblings adapt in families with an individual with DMD.
Eligibility:
- One parent and one child, age 13-18, from a family where another child has DMD.
- The parent and the child must be able to read and write English.
Design:
- One parent from each family will complete a survey about how family members communicate and relate with each other. The parent will also answer questions about the behavior of the child without DMD. This survey will take you about 40 minutes to complete.
- One child from each family, either a boy or a girl, will also complete a survey. This survey asks about how he/she views him/herself. It also asks about how he/she interacts with peers and family members and how he/she behaves. The survey also asks how satisfied he/she is with how his/her family functions. This survey takes about 30 minutes to finish.
Read the detailed description
This study proposes to explore the role of family functioning in promoting adaptation in unaffected siblings of children with Duchenne muscular dystrophy (DMD). Although evidence suggests that family functioning may be a predictor of adaptation in caregivers of children with chronic illnesses, little research has been conducted on the relationships between aspects of family functioning and the adaptation of unaffected siblings. Evidence in the literature suggests that aspects of family functioning may play a key role in adaptation. Moreover, the role of DMD-specific communication in facilitating sibling adaptation has not yet been explored in the literature and further insight may be derived from exploring this relationship. The goals of this study are to better understand the relationship of family functioning with the adaptation of unaffected siblings, as well as to explore the timing, extent (depth and content), and the characteristics of initiation of discussion of parent-sibling communication around DMD. Currently, some evidence exists to direct the creation of interventions that reinforce a family-centered approach to facilitate adaptation of family members to living with a child with a chronic health condition. Nevertheless, more insight is needed to understand how family processes affect individual adaptation, especially that of the unaffected sibling, in order to maximize the effectiveness of future interventions with this population.
- Conditions
- Genetic Disease, Communication
- Keywords
- Adaptation, Duchenne Muscular Dystrophy, Communication about Duchenne Muscular Dystrophy, Sibling
- Medical subject headings
- Genetic Diseases, Inborn, Communication, Muscular Dystrophy, Duchenne
What is being measured
The primary outcome is the main question the study is designed to answer.
adaptation, behavior problems, self-concept, pro-social behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study start7 Jun 2011
- Study completion7 Jan 2016
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 Genetic DiseaseStudies 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
- Time perspective
- Other
- Enrolment
- 33 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
- NCT01386515
- Sponsor's protocol ID
- 999911177
- Other IDs
- 11-HG-N177
- Status last verified
- 7 Jan 2016
- First submitted
- 30 Jun 2011
- Last updated
- 12 Dec 2019
- Results posted
- No
Publications
Branstetter JE, Domian EW, Williams PD, Graff JC, Piamjariyakul U. Communication themes in families of children with chronic conditions. Issues Compr Pediatr Nurs. 2008 Oct-Dec;31(4):171-84. doi: 10.1080/01460860802475184.
PubMed 19021037Bushby K, Finkel R, Birnkrant DJ, Case LE, Clemens PR, Cripe L, Kaul A, Kinnett K, McDonald C, Pandya S, Poysky J, Shapiro F, Tomezsko J, Constantin C; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 2: implementation of multidisciplinary care. Lancet Neurol. 2010 Feb;9(2):177-89. doi: 10.1016/S1474-4422(09)70272-8. Epub 2009 Nov 27.
PubMed 19945914Chen JY, Clark MJ. Family function in families of children with Duchenne muscular dystrophy. Fam Community Health. 2007 Oct-Dec;30(4):296-304. doi: 10.1097/01.FCH.0000290542.10458.f8.
PubMed 17873636
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Family Functioning in Promoting Adaptation in Siblings of Individuals With Duchenne Muscular Dystrophy (DMD)
- ClinicalTrials.gov ID
- NCT01386515
- Acronym / sponsor ID
- 999911177
- Conditions
- Genetic Disease, Communication
- Keywords
- Adaptation, Duchenne Muscular Dystrophy, Communication about Duchenne Muscular Dystrophy, Sibling
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- 7 Jun 2011
- Study completion
- 7 Jan 2016
- First posted
- 1 Jul 2011 (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:
We want to learn more about the relationship between the way families function and how children adapt to having a sibling with Duchenne muscular dystrophy (DMD). What we learn will help us design better interventions for families.
Objective:
- To learn more about how families with an individual with DMD function.
- To learn how siblings adapt in families with an individual with DMD.
Eligibility:
- One parent and one child, age 13-18, from a family where another child has DMD.
- The parent and the child must be able to read and write English.
Design:
- One parent from each family will complete a survey about how family members communicate and relate with each other. The parent will also answer questions about the behavior of the child without DMD. This survey will take you about 40 minutes to complete.
- One child from each family, either a boy or a girl, will also complete a survey. This survey asks about how he/she views him/herself. It also asks about how he/she interacts with peers and family members and how he/she behaves. The survey also asks how satisfied he/she is with how his/her family functions. This survey takes about 30 minutes to finish.
Detailed description
This study proposes to explore the role of family functioning in promoting adaptation in unaffected siblings of children with Duchenne muscular dystrophy (DMD). Although evidence suggests that family functioning may be a predictor of adaptation in caregivers of children with chronic illnesses, little research has been conducted on the relationships between aspects of family functioning and the adaptation of unaffected siblings. Evidence in the literature suggests that aspects of family functioning may play a key role in adaptation. Moreover, the role of DMD-specific communication in facilitating sibling adaptation has not yet been explored in the literature and further insight may be derived from exploring this relationship. The goals of this study are to better understand the relationship of family functioning with the adaptation of unaffected siblings, as well as to explore the timing, extent (depth and content), and the characteristics of initiation of discussion of parent-sibling communication around DMD. Currently, some evidence exists to direct the creation of interventions that reinforce a family-centered approach to facilitate adaptation of family members to living with a child with a chronic health condition. Nevertheless, more insight is needed to understand how family processes affect individual adaptation, especially that of the unaffected sibling, in order to maximize the effectiveness of future interventions with this population.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Parent or caregiver of child with DMD and child without DMD
- Lives with child that does not have DMD
- 18 or older
- Reads/Writes English
- Sibling of child with DMD
Key exclusion criteria (0 listed)
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
adaptation, behavior problems, self-concept, pro-social behavior
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 19021037Branstetter JE, Domian EW, Williams PD, Graff JC, Piamjariyakul U. Communication themes in families of children with chronic conditions. Issues Compr Pediatr Nurs. 2008 Oct-Dec;31(4):171-84. doi: 10.1080/01460860802475184.
- Background: PubMed 19945914Bushby K, Finkel R, Birnkrant DJ, Case LE, Clemens PR, Cripe L, Kaul A, Kinnett K, McDonald C, Pandya S, Poysky J, Shapiro F, Tomezsko J, Constantin C; DMD Care Considerations Working Group. Diagnosis and management of Duchenne muscular dystrophy, part 2: implementation of multidisciplinary care. Lancet Neurol. 2010 Feb;9(2):177-89. doi: 10.1016/S1474-4422(09)70272-8. Epub 2009 Nov 27.
- Background: PubMed 17873636Chen JY, Clark MJ. Family function in families of children with Duchenne muscular dystrophy. Fam Community Health. 2007 Oct-Dec;30(4):296-304. doi: 10.1097/01.FCH.0000290542.10458.f8.
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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 Genetic Disease and Communication, 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 10 inclusion and 0 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: stopped early, as of the sponsor's last update on 12 Dec 2019. 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 was stopped early. Results are not available in the source record.
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?
adaptation, behavior problems, self-concept, pro-social behavior. 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 NCT01386515, 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 12 Dec 2019.