Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03354403
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2017-11-25
Brief Title:
Mothers Experiences With X-linked Retinoschisis Compared to Fathers Experiences
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Mothers Experiences With X-linked Retinoschisis Compared to Fathers Experiences
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
X-linked retinoschisis XLRS is a genetic condition It usually presents in boys in childhood with vision loss Genetic conditions affect the people who have it and also their family members Researchers want to learn if mothers and fathers react differently when a son gets XLRS They also want to learn how personality impacts the way people react This will help researchers find better ways to support families living with XLRS
Objective
To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS Also to study personality differences between mothers and fathers
Eligibility
Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033
Design
Participants will be asked questions in person or by phone This will last 30 90 minutes They will be asked about their experience with XLRS and how it has impacted their family The interview will be recorded
Participants will complete a survey about personality traits It will be anonymous It can be completed by mail email or fax It will take about 15 minutes
Participants data may be shared with others including those not at NIH if they agree Their data may be stored
Sponsoring Institution National Eye Institute
X-linked retinoschisis XLRS is a genetic condition It usually presents in boys in childhood with vision loss Genetic conditions affect the people who have it and also their family members Researchers want to learn if mothers and fathers react differently when a son gets XLRS They also want to learn how personality impacts the way people react This will help researchers find better ways to support families living with XLRS
Objective
To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS Also to study personality differences between mothers and fathers
Eligibility
Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033
Design
Participants will be asked questions in person or by phone This will last 30 90 minutes They will be asked about their experience with XLRS and how it has impacted their family The interview will be recorded
Participants will complete a survey about personality traits It will be anonymous It can be completed by mail email or fax It will take about 15 minutes
Participants data may be shared with others including those not at NIH if they agree Their data may be stored
Sponsoring Institution National Eye Institute
Detailed Description:
OBJECTIVE The objective of this study is to explore the experiences of mothers of sons with X-linked retinoschisis XLRS compared to fathers of sons with XLRS and to draft a personality profile of both mothers and fathers based on the findings
TAB
STUDY POPULATION Up to 50 mothers of sons of all ages diagnosed with XLRS are eligible to participate in this study Up to 50 fathers of sons of all ages with XLRS are also eligible to participate and will serve as a comparison group
DESIGN This is a pilot mixed-methods study that involves a cross sectional qualitative interview and a self-administered questionnaire Participants will be recruited through a parent study Clinical and Molecular Studies of X-linked Retinoschisis 03-EI-0033 Interviews will be conducted either in person at the National Institutes of Health Clinical Center NIH CC or by telephone The interview will explore the experiences and impact of having a son with XLRS Interviews will be recorded transcribed verbatim coded by two independent coders and analyzed thematically Participants will also be asked to complete a questionnaire to assess personality traits anxiety and optimism using scales shown to be valid and reliable in the general population and in clinical samples Results from these scales will provide information about variables that cannot be reliably assessed from an interview This study is not designed to assess causality rather it will be used to generate hypotheses and inform future social and behavioral andor basic science research studies of parents of sons with XLRS
OUTCOME MEASURES The primary outcomes of this study include a description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS and a preliminary personality profile of mothers and fathers
TAB
STUDY POPULATION Up to 50 mothers of sons of all ages diagnosed with XLRS are eligible to participate in this study Up to 50 fathers of sons of all ages with XLRS are also eligible to participate and will serve as a comparison group
DESIGN This is a pilot mixed-methods study that involves a cross sectional qualitative interview and a self-administered questionnaire Participants will be recruited through a parent study Clinical and Molecular Studies of X-linked Retinoschisis 03-EI-0033 Interviews will be conducted either in person at the National Institutes of Health Clinical Center NIH CC or by telephone The interview will explore the experiences and impact of having a son with XLRS Interviews will be recorded transcribed verbatim coded by two independent coders and analyzed thematically Participants will also be asked to complete a questionnaire to assess personality traits anxiety and optimism using scales shown to be valid and reliable in the general population and in clinical samples Results from these scales will provide information about variables that cannot be reliably assessed from an interview This study is not designed to assess causality rather it will be used to generate hypotheses and inform future social and behavioral andor basic science research studies of parents of sons with XLRS
OUTCOME MEASURES The primary outcomes of this study include a description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS and a preliminary personality profile of mothers and fathers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 18-EI-0016 | None | None | None |