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Mothers Experiences With X-linked Retinoschisis Compared to Fathers Experiences

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ClinicalTrials.gov Identifier: NCT03354403
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : November 1, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

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


Condition or disease
Retinoschisis X-Linked

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.

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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 and/or 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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Mothers' Experiences With X-linked Retinoschisis Compared to Fathers' Experiences
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
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.



Primary Outcome Measures :
  1. Description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS [ Time Frame: Study Completion ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria
  • INCLUSION CRITERIA:

Participants may be eligible to take part in this study if they: Have a biological son of any age with XLRS who is enrolled in XLRS Clinical and Molecular Studies protocol (03-EI-0033).

EXCLUSION CRITERIA:

-Participants may not be able to take part in this study if they:

  • Are unable to understand and comply with the procedures of this study.
  • Cannot communicate in English orally and in writing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354403


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Amy E Turriff National Eye Institute (NEI)
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03354403    
Other Study ID Numbers: 180016
18-EI-0016
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
XLRS
RS1
Carrier
Additional relevant MeSH terms:
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Retinoschisis
Retinal Degeneration
Retinal Diseases
Eye Diseases