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Mothers Experiences With X-linked Retinoschisis Compared to Fathers Experiences

Completed
Conditions
Retinoschisis
X-Linked
Registration Number
NCT03354403
Lead Sponsor
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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
12
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Description of the experiences of mothers of sons with XLRS compared to fathers of sons with XLRSStudy Completion
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

National Institutes of Health Clinical Center

🇺🇸

Bethesda, Maryland, United States

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