Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005016
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-04-04
Brief Title:
Study of the Experiences and Needs of Parents Continuing a Pregnancy Following a Prenatal Diagnosis of Holopresencephaly
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Experiences and Needs of Parents Continuing a Pregnancy Following Abnormal Prenatal Results The Case of Holoprosencephaly
Status:
COMPLETED
Status Verified Date:
2000-03
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:
This study will examine the experiences of parents who decided to continue a pregnancy after receiving a prenatal diagnosis of holopresencephaly HPE HPE results from a genetic defect that can cause facial abnormalities such as cleft lip and cleft palate learning disabilities muscle weakness problems with digestion sleep and muscle control and other disabilities The severity of symptoms varies greatly among affected children
Parents whose child was diagnosed before birth with HPE may be eligible for this study It involves a one-time interview that takes from about 45 to 60 minutes The interview is conducted either in person or by telephone and consists of three parts as follows
1 The experience of receiving the diagnosis of HPE during the pregnancy includes general questions such as when and how HPE was diagnosed what kind of information the parent received the parents reaction to the diagnosis what genetic counseling if any the parents received and so forth
2 Emotional and informational needs includes questions about the parents specific emotional and informational needs from the time of diagnosis until the babys birth and the parents reactions to support that was given
3 Questionnaire includes questions about the parent and his or her child such as the parents age gender marital status and religious background the childs age gender medical problems and so forth The questionnaire will be completed verbally for telephone interviews and in writing for in-person interviews The interview will be tape-recorded and will be kept confidential
Information from this study will provide health professionals including genetic counselors more effective strategies for helping other parents who face similar prenatal diagnoses
Parents whose child was diagnosed before birth with HPE may be eligible for this study It involves a one-time interview that takes from about 45 to 60 minutes The interview is conducted either in person or by telephone and consists of three parts as follows
1 The experience of receiving the diagnosis of HPE during the pregnancy includes general questions such as when and how HPE was diagnosed what kind of information the parent received the parents reaction to the diagnosis what genetic counseling if any the parents received and so forth
2 Emotional and informational needs includes questions about the parents specific emotional and informational needs from the time of diagnosis until the babys birth and the parents reactions to support that was given
3 Questionnaire includes questions about the parent and his or her child such as the parents age gender marital status and religious background the childs age gender medical problems and so forth The questionnaire will be completed verbally for telephone interviews and in writing for in-person interviews The interview will be tape-recorded and will be kept confidential
Information from this study will provide health professionals including genetic counselors more effective strategies for helping other parents who face similar prenatal diagnoses
Detailed Description:
Holoprosencephaly HPE is a condition that when found prenatally offers parents a poor but often uncertain prognosis for their baby Parents that continue the pregnancy given this diagnosis are left to endure the remainder of the pregnancy and the ambiguity involved in this highly variable condition Previous studies have examined the psychological and social impact of prenatal diagnosis on parents and the outcomes of the pregnancy in conditions such as Down syndrome and sex chromosome abnormalities Because the majority of parents receiving abnormal prenatal information terminate their pregnancies most studies have focused on these parents experiences specifically the mothers However little is known about the experiences of parents both fathers and mothers continuing a pregnancy given abnormal prenatal information especially in highly variable conditions such as HPE
In this study the experiences and needs of parents who received the diagnosis of HPE prenatally will be explored Study participants will be drawn from several sites that include an existing molecular diagnostic protocol for HPE at the University of Pennsylvania clinical patients seen at the University of Michigan HPE family resources and an upcoming conference on HPE to be held in April of 2000 Through semi-structured interviews fathers and mothers of children with HPE who were diagnosed prenatally will be asked to talk individually about their experiences of receiving the diagnosis and continuing with the pregnancy Their perceived informational emotional and supportive needs at that time will be explored In addition their thoughts on the health care professionals role in meeting these needs will be discussed A brief questionnaire following the interview will gather quantitative data to serve as descriptors of the population and to help interpret the qualitative findings The questionnaire includes demographic questions as well as a scale measuring tolerance for ambiguity and questions regarding the parents perceived severity of their childs diagnosis of HPE
Interviews will be analyzed qualitatively through thematic analysis Specifically recurring themes that emerge from interview transcripts will be analyzed for content and patterns In addition descriptive statistics will be applied to the questionnaire data and will be used to aid in the interpretation of the qualitative findings An exploration of the experiences and needs of fathers and mothers who receive the diagnosis of HPE prenatally will offer a better understanding for health care professionals specifically genetic counselors regarding their role in working with parents continuing a pregnancy given prenatal information about a fetal anomaly
In this study the experiences and needs of parents who received the diagnosis of HPE prenatally will be explored Study participants will be drawn from several sites that include an existing molecular diagnostic protocol for HPE at the University of Pennsylvania clinical patients seen at the University of Michigan HPE family resources and an upcoming conference on HPE to be held in April of 2000 Through semi-structured interviews fathers and mothers of children with HPE who were diagnosed prenatally will be asked to talk individually about their experiences of receiving the diagnosis and continuing with the pregnancy Their perceived informational emotional and supportive needs at that time will be explored In addition their thoughts on the health care professionals role in meeting these needs will be discussed A brief questionnaire following the interview will gather quantitative data to serve as descriptors of the population and to help interpret the qualitative findings The questionnaire includes demographic questions as well as a scale measuring tolerance for ambiguity and questions regarding the parents perceived severity of their childs diagnosis of HPE
Interviews will be analyzed qualitatively through thematic analysis Specifically recurring themes that emerge from interview transcripts will be analyzed for content and patterns In addition descriptive statistics will be applied to the questionnaire data and will be used to aid in the interpretation of the qualitative findings An exploration of the experiences and needs of fathers and mothers who receive the diagnosis of HPE prenatally will offer a better understanding for health care professionals specifically genetic counselors regarding their role in working with parents continuing a pregnancy given prenatal information about a fetal anomaly
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 |
|---|---|---|---|
| 00-HG-0104 | None | None | None |