Ignite Creation Date:
2024-05-05 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00528762
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2007-09-11
Brief Title:
Mexican and African American Family Focus Groups on Puberty
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Mexican and African American Family Focus Groups on Puberty
Status:
COMPLETED
Status Verified Date:
2012-07
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:
Primary Objective
For focus groups of Mexican American and African-American girls and focus groups of their parents to explore factors that could enhance the conduct of a future study of puberty and body mass
Specifically these focus groups will address
Whether clinical assessment of pubertal staging is acceptable
How to enhance cooperation by parents and their daughters of different socioeconomic groups among families with different levels of acculturation and girls of different body mass indices
Explore whether established questionnaire items about puberty that have been used in traditional surveys require culture-specific changes to improve exposure assessment
Explore the acceptability of self-reported pictograms for body image and for developmental assessment by girls
For focus groups of Mexican American and African-American girls and focus groups of their parents to explore factors that could enhance the conduct of a future study of puberty and body mass
Specifically these focus groups will address
Whether clinical assessment of pubertal staging is acceptable
How to enhance cooperation by parents and their daughters of different socioeconomic groups among families with different levels of acculturation and girls of different body mass indices
Explore whether established questionnaire items about puberty that have been used in traditional surveys require culture-specific changes to improve exposure assessment
Explore the acceptability of self-reported pictograms for body image and for developmental assessment by girls
Detailed Description:
For Parents
This study will involve 5 focus groups Mothers will take part in 1 of 2 focus groups with other mothers Fathers will take part in a focus group with other fathers Girls will take part in 1 of 2 focus groups with other girls Any eligible parent will be able to participate even if the daughter chooses not to participate in the focus group activities At the start of each focus group the moderators will begin with a general session about health related topics but for the girls any discussion about pubertal development will take place in two separate groups with the 6-9 yr olds in one group and 10-12 yr olds in another group Each group will have about 8 to 10 participants who are all comfortable speaking the same language
The focus groups will be led by a moderator a person who will lead the talk and answer any questions participants may have The moderator will speak both English and Spanish and you will be assigned to the group where your preferred language is spoken The discussions will involve talk about puberty and body image such as the typical age for a girl to start puberty body changes girls go through in puberty and girls level of comfort with how their body looks Parents of the girls will also be asked to compare their experiences during puberty with their daughters experiences
Researchers want to know if you would be comfortable with your daughter taking part in a clinical research study that is planned for the future Information about this future study will also be presented to each group for discussion The focus group talks will last about 1 12 hours They will be conducted in the community where you live You will be told the location before you agree to take part in this study
All of the discussions will be audio taped and will be kept confidential The tapes will not be heard by anyone other than the research staff They will be kept safe in a locked cabinet that stores other confidential research materials and will be destroyed at the end of this study
Your participation in this study will be over after your focus group discussion has ended
This is an investigational study Up to 50 parents will take part in this study All will be enrolled at M D Anderson
For Children
This study will have 5 focus groups per ethnic groups Mothers will be in 1 of 2 focus groups with other mothers Fathers will be in a focus group with other fathers The moderator will speak both English and Spanish and you will be assigned to the group where your preferred language is spoken Girls will be in 1 of 2 focus groups with other girls At the start of each focus group the moderators will begin with a general session about health related topics but for the girls any discussion about pubertal development will take place in two separate groups with the 6-9 yr olds in one group and 10-12 yr olds in another group Each group will have about 8 to 10 participants who are all comfortable speaking the same language
The focus groups will be led by a moderator a person who will lead the talk and answer any questions participants may have The discussions will involve talk about your thoughts on growth and development and body image such as the age you started developing how your body changes and your level of comfort with how your body looks Your parents will also be asked to compare their experiences during puberty with your experience You will also be asked about your level of comfort with a visit to the doctor and with having your blood drawn and needle sticks
Researchers also want to know if you would be comfortable taking part in a clinical research study that is planned for the future Information about this future study will also be presented to each group for discussion The focus group talks will last about 1 12 hours
All of the discussions will be audio taped and will be kept confidential The tapes will not be heard by anyone other than the research staff They will be kept safe in a locked cabinet that stores other confidential research materials and will be destroyed at the end of this study
Your participation in this study will be over after your focus group discussion has ended
This is an investigational study You will be given the art projects that you created during your focus group for your time and participation Up to 50 girls will take part in this study All will be enrolled at M D Anderson
This study will involve 5 focus groups Mothers will take part in 1 of 2 focus groups with other mothers Fathers will take part in a focus group with other fathers Girls will take part in 1 of 2 focus groups with other girls Any eligible parent will be able to participate even if the daughter chooses not to participate in the focus group activities At the start of each focus group the moderators will begin with a general session about health related topics but for the girls any discussion about pubertal development will take place in two separate groups with the 6-9 yr olds in one group and 10-12 yr olds in another group Each group will have about 8 to 10 participants who are all comfortable speaking the same language
The focus groups will be led by a moderator a person who will lead the talk and answer any questions participants may have The moderator will speak both English and Spanish and you will be assigned to the group where your preferred language is spoken The discussions will involve talk about puberty and body image such as the typical age for a girl to start puberty body changes girls go through in puberty and girls level of comfort with how their body looks Parents of the girls will also be asked to compare their experiences during puberty with their daughters experiences
Researchers want to know if you would be comfortable with your daughter taking part in a clinical research study that is planned for the future Information about this future study will also be presented to each group for discussion The focus group talks will last about 1 12 hours They will be conducted in the community where you live You will be told the location before you agree to take part in this study
All of the discussions will be audio taped and will be kept confidential The tapes will not be heard by anyone other than the research staff They will be kept safe in a locked cabinet that stores other confidential research materials and will be destroyed at the end of this study
Your participation in this study will be over after your focus group discussion has ended
This is an investigational study Up to 50 parents will take part in this study All will be enrolled at M D Anderson
For Children
This study will have 5 focus groups per ethnic groups Mothers will be in 1 of 2 focus groups with other mothers Fathers will be in a focus group with other fathers The moderator will speak both English and Spanish and you will be assigned to the group where your preferred language is spoken Girls will be in 1 of 2 focus groups with other girls At the start of each focus group the moderators will begin with a general session about health related topics but for the girls any discussion about pubertal development will take place in two separate groups with the 6-9 yr olds in one group and 10-12 yr olds in another group Each group will have about 8 to 10 participants who are all comfortable speaking the same language
The focus groups will be led by a moderator a person who will lead the talk and answer any questions participants may have The discussions will involve talk about your thoughts on growth and development and body image such as the age you started developing how your body changes and your level of comfort with how your body looks Your parents will also be asked to compare their experiences during puberty with your experience You will also be asked about your level of comfort with a visit to the doctor and with having your blood drawn and needle sticks
Researchers also want to know if you would be comfortable taking part in a clinical research study that is planned for the future Information about this future study will also be presented to each group for discussion The focus group talks will last about 1 12 hours
All of the discussions will be audio taped and will be kept confidential The tapes will not be heard by anyone other than the research staff They will be kept safe in a locked cabinet that stores other confidential research materials and will be destroyed at the end of this study
Your participation in this study will be over after your focus group discussion has ended
This is an investigational study You will be given the art projects that you created during your focus group for your time and participation Up to 50 girls will take part in this study All will be enrolled at M D Anderson
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