Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219336
Status:
COMPLETED
Last Update Posted:
2016-09-30
First Post:
2005-09-14
Brief Title:
A Media Based Motivational Intervention to Prevent Alcohol Exposed Pregnancies AEPs
Sponsor:
Nova Southeastern University
Organization:
Nova Southeastern University
Study Overview
Official Title:
A Media Based Motivational Intervention to Reduce Alcohol Exposed Pregnancies AEPs
Status:
COMPLETED
Status Verified Date:
2016-09
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:
The study evaluated the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies AEP with female students and non-students 18 to 44 years of age living in Florida The investigators hypothesize that the motivational intervention will significantly reduce more womens risk of an AEP than will an informational intervention aimed at preventing fetal alcohol syndrome Materials will be available in Spanish and English
Detailed Description:
The proposed project will evaluate the effectiveness of a mail-based self-guided motivational intervention based on Project CHOICES to reduce alcohol-exposed pregnancies AEP among students and non-students Participants will be women 18 to 44 years of age who are at risk of an AEP The community targeted will be the state of Florida Materials were available in Spanish and English The intervention will be based on the investigators previous experience in a promoting self-change of drinking behavior at a community level and b preventing reduced risk for AEP through the use of a motivational interventional materials used in Project CHOICES Using a 2 group randomized design the self-guided motivational intervention will be compared to an intervention directed at preventing fetal alcohol syndrome FAS The FAS prevention condition a brochure developed by the CDC served as the standard treatment control group in that most information available at the community level concerning the effects of alcohol on the developing fetus relate to FAS eg warning labels on alcoholic beverage containers It is suggested that many women particularly college students at risk for AEP do not view themselves as at risk for FAS and therefore do not view FAS-oriented prevention messages as personally relevant The proposed experimental design will evaluate a mail-based strategy that could be easily implemented throughout communities The proposed study design will have more methodological rigor and allow a more careful evaluation than would be possible if the intervention was initially targeted at the entire community The follow-up will be the entire 6-months post-interventionIf successful this low-cost intervention can be readily disseminated throughout the local area Specific objectives are as follows
1 Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets
2 Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs
3 Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS using the 3 primary outcome measures in previous Project CHOICES studies a AEP reduced risk through reduced drinking or effective contraception or both b AEP reduced risk through drinking only and c reduced risk through effective contraception only
4 Disseminate results of the study to health care providers in the local community
1 Develop an evidence-based intervention to reduce alcohol-exposed pregnancies that can be easily disseminated at a community level through the mail and other media outlets
2 Implement the AEP prevention intervention using a randomized controlled trial with women recruited from a community at higher than normal risk for AEPs
3 Evaluate the efficacy of the AEP prevention intervention for reducing AEP risk as compared to a community level intervention aimed at preventing FAS using the 3 primary outcome measures in previous Project CHOICES studies a AEP reduced risk through reduced drinking or effective contraception or both b AEP reduced risk through drinking only and c reduced risk through effective contraception only
4 Disseminate results of the study to health care providers in the local community
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 |
|---|---|---|---|
| U50CCU300860 | OTHER_GRANT | CDC | None |