Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
Primary Purpose
Fetal Alcohol Syndrome, Teen Pregnancy
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
An educational video about Fetal Alcohol Syndrome
Sponsored by
About this trial
This is an interventional prevention trial for Fetal Alcohol Syndrome focused on measuring Fetal Alcohol Syndrome, Teen pregnancy
Eligibility Criteria
Inclusion Criteria:
- Pregnant teens aged 12 to 16 years
Exclusion Criteria:
Sites / Locations
- Grand Expectations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
The group selected to watch the video.
Outcomes
Primary Outcome Measures
To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.
Secondary Outcome Measures
Full Information
NCT ID
NCT00747630
First Posted
September 4, 2008
Last Updated
December 14, 2012
Sponsor
Texas Tech University Health Sciences Center
1. Study Identification
Unique Protocol Identification Number
NCT00747630
Brief Title
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
Official Title
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Terminated
Why Stopped
This project was not a clinical trial requiring registration
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University Health Sciences Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the efficacy of a video about FAS to determine whether it has an impact on knowledge about FAS and their likelihood to participate in risk taking behavior.
Detailed Description
Teenage mothers are asked to participate in the study and then randomized into an intervention or control group. Both groups take a multiple choice survey and then are randomized to either watch a video about FAS or not. After the video (or not for the controls) they then take a post video short answer survey. The survey results are then scored and statistical analysis performed to determine whether the video intervention increased their knowledge about FAS and their likelihood to drink alcohol during pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Alcohol Syndrome, Teen Pregnancy
Keywords
Fetal Alcohol Syndrome, Teen pregnancy
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The group selected to watch the video.
Intervention Type
Other
Intervention Name(s)
An educational video about Fetal Alcohol Syndrome
Intervention Description
A 20 minute video about FAS
Primary Outcome Measure Information:
Title
To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.
Time Frame
Immediate
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pregnant teens aged 12 to 16 years
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Camp, MD
Organizational Affiliation
Texas Tech Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grand Expectations
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating the Efficacy of a Video Based Intervention to Educate Teen Moms About Fetal Alcohol Syndrome (FAS)
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