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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

About this trial

This is an interventional prevention trial for Fetal Alcohol Syndrome focused on measuring Fetal Alcohol Syndrome, Teen pregnancy

Eligibility Criteria

12 Years - 16 Years (Child)FemaleDoes not accept healthy volunteers

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

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

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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