NCT00747630

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started May 2006

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

December 17, 2012

Status Verified

December 1, 2012

Enrollment Period

3.7 years

First QC Date

September 4, 2008

Last Update Submit

December 14, 2012

Conditions

Fetal Alcohol SyndromeTeen Pregnancy

Keywords

Fetal Alcohol SyndromeTeen pregnancy

Outcome Measures

Primary Outcomes (1)

  • To determine whether an educational video on FAS increases maternal knowledge on the subject and affects their likelihood to drink alcohol.

    Immediate

Study Arms (1)

Intervention

EXPERIMENTAL

The group selected to watch the video.

Other: An educational video about Fetal Alcohol Syndrome

Interventions

An educational video about Fetal Alcohol SyndromeOTHER

A 20 minute video about FAS

Intervention

Eligibility Criteria

Age12 Years - 16 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Pregnant teens aged 12 to 16 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Expectations

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Tammy Camp, MD

    Texas Tech Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2008

First Posted

September 5, 2008

Study Start

May 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

December 17, 2012

Record last verified: 2012-12

Locations

US(1)