NCT00966212

Brief Summary

The study has the potential to improve understanding of the link between early alcohol and sexual initiation and to provide a proven, selective, female-focused intervention for addressing these risks. The goal is to set young women on a course that protects their health and reduces the burden that problem drinking and HIV disease is taking on African American and Latino communities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 3, 2012

Status Verified

June 1, 2012

Enrollment Period

6 years

First QC Date

August 25, 2009

Last Update Submit

June 29, 2012

Conditions

Prevention

Outcome Measures

Primary Outcomes (3)

  • positive parenting practices

    3 months

  • alcohol use

    3 months

  • risk behaviors

    3 months

Study Arms (2)

health promotion materials

NO INTERVENTION

print parent education

ACTIVE COMPARATOR
Behavioral: parent education

Interventions

parent educationBEHAVIORAL

Especially for Daughters audio-cd parent education

print parent education

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • th grade girls and parents at participating schools

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Education Development Center

Newton, Massachusetts, 02458, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 26, 2009

Study Start

September 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 3, 2012

Record last verified: 2012-06

Locations

US(1)