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Parent Education for Young Teen Females

NCT ID: NCT00966212

Last Updated: 2012-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2009-09-30

Brief Summary

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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.

Detailed Description

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The aims of this study are to to characterize and address the combined risks of early alcohol use and early sexual initiation within a population of urban African American and Latina adolescent females who are at high risk for HIV, AIDS, and other STI. Past research by the investigative team has documented that nearly 10% of females in our target population have initiated sex by fall of 7th grade and more than half have done so by spring of 10thgrade. Although alcohol use is more comparable with national figures, the combination of early alcohol and early sexual initiation is troubling, yet under-addressed by existing interventions. We will develop and test an intervention that builds upon a promising strategy for influencing adolescents: parent education. Three parenting mechanisms shown to influence adolescent risk behavior are targeted: parental monitoring, household rule setting, and communication. Informed by a community advisory board and a series of focus groups, a set of three audio-cds for parents of young adolescents will be developed. Through dramatic role-model stories, these CDs will help parents address alcohol prevention and the link between early alcohol use and sexual initiation and risk taking. Families and middle school daughters will then be enrolled into a randomized pilot test of the intervention's efficacy. Parent and student surveys will be conducted at baseline and 3-month post-intervention follow up to assess whether the intervention is beneficial in terms of promoting positive parenting practices, positive attitudes toward healthy behaviors, and reducing girls' risks.

Conditions

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Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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health promotion materials

Group Type NO_INTERVENTION

No interventions assigned to this group

print parent education

Group Type ACTIVE_COMPARATOR

parent education

Intervention Type BEHAVIORAL

Especially for Daughters audio-cd parent education

Interventions

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parent education

Especially for Daughters audio-cd parent education

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 8th grade girls and parents at participating schools

Exclusion Criteria

* Non-English speaking
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Education Development Center, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Lydia O'Donnell

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Education Development Center

Newton, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R01AA014515

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6241

Identifier Type: -

Identifier Source: org_study_id