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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00966212
Other study ID # 6241
Secondary ID 1R01AA014515
Status Completed
Phase Phase 2/Phase 3
First received August 25, 2009
Last updated June 29, 2012
Start date September 2003
Est. completion date September 2009

Study information

Verified date June 2012
Source Education Development Center, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- 8th grade girls and parents at participating schools

Exclusion Criteria:

- Non-English speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
parent education
Especially for Daughters audio-cd parent education

Locations

Country Name City State
United States Education Development Center Newton Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Education Development Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary positive parenting practices 3 months No
Primary alcohol use 3 months No
Primary risk behaviors 3 months No
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