Parent Education for Young Teen Females

Prevention Clinical Trial

Official title:

Reducing Alcohol & Risks Among Young Females

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

• Prevention

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