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Parent Education for Young Teen Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966212
First Posted: August 26, 2009
Last Update Posted: July 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lydia O'Donnell, Education Development Center, Inc.
  Purpose
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.

Condition Intervention Phase
Prevention Behavioral: parent education Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Alcohol & Risks Among Young Females

Further study details as provided by Lydia O'Donnell, Education Development Center, Inc.:

Primary Outcome Measures:
  • positive parenting practices [ Time Frame: 3 months ]
  • alcohol use [ Time Frame: 3 months ]
  • risk behaviors [ Time Frame: 3 months ]

Enrollment: 500
Study Start Date: September 2003
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: health promotion materials
Active Comparator: print parent education Behavioral: parent education
Especially for Daughters audio-cd parent education

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 8th grade girls and parents at participating schools

Exclusion Criteria:

  • Non-English speaking
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966212


Locations
United States, Massachusetts
Education Development Center
Newton, Massachusetts, United States, 02458
Sponsors and Collaborators
Education Development Center, Inc.
  More Information

Responsible Party: Lydia O'Donnell, Senior Scientist, Education Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00966212     History of Changes
Other Study ID Numbers: 6241
1R01AA014515 ( U.S. NIH Grant/Contract )
First Submitted: August 25, 2009
First Posted: August 26, 2009
Last Update Posted: July 3, 2012
Last Verified: June 2012