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Parent Education for Young Teen Females

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.
ClinicalTrials.gov Identifier: NCT00966212
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : July 3, 2012
Information provided by (Responsible Party):
Lydia O'Donnell, Education Development Center, Inc.

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.

Condition or disease Intervention/treatment Phase
Prevention Behavioral: parent education Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Alcohol & Risks Among Young Females
Study Start Date : September 2003
Primary Completion Date : September 2009
Study Completion Date : September 2009

Arm Intervention/treatment
No Intervention: health promotion materials
Active Comparator: print parent education Behavioral: parent education
Especially for Daughters audio-cd parent education

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • 8th grade girls and parents at participating schools

Exclusion Criteria:

  • Non-English speaking

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

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

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 Posted: August 26, 2009    Key Record Dates
Last Update Posted: July 3, 2012
Last Verified: June 2012