Parent Education for Young Teen Females

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lydia O'Donnell, Education Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00966212
First received: August 25, 2009
Last updated: June 29, 2012
Last verified: June 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing Alcohol & Risks Among Young Females

Further study details as provided by Education Development Center, Inc.:

Primary Outcome Measures:
  • positive parenting practices [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • alcohol use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • risk behaviors [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 8th grade girls and parents at participating schools

Exclusion Criteria:

  • Non-English speaking
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00966212

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

No publications provided

Responsible Party: Lydia O'Donnell, Senior Scientist, Education Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00966212     History of Changes
Other Study ID Numbers: 6241, 1R01AA014515
Study First Received: August 25, 2009
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 08, 2014