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Clinical Trials

MainTitle

Reducing HIV Risks in African American Teens

The recruitment status of this study is unknown.

Verified June 2012

Sponsor
Education Development Center, Inc.


Information provided by (Responsible Party)
Lydia O'Donnell, Education Development Center, Inc.

ClinicalTrials.gov Identifier
NCT00963963

First received: August 21, 2009
Last updated: June 29, 2012
Last Verified: June 2012
History of Changes
Purpose

Purpose

This study is developing and testing an innovative, parent education intervention, Preparing Our Sons and Daughters for Healthy Futures. This intervention aims to reduce HIV risk among African American and other Black youth living in high-poverty urban neighborhoods. Investigators, working with a community advisory board and focus groups of youth and parents, will develop a multi-year set of audio-CDs to promote positive parenting practices that support young adolescents in establishing healthy patterns of behavior. This parent education intervention will be tested in a field trial with families of 6th graders recruited from multiple schools in New York City. Baseline and annual follow up surveys will be conducted until youth enter high school. Families receiving the intervention will be compared to those assigned to either an attention-controlled print materials condition or a non-attention controlled condition. It is hypothesized that youth whose parents receive the intervention will delay sexual initiation and report fewer sexual risks, and that their parents will report more positive parenting practices.

Condition Intervention Phase
HIV Infections

Behavioral : Healthy Futures parent education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing HIV Risks in African American Teens in High Poverty Urban Settings

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

Primary Outcome Measures

  • youth risk behaviors [ Time Frame: 12 months ]

Estimated Enrollment: 1200
Study Start Date: April 2006
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: health promotion materials
Parents receive health promotion booklets
Behavioral: Healthy Futures parent education

Multi-year audio CD parent education

Active Comparator: attention-controlled parent print materials
Booklets on adolescent sexuality and health
Behavioral: Healthy Futures parent education

Multi-year audio CD parent education

Experimental: audio-CD parent education
audio-CDs on parenting practices
Behavioral: Healthy Futures parent education

Multi-year audio CD parent education

Eligibility

Eligibility

Ages Eligible for Study: 11 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria:

  • Attendance at selected schools
  • 6th graders and their parents


Exclusion Criteria:
  • Non-English speaking

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963963

Locations

United States, Massachusetts
Education Development Center
Newton, Massachusetts, United States, 02458

Sponsors and Collaborators

Education Development Center, Inc.
More Information

More Information


Responsible Party: Lydia O'Donnell, Senior Scientist, Education Development Center, Inc.  
ClinicalTrials.gov Identifier: NCT00963963   History of Changes  
Other Study ID Numbers: 5R01HD054297  
  5R01HD054297  
Study First Received: August 21, 2009  
Last Updated: June 29, 2012  

Keywords provided by Lydia O'Donnell, Education Development Center, Inc.:

sexual health
adolescent health
parent education
HIV Seronegativity
treatment experienced

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.