Reducing HIV Risks in African American Teens

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Education Development Center, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
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
  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: Open Label
Primary Purpose: Prevention
Official Title: Reducing HIV Risks in African American Teens in High Poverty Urban Settings

Resource links provided by NLM:


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

Primary Outcome Measures:
  • youth risk behaviors [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-English speaking
  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

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by Education Development Center, Inc.:
sexual health
adolescent health
parent education
Adolescent health
HIV Seronegativity
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 14, 2014