- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00963963
Reducing HIV Risks in African American Teens
January 30, 2018 updated by: Lydia O'Donnell, Education Development Center, Inc.
Reducing HIV Risks in African American Teens in High Poverty Urban Settings
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Newton, Massachusetts, United States, 02458
- Education Development Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Attendance at selected schools
- 6th graders and their parents
Exclusion Criteria:
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: health promotion materials
Parents receive health promotion booklets
|
Multi-year audio CD parent education
|
Active Comparator: attention-controlled parent print materials
Booklets on adolescent sexuality and health
|
Multi-year audio CD parent education
|
Experimental: audio-CD parent education
audio-CDs on parenting practices
|
Multi-year audio CD parent education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
youth risk behaviors
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2006
Primary Completion (Actual)
April 30, 2013
Study Completion (Actual)
April 30, 2013
Study Registration Dates
First Submitted
August 21, 2009
First Submitted That Met QC Criteria
August 21, 2009
First Posted (Estimate)
August 24, 2009
Study Record Updates
Last Update Posted (Actual)
February 1, 2018
Last Update Submitted That Met QC Criteria
January 30, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01HD054297 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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