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Peer Mentors for Adolescents in HIV Affected Families

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00056953
First received: March 26, 2003
Last updated: July 27, 2005
Last verified: July 2005
History of Changes
  Purpose

This study will evaluate the effectiveness of a peer mentoring program designed for youths ages 9 to 15 whose parents or guardians are HIV infected. The program will focus on the youths' mental health, school performance, alcohol and drug use, personal and social behaviors, and behaviors that might expose them to HIV. The study is expected to enroll predominantly minority youth.


Condition Intervention Phase
Adolescent Behavior
Health Behavior
HIV Seronegativity
 Behavioral: Peer mentoring program
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peer Mentors for Early Adolescents in HIV-Affected Families

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • substance use; association with substance using peers

Estimated Enrollment: 160
Study Start Date: September 1999
Estimated Study Completion Date: November 2004
Detailed Description:

This study will conduct an efficacy trial of peer mentoring for a high-risk, predominantly minority population of 9- to 15-year-old youths whose parents are HIV infected. The study will also determine mechanisms (mediating variables) through which peer mentoring improves outcomes for the mentees, for example, consistency and continuity of relationship, teaching/role modeling, emotional support/empathy, advocacy, and behavioral reinforcement. After the conclusion of the efficacy trial, the study will continue through naturalistic longitudinal research for an additional 2 years in order to examine the long-term outcomes of peer mentoring.

Participants are randomized to either the peer mentoring program or a control condition (a recreation program). Surveys are conducted at entry into the study, at 6 months, 1 year, and then annually for 2 years. Youths will also participate in focus groups. The surveys and focus groups will assess the youths’ psychological functioning, academic adjustment, alcohol and drug use, HIV risk behaviors, delinquent/violent behaviors, peer relationships, prosocial activities, and coping/problem-solving skills. The study will also evaluate family outcomes, including parent/guardian functioning and improved permanency planning.

  Eligibility

Ages Eligible for Study:   9 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • HIV infected parent or guardian
  • No previous involvement in the mentoring program
  • Adolescent assent
  • Parental consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056953

Locations
United States, New York
Health People
New York, New York, United States, 10455
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Stephen Magura, Ph.D. National Development and Research Institutes, Inc.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00056953     History of Changes
Other Study ID Numbers: 5R01HD37350-3
Study First Received: March 26, 2003
Last Updated: July 27, 2005
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
health behavior
adolescent behavior
peer mentoring

ClinicalTrials.gov processed this record on May 21, 2013