Peer Mentors for Adolescents in HIV Affected Families

Health Behavior Clinical Trial

Official title:

Peer Mentors for Early Adolescents in HIV-Affected Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056953
• Other study ID #: 5R01HD37350-3
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2003
• Last updated: July 27, 2005
• Start date: September 1999
• Est. completion date: November 2004

Study information

• Verified date: July 2005
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 15 Years

Eligibility

Inclusion Criteria

• HIV infected parent or guardian

• No previous involvement in the mentoring program

• Adolescent assent

• Parental consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Behavior
• HIV Seronegativity

Intervention

Behavioral:
• Peer mentoring program

Locations

Country	Name	City	State
United States	Health People	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rosenblum A, Magura S, Fong C, Cleland C, Norwood C, Casella D, Truell J, Curry P. Substance use among young adolescents in HIV-affected families: resiliency, peer deviance, and family functioning. Subst Use Misuse. 2005;40(5):581-603. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	substance use; association with substance using peers