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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00056953
Other study ID # 5R01HD37350-3
Secondary ID
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
Est. primary completion date
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


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
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