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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00774592 |
This study will examine whether pairing an in-school HIV education program and a parent training program will reduce prevalence of behaviors that present high risk of HIV infection in youth in the Bahamas.
Condition | Intervention |
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HIV Infections |
Behavioral: FOYC Behavioral: GFI Behavioral: Wonderous Wetlands Behavioral: CImPACT |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Adolescent Risk Reduction in the Bahamas-Peers and Parents |
Enrollment: | 1360 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Focus on Youth in the Caribbean (FOYC) plus Caribbean Informed Parents and Children Together (CImPACT)
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Behavioral: FOYC
FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
Behavioral: CImPACT
CImPACT is a parent intervention addressing parental monitoring and communication with youth. It consists of a 20-minute video, a condom practice, and role play simulating a parent-child discussion.
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2: Experimental
FOYC plus Goal For It (GFI)
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Behavioral: FOYC
FOYC is a face-to-face, eight-session, group behavioral intervention based on protection motivation theory and emphasizing skills and decision-making.
Behavioral: GFI
GFI is a one-session parent intervention consisting of a 20-minute video followed by a discussion regarding the process of setting and reaching goals.
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3: Active Comparator
Wonderous Wetlands plus GFI
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Behavioral: Wonderous Wetlands
Wonderous Wetlands is an eight-session, group intervention for youth. It includes field projects and discussions based on ways to save our environment.
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HIV infection in the Bahamas is the leading cause of death among Bahamians between the ages of 15 and 44. It is estimated that 4.13% of adults in the Bahamas are HIV infected, and the Bahamas has the highest annual incidence of AIDS in the English-speaking Caribbean. One cause for these high rates of infection is the prevalence of risky behaviors among Bahamian youth. Among youth between the ages of 13 and 15, 32% are sexually experienced, with that rate rising to 57% among youth age 16 or older. Approximately half of these adolescents have never used birth control, and only one third use birth control consistently.
This study will examine the benefits of combining a youth HIV prevention education program with a parental program focused on communication and monitoring. The youth education program, developed in the United States but modified to address Caribbean culture, is called Focus on Youth in the Caribbean (FOYC). FOYC has already been shown to be effective in increasing condom use, knowledge of HIV, and knowledge of risks associated with unprotected sex and drug use. Including parents in this intervention effort may broaden and sustain its effects. A study of seventh to eleventh graders found that teens were six times less likely to engage in sexual activity if they thought their mothers disapproved of it. The study also found that teens often did not have a clear idea of what their parents approved of or disapproved of, indicating a need for better communication between parents and children. Other studies have shown that parents who monitor their children reduce the likelihood that those children have unprotected sex or use drugs. The parental intervention program, called Caribbean Informed Parents and Children Together (CImPACT), has been shown to increase communication between parents and children and, when paired with a face-to-face intervention, enhance condom skills and lower rates of sex, unprotected sex, cigarette use, and alcohol use. This study will examine whether pairing the FOYC and CImPACT interventions will reduce prevalence of behaviors that present high risk of HIV infection in youth in the Bahamas.
Parents will be randomly assigned to receive either the CImPACT program or a control program called Goal for It (GFI), both of which will be implemented in a 1.5-hour training session. Schools will be randomly assigned to receive either the FOYC program or a control program entitled Wonderous Wetlands. Both programs will be implemented as part of the curriculum in 15 Bahamian elementary schools. Children, therefore, will be part of 1 of 3 groups:
Parents and children will be assessed at the beginning of the study and after 6, 12, 18, 24, and 36 months. These assessments will include questionnaires measuring high-risk behaviors, conceptions of risks and rewards involved in high-risk behaviors, and parent and adolescent communication and monitoring.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
United States, Michigan | |
Wayne State University School of Medicine | |
Detroit, Michigan, United States, 48230 |
Principal Investigator: | Bonita F. Stanton, MD | Wayne State University School of Medicine |
Responsible Party: | Wayne State University School of Medicine ( Bonita F. Stanton, MD ) |
Study ID Numbers: | R01 MH069229, DAHBR 9A-ASPC |
Study First Received: | October 16, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00774592 |
Health Authority: | United States: Federal Government |
Adolescent Risk Reduction HIV/AIDS Prevention Behavioral Change HIV |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |