| Descriptive Information Fields | |||||||||
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| Brief Title † | A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents | ||||||||
| Official Title † | Reducing Teen Sexual Behavior: A Clinic-Based Approach | ||||||||
| Brief Summary | This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents. |
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| Detailed Description | In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative health consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American adolescents in grades 6, 7, and 8. The primary aim will be to develop an intervention that parents can use to address the issue of sexual risk behavior with their children. The intervention will take place in a primary health care clinic when mothers accompany their children for annual physical exams. Mothers will meet with a social worker for approximately 25 minutes while their children are being examined by the physician. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities. All parents will also receive three follow-up phone calls to increase the probability that the homework tasks will be completed. Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an additional meeting with a clinic social worker. Parents in the experimental group will meet with the social worker to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior. Parents in the active control group will meet with the social worker to discuss adolescent nutrition and receive informational brochures. Three booster sessions will take place via telephone for parents in the experimental and active control groups. The first booster call will occur approximately 1 month after study entry, the second will occur 5 months after the intervention ends, and the third will occur 9 months post intervention. No such booster calls will be provided to parents in the passive control condition. |
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| Study Phase | |||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Other, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Incidence of vaginal sexual intercourse measured [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Incidence of condom use [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] Incidence of oral sex [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] Incidence of anal sex [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] Number of sexual partners [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] Behavioral intentions [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ] |
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| Condition † | Behavior and Behavior Mechanisms | ||||||||
| Intervention † | Behavioral: Active control on hygeine and nutrition Behavioral: Families Talking Together |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 810 | ||||||||
| Start Date † | April 2007 | ||||||||
| Completion Date | December 2009 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 11 Years to 14 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00461487 | ||||||||
| Organization ID | R34 MH78719 | ||||||||
| Secondary IDs †† | DAHBR 9A-ASAP | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | April 16, 2007 | ||||||||
| Last Updated Date | August 18, 2008 | ||||||||
