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Clinical Trials/NCT00461487
NCT00461487
Completed
N/A

Reducing Teen Sexual Behavior: A Clinic-Based Approach

Columbia University1 site in 1 country530 target enrollmentApril 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Behavior and Behavior Mechanisms
Sponsor
Columbia University
Enrollment
530
Locations
1
Primary Endpoint
Incidence of vaginal sexual intercourse measured
Status
Completed
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
August 2010
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescent must be between the ages of 11 and 14 years old, and in grades 6, 7, or 8
  • Adolescent is able to agree to being a participant
  • Able to participate in questionnaire and intervention activities
  • Latino or African-American descent

Exclusion Criteria

  • Any cognitive or psychiatric disability that would prevent successful participation in questionnaires and intervention activities

Outcomes

Primary Outcomes

Incidence of vaginal sexual intercourse measured

Time Frame: Measured at Months 3 and 12 post-treatment

Secondary Outcomes

  • Incidence of condom use(Measured at Months 3 and 12 post-treatment)
  • Incidence of oral sex(Measured at Months 3 and 12 post-treatment)
  • Incidence of anal sex(Measured at Months 3 and 12 post-treatment)
  • Number of sexual partners(Measured at Months 3 and 12 post-treatment)
  • Behavioral intentions(Measured at Months 3 and 12 post-treatment)

Study Sites (1)

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