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A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
This study is ongoing, but not recruiting participants.
Study NCT00461487   Information provided by National Institute of Mental Health (NIMH)
First Received: April 16, 2007   Last Updated: April 8, 2009   History of Changes

April 16, 2007
April 8, 2009
April 2007
December 2009   (final data collection date for primary outcome measure)
Incidence of vaginal sexual intercourse measured [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ]
Incidence of vaginal sexual intercourse (measured 3 and 12 months post-intervention)
Complete list of historical versions of study NCT00461487 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence of condom use
  • Incidence of oral sex
  • Incidence of anal sex
  • Number of sexual partners
  • Behavioral intentions (all measured 3 and 12 months post-intervention)
 
A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
Reducing Teen Sexual Behavior: A Clinic-Based Approach

This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.

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.

 
Interventional
Other, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Behavior and Behavior Mechanisms
  • Behavioral: Active control on hygiene and nutrition
  • Behavioral: Families Talking Together
  • Experimental: Participants will receive sex education information during the physical exam
  • Active Comparator: Participants will receive information on hygiene and nutrition during the physical exam
  • No Intervention: Passive control participants will not receive any additional information during the physical exam
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
810
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
11 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00461487
Vincent Guilamo-Ramos, Columbia University School of Social Work
R34 MH078719, DAHBR 9A-ASAP
National Institute of Mental Health (NIMH)
 
Principal Investigator: Vincent Guilamo-Ramos, PhD Columbia University
National Institute of Mental Health (NIMH)
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP