A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
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|ClinicalTrials.gov Identifier: NCT00461487|
Recruitment Status : Completed
First Posted : April 18, 2007
Last Update Posted : July 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Behavior and Behavior Mechanisms||Behavioral: Active control on hygiene and nutrition Behavioral: Families Talking Together||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||530 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Reducing Teen Sexual Behavior: A Clinic-Based Approach|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2010|
Participants will receive sex education information during the physical exam
Behavioral: Families Talking Together
The intervention will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. A mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. There will be three follow-up booster sessions administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
Active Comparator: 2
Participants will receive information on hygiene and nutrition during the physical exam
Behavioral: Active control on hygiene and nutrition
The active control group will take place in a primary healthcare clinic and will be coordinated through allied health professionals when physicians see youth for their annual physical examination. The mother of the adolescent will meet with a social work interventionist for approximately 25 minutes while her child is being examined by the physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
No Intervention: 3
Passive control participants will not receive any additional information during the physical exam
- Incidence of vaginal sexual intercourse measured [ Time Frame: Measured at Months 3 and 12 post-treatment ]
- Incidence of condom use [ Time Frame: Measured at Months 3 and 12 post-treatment ]
- Incidence of oral sex [ Time Frame: Measured at Months 3 and 12 post-treatment ]
- Incidence of anal sex [ Time Frame: Measured at Months 3 and 12 post-treatment ]
- Number of sexual partners [ Time Frame: Measured at Months 3 and 12 post-treatment ]
- Behavioral intentions [ Time Frame: Measured at Months 3 and 12 post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461487
|United States, New York|
|Columbia University School of Social Work|
|New York, New York, United States, 10027|
|Principal Investigator:||Vincent Guilamo-Ramos, PhD||Columbia University|