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A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326806
First Posted: March 31, 2011
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Vincent Guilamo-Ramos, New York University
  Purpose
The purpose of this study is to test the efficacy of a parent-based intervention designed to prevent adolescent sexual risk behavior in Latino and African American inner city youth. The intervention will be administered in the context of mothers waiting for their children to complete an annual physical exam required for school admission.

Condition Intervention
Behavior and Behavior Mechanisms Behavioral: Families Talking Together Behavioral: Active Control on Hygiene & Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Reducing Teen Sexual Behavior: A Clinic-Based Approach

Further study details as provided by Vincent Guilamo-Ramos, New York University:

Primary Outcome Measures:
  • Incidence of vaginal intercourse [ Time Frame: Measured at 3 months post-treatment ]

Secondary Outcome Measures:
  • Incidence of condom use [ Time Frame: Measured at 3 months post-treatment ]
  • Incidence of oral sex [ Time Frame: Measured at 3 months post-treatment ]
  • Number of sexual partners [ Time Frame: Measured at 3 months post-treatment ]
  • Behavioral intentions [ Time Frame: Measured at 3 months post-treatment ]
    Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.

  • Incidence of condom use [ Time Frame: Measured at 12-months post-treatment ]
  • Incidence of oral sex [ Time Frame: Measured at 12 months post-treatment ]
  • Number of sexual partners [ Time Frame: Measured at 12 months post-treatment ]
  • Behavioral intentions [ Time Frame: Measured at 12 months post-treatment ]
    Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.

  • Incidence of vaginal intercourse [ Time Frame: Measured at 12 months post-intervention ]

Enrollment: 1800
Actual Study Start Date: July 19, 2010
Study Completion Date: May 31, 2016
Primary Completion Date: May 31, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sex Education + Standard Care
Participating mothers will receive sex education information while their child is having a physical exam.
Behavioral: Families Talking Together
The intervention will take place in a primary health care 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 an interventionist for approximately 30 minutes while her child is being examined by a 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: Hygiene & Nutrition Education + Standard Care
Participating mothers will receive information on hygiene and nutrition while their child is having a physical exam.
Behavioral: Active Control on Hygiene & Nutrition
The active control group will take place in a primary health care 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 30 minutes while her child is being examined by a physician. During this time, the active control on hygiene and nutrition will be delivered to the mother.
No Intervention: No Education + Standard Care
Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam.

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 consequences of early, risky sexual activity. This study will focus on inner-city Latino and African-American early adolescents ages 11 to 14. The primary aim will be to test and refine an intervention developed for parents 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 work interventionist for approximately 30 minutes while their children are being examined by a 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 social work interventionist. Parents in the experimental group will meet with the social work interventionist 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 work interventionist 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adolescents must be between the ages of 11 and 14 years old
  • Adolescent is able to agree to being a participant
  • Participant must be able to participate in questionnaire and intervention activities
  • Participant must be of Latino or African American descent

Exclusion Criteria:

  • Any cognitive or psychiatric disability that would prevent successful participation in questionnaire or intervention activities
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01326806


Locations
United States, New York
New York University, Silver School of Social Work
New York, New York, United States, 10003
Sponsors and Collaborators
New York University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Vincent Guilamo-Ramos, PhD New York University
  More Information

Responsible Party: Vincent Guilamo-Ramos, Professor, New York University
ClinicalTrials.gov Identifier: NCT01326806     History of Changes
Other Study ID Numbers: NIH_066159
R01HD066159 ( U.S. NIH Grant/Contract )
First Submitted: March 28, 2011
First Posted: March 31, 2011
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Vincent Guilamo-Ramos, New York University:
Parent-based intervention
Sexual risk behavior
Adolescents