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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Columbia University

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.

Condition or disease Intervention/treatment Phase
Behavior and Behavior Mechanisms Behavioral: Active control on hygiene and nutrition Behavioral: Families Talking Together Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Arm Intervention/treatment
Experimental: 1
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



Primary Outcome Measures :
  1. Incidence of vaginal sexual intercourse measured [ Time Frame: Measured at Months 3 and 12 post-treatment ]

Secondary Outcome Measures :
  1. Incidence of condom use [ Time Frame: Measured at Months 3 and 12 post-treatment ]
  2. Incidence of oral sex [ Time Frame: Measured at Months 3 and 12 post-treatment ]
  3. Incidence of anal sex [ Time Frame: Measured at Months 3 and 12 post-treatment ]
  4. Number of sexual partners [ Time Frame: Measured at Months 3 and 12 post-treatment ]
  5. Behavioral intentions [ Time Frame: Measured at Months 3 and 12 post-treatment ]


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

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): NCT00461487


Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Vincent Guilamo-Ramos, PhD Columbia University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00461487     History of Changes
Other Study ID Numbers: AAAC1456
R34MH078719 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASAP
First Posted: April 18, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Columbia University:
Adolescent Behavior
Communication
Health Behavior
Risk-Taking
Sexual Behavior