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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00461487
First received: April 16, 2007
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 Intervention
Behavior and Behavior Mechanisms
Behavioral: Active control on hygiene and nutrition
Behavioral: Families Talking Together

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Reducing Teen Sexual Behavior: A Clinic-Based Approach

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Incidence of vaginal sexual intercourse measured [ Time Frame: Measured at Months 3 and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 530
Study Start Date: April 2007
Study Completion Date: August 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461487

Locations
United States, New York
Columbia University School of Social Work
New York, New York, United States, 10027
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Vincent Guilamo-Ramos, PhD Columbia University
  More Information

No publications provided by Columbia University

Additional 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, DAHBR 9A-ASAP
Study First Received: April 16, 2007
Last Updated: July 9, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on September 18, 2014