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

Behavior and Behavior Mechanisms Clinical Trial

Official title:

Reducing Teen Sexual Behavior: A Clinic-Based Approach

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461487
• Other study ID #: AAAC1456
• Secondary ID: R34MH078719DAHBR
• Status: Completed
• Phase: N/A
• First received: April 16, 2007
• Last updated: July 9, 2013
• Start date: April 2007
• Est. completion date: August 2010

Study information

• Verified date: July 2013
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: August 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Behavior and Behavior Mechanisms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University School of Social Work	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of vaginal sexual intercourse measured		Measured at Months 3 and 12 post-treatment	No
Secondary	Incidence of condom use		Measured at Months 3 and 12 post-treatment	No
Secondary	Incidence of oral sex		Measured at Months 3 and 12 post-treatment	No
Secondary	Incidence of anal sex		Measured at Months 3 and 12 post-treatment	No
Secondary	Number of sexual partners		Measured at Months 3 and 12 post-treatment	No
Secondary	Behavioral intentions		Measured at Months 3 and 12 post-treatment	No