Clinical trial NCT00461487: A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents
Official title: Reducing Teen Sexual Behavior: A Clinic-Based Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Keywords: Adolescent Behavior
Communication
Health Behavior
Risk-Taking
Sexual Behavior
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-04-18
Enrollment: 530
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Incidence of vaginal sexual intercourse measured
timeFrame: Measured at Months 3 and 12 post-treatment
Secondary outcomes:
measure: Incidence of condom use
timeFrame: Measured at Months 3 and 12 post-treatment
measure: Incidence of oral sex
timeFrame: Measured at Months 3 and 12 post-treatment
measure: Incidence of anal sex
timeFrame: Measured at Months 3 and 12 post-treatment
measure: Number of sexual partners
timeFrame: Measured at Months 3 and 12 post-treatment
measure: Behavioral intentions
timeFrame: Measured at Months 3 and 12 post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Social Work
state: New York
Study officials:
affiliation: Columbia University
name: Vincent Guilamo-Ramos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guilamo-Ramos V, Bouris A, Jaccard J, Gonzalez B, McCoy W, Aranda D. A parent-based intervention to reduce sexual risk behavior in early adolescence: building alliances between physicians, social workers, and parents. J Adolesc Health. 2011 Feb;48(2):159-63. doi: 10.1016/j.jadohealth.2010.06.007.