Clinical trial NCT01326806: 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: Parent-based intervention
Sexual risk behavior
Adolescents
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2011-03-31
Enrollment: 1800
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.

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 Latino and African-American early adolescents ages 11 to 14.

The primary aim for this study will be to test and refine a triadic intervention developed for healthcare providers and parents to address the issue of sexual risk behavior among African American and Latino adolescents.

The triadic intervention will take place in a pediatric health care clinic when mothers accompany their children for a non-acute care visit. Mothers will meet with a provider extender (medical assistant, social worker, counselor) for approximately 30 minutes while their children are being examined by a healthcare provider. 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. The healthcare provider will endorse the intervention separately for mothers and adolescents. All parents will also receive one follow-up phone call 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 intervention session with a provider extender. Parents in the experimental group will meet with the provider extender 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 provider extender to discuss adolescent nutrition and receive informational brochures.

One booster session will take place via telephone for parents in the experimental and active control groups. The booster call will occur approximately 1 month after study entry. No such booster calls will be provided to parents in the passive control condition.

Eligibility 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

Primary outcomes:
measure: Incidence of vaginal intercourse
timeFrame: Measured at 12 months post-intervention
measure: Incidence of condom use
timeFrame: Measured at 12-months post-intervention
Secondary outcomes:
measure: Number of sexual partners
timeFrame: Measured at 12 months post-intervention
measure: Behavioral intentions
timeFrame: Measured at 12 months post-intervention
measure: Incidence of vaginal intercourse
timeFrame: Measured at 3 months post-intervention
measure: Incidence of condom use
timeFrame: Measured at 3 months post-intervention
measure: Number of sexual partners
timeFrame: Measured at 3 months post-intervention
measure: Behavioral intentions
timeFrame: Measured at 3 months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Vincent Guilamo-Ramos, PhD, ANP-BC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guilamo-Ramos V, Benzekri A, Thimm-Kaiser M, Dittus P, Ruiz Y, Cleland CM, McCoy W. A Triadic Intervention for Adolescent Sexual Health: A Randomized Clinical Trial. Pediatrics. 2020 May;145(5):e20192808. doi: 10.1542/peds.2019-2808.