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

Reducing Teen Sexual Behavior: A Clinic-Based Approach

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.

Study Overview

• Status: Completed
• Conditions: Behavior and Behavior Mechanisms
• Intervention / Treatment: Behavioral: Families Talking Together; Behavioral: Active Control on Hygiene & Nutrition

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.

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sex Education + Standard Care; Participating mothers will receive sex education information while their child is having a physical exam.	Behavioral: Families Talking Together; The intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. 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. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
Active Comparator: Hygiene & Nutrition Education + Standard Care; Participating mothers will receive information on hygiene and nutrition while their child is having a physical exam.	Behavioral: Active Control on Hygiene & Nutrition; The active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother.
No Intervention: No Education + Standard Care; Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of vaginal intercourse	Measured at 12 months post-intervention
Incidence of condom use	Measured at 12-months post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of sexual partners		Measured at 12 months post-intervention
Behavioral intentions	Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.	Measured at 12 months post-intervention
Incidence of vaginal intercourse		Measured at 3 months post-intervention
Incidence of condom use		Measured at 3 months post-intervention
Number of sexual partners		Measured at 3 months post-intervention
Behavioral intentions	Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.	Measured at 3 months post-intervention

Collaborators and Investigators

• Sponsor: New York University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Vincent Guilamo-Ramos, PhD, ANP-BC, New York University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2012
• Primary Completion (Actual): May 31, 2016
• Study Completion (Actual): May 31, 2016

Study Registration Dates

• First Submitted: March 28, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Parent-based intervention; Sexual risk behavior
• Other Study ID Numbers: NIH_066159; R01HD066159 (U.S. NIH Grant/Contract)