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

New York University (NYU) logo

New York University (NYU)

Status

Completed

Conditions

Behavior and Behavior Mechanisms

Treatments

Behavioral: Active Control on Hygiene & Nutrition
Behavioral: Families Talking Together

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01326806
R01HD066159 (U.S. NIH Grant/Contract)
NIH_066159

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,800 patients

Sex

All

Ages

11 to 14 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,800 participants in 3 patient groups

Sex Education + Standard Care
Experimental group
Description:
Participating mothers will receive sex education information while their child is having a physical exam.
Treatment:
Behavioral: Families Talking Together
Hygiene & Nutrition Education + Standard Care
Active Comparator group
Description:
Participating mothers will receive information on hygiene and nutrition while their child is having a physical exam.
Treatment:
Behavioral: Active Control on Hygiene & Nutrition
No Education + Standard Care
No Intervention group
Description:
Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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