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Completed

NCT Number: NCT00461487

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

This study will evaluate the effectiveness of a parent-based intervention in reducing sexual risk behavior in high-risk Latino and African-American adolescents.

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Key information

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University School of Social Work

New York, 10027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active control on hygiene and nutrition

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Incidence of vaginal sexual intercourse measured

    Time frame: Measured at Months 3 and 12 post-treatment

Secondary outcomes

  1. Incidence of condom use

    Time frame: Measured at Months 3 and 12 post-treatment

  2. Incidence of oral sex

    Time frame: Measured at Months 3 and 12 post-treatment

  3. Incidence of anal sex

    Time frame: Measured at Months 3 and 12 post-treatment

  4. Number of sexual partners

    Time frame: Measured at Months 3 and 12 post-treatment

  5. Behavioral intentions

    Time frame: Measured at Months 3 and 12 post-treatment

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Reducing Teen Sexual Behavior: A Clinic-Based Approach

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 18, 2007
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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