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All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students

NCT ID: NCT00167505

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-07-31

Brief Summary

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This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that included abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that included abstinence and condom/contraceptive information and skills. Each intervention consists of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth.

Detailed Description

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This study will evaluate the efficacy of a risk avoidance program for middle school students and a theoretically-comparable risk reduction program relative to standard care. The study design is a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools were randomly assigned to a risk avoidance intervention, five to a risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,800 7th grade students were recruited into the study and will be followed over a three-year period. Based on a formative study, a pilot study, and input from community groups and a national panel of experts, two comparable curricula were developed. The risk avoidance curriculum emphasizes sexual abstinence until marriage and includes the requirements for abstinence education as defined in Title V, Section 510. The risk reduction curriculum emphasizes abstinence and addresses condom and contraceptive use. The risk avoidance and risk reduction interventions each consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. Each intervention was delivered by trained facilitators. The effect of the interventions will be evaluated by assessing sexual risk-taking behaviors of participants in each intervention (proportion of students initiating sexual intercourse, proportion that are sexually active, number of times of unprotected sex, number of sexual partners) relative to the comparison group. Risk assessment data from students was collected by using an audio computer-assisted self-interview (ACASI) approach for the collection of baseline, 6-, 18-, and 24-month data. Parental permission and child assent were required prior to participation. In addition, we will conduct a 36-month follow-up survey and a one-time urine-based test for chlamydia, gonorrhea, and trichomonas which will provide additional longitudinal data to assess the impact of each curriculum, relative to standard care.

Conditions

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Sexually Transmitted Diseases Pregnancy HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Risk Avoidance

The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Group Type EXPERIMENTAL

Risk Avoidance Intervention

Intervention Type BEHAVIORAL

The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Risk Reduction

The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Group Type EXPERIMENTAL

Risk Reduction Intervention

Intervention Type BEHAVIORAL

The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Interventions

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Risk Avoidance Intervention

The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Intervention Type BEHAVIORAL

Risk Reduction Intervention

The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 7th graders attending regular classes in Houston Independent School District

Exclusion Criteria

* No students will be excluded based on race/ethnicity, age, or gender
* Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study.
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Department of Health and Human Services

FED

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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The University of Texas Health Science Center, Houston

Principal Investigators

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Christine Markham, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Houston School of Public Health

Locations

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University of Texas Houston School of Public Health

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NCT00167505

Identifier Type: -

Identifier Source: secondary_id

U48DP000057

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00207545

Identifier Type: -

Identifier Source: nct_alias