Overview

This trial is active, not recruiting.

Conditions pregnancy, sexually transmitted diseases
Treatments sei classroom curriculum, control classroom curriculum, 3 school wide components, 1 school wide component
Sponsor Public Health Institute, California
Collaborator University of Southern California
Start date September 2011
End date May 2014
Trial size 2379 participants
Trial identifier NCT02009046, 04704-01-01

Summary

This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages. It is hypothesized that the 12-session classroom curriculum is more effective than a 3-session control sex education curriculum. It is also hypothesized that the full SEI package (all four components) is more effective than the control condition (control curriculum and clinical services only).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Experimental)
Participants receive the SEI classroom curriculum.
sei classroom curriculum
Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.
(Active Comparator)
Participants receive the control classroom curriculum.
control classroom curriculum
Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.
(Experimental)
Participants receive three school wide components (peer advocacy and education, parent education, clinical services linkages).
3 school wide components
Participants receive all three school wide components. The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. This clinical services linkages includes "clinic without walls" health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.
(Active Comparator)
Participants receive one of the three school wide components (clinical services linkages).
1 school wide component
Participants receive one of the three school wide components, the clinical services linkages. This component includes "clinic without walls" health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.

Primary Outcomes

Measure
Pregnancy Risk
time frame: 1 year
Sexually transmitted infection (STI) risk
time frame: 1 year
Multiple sexual partners
time frame: 1 year
Use of sexual and reproductive health services
time frame: 1 year

Secondary Outcomes

Measure
Ever had sex
time frame: 1 year
Ever had oral sex
time frame: 1 year
Recent sexual activity
time frame: 1 year
Recent oral sex activity
time frame: 1 year
Condom use at last sex
time frame: 1 year
Contraceptive use at last sex
time frame: 1 year
Currently have condom
time frame: 1 year

Eligibility Criteria

Male or female participants from 13 years up to 16 years old.

Inclusion Criteria: - 9th grade student at a participating high school in East or South Los Angeles - Written parent/guardian consent and student assent to participate Exclusion Criteria: - None

Additional Information

Official title Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
Principal investigator Norman A. Constantine, PhD
Description This study examines the effectiveness of the Sexuality Education Initiative (SEI), a comprehensive, multi-component, rights-based sexuality education program developed and implemented by Planned Parenthood Los Angeles for high school students. The primary goal of the SEI is to improve the sexual and reproductive health of youth attending Los Angeles high schools. The SEI consists of four intervention components: (1) a 12-session gender-sensitive, rights-based, comprehensive sexuality education curriculum, (2) a peer education and advocacy component, (3) a parent education component, and (4) clinical services linkages. - The 12-session gender-sensitive, rights-based classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. - The peer education and advocacy component recruits, trains and supervises students through an after-school leadership program to serve as school-wide resources to their peers, organize health events at school, and refer students to school-based clinic services. - The parent education component consists of a series of sessions for parents, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. - The in-school clinical services component provides "clinic without walls" health services on campus, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also trains teachers and school staff to distribute condoms to students as needed. The evaluation design involves two levels of randomization: First, all schools are randomized into one of two conditions: receiving all three SEI school wide components (peer, parent, clinical services) or receiving only one of these three school wide components (clinical services). Schools are randomized within matched pairs of demographically similar schools. Second, within each school, classrooms are randomized into one of two conditions: a basic 3-session sex education curriculum (control) or the 12-session SEI curriculum (intervention). Thus, all participating 9th grade students will receive at least three sexuality education curriculum sessions and access to on-site clinic services. The primary research questions for the evaluation are: 1. Is the 12-session SEI gender-sensitive, rights-based sexuality education curriculum more effective than a 3-session comparison curriculum in reducing risk of unwanted pregnancy and sexually transmitted infections (STIs) among high school students? 2. Is the full comprehensive program (all four components as a package) more effective than the two-component comparison condition (only the 3-session comparison curriculum and the clinical services linkages) in reducing risk of teen pregnancies and STIs? The first hypothesis is that the 12-session SEI gender-sensitive, rights-based curriculum is more effective than the 3-session comparison curriculum in improving sexual health outcomes (as defined in section 7) among program participants one year after participation in the program. The second hypothesis is that the full SEI program (all four components as a package) is more effective than the comparison condition (only the 3-session comparison curriculum and the clinical services linkages) in improving sexual health outcomes one year after participation. In addition to addressing these questions using the designated primary and secondary outcomes, this study will examine changes in the following short-term outcomes that measure critical concepts being addressed by the curriculum and serve as the hypothesized mediators in the SEI theory of change: - Attitudes about rights in sexual relationships - Communication about relationships, rights and sexuality with partners - Communication about relationships, rights and sexuality with parents/ guardians - Access to accurate information about sexuality and sexual health - Knowledge about sex, sexuality and sexual risk protection - Self-efficacy to assert sexual limits and manage risky situations - Intentions to protect self from sexual risk - Awareness of sexual and reproductive health services
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Public Health Institute, California.