Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students (SEI)

Public Health Institute, California

Status: Completed

Conditions: Sexually Transmitted Diseases; Pregnancy

Treatments: Behavioral: SEI Classroom Curriculum; Behavioral: SEI Curriculum + 3 School Components; Behavioral: Control Curriculum + 1 School Component; Behavioral: Control Classroom Curriculum

Study type: Interventional

Funder types: Other

Identifiers

NCT02009046

04704-01-01

Details and patient eligibility

About

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).

Full 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

Enrollment: 1,909 patients

Sex: All

Ages: 13 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,909 participants in 4 patient groups

SEI Classroom Curriculum

Experimental group

Description:

Participants receive the SEI classroom curriculum.

Treatment:

Behavioral: SEI Classroom Curriculum

Control Classroom Curriculum

Active Comparator group

Description:

Participants receive the control classroom curriculum.

Treatment:

Behavioral: Control Classroom Curriculum

SEI Curriculum + 3 School Components

Experimental group

Description:

Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).

Treatment:

Behavioral: SEI Curriculum + 3 School Components

Control Curriculum + 1 School Component

Active Comparator group

Description:

Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).

Treatment:

Behavioral: Control Curriculum + 1 School Component