Clinical trial NCT02009046: Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
Official title: Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Sexually Transmitted Diseases
Keywords: Adolescent
Sex education
Sexuality education
Sexually transmitted diseases
Pregnancy
Sexual behavior
Sexuality
Relationship rights
Gender norms
Human rights
Intervention studies
Parent intervention
Peer intervention
Lead sponsor: Public Health Institute, California
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Planned Parenthood Los Angeles
name: Ford Foundation
First posted: 2013-12-11
Enrollment: 1909
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Participants With Pregnancy Risk
timeFrame: 1 year
measure: Percent of Participants With Sexually Transmitted Infection (STI) Risk
timeFrame: 1 year
measure: Percent of Participants With Multiple Sexual Partners
timeFrame: 1 year
measure: Percent of Participants Who Ever Used Sexual and Reproductive Health Services
timeFrame: 1 year
Secondary outcomes:
measure: Percent of Participants Who Ever Had Sex
timeFrame: 1 year
measure: Percent of Participants Who Ever Had Oral Sex
timeFrame: 1 year
measure: Percent of Participants With Recent Sexual Activity
timeFrame: 1 year
measure: Percent of Participants With Recent Oral Sex Activity
timeFrame: 1 year
measure: Percent of Participants Who Used Condom at Last Sex
timeFrame: 1 year
measure: Percent of Participants Who Used Contraceptive at Last Sex
timeFrame: 1 year
measure: Percent of Participants Who Currently Have Condom
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Planned Parenthood Los Angeles
state: California
Study officials:
affiliation: Public Health Institute
name: Norman A. Constantine, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Louise A. Rohrbach, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Constantine NA, Jerman P, Berglas NF, Angulo-Olaiz F, Chou CP, Rohrbach LA. Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial. BMC Public Health. 2015 Mar 26;15:293. doi: 10.1186/s12889-015-1625-5.