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

• ClinicalTrials.gov Identifier: NCT02009046
• Recruitment Status: Completed
• First Posted: December 11, 2013
• Results First Posted: October 19, 2018
• Last Update Posted: November 29, 2018
• Sponsor: Public Health Institute, California
• Collaborators: University of Southern California; Planned Parenthood Los Angeles; Ford Foundation
• Information provided by (Responsible Party): Public Health Institute, California

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pregnancy; Sexually Transmitted Diseases	Behavioral: SEI Classroom Curriculum; Behavioral: Control Classroom Curriculum; Behavioral: SEI Curriculum + 3 School Components; Behavioral: Control Curriculum + 1 School Component	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1909 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
• Study Start Date: September 2011
• Actual Primary Completion Date: May 2014
• Actual Study Completion Date: May 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: SEI Classroom Curriculum; Participants receive the SEI classroom curriculum.	Behavioral: 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: Control Classroom Curriculum; Participants receive the control classroom curriculum.	Behavioral: 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: SEI Curriculum + 3 School Components; Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).	Behavioral: SEI Curriculum + 3 School Components; Participants receive SEI classroom curriculum and all three school wide components. The peer education/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. The clinical services linkages includes 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: Control Curriculum + 1 School Component; Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).	Behavioral: Control Curriculum + 1 School Component; Participants receive control classroom curriculum and one of the three school wide components, the clinical services linkages. This component includes 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.

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants With Pregnancy Risk [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms
2. Percent of Participants With Sexually Transmitted Infection (STI) Risk [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms
3. Percent of Participants With Multiple Sexual Partners [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner
4. Percent of Participants Who Ever Used Sexual and Reproductive Health Services [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report ever using sexual and reproductive health services

Secondary Outcome Measures :

1. Percent of Participants Who Ever Had Sex [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report ever engaging in vaginal and/or anal sexual intercourse
2. Percent of Participants Who Ever Had Oral Sex [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report ever engaging in oral sexual intercourse
3. Percent of Participants With Recent Sexual Activity [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report engaging in vaginal and/or anal sexual intercourse during the last 3 months
4. Percent of Participants With Recent Oral Sex Activity [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report engaging in oral sexual intercourse in the last 3 months
5. Percent of Participants Who Used Condom at Last Sex [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report using a condom the last time they had sexual intercourse
6. Percent of Participants Who Used Contraceptive at Last Sex [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report using birth control and/or condoms the last time they had sexual intercourse
7. Percent of Participants Who Currently Have Condom [ Time Frame: 1 year ]
   Between-arm difference in percent of youth who report currently having a condom with them (e.g., in a pocket, purse or backpack)

Eligibility Criteria

• Ages Eligible for Study: 13 Years to 16 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, California

Planned Parenthood Los Angeles

Los Angeles, California, United States, 90007

Sponsors and Collaborators

Public Health Institute, California

University of Southern California

Planned Parenthood Los Angeles

Ford Foundation

Investigators

• Principal Investigator: Norman A. Constantine, PhD; Public Health Institute
• Principal Investigator: Louise A. Rohrbach, PhD, MPH; University of Southern California

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Public Health Institute, California
• ClinicalTrials.gov Identifier: NCT02009046
• Other Study ID Numbers: 04704-01-01
• First Posted: December 11, 2013
• Results First Posted: October 19, 2018
• Last Update Posted: November 29, 2018
• Last Verified: November 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Public Health Institute, California:

Adolescent; Sex education; Sexuality education; Sexually transmitted diseases; Pregnancy; Sexual behavior; Sexuality; Relationship rights; Gender norms; Human rights; Intervention studies; Parent intervention; Peer intervention

Additional relevant MeSH terms:

Sexually Transmitted Diseases; Communicable Diseases; Infections; Disease Attributes; Pathologic Processes