search
Back to results

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

Primary Purpose

Pregnancy, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SEI Classroom Curriculum
Control Classroom Curriculum
SEI Curriculum + 3 School Components
Control Curriculum + 1 School Component
Sponsored by
Public Health Institute, California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Adolescent, Sex education, Sexuality education, Sexually transmitted diseases, Pregnancy, Sexual behavior, Sexuality, Relationship rights, Gender norms, Human rights, Intervention studies, Parent intervention, Peer intervention

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts 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

Sites / Locations

  • Planned Parenthood Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

SEI Classroom Curriculum

Control Classroom Curriculum

SEI Curriculum + 3 School Components

Control Curriculum + 1 School Component

Arm Description

Participants receive the SEI classroom curriculum.

Participants receive the control classroom curriculum.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 18, 2013
Last Updated
November 1, 2018
Sponsor
Public Health Institute, California
Collaborators
University of Southern California, Planned Parenthood Los Angeles, Ford Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02009046
Brief Title
Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
Acronym
SEI
Official Title
Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Public Health Institute, California
Collaborators
University of Southern California, Planned Parenthood Los Angeles, Ford Foundation

4. Oversight

Data Monitoring Committee
No

5. 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).
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: 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? 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1909 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEI Classroom Curriculum
Arm Type
Experimental
Arm Description
Participants receive the SEI classroom curriculum.
Arm Title
Control Classroom Curriculum
Arm Type
Active Comparator
Arm Description
Participants receive the control classroom curriculum.
Arm Title
SEI Curriculum + 3 School Components
Arm Type
Experimental
Arm Description
Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).
Arm Title
Control Curriculum + 1 School Component
Arm Type
Active Comparator
Arm Description
Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).
Intervention Type
Behavioral
Intervention Name(s)
SEI Classroom Curriculum
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Classroom Curriculum
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SEI Curriculum + 3 School Components
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control Curriculum + 1 School Component
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Participants With Pregnancy Risk
Description
Between-arm difference in percent of youth who report engaging in recent sexual intercourse but not using birth control and/or condoms
Time Frame
1 year
Title
Percent of Participants With Sexually Transmitted Infection (STI) Risk
Description
Between-arm difference in percent of youth who report engaging in recent vaginal, anal and/or oral sexual intercourse but not using condoms
Time Frame
1 year
Title
Percent of Participants With Multiple Sexual Partners
Description
Between-arm difference in percent of youth who report having more than one recent vaginal, anal and/or oral sexual partner
Time Frame
1 year
Title
Percent of Participants Who Ever Used Sexual and Reproductive Health Services
Description
Between-arm difference in percent of youth who report ever using sexual and reproductive health services
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percent of Participants Who Ever Had Sex
Description
Between-arm difference in percent of youth who report ever engaging in vaginal and/or anal sexual intercourse
Time Frame
1 year
Title
Percent of Participants Who Ever Had Oral Sex
Description
Between-arm difference in percent of youth who report ever engaging in oral sexual intercourse
Time Frame
1 year
Title
Percent of Participants With Recent Sexual Activity
Description
Between-arm difference in percent of youth who report engaging in vaginal and/or anal sexual intercourse during the last 3 months
Time Frame
1 year
Title
Percent of Participants With Recent Oral Sex Activity
Description
Between-arm difference in percent of youth who report engaging in oral sexual intercourse in the last 3 months
Time Frame
1 year
Title
Percent of Participants Who Used Condom at Last Sex
Description
Between-arm difference in percent of youth who report using a condom the last time they had sexual intercourse
Time Frame
1 year
Title
Percent of Participants Who Used Contraceptive at Last Sex
Description
Between-arm difference in percent of youth who report using birth control and/or condoms the last time they had sexual intercourse
Time Frame
1 year
Title
Percent of Participants Who Currently Have Condom
Description
Between-arm difference in percent of youth who report currently having a condom with them (e.g., in a pocket, purse or backpack)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman A. Constantine, PhD
Organizational Affiliation
Public Health Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Louise A. Rohrbach, PhD, MPH
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Planned Parenthood Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25886554
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs