Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
NCT ID: NCT02009046
Last Updated: 2018-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1909 participants
INTERVENTIONAL
2011-09-30
2014-05-31
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SEI Classroom Curriculum
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.
Control Classroom Curriculum
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.
SEI Curriculum + 3 School Components
Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages).
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.
Control Curriculum + 1 School Component
Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages).
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* Written parent/guardian consent and student assent to participate
Exclusion Criteria
13 Years
16 Years
ALL
Yes
Sponsors
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University of Southern California
OTHER
Planned Parenthood Los Angeles
UNKNOWN
Ford Foundation
OTHER
Public Health Institute, California
OTHER
Responsible Party
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Principal Investigators
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Norman A. Constantine, PhD
Role: PRINCIPAL_INVESTIGATOR
Public Health Institute
Louise A. Rohrbach, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Planned Parenthood Los Angeles
Los Angeles, California, United States
Countries
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References
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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.
Other Identifiers
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04704-01-01
Identifier Type: -
Identifier Source: org_study_id
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