PregnancySEINCT02009046
Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
A study testing SEI Classroom Curriculum and SEI Curriculum + 3 School Components in people with Pregnancy and Sexually Transmitted Diseases, run by Public Health Institute, California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sexually Transmitted Diseases
- What is being tested?
- SEI Classroom Curriculum and SEI Curriculum + 3 School Components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,909 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9th grade student at a participating high school in East or South Los Angeles
- Written parent/guardian consent and student assent to participate
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood Los Angeles
Los Angeles, California, 90007
About this study
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).
Read the 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
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Being tested
- SEI Classroom Curriculum, Control Classroom Curriculum, SEI Curriculum + 3 School Components, Control Curriculum + 1 School Component
- 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
- Medical subject headings
- Sexually Transmitted Diseases, Sexual Behavior, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEI Classroom CurriculumBehavioural
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 CurriculumBehavioural
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 ComponentsBehavioural
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 ComponentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SEI Classroom Curriculum | Experimental | Participants receive the SEI classroom curriculum. Receives: Behavioral: SEI Classroom Curriculum |
| Control Classroom Curriculum | Active comparator | Participants receive the control classroom curriculum. Receives: Behavioral: Control Classroom Curriculum |
| SEI Curriculum + 3 School Components | Experimental | Participants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). Receives: Behavioral: SEI Curriculum + 3 School Components |
| Control Curriculum + 1 School Component | Active comparator | Participants receive control classroom curriculum and one of the three school wide components (clinical services linkages). Receives: Behavioral: Control Curriculum + 1 School Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
Secondary outcomes (7)
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
Measured: 1 year
Percent of Participants Who Ever Had Oral Sex
Between-arm difference in percent of youth who report ever engaging in oral sexual intercourse
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Institute, California
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California, Planned Parenthood Los Angeles, Ford Foundation
- Responsible party
- Sponsor
- Investigators
- Norman A. Constantine, PhD, Principal investigator, Public Health InstituteLouise A. Rohrbach, PhD, MPH, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009046
- Sponsor's protocol ID
- 04704-01-01
- Acronym
- SEI
- Status last verified
- Nov 2018
- First submitted
- 18 Nov 2013
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25886554
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
- ClinicalTrials.gov ID
- NCT02009046
- Acronym / sponsor ID
- SEI / 04704-01-01
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Keywords
- Adolescent, Sex education, Sexuality education, Sexually transmitted diseases, Pregnancy, Sexual behavior, Sexuality, Relationship rights
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,909 participants (actual)
- Lead sponsor
- Public Health Institute, CaliforniaUniversity, hospital or other
- Collaborators
- University of Southern California, Planned Parenthood Los Angeles, Ford Foundation
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 19 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SEI Classroom Curriculum | Experimental | Behavioral: SEI Classroom CurriculumParticipants receive the SEI classroom curriculum. |
| Control Classroom Curriculum | Active comparator | Behavioral: Control Classroom CurriculumParticipants receive the control classroom curriculum. |
| SEI Curriculum + 3 School Components | Experimental | Behavioral: SEI Curriculum + 3 School ComponentsParticipants receive SEI classroom curriculum and three school wide components (peer advocacy and education, parent education, clinical services linkages). |
| Control Curriculum + 1 School Component | Active comparator | Behavioral: Control Curriculum + 1 School ComponentParticipants receive control classroom curriculum and one of the three school wide components (clinical services linkages). |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 9th grade student at a participating high school in East or South Los Angeles
- Written parent/guardian consent and student assent to participate
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEI Classroom CurriculumParticipants 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. | Behavioural | SEI Classroom Curriculum |
| Control Classroom CurriculumParticipants 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. | Behavioural | Control Classroom Curriculum |
| SEI Curriculum + 3 School ComponentsParticipants 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. | Behavioural | SEI Curriculum + 3 School Components |
| Control Curriculum + 1 School ComponentParticipants 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. | Behavioural | Control Curriculum + 1 School Component |
Primary outcome
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
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
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
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
7 secondary outcomes
Percent of Participants Who Ever Had Sex
Time frame: 1 year
Percent of Participants Who Ever Had Oral Sex
Time frame: 1 year
Percent of Participants With Recent Sexual Activity
Time frame: 1 year
Percent of Participants With Recent Oral Sex Activity
Time frame: 1 year
Percent of Participants Who Used Condom at Last Sex
Time frame: 1 year
Percent of Participants Who Used Contraceptive at Last Sex
Time frame: 1 year
Percent of Participants Who Currently Have Condom
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25886554Constantine 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman A. Constantine, PhD principal investigator
Public Health Institute
Louise A. Rohrbach, PhD, MPH principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEI Classroom Curriculum and SEI Curriculum + 3 School Components in people with Pregnancy and Sexually Transmitted Diseases, run by Public Health Institute, California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants With Pregnancy Risk (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02009046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.