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

NCT02009046 | Completed Results

• 1 other identifier: 04704-01-01
• Study Type: interventional
• Target: 1,909
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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

  1 year

Secondary Outcomes (7)

• Percent of Participants Who Ever Had Sex

  1 year

• Percent of Participants Who Ever Had Oral Sex

  1 year

• Percent of Participants With Recent Sexual Activity

  1 year

• Percent of Participants With Recent Oral Sex Activity

  1 year

• Percent of Participants Who Used Condom at Last Sex

  1 year

Study Arms (4)

SEI Classroom Curriculum

EXPERIMENTAL

Participants receive the SEI classroom curriculum.

Behavioral: SEI Classroom Curriculum

Control Classroom Curriculum

ACTIVE COMPARATOR

Participants receive the control classroom curriculum.

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).

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).

Behavioral: Control Curriculum + 1 School Component

Interventions

SEI Classroom Curriculum BEHAVIORAL

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.

SEI Classroom Curriculum

Control Classroom Curriculum BEHAVIORAL

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.

Control Classroom Curriculum

SEI Curriculum + 3 School Components BEHAVIORAL

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.

SEI Curriculum + 3 School Components

Control Curriculum + 1 School Component BEHAVIORAL

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.

Control Curriculum + 1 School Component

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• th grade student at a participating high school in East or South Los Angeles
• Written parent/guardian consent and student assent to participate

You may not qualify if:

• None

Sponsors & Collaborators

• Public Health Institute, California: lead
• University of Southern California: collaborator
• Planned Parenthood Los Angeles: collaborator
• Ford Foundation: collaborator

Study Sites (1)

Planned Parenthood Los Angeles

Los Angeles, California, 90007, United States

Location

Related Publications (1)

• 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.

  PMID: 25886554 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases; Sexual Behavior; Sexuality

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Norman A. Constantine, Ph.D.
• Organization: PHI

nconstantine@berkeley.edu

925-284-8118

Study Officials

• Norman A. Constantine, PhD

  Public Health Institute

  PRINCIPAL INVESTIGATOR

• Louise A. Rohrbach, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: December 11, 2013
• Study Start: September 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 29, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-11

Locations

US (1)