NCT04079608

Brief Summary

High School FLASH is a 15-session comprehensive sexual health curriculum designed for classroom settings in grades 9 to 12. The basis of High School FLASH is a public health approach to behavior change. The primary strategy used in the FLASH curriculum for preventing teen pregnancy, sexually transmitted diseases (STDs), and sexual violence is to address student behaviors and attitudes. To this end, FLASH uses a harm reduction and behavior change framework, implements best practices as outlined in the research on effective programs, addresses risk and protective factors for program goals, and rests on the theory of planned behavior. The instructional approach of High School FLASH employs key concepts in every lesson, which enables teachers to hone in on the risk and protective factors outlined in the curriculum logic model. The curriculum covers the following topics: reproductive system, pregnancy, sexual orientation and gender identity, healthy relationships, coercion and consent, online safety, abstinence, birth control, preventing human immunodeficiency virus (HIV) and other STDs, condoms, STD testing, communicating and decision making, and improving school health. The curriculum aligns with national health education standards.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,597

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2.3 years

First QC Date

September 3, 2019

Last Update Submit

September 9, 2019

Conditions

Pregnancy RelatedSexual BehaviorSTD

Keywords

PregnancyAdolescentsSTDDecision makingHarm reductionPrevention education

Outcome Measures

Primary Outcomes (4)

  • Self-reported rates of vaginal sex

    Measured with a single item required and provided by the funder: "In the past 3 months, have you had vaginal intercourse, even once?" Yes/No

    3 months post-intervention

  • Self-reported rates of vaginal sex

    Measured with a single item required and provided by the funder: "In the past 3 months, have you had vaginal intercourse, even once?" Yes/No

    12 months post-intervention

  • Self-reported rates of vaginal sex without a condom or other birth control

    Combined the following two questions required and provided by the funder: "In the past 3 months, have you had vaginal intercourse without you or your partner using a condom?" and "In the past 3 months, how many times have you had vaginal intercourse without you or your partner using any of these methods of birth control: birth control pills, the shot, the patch, the ring, intrauterine device (IUD), or Implant" New outcome was coded 'yes' if either question was endorsed and 'no' if both questions were responded to as 'no'

    3 months post-intervention

  • Self-reported rates of vaginal sex without a condom or other birth control

    Combined the following two questions required and provided by the funder: "In the past 3 months, have you had vaginal intercourse without you or your partner using a condom?" and "In the past 3 months, how many times have you had vaginal intercourse without you or your partner using any of these methods of birth control: birth control pills, the shot, the patch, the ring, intrauterine device (IUD), or Implant" New outcome was coded 'yes' if either question was endorsed and 'no' if both questions were responded to as 'no'

    12 months post-intervention

Secondary Outcomes (6)

  • Self-reported initiation of vaginal sex

    3 months post-intervention

  • Self-reported initiation of vaginal sex

    12 months post-intervention

  • Self-reported knowledge of sexually transmitted disease (STD) testing

    3 months post-intervention

  • Self-reported knowledge of sexually transmitted disease (STD) testing

    12 months post-intervention

  • Self-reported comfort with family communication regarding sexual health

    3 months post-intervention

  • +1 more secondary outcomes

Study Arms (2)

FLASH curriculum

EXPERIMENTAL

Students who will receive the FLASH high school curriculum.

Behavioral: FLASH curriculum

Sexual Health Education for Adolescents

ACTIVE COMPARATOR

Students will receive a five-session knowledge-based sexual health curriculum designed for classroom settings.

Behavioral: Sexual Health Education for Adolescents

Interventions

FLASH curriculumBEHAVIORAL

High School FLASH is a 15-session comprehensive sexual health curriculum designed for classroom settings in grades 9 to 12. The basis of High School FLASH is a public health approach to behavior change. The primary strategy used in the FLASH curriculum for preventing teen pregnancy, sexually transmitted diseases (STDs), and sexual violence is to address student behaviors and attitudes. To this end, FLASH uses a harm reduction and behavior change framework, implements best practices as outlined in the research on effective programs, addresses risk and protective factors for program goals, and rests on the theory of planned behavior. The instructional approach of High School FLASH employs key concepts in every lesson, which enables teachers to hone in on the risk and protective factors outlined in the curriculum logic model.

FLASH curriculum
Sexual Health Education for AdolescentsBEHAVIORAL

Sexual Health Education for Adolescents is a five-session knowledge-based sexual health curriculum designed for classroom settings. The lessons cover the reproductive system, pregnancy, birth control, abstinence, human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs), and healthy relationships. The goal of the curriculum is to increase student knowledge in all content areas. The primary strategy employed by Sexual Health Education for Adolescents is to address the cognitive learning domain. The curriculum aligns to national health education standards and is intended to be implemented by classroom teachers. The lessons can be delivered according to the schedule that works best for schools (e.g., twice a week, once a week, every days) within a school semester.

Sexual Health Education for Adolescents

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • District level eligibility: Districts must have been from regions with teen birth rates at or above the national average at the time of study recruitment. They also much have agreed with randomization of mainstream schools to either High School FLASH or the five-session knowledge-based comparison condition. We worked with 7 different districts in two different regions of the U.S. - the Midwest (2 districts) and the South (5 districts).
  • School level eligibility: Schools were eligible to participate if they: (1) agreed with inviting all students in targeted grade level in the fall semester required class to take part in the study (9th or 10th grades depending on health education course placement); (2) had a policy environment that enabled implementation of all FLASH components if randomized to intervention condition; (3) were in a district not currently mandating comprehensive sexuality education or using an evidence-based sexual health curriculum in school or for after-school programs; and (4) have schools large enough to ideally contribute 40 or more students to the study.
  • Student level eligibility: Student enrollment into the study must have included (1) being in targeted classes during the enrollment window (fall semester 2016 in the Midwest and fall semester 2017 in the South), (2) providing positive parent consent to take part in study survey; and (3) providing assent to take part in the survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETR

Scotts Valley, California, 95066, United States

Location

MeSH Terms

Conditions

Sexual BehaviorHarm Reduction

Interventions

Sex Education

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

SexologyBehavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Karin Coyle, PhD

    ETR

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 6, 2019

Study Start

October 5, 2016

Primary Completion

January 30, 2019

Study Completion

June 30, 2019

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)