NCT03559855

Brief Summary

This study is a randomized controlled trial testing the effectiveness of a program provided in Colorado high schools by the Center for Relationship Education based in Denver, Colorado. 14 schools are randomly assigned to either provide the Real Essentials curriculum as part of health or similar classes or teach these classes as usual. The study design includes surveys administered pre-program, post-program and at 6-month and 12-month follow ups. Primary study outcomes are increased knowledge of healthy relationships and reduced risky sexual behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,135

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

1.8 years

First QC Date

May 23, 2018

Last Update Submit

November 19, 2021

Conditions

Responsible Sex

Outcome Measures

Primary Outcomes (2)

  • Healthy Relationship Knowledge and Skills

    This outcome is measured by self-report survey.

    Change from pre-program through 1 year

  • Risky Sexual Behavior

    This outcome is measured by self-report survey.

    Change from pre-program through 1 year

Study Arms (2)

Real Essentials

EXPERIMENTAL

The Real Essentials curriculum is delivered in class to students by the Center for Relationship Education staff. It consists of 5 to 6 hours of healthy relationship education.

Behavioral: Real Essentials

Class as Usual

NO INTERVENTION

For the Class-as-Usual condition, there is no change in class content. Teachers offer what they typically offer.

Interventions

Real EssentialsBEHAVIORAL

The REAL Essentials curriculum is a healthy relationship education program for youth developed by the Center for Relationship Education.

Real Essentials

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must be enrolled in designated classes at 14 participating high schools schools in Colorado

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Denver

Denver, Colorado, 80208-3500, United States

Location

MeSH Terms

Conditions

Safe Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

May 23, 2018

First Posted

June 18, 2018

Study Start

August 31, 2017

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations

US(1)