Evaluation of High School-based Relationship Education

Evaluation of High School-based Relationship Education: Center for Relationship Education

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.

Study Overview

• Status: Completed
• Conditions: Responsible Sex
• Intervention / Treatment: Behavioral: Real Essentials

• Study Type: Interventional
• Enrollment (Actual): 1135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80208-3500
      • University of Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real Essentials; 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; The REAL Essentials curriculum is a healthy relationship education program for youth developed by the Center for Relationship Education.
No Intervention: Class as Usual; For the Class-as-Usual condition, there is no change in class content. Teachers offer what they typically offer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Denver

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2017
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 977115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No