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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03559855
Other study ID # 977115
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2017
Est. completion date July 1, 2019

Study information

Verified date November 2021
Source University of Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1135
Est. completion date July 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Must be enrolled in designated classes at 14 participating high schools schools in Colorado Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Denver Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Denver

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Healthy Relationship Knowledge and Skills This outcome is measured by self-report survey. Change from pre-program through 1 year
Primary Risky Sexual Behavior This outcome is measured by self-report survey. Change from pre-program through 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04180358 - Capacity Builders Inc. Navajo Youth Builders Personal Responsibility Education Innovation Strategies Project N/A