Responsible SexNCT03559855
Evaluation of High School-based Relationship Education
A study testing Real Essentials in people with Responsible Sex, run by University of Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Responsible Sex
- What is being tested?
- Real Essentials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,135 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 1 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must be enrolled in designated classes at 14 participating high schools schools in Colorado
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Responsible Sex
- Being tested
- Real Essentials
- Medical subject headings
- Safe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real EssentialsBehavioural
The REAL Essentials curriculum is a healthy relationship education program for youth developed by the Center for Relationship Education.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Relationship Knowledge and Skills
This outcome is measured by self-report survey.
Measured: Change from pre-program through 1 year
Risky Sexual Behavior
This outcome is measured by self-report survey.
Measured: Change from pre-program through 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start31 Aug 2017
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Responsible SexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Galena Rhoades, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559855
- Sponsor's protocol ID
- 977115
- Status last verified
- Nov 2021
- First submitted
- 23 May 2018
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of High School-based Relationship Education: Center for Relationship Education
- ClinicalTrials.gov ID
- NCT03559855
- Acronym / sponsor ID
- 977115
- Conditions
- Responsible Sex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,135 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real Essentials | Experimental | Behavioral: Real EssentialsThe 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. |
| Class as Usual | No intervention | –For the Class-as-Usual condition, there is no change in class content. Teachers offer what they typically offer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Must be enrolled in designated classes at 14 participating high schools schools in Colorado
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real EssentialsThe REAL Essentials curriculum is a healthy relationship education program for youth developed by the Center for Relationship Education. | Behavioural | Real Essentials |
Primary outcome
Healthy Relationship Knowledge and Skills
Time frame: Change from pre-program through 1 year
This outcome is measured by self-report survey.
Risky Sexual Behavior
Time frame: Change from pre-program through 1 year
This outcome is measured by self-report survey.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Essentials in people with Responsible Sex, run by University of Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthy Relationship Knowledge and Skills (time frame: Change from pre-program through 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.