Testing the Effectiveness of Relationship Smarts and the Effects of Enhanced Facilitator Training

May 13, 2019 updated by: Mathematica Policy Research, Inc.

Testing the Effectiveness of Relationship Smarts Curriculum and the Effects of Enhanced Facilitator Training

This project will test the effectiveness of offering healthy marriage and relation education for youth as part of the regular school curriculum and examine whether providing enhanced training and support for facilitators shows promise for enhancing the effects on high school students. The evaluation will examine a range of students' relationship outcomes, including their attitudes toward relationships, their knowledge of healthy relationships, their communication skills, and the characteristics of their current relationship.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Family Bridges will deliver the "Relationship Smarts +" program to students at 10 Chicago-area high schools. The RS+ curriculum will be delivered to 9th grade students in the target schools and classrooms during the 2016-2017 and 2017-2018 school years. The curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week.The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making. Using a three-arm randomized controlled trial design, this study will test the effectiveness of offering RS+ as part of the regular school curriculum on the students' knowledge of healthy relationships, their communication skills, and the characteristics of their current relationship. In addition to testing the effects of the curriculum, the study will also test the effects of providing enhanced training and support to facilitators.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Oak Park, Illinois, United States, 60302
        • Family Bridges, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students must be age 17 or younger
  • have consent from a parent or guardian for evaluation activities
  • provide assent for evaluation activities.

Exclusion Criteria:

  • Students in evaluation classrooms who do not meet these criteria will still receive programming, but will not be included in the STREAMS data collection activities or in the study's analysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control
Control group members will receive an alternate curriculum that is not related to relationship education. Family Bridges has identified a computer programming curriculum, Codeacademy, that teaches students how to use HTML.
Behavioral: Codeacademy
a computer programming curriculum, Codeacademy, that teaches students how to use HTML.
Experimental: RS+
The RS+ curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week. The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making.
Behavioral: RS+
The curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week. The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making.
Experimental: RS+ with enhanced facilitator support
The RS+ curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week. The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making. Affiliates assigned to this enhanced treatment group will participate in enhanced facilitator training and support activities.
Behavioral: RS+
The curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week. The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge about Healthy Relationships
Time Frame: end of programming (approx. 12 weeks after beginning of programming )
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
end of programming (approx. 12 weeks after beginning of programming )
Attitudes about Healthy Relationships
Time Frame: end of programming (approx. 12 weeks after beginning of programming )
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
end of programming (approx. 12 weeks after beginning of programming )
Knowledge about Healthy Relationships
Time Frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
1 year follow-up
Attitudes about Healthy Relationships
Time Frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
1 year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Communications skills
Time Frame: end of programming (approx. 12 weeks after beginning of programming )
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
end of programming (approx. 12 weeks after beginning of programming )
Characteristics of current romantic relationship
Time Frame: end of programming (approx. 12 weeks after beginning of programming )
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
end of programming (approx. 12 weeks after beginning of programming )
Communications skills
Time Frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
1 year follow-up
Characteristics of current romantic relationship
Time Frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mathematica Policy Research, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Department of Health and Human Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Diane Paulsell, Mathematica Policy Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPR-500098-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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