KnowledgeNCT02831413
Testing the Effectiveness of Relationship Smarts and the Effects of Enhanced Facilitator Training
A study testing RS+ and Codeacademy in people with Knowledge and Attitude, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 yearsHealthy volunteers can take part
- What is being tested?
- RS+ and Codeacademy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jan 2018
- 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 Up to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students must be age 17 or younger
- have consent from a parent or guardian for evaluation activities
- provide assent for evaluation activities.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- RS+, Codeacademy
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RS+Behavioural
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.
CodeacademyBehavioural
a computer programming curriculum, Codeacademy, that teaches students how to use HTML.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | 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. Receives: Behavioral: Codeacademy |
| RS+ | Experimental | 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. Receives: Behavioral: RS+ |
| RS+ with enhanced facilitator support | Experimental | 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. Receives: Behavioral: RS+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge about Healthy Relationships
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: end of programming (approx. 12 weeks after beginning of programming )
Attitudes about Healthy Relationships
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: end of programming (approx. 12 weeks after beginning of programming )
Knowledge about Healthy Relationships
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: 1 year follow-up
Attitudes about Healthy Relationships
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: 1 year follow-up
Secondary outcomes (4)
Communications skills
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: end of programming (approx. 12 weeks after beginning of programming )
Characteristics of current romantic relationship
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: end of programming (approx. 12 weeks after beginning of programming )
Communications skills
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: 1 year follow-up
Characteristics of current romantic relationship
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Measured: 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KnowledgeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Diane Paulsell, Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831413
- Sponsor's protocol ID
- MPR-500098-FB
- Status last verified
- May 2019
- First submitted
- 2 Jun 2016
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of Relationship Smarts Curriculum and the Effects of Enhanced Facilitator Training
- ClinicalTrials.gov ID
- NCT02831413
- Acronym / sponsor ID
- MPR-500098-FB
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: CodeacademyControl 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. |
| RS+ | Experimental | Behavioral: 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. |
| RS+ with enhanced facilitator support | Experimental | Behavioral: 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. Affiliates assigned to this enhanced treatment group will participate in enhanced facilitator training and support activities. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Students must be age 17 or younger
- have consent from a parent or guardian for evaluation activities
- provide assent for evaluation activities.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | RS+, RS+ with enhanced facilitator support |
| Codeacademya computer programming curriculum, Codeacademy, that teaches students how to use HTML. | Behavioural | Control |
Primary outcome
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.
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.
Knowledge about Healthy Relationships
Time frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
Attitudes about Healthy Relationships
Time frame: 1 year follow-up
audio computer-assisted self-administered interviewing (ACASI) software on tablet devices.
4 secondary outcomes
Communications skills
Time frame: 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 )
Communications skills
Time frame: 1 year follow-up
Characteristics of current romantic relationship
Time frame: 1 year follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Individual participant dataSharing planned: No
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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.
Diane Paulsell principal investigator
Mathematica Policy Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RS+ and Codeacademy in people with Knowledge and Attitude, run by Mathematica Policy Research, Inc. 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 3 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: withdrawn, as of the sponsor's last update on 15 May 2019. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Knowledge about Healthy Relationships (time frame: end of programming (approx. 12 weeks after beginning of programming )). The study lists 4 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 15 May 2019.