AttitudesNCT02832856
Testing the Effectiveness of the Full and Abridged Relationship Smarts Curriculum for 9th Grade Students
A study testing Healthy Relationship Education and Job Readiness Curriculum in people with Attitudes and Knowledge, run by Mathematica Policy Research, Inc. at 1 site in United States.
Trial summary
This evaluation will test the program effectiveness of a relationship education program (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on outcomes of knowledge. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- What is being tested?
- Healthy Relationship Education and Job Readiness Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,180 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2021
- 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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- high school students in 9th grade health classes
- must be enrolled in one of the targeted health classes
- permission from a parent or guardian to participate in both the program and the evaluation
Who cannot join
- non-students
- students in other grades of high school
- students not enrolled in health class
- students without parental permission to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Effectiveness of the Full and Abridged Versions of the Relationship Smarts Curriculum for 9th Grade Students
This evaluation will test the program effectiveness of a relationship education program (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is more effective than a control curriculum of job-readiness programming, and 2) whether an abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson version.
Read the detailed description
MTCI plans to deliver the Relationship Smarts PLUS (RS+) education curriculum to youth in high schools during the regular school day. RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making. MORE THAN CONQUERORS, INC. (MTCI) plans to deliver the curriculum to 9th grade students as part of a required, semester-long health class. The program will be delivered by trained facilitators from MTCI in coordination with each participating school.
To be eligible to participate, students must be enrolled in one of the targeted health classes and have permission from a parent or guardian to participate in both the MATURE Plus II program and the STREAMS evaluation.The study plans to enroll 1,840 students over the entire two-year evaluation period.
At the start of each semester, the targeted sections of 9th grade health class will be randomly assigned into one of three research groups: (1) a group that receives the full, 12-lesson RS+ curriculum, (2) a group that receives a "summary" 8-lesson version of the RS+ curriculum and four lessons on career planning and job readiness, or (3) a control group that receives lessons on career planning and job readiness without any lessons from the RS+ curriculum.
All students for whom consent and assent have been obtained will be asked to complete three surveys: (1) a baseline survey administered in health class near the start of the semester, (2) a post-program survey administered in health class near the end of the semester, and (3) a one-year follow-up survey administered about 12 months after the baseline survey, during 10th grade
- Being tested
- Healthy Relationship Education, Job Readiness Curriculum
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Relationship EducationBehavioural
RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The full curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making.
Job Readiness CurriculumBehavioural
Beginning to Work it Out (BWIO) assists youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as "soft skills" such as emotional self-management and problem-solving skills.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control group members will receive a job readiness curriculum entitled Beginning to Work it Out (BWIO) that assists at-risk youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as "soft skills" such as emotional self-management and problem-solving skills. Receives: Behavioral: Job Readiness Curriculum |
| Full Relationship Smarts Curriculum | Experimental | This group receives the behavioral intervention of the healthy relationship education in the form of the full, 12-lesson RS+ curriculum over approximately 12 weeks. Receives: Behavioral: Healthy Relationship Education |
| Abridged Relationship Smarts Curriculum | Experimental | This group receives the behavioral intervention of the healthy relationship education in the form of the "summary" 8-lesson version of the RS+ curriculum - as well as four lessons on career planning and job readiness over approximately 12 weeks. Receives: Behavioral: Healthy Relationship Education; Behavioral: Job Readiness Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived general relationship skills
Six-item scale (range: 1 to 4)
Measured: one year after random assignment
Perceived conflict management skills
Five-item scale (range: 1 to 4)
Measured: one year after random assignment
Disapproval of teen dating violence
Twelve-item scale (range: 1 to 4)
Measured: one year after random assignment
Constraining beliefs about marriage
Series of three separate continuous variables (range: 1 to 4)
Measured: one year after random assignment
Knowledge of pregnancy and STIs
Continuous index variable: sum of correct responses to five true/false statements
Measured: one year after random assignment
Desire to avoid teen pregnancy
series of three separate continuous variables (range: 1 to 4)
Measured: one year after random assignment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2019
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AttitudesStudies 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
- 1,180 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
- Brian Goesling, PhD, Principal investigator, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832856
- Sponsor's protocol ID
- MPR-500098-MTC
- Status last verified
- Apr 2022
- First submitted
- 8 Jul 2016
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Restricted use files will be made available to researchers through the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectiveness of the Full and Abridged Versions of the Relationship Smarts Curriculum for 9th Grade Students
- ClinicalTrials.gov ID
- NCT02832856
- Acronym / sponsor ID
- MPR-500098-MTC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Aug 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 14 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 evaluation will test the program effectiveness of a relationship education program (Relationship Smarts PLUS)and an abridged version of the program to 9th Grade Students on outcomes of knowledge. It will test 1) whether the Relationship Smarts (RS) Curriculum is more effective than a control curriculum of job-readiness programming, and 2) whether an abridged 8-lesson version of the RS Curriculum can be as effective as the full 12-lesson version.
Detailed description
MTCI plans to deliver the Relationship Smarts PLUS (RS+) education curriculum to youth in high schools during the regular school day. RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making. MORE THAN CONQUERORS, INC. (MTCI) plans to deliver the curriculum to 9th grade students as part of a required, semester-long health class. The program will be delivered by trained facilitators from MTCI in coordination with each participating school.
To be eligible to participate, students must be enrolled in one of the targeted health classes and have permission from a parent or guardian to participate in both the MATURE Plus II program and the STREAMS evaluation.The study plans to enroll 1,840 students over the entire two-year evaluation period.
At the start of each semester, the targeted sections of 9th grade health class will be randomly assigned into one of three research groups: (1) a group that receives the full, 12-lesson RS+ curriculum, (2) a group that receives a "summary" 8-lesson version of the RS+ curriculum and four lessons on career planning and job readiness, or (3) a control group that receives lessons on career planning and job readiness without any lessons from the RS+ curriculum.
All students for whom consent and assent have been obtained will be asked to complete three surveys: (1) a baseline survey administered in health class near the start of the semester, (2) a post-program survey administered in health class near the end of the semester, and (3) a one-year follow-up survey administered about 12 months after the baseline survey, during 10th grade
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: Job Readiness CurriculumControl group members will receive a job readiness curriculum entitled Beginning to Work it Out (BWIO) that assists at-risk youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as "soft skills" such as emotional self-management and problem-solving skills. |
| Full Relationship Smarts Curriculum | Experimental | Behavioral: Healthy Relationship EducationThis group receives the behavioral intervention of the healthy relationship education in the form of the full, 12-lesson RS+ curriculum over approximately 12 weeks. |
| Abridged Relationship Smarts Curriculum | Experimental | Behavioral: Healthy Relationship Education, Behavioral: Job Readiness CurriculumThis group receives the behavioral intervention of the healthy relationship education in the form of the "summary" 8-lesson version of the RS+ curriculum - as well as four lessons on career planning and job readiness over approximately 12 weeks. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- high school students in 9th grade health classes
- must be enrolled in one of the targeted health classes
- permission from a parent or guardian to participate in both the program and the evaluation
Key exclusion criteria (4 listed)
- non-students
- students in other grades of high school
- students not enrolled in health class
- students without parental permission to participate
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 |
|---|---|---|
| Healthy Relationship EducationRS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The full curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making. | Behavioural | Abridged Relationship Smarts Curriculum, Full Relationship Smarts Curriculum |
| Job Readiness CurriculumBeginning to Work it Out (BWIO) assists youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as "soft skills" such as emotional self-management and problem-solving skills. | Behavioural | Abridged Relationship Smarts Curriculum, Control |
Primary outcome
Perceived general relationship skills
Time frame: one year after random assignment
Six-item scale (range: 1 to 4)
Perceived conflict management skills
Time frame: one year after random assignment
Five-item scale (range: 1 to 4)
Disapproval of teen dating violence
Time frame: one year after random assignment
Twelve-item scale (range: 1 to 4)
Constraining beliefs about marriage
Time frame: one year after random assignment
Series of three separate continuous variables (range: 1 to 4)
Knowledge of pregnancy and STIs
Time frame: one year after random assignment
Continuous index variable: sum of correct responses to five true/false statements
Desire to avoid teen pregnancy
Time frame: one year after random assignment
series of three separate continuous variables (range: 1 to 4)
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 22 Apr 2022.
- Individual participant dataSharing planned: Yes. Restricted use files will be made available to researchers through the Inter-University Consortium for Political and Social Research (ICPSR) at the University of Michigan
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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.
Brian Goesling, PhD 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 Healthy Relationship Education and Job Readiness Curriculum in people with Attitudes and Knowledge, 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 4 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 22 Apr 2022. 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 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?
Perceived general relationship skills (time frame: one year after random assignment). The study lists 6 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 22 Apr 2022.