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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD083445 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Texas Medical Branch, Galveston | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This study is a school-based trial of the 7th grade version of Fourth R, a promising teen dating violence prevention program, with 24 ethnically diverse middle schools in one of the nation's largest school districts to determine the impact of the program by comparing students in intervention schools with those in control schools.
The prevalence of teen dating violence (TDV), as well as the adverse mental, physical, and relationship health outcomes associated with it, underscores the need for effective TDV prevention programs, of which there are few.
The study will evaluate a new 7th-grade version of Fourth R, which has been rewritten to be developmentally appropriate and correspond to national health standards for this younger age. The 7th-grade version of Fourth R is innovative because it emphasizes socio-emotional learning, includes lessons on mental health, and addresses technology and cyber TDV. These additional components will strengthen the core social-emotional competencies of youth, competencies that are critical for the creation of healthy relationships and avoidance of unhealthy ones. A TDV prevention program aimed at promoting healthy relationships at this developmentally important age holds tremendous promise.
The primary aim is to determine whether Fourth R reduces students' TDV, as indexed by less perpetration and victimization of physical, sexual, and psychological TDV, relative to students in control schools.
The secondary aims are to determine whether Fourth R, relative to control, 1) improves students' [relationship quality], emotional well-being, and increases their acquisition and use of healthy relationship skills, as indexed by improved problem-solving, communication, and conflict resolution skills; 2) ameliorates the modifiable cognitive and behavioral correlates associated with the perpetration and victimization of TDV, as indexed by fewer attitudes justifying dating violence, decreased substance use, risky sexual behavior, fighting, and bullying, increased school connectedness, improved academic performance, and decreased psychological symptoms; and [3) improves school climate as indexed by student, teacher, and staff reports of school environment as it relates to healthy relationships and TDV; and by reductions in school disciplinary actions related to violence, substance use, and academic failure]. Prespecified differences by gender and ethnicity will be examined, as well as the acquisition and utilization of various program components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fourth R | Experimental | Fourth R: 27 lesson curriculum addressing youth risk and health promoting behaviors |
|
| Control | No Intervention | Control: Treatment as usual (standard health class curriculum) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fourth R | Behavioral | Fourth R integrates the promotion of healthy relationship skills and prevention of teen dating violence into existing school curricula so that students receive regular course credit in health. Fourth R is grounded in social cognitive theory in which youth learn to formulate and choose behavior strategies, which translate into knowledge and practice in decision-making, non-aggressive conflict resolution skills, and self-efficacy.. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Perpetration of Physical Teen Dating Violence (TDV) | Determine whether Fourth R reduces students' TDV, as indexed by less perpetration of physical TDV, relative to students in control schools. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Alcohol/Marijuana Use | Provides the number of participants reporting alcohol/marijuana use. | 1 year |
| Number of Participants Reporting Physical Fights | Provides the number of participants reporting physical fights. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff R Temple, PhD | UTMB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Independent School District | Houston | Texas | 77092 | United States | ||
| Fort Bend Independent School District |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34615696 | Result | Temple JR, Baumler E, Wood L, Thiel M, Peskin M, Torres E. A Dating Violence Prevention Program for Middle School Youth: A Cluster Randomized Trial. Pediatrics. 2021 Nov;148(5):e2021052880. doi: 10.1542/peds.2021-052880. Epub 2021 Oct 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | The students who participated in the Fourth R. The Fourth R, is a classroom-based curriculum delivered by existing teachers and consists of 21 lessons on injury prevention, substance use, and growth and development. |
| FG001 | Control Group | The students who received the standard health class curriculum. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of students who were included in the baseline survey analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | The students who participated in the Fourth R. The Fourth R, is a classroom-based curriculum delivered by existing teachers and consists of 21 lessons on injury prevention, substance use, and growth and development. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Perpetration of Physical Teen Dating Violence (TDV) | Determine whether Fourth R reduces students' TDV, as indexed by less perpetration of physical TDV, relative to students in control schools. | Main study outcome was analyzed on the subset of students who reported having had a boyfriend or girlfriend in the last 12 months at the 1 year follow up | Posted | Count of Participants | Participants | 1 year |
|
Participants could self-report any adverse events over the course of the 5-year study. Participants were contacted and took surveys at baseline, when students were in 7th grade and at 12-, 24-, and 36-months post-intervention, when students were in 8th, 9th, and 10th grade, respectively. Participants were given study contact and resource information at each data collection and could contact study staff at any time to report any adverse events.
Staff and teachers were instructed to immediately contact the principal investigator and the project director if any adverse event occurs and appropriate action would be taken. Teachers received information on confidentiality and disclosure issues. At the beginning of the intervention, teachers informed students about restrictions on his/her ability to keep certain information confidential. Any adverse event must also be reported to the Institutional Review Board (IRB).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | The students who participated in the Fourth R. The Fourth R, is a classroom-based curriculum delivered by existing teachers and consists of 21 lessons on injury prevention, substance use, and growth and development. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Thiel | UT Health Houston | 713-818-6281 | melanie.thiel@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2020 | Nov 18, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 1 year |
| Bully Perpetration | Bully perpetration was measured on a scale from 1 to 5, where higher on the scale indicates increased perpetration. | 1 year |
| Sugar Land |
| Texas |
| 77479 |
| United States |
| Tracking info missing |
|
The students who received the standard health class curriculum. |
| BG002 | Total | Total of all reporting groups |
| Study School |
|
| Participants |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| Physical Dating Violence (DV) Perpetration | Count of Participants | Participants | Participants |
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| Living Situation | Count of Participants | Participants | Participants |
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| Parent Education | Count of Participants | Participants | Participants |
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| Number of Sexually Experienced Participants | Count of Participants | Participants | Participants |
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| Total Student Enrollment in Study School, mean (SD) | Mean | Standard Deviation | Students enrollment | Study School |
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| Study School with >500 students | Count of Units | Study School | Study School |
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| Seventh-grade student enrollment, mean (SD) | Mean | Standard Deviation | 7th grade students | Study School |
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| Number of schools with small (versus large) territory | Number | number of study schools | Study School |
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| Schools with >50% economically disadvantaged | This information was gathered from the Texas Education Agency School Report from 2017-2018. | Number | number of study schools | Study School |
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The students who received the standard health class curriculum. |
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| Secondary | Number of Participants Reporting Alcohol/Marijuana Use | Provides the number of participants reporting alcohol/marijuana use. | Posted | Count of Participants | Participants | 1 year |
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| Secondary | Number of Participants Reporting Physical Fights | Provides the number of participants reporting physical fights. | Posted | Count of Participants | Participants | 1 year |
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|
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| Secondary | Bully Perpetration | Bully perpetration was measured on a scale from 1 to 5, where higher on the scale indicates increased perpetration. | Posted | Mean | Standard Deviation | score on a scale | 1 year |
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| 0 |
| 1,237 |
| 0 |
| 1,237 |
| 0 |
| 1,237 |
| EG001 | Control Group | The students who received the standard health class curriculum. | 0 | 1,531 | 0 | 1,531 | 0 | 1,531 |
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