- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03482687
It's Your Game: An Innovative Approach to Preventing Teen Dating Violence
March 22, 2018 updated by: Melissa Peskin, The University of Texas Health Science Center, Houston
The purpose of this study is to evaluate Me & You: Building Healthy Relationships, a classroom- and computer-based healthy relationships and dating violence prevention curriculum for 6th grade students, in a large, urban public school district in Southeast Texas.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this three year study is to evaluate Me & You: Building Healthy Relationships, a classroom- and computer-based healthy relationships and dating violence prevention curriculum for 6th grade students, in a large, urban public school district in Southeast Texas.
This curriculum was adapted from an existing effective sex education and relationship curriculum, It's Your Game…Keep it Real (IYG), which was enhanced to more explicitly address teen dating violence (TDV) and encompass multiple levels of the social-ecological model (e.g., youth, family, school staff).
A randomized two-arm, nested design was conducted among 6th grade students, where students receiving the curriculum were compared to students receiving usual care.
Ten middle schools participated in the study, five schools were randomly assigned to receive the curriculum and five to receive usual care.
Outcomes were assessed at baseline, immediately following the intervention, and 12 months after baseline.
Parental permission and student assent were obtained prior to administration of the surveys.
The primary hypothesis is that students who receive the curriculum will have significantly lower TDV perpetration than those who do not receive the curriculum.
Study Type
Interventional
Enrollment (Actual)
834
Phase
- 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
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Texas
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Houston, Texas, United States, 77030
- Melissa Fleschler Peskin
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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
Ages Eligible for Study
11 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 6th graders attending regular classes in ten study schools in large, urban school district in Southeast Texas
Exclusion Criteria:
- No students were excluded based on race/ethnicity, age, or gender.
- Students were informed that surveys and the intervention were only available in English and were asked to consider their comfort level with participating in the study.
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Me & You: Building Healthy Relationships
Me & You: Building Healthy Relationships is a classroom- and computer-based healthy relationships curriculum for middle school students.
It consists of thirteen 25-minute lessons: 5 classroom, 5 computer-only, and 3 classroom-computer hybrid.
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Me & You: Building Healthy Relationships is a classroom- and computer-based healthy relationships curriculum for middle school students.
It consists of thirteen 25-minute lessons: 5 classroom, 5 computer-only, and 3 classroom-computer hybrid.
The curriculum integrates group-based classroom activities (e.g., role-plays, group discussion, and other skill-building activities) and computer-based activities, some of which are individually tailored.
The curriculum was adapted from an existing effective sex education and relationship curriculum, It's Your Game…Keep it Real (IYG), which was enhanced to more explicitly address teen dating violence (TDV).
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No Intervention: Comparison Group
No intervention was provided, only usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percent of youth who perpetrated any type of teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
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Percent of youth who were victimized by any type of teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent of youth who perpetrated psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
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Percent of youth who were victimized by psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
|
Validated self report measure by Wolfe et al.
|
One year
|
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Percent of youth who perpetrated physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
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Percent of youth who were victimized by physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
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Percent of youth who perpetrated sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
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Percent of youth who were victimized by sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time Frame: One year
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Validated self report measure by Wolfe et al.
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One year
|
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Percent of youth who perpetrated electronic teen dating violence as indicated measures adapted from Picard and Zweig
Time Frame: One year
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Validated self report measure by Picard et al. and Zweig et al.
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One year
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Percent of youth who were victimized by electronic teen dating violence as indicated measures adapted from Picard and Zweig
Time Frame: One year
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Validated self report measure by Picard et al. and Zweig et al.
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One year
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Mean score reflecting student norms toward violence for boys and girls as indicated byt the Acceptance of Dating Abuse Survey
Time Frame: One year
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Validated self report measure by Foshee et al.
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One year
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Mean score for self-efficacy to resolve conflict as indicated by the Teen Conflict Survey
Time Frame: One year
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Validated self report measure by Dahlberg et al.
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One year
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Mean score of constructive and destructive conflict resolution skills as indicated by valid scales developed by Foshee et al.
Time Frame: One year
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Validated self report measure by Foshee et al.
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One year
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Mean score for attitudes towards sexting as indicated by a scale developed by Strassberg et al.
Time Frame: One year
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Validated self report measure by Strassberg et al.
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One year
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Mean score related to a student's belief in the need for help for dating violence victimization as indicated by measures developed by Foshee et al.
Time Frame: One year
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Validated self report measure by Foshee et al.
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One year
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Mean score for perceived peer dating violence perpetration (from the perspective of student) - newly developed
Time Frame: One year
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newly developed self-report measure
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One year
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Mean score for parental communication about drugs, sex, and relationships as indicated by measures developed by Tharp et al.
Time Frame: One year
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Validated self report measure by Tharp and Noonan
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One year
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Percent of youth who indicated social support from source as indicated by measures adapted from the Social Support Rating Scale
Time Frame: One year
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Validated self report measure by Cauce et al.
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One year
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Percent of youth who perpetrated bullying as indicated by measures developed by Wang et al.
Time Frame: One year
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Validated self report measure by Wang et al.
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One year
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Percent of youth who were victimized by bullying as indicated by measures developed from Wang et al.
Time Frame: One year
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Validated self report measure by Wang et al.
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One year
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Percent of youth reported one or more positive coping strategies as indicated by the Kidcope-Child Survey Form
Time Frame: One year
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Kidcope-Child Form by Laslo et al.
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One year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Melissa Peskin, PhD, University of Texas Houston School of Public Health
- Principal Investigator: Susan Tortolero Emery, PhD, University of Texas Houston School of Public Health
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
September 1, 2012
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
May 25, 2016
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2018
Last Update Submitted That Met QC Criteria
March 22, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SPH-12-0593
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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