Adolescent BehaviorNCT03482687
It's Your Game: An Innovative Approach to Preventing Teen Dating Violence
A study testing Me & You: Building Healthy Relationships in people with Adolescent Behavior and Interpersonal Relationships, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Interpersonal Relationships, Domestic Violence
- What is being tested?
- Me & You: Building Healthy Relationships
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 834 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2015
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6th graders attending regular classes in ten study schools in large, urban school district in Southeast Texas
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Me & You: Building Healthy Relationships
- Keywords
- adolescent behavior, interpersonal relationships, intimate partner violence, violence/prevention & control, program evaluation, teen dating violence
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Me & You: Building Healthy RelationshipsBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Me & You: Building Healthy Relationships | Experimental | 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. Receives: Behavioral: Me & You: Building Healthy Relationships |
| Comparison Group | No intervention | No intervention was provided, only usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of youth who perpetrated any type of teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who were victimized by any type of teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Secondary outcomes (19)
Percent of youth who perpetrated psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who were victimized by psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who perpetrated physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who were victimized by physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who perpetrated sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who were victimized by sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Validated self report measure by Wolfe et al.
Measured: One year
Percent of youth who perpetrated electronic teen dating violence as indicated measures adapted from Picard and Zweig
Validated self report measure by Picard et al. and Zweig et al.
Measured: One year
Percent of youth who were victimized by electronic teen dating violence as indicated measures adapted from Picard and Zweig
Validated self report measure by Picard et al. and Zweig et al.
Measured: One year
Mean score reflecting student norms toward violence for boys and girls as indicated byt the Acceptance of Dating Abuse Survey
Validated self report measure by Foshee et al.
Measured: One year
Mean score for self-efficacy to resolve conflict as indicated by the Teen Conflict Survey
Validated self report measure by Dahlberg et al.
Measured: One year
Percent of youth reported one or more positive coping strategies as indicated by the Kidcope-Child Survey Form
Kidcope-Child Form by Laslo et al.
Measured: One year
Mean score of constructive and destructive conflict resolution skills as indicated by valid scales developed by Foshee et al.
Validated self report measure by Foshee et al.
Measured: One year
Mean score for attitudes towards sexting as indicated by a scale developed by Strassberg et al.
Validated self report measure by Strassberg et al.
Measured: One year
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.
Validated self report measure by Foshee et al.
Measured: One year
Mean score for perceived peer dating violence perpetration (from the perspective of student) - newly developed
newly developed self-report measure
Measured: One year
Mean score for parental communication about drugs, sex, and relationships as indicated by measures developed by Tharp et al.
Validated self report measure by Tharp and Noonan
Measured: One year
Percent of youth who indicated social support from source as indicated by measures adapted from the Social Support Rating Scale
Validated self report measure by Cauce et al.
Measured: One year
Percent of youth who perpetrated bullying as indicated by measures developed by Wang et al.
Validated self report measure by Wang et al.
Measured: One year
Percent of youth who were victimized by bullying as indicated by measures developed from Wang et al.
Validated self report measure by Wang et al.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 834 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Peskin, The University of Texas Health Science Center, Houston
- Investigators
- Melissa Peskin, PhD, Principal investigator, University of Texas Houston School of Public HealthSusan Tortolero Emery, PhD, Principal investigator, University of Texas Houston School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482687
- Sponsor's protocol ID
- HSC-SPH-12-0593
- Status last verified
- Mar 2018
- First submitted
- 25 May 2016
- Last updated
- 29 Mar 2018
- 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- It's Your Game: An Innovative Approach to Preventing Teen Dating Violence
- ClinicalTrials.gov ID
- NCT03482687
- Acronym / sponsor ID
- HSC-SPH-12-0593
- Keywords
- adolescent behavior, interpersonal relationships, intimate partner violence, violence/prevention & control, program evaluation, teen dating violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 29 Mar 2018 (actual)
- 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Me & You: Building Healthy Relationships | Experimental | Behavioral: Me & You: Building Healthy RelationshipsMe \& 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. |
| Comparison Group | No intervention | –No intervention was provided, only usual care. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 6th graders attending regular classes in ten study schools in large, urban school district in Southeast Texas
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Me & You: Building Healthy RelationshipsMe \& 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). | Behavioural | Me & You: Building Healthy Relationships |
Primary outcome
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
Validated self report measure by Wolfe et al.
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
Validated self report measure by Wolfe et al.
19 secondary outcomes
Percent of youth who perpetrated psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time frame: One year
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
Percent of youth who perpetrated physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time frame: One year
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
Percent of youth who perpetrated sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory
Time frame: One year
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
Percent of youth who perpetrated electronic teen dating violence as indicated measures adapted from Picard and Zweig
Time frame: One year
Percent of youth who were victimized by electronic teen dating violence as indicated measures adapted from Picard and Zweig
Time frame: One year
Mean score reflecting student norms toward violence for boys and girls as indicated byt the Acceptance of Dating Abuse Survey
Time frame: One year
Mean score for self-efficacy to resolve conflict as indicated by the Teen Conflict Survey
Time frame: One year
Percent of youth reported one or more positive coping strategies as indicated by the Kidcope-Child Survey Form
Time frame: One year
Mean score of constructive and destructive conflict resolution skills as indicated by valid scales developed by Foshee et al.
Time frame: One year
Mean score for attitudes towards sexting as indicated by a scale developed by Strassberg et al.
Time frame: One year
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
Mean score for perceived peer dating violence perpetration (from the perspective of student) - newly developed
Time frame: One year
Mean score for parental communication about drugs, sex, and relationships as indicated by measures developed by Tharp et al.
Time frame: One year
Percent of youth who indicated social support from source as indicated by measures adapted from the Social Support Rating Scale
Time frame: One year
Percent of youth who perpetrated bullying as indicated by measures developed by Wang et al.
Time frame: One year
Percent of youth who were victimized by bullying as indicated by measures developed from Wang et al.
Time frame: One year
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 29 Mar 2018.
- 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.
Melissa Peskin, PhD principal investigator
University of Texas Houston School of Public Health
Susan Tortolero Emery, PhD principal investigator
University of Texas Houston School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Me & You: Building Healthy Relationships in people with Adolescent Behavior and Interpersonal Relationships, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 2 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 29 Mar 2018. 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. 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?
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). The study lists 2 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 29 Mar 2018.