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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03482687
Other study ID # HSC-SPH-12-0593
Secondary ID
Status Completed
Phase N/A
First received May 25, 2016
Last updated March 22, 2018
Start date September 2012
Est. completion date May 2015

Study information

Verified date March 2018
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 834
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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 Design


Intervention

Behavioral:
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. 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).

Locations

Country Name City State
United States Melissa Fleschler Peskin Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. One year
Primary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary 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. One year
Secondary Mean score for self-efficacy to resolve conflict as indicated by the Teen Conflict Survey Validated self report measure by Dahlberg et al. One year
Secondary 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. One year
Secondary 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. One year
Secondary Mean score for attitudes towards sexting as indicated by a scale developed by Strassberg et al. Validated self report measure by Strassberg et al. One year
Secondary 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. One year
Secondary Mean score for perceived peer dating violence perpetration (from the perspective of student) - newly developed newly developed self-report measure One year
Secondary 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 One year
Secondary 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. One year
Secondary Percent of youth who perpetrated bullying as indicated by measures developed by Wang et al. Validated self report measure by Wang et al. One year
Secondary 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. One year
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