NCT03482687

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
834

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.7 years

First QC Date

May 25, 2016

Last Update Submit

March 22, 2018

Conditions

Adolescent BehaviorInterpersonal RelationshipsDomestic ViolencePhysical Violence

Keywords

adolescent behaviorinterpersonal relationshipsintimate partner violenceviolence/prevention & controlprogram evaluationteen dating violence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (19)

  • Percent of youth who perpetrated psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory

    One year

  • Percent of youth who were victimized by psychological teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory

    One year

  • Percent of youth who perpetrated physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory

    One year

  • Percent of youth who were victimized by physical teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory

    One year

  • Percent of youth who perpetrated sexual teen dating violence as indicated by the Conflict in Adolescent Dating Relationships Inventory

    One year

  • +14 more secondary outcomes

Study Arms (2)

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.

Behavioral: Me & You: Building Healthy Relationships

Comparison Group

NO INTERVENTION

No intervention was provided, only usual care.

Interventions

Me & You: Building Healthy RelationshipsBEHAVIORAL

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).

Me & You: Building Healthy Relationships

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th graders attending regular classes in ten study schools in large, urban school district in Southeast Texas

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melissa Fleschler Peskin

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Health Promotion and Behavioral Sciences

Study Record Dates

First Submitted

May 25, 2016

First Posted

March 29, 2018

Study Start

September 1, 2012

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)