- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05225727
Me & You-Tech: A Socio-Ecological Solution to Teen Dating Violence for the Digital Age (MYTech)
May 7, 2024 updated by: Melissa Peskin, The University of Texas Health Science Center, Houston
The purpose of this study is to develop and evaluate a multi-level (youth, parent, school) Internet-based dating violence prevention program, 'Me & You-Tech' (MYT) for 6th-grade middle school students.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
Detailed Description
The purpose of this three year study is to develop and evaluate Me & You - Tech, a computer-based healthy relationships and dating violence prevention curriculum for 6th grade students.
The curriculum will be developed and adapted from an existing effective healthy relationship curriculum, Me & You: Building Healthy Relationships.
A randomized two-arm design will be conducted among 6th grade students, where students receiving the curriculum were compared to students receiving usual care.
Four middle schools participated in the study, 2 schools were randomly assigned to receive the curriculum and two to receive usual care.
Outcomes were assessed at baseline, 3 months following completion of the intervention, and 9 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 teen dating violence perpetration than those who do not receive the curriculum.
Study Type
Interventional
Enrollment (Estimated)
300
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
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
-
-
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
Description
Inclusion Criteria:
- 6th grade student
- Currently attending a middle school
Exclusion Criteria:
- Previous participation in usability and feasibility testing
- Inability to complete activities
- Inability to read English
- Lack of home internet connectivity
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 |
---|---|
Experimental: Intervention
Students randomized to the intervention group will receive Me & You Tech in place of their standard health education.
|
The 13 MYT lessons will train youth to adopt a zero tolerance approach to dating violence (DV) and contain activities to enable youth to recognize healthy (non-abusive) and unhealthy (abusive) relationships, assess their own relationships, and adopt and practice a lifestyle paradigm of select-detect-protect informed by SCT self-regulatory frameworks.
Within this lifestyle paradigm, youth select their personal rules to have only healthy (non-abusive) relationships, detect unhealthy (abusive) relationships that might threaten their rules, and learn to protect their rules using communication, management, and avoidance skills.
MYT will tailor content by gender, relationship status, and the youth's DV profile of perpetration or victimization based on the Conflict in Adolescent Dating and Relationship Inventory (CADRI).
|
No Intervention: Control
Students assigned to the standard care condition will receive their usual health education which usually includes knowledge-based content on violence prevention taught from the state textbook
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
Time Frame: One year
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
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
|
Validated self report measure by Wolfe et al.
|
One year
|
Percent of youth who perpetrated electronic teen dating violence as indicated measures adapted from Picard and Zweig
Time Frame: One year
|
Validated self report measure by Picard et al. and Zweig et al.
|
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
|
Validated self report measure by Picard et al. and Zweig et al.
|
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
|
Validated self report measure by Foshee et al.
|
One year
|
Mean score for self-efficacy to resolve conflict as indicated by the Teen Conflict Survey
Time Frame: One year
|
Validated self report measure by Dahlberg et al.
|
One year
|
Percent of youth reported one or more positive coping strategies as indicated by the Kidcope-Child Survey Form
Time Frame: One year
|
Kidcope-Child Form by Laslo et al
|
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
|
Validated self report measure by Foshee et al.
|
One year
|
Mean score for attitudes towards sexting as indicated by a scale developed by Strassberg et al.
Time Frame: One year
|
Validated self report measure by Strassberg et al.
|
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
|
Validated self report measure by Foshee et al.
|
One year
|
Mean score for perceived peer dating violence perpetration (from the perspective of student) - newly developed
Time Frame: One year
|
newly developed self-report measure
|
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
|
Validated self report measure by Tharp and Noonan
|
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
|
Validated self report measure by Cauce et al.
|
One year
|
Percent of youth who perpetrated bullying as indicated by measures developed by Wang et al.
Time Frame: One year
|
Validated self report measure by Wang et al.
|
One year
|
Percent of youth who were victimized by bullying as indicated by measures developed from Wang et al.
Time Frame: One year
|
Validated self report measure by Wang et al.
|
One year
|
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: Ross Shegog, 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 (Actual)
October 1, 2022
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
January 24, 2022
First Submitted That Met QC Criteria
January 24, 2022
First Posted (Actual)
February 4, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2024
Last Update Submitted That Met QC Criteria
May 7, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SPH-19-0253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Domestic Violence
-
Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
-
Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
-
University of the Virgin IslandsUnknownDomestic Violence | Domestic AbuseVirgin Islands (U.S.)
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
-
Funmilola OlaOlorunUniversity of IbadanCompletedDomestic Violence | Violence | AttitudeNigeria
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Yale UniversityOffice on Violence Against Women (OVW)Not yet recruiting
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingDomestic ViolencePeru
-
Medical University of South CarolinaAgency for Healthcare Research and Quality (AHRQ)Completed
Clinical Trials on Me & You - Tech
-
VA Office of Research and DevelopmentCompleted
-
The University of Texas Health Science Center,...CompletedDomestic Violence | Adolescent Behavior | Physical Violence | Interpersonal RelationshipsUnited States
-
University of Split, School of MedicineRecruitingDry Skin; Eczema | Skin HyperpigmentationCroatia
-
University of South CarolinaCompleted
-
Medical College of WisconsinTerminatedDiabetes Mellitus, Type 2United States
-
University of Alabama at BirminghamNot yet recruitingType 2 Diabetes | Physical Disability
-
Mayo ClinicCompleted
-
University of South CarolinaUnknown
-
The University of Texas Health Science Center,...National Institute of Mental Health (NIMH)CompletedSexually Transmitted Diseases | HIVUnited States
-
University of OxfordEuropean and Developing Countries Clinical Trials Partnership (EDCTP)Completed