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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05225727
Other study ID # HSC-SPH-19-0253
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date May 2024

Study information

Verified date May 2024
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 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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 Design


Intervention

Behavioral:
Me & You - Tech
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).

Locations

Country Name City State
United States University of Texas Health Science Center at Houston Houston Texas

Sponsors (3)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston Radiant Creative Group, LLC, University of Texas

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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