Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents

• ClinicalTrials.gov Identifier: NCT04564261
• Recruitment Status: Active, not recruiting
• First Posted: September 25, 2020
• Last Update Posted: October 19, 2021
• Sponsor: Johns Hopkins University
• Collaborators: Centers for Disease Control and Prevention; University of Missouri-Columbia
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

Brief Summary:

Intimate partner violence (IPV), including violence in teen dating relationships [teen dating violence (TDV)], is a common and a serious threat to adolescent health, safety, and well-being. TDV may include psychological/emotional abuse, sexual harassment or coercion, stalking (including cyberstalking), and physical or sexual violence. For many, the first experience of violence is in a dating or casual relationship with a partner or acquaintance during adolescence. Therefore, the objective of this study is to examine the effectiveness of an adapted version of the myPlan app for adolescents (ages 15-17 years) to prevent and respond to TDV. myPlan is an app available for mobile download or by web browser that interactively assists users to assess the health and safety of user's intimate relationship, receive personalized strategies on how build healthier relationships, stay safe and healthy while navigating an unsafe relationship, and get connected to support and resources.

Condition or disease	Intervention/treatment	Phase
Intimate Partner Violence	Behavioral: Personalized Healthy Relationship and Safety Planning Tool; Behavioral: Usual Care Teen Relationship and Health Website	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 617 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
• Actual Study Start Date: December 6, 2020
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: July 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: myPlan Teen Group; Personalized Healthy Relationship and Safety Planning Tool.	Behavioral: Personalized Healthy Relationship and Safety Planning Tool; The app delivers evidence-based information and resources in three sections: My Relationship: contains a series of activities (e.g., "quizzes") to raise awareness of common myths about unhealthy relationships, determine characteristics of healthy relationships, examine the red flags in an unhealthy relationship, and assess risk factors for more severe abuse. Participants are provided with personalized messages about their relationship health and safety based on the answers they endorse. My Strategies: personalized strategies to increase participants' safety and well-being based on responses in the previous section. My Resources: direct links to the National Dating Abuse hotline, textline, and chatline, as well as personalized health and safety resources.; Other Name: myPlan Teen
Active Comparator: Usual Care Teen Control Group; Usual Care Teen Relationships and Health Resource.	Behavioral: Usual Care Teen Relationship and Health Website; The control group website will provide participants with tools to learn about health topics including examining healthy relationships. The resources will be targeted to adolescents. The control group website is not personalized to the participant or their relationship.

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in safety behaviors measured by the Safety Behavior Checklist [ Time Frame: Baseline, 3-, 6-, 12-months ]
   Percent of safety behaviors that a person has tried that they found helpful measured on checklist adapted from Intimate Partner Violence Strategies Index to assess for the range of formal and informal help seeking strategies used to halt, escape, or resist violence, and the helpfulness of each strategy.
2. Change from baseline in State of Change in Enacting Safety Behaviors [ Time Frame: Baseline, 3-, 6-, 12-months ]
   Score on a 0 - 5 scale indicating stage a person is in with regard to taking action to make their relationship healthy with 0 indicating no action and 5 indicating full action.

Secondary Outcome Measures :

1. Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI) [ Time Frame: Baseline, 3-, 6-, 12-months ]
   CADRI is an 11 item scale with a 5 point response scale (never to always) that measures the frequency of experiencing different forms of dating abuse
2. Change from baseline in survivors' depression measured by Pediatric Depressive Symptoms - Short Form 8a. [ Time Frame: Baseline, 3-, 6-, 12-months ]
   The Pediatric Depressive Symptoms - SF 8a is an 8 items scale with a 5 point response scale (never to always) that measures the frequency of different depressive symptoms. It was developed as part of the Patient-Reported Outcomes Measurement Information System (PROMIS).

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Between the ages of 15-17 years old
• Lives in the United States
• Reports current or past 6 months physical violence, sexual violence, emotional abuse, verbal abuse, or staking (including cyberstalking or electronic aggression) by a dating/casual/intimate/ex-intimate partner
• Speaks/reads English
• Has access to a safe device (e.g., smartphone, tablet, or computer) with internet access and comfortable downloading an app or using the internet
• Has a safe contact phone number or email address

Exclusion Criteria:

• Younger than 15 years of age
• Older than 17 years of age
• Does not report current or past 6 months abuse from a dating/casual/intimate/ex- intimate partner
• Does not speak/read English
• Does not have access to a safe device (e.g., smartphone, tablet, or computer) with internet access
• Does not have a safe contact phone number or email address

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins University School of Nursing

Baltimore, Maryland, United States, 21205

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65233

Sponsors and Collaborators

Johns Hopkins University

Centers for Disease Control and Prevention

University of Missouri-Columbia

Investigators

• Principal Investigator: Nancy E Glass, PhD; Johns Hopkins University

More Information

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT04564261
• Other Study ID Numbers: IRB00241935; R01CE002979 ( U.S. NIH Grant/Contract )
• First Posted: September 25, 2020
• Last Update Posted: October 19, 2021
• Last Verified: October 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins University:

Intimate Partner Violence; Dating Violence; Relationships; Safety Planning; Adolescent; Technology; App; Teen