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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04564261
Other study ID # IRB00241935
Secondary ID R01CE002979
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2020
Est. completion date August 25, 2022

Study information

Verified date July 2022
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 617
Est. completion date August 25, 2022
Est. primary completion date August 25, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Johns Hopkins University School of Nursing Baltimore Maryland
United States University of Missouri Columbia Missouri

Sponsors (3)

Lead Sponsor Collaborator
Johns Hopkins University Centers for Disease Control and Prevention, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in safety behaviors measured by the Safety Behavior Checklist 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. Baseline, 3-, 6-, 12-months
Primary Change from baseline in State of Change in Enacting Safety Behaviors 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. Baseline, 3-, 6-, 12-months
Secondary Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI) 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 Baseline, 3-, 6-, 12-months
Secondary Change from baseline in survivors' depression measured by Pediatric Depressive Symptoms - Short Form 8a. 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). Baseline, 3-, 6-, 12-months
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