NCT04564261

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
617

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

September 21, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

December 6, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2022

Completed
Last Updated

September 2, 2022

Status Verified

July 1, 2022

Enrollment Period

1.7 years

First QC Date

September 21, 2020

Last Update Submit

September 1, 2022

Conditions

Keywords

Intimate Partner ViolenceDating ViolenceRelationshipsSafety PlanningAdolescentTechnologyAppTeen

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI)

    Baseline, 3-, 6-, 12-months

  • Change from baseline in survivors' depression measured by Pediatric Depressive Symptoms - Short Form 8a.

    Baseline, 3-, 6-, 12-months

Study Arms (2)

myPlan Teen Group

EXPERIMENTAL

Personalized Healthy Relationship and Safety Planning Tool.

Behavioral: Personalized Healthy Relationship and Safety Planning Tool

Usual Care Teen Control Group

ACTIVE COMPARATOR

Usual Care Teen Relationships and Health Resource.

Behavioral: Usual Care Teen Relationship and Health Website

Interventions

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.

Also known as: myPlan Teen
myPlan Teen Group

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.

Usual Care Teen Control Group

Eligibility Criteria

Age15 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

University of Missouri

Columbia, Missouri, 65233, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Nancy E Glass, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2020

First Posted

September 25, 2020

Study Start

December 6, 2020

Primary Completion

August 25, 2022

Study Completion

August 25, 2022

Last Updated

September 2, 2022

Record last verified: 2022-07

Locations