NCT02236663

Brief Summary

Intimate partner violence (IPV), including violence in dating relationships (dating violence, DV) is a widespread and serious public health problem. Among U.S. female IPV survivors, 47.1% report their first abusive relationship occurred at college age (age 18-24). Similarly, in national surveys, adults respondents 18-24 years of age report the highest rate of stalking victimization, most commonly by a former intimate partner. Safety planning is the most widely used intervention to prevent and respond to IPV, yet the vast majority of abused women never access safety planning services. Our challenge is to increase college women's access to safety planning, with the opportunity to consider their unique safety priorities and level of danger during and when ending an abusive relationship. In addition, while "bystander" interventions that train peers to safely intervene have been shown to be effective in sexual assault prevention on campus, and college women in abusive relationships most frequently disclose IPV to a friend, no similar interventions have been tested with friends for IPV response on campuses. Therefore, the objective of the study is to evaluate the:

  1. 1.effectiveness of an interactive, personalized smart phone and web based safety application ("App") intervention in Maryland and Oregon with: 1) college women (age 18-24) who experience IPV and 2) friends (age 18-24) of women experiencing IPV. The safety decision App allows the user to enter information on: a) relationship health; b) safety priorities; and c) severity of violence/danger in relationship. The App then uses the information to provide the user with a personalized safety planning information and resources; and
  2. 2.dissemination of the App nationally to determine the reach, adoption, implementation and maintenance of App use among university/college students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2020

Completed
Last Updated

June 2, 2020

Status Verified

June 1, 2020

Enrollment Period

2.3 years

First QC Date

September 8, 2014

Last Update Submit

June 1, 2020

Conditions

Keywords

Intimate Partner ViolenceDating ViolenceRelationshipsSafety PlanningCollegeStudentApp

Outcome Measures

Primary Outcomes (4)

  • Change from baseline in survivors' use of safety strategies on Safety Behavior Checklist at 12 months

    Adapted from Intimate Partner Violence Strategies Index to assess for survivors the range of strategies used to halt, escape, or resist violence, and the helpfulness of each strategy.

    Baseline, 12 Months

  • Change from baseline in survivors' and friends' decisional conflict on Decisional Conflict Scale (DCS) immediately post intervention.

    The DCS consists of twelve items, with each question having three response options (yes, no, and unsure). The DCS provides a total score, which is a measure of the decision process, as well as scores for four subscales (feeling informed, certainty about decision, values clarity, and support), with higher scores on the DCS indicating a greater degree of decisional conflict (indicative of a poorer decision process). Will be used to assess decisional conflict with survivors and friends.

    Baseline, immediately post intervention

  • Change from baseline in friends' efficacy to intervene on adapted Self-efficacy to Deal with Violence Scale at 12 months

    19 times scale adapted to assess friends of survivors' confidence to intervene.

    Baseline, 12 months

  • Changes from baseline in friends' supportive behaviors on Supportive Behaviors Checklist at 12 months

    Assesses supportive behaviors used to assist a friend experiencing intimate partner violence.

    Baseline, 12 months

Secondary Outcomes (5)

  • Change from baseline in survivors' drug and alcohol use on adapted Monitoring the Future Drug and Alcohol Questionnaire at 12 months.

    Baseline, 12 months

  • Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months

    Baseline, 12 months

  • Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo

    Baseline, 12 month

  • Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months

    Baseline, 12 months

  • Changes from baseline in friends' attitudes on the Intimate Partner Violence on the Acceptance of Dating Violence Scale at 12 months

    Baseline, 12 months

Study Arms (2)

App Based Safety Decision Aid

EXPERIMENTAL

Personalized App-Based Safety Decision Aid

Behavioral: Personalized App-Based Safety Decision Aid

Control App

ACTIVE COMPARATOR

Usual Care Safety Plan

Behavioral: Usual Care Safety Planing App

Interventions

The control group App will provide women and friends with basic safety planning information and a brief resource list of IPV resources. The resources will be targeted to college students age 18-24 years. The control group App safety plan is not personalized to woman/friend's safety priorities and danger in the relationship.

Control App

Setting of priorities for safety: participants will establish priorities by making pairwise comparisons of importance between 5 factors. Danger Assessment: asks participants to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger and safety planning information and resources based on their level of danger. Personalized action plan: Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented tailored to their level of danger and priority settings. The participant is given the option to print results and the personalized plan.

App Based Safety Decision Aid

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females who report current physical violence, sexual violence, psychological abuse or stalking by a dating/intimate/ex-intimate partner, or who have a female friend currently experiencing abuse from dating/intimate/ex-intimate partner.
  • Males who have a female friend currently experiencing physical violence, sexual violence, psychological abuse or stalking by a dating/intimate/ex-intimate partner
  • English speaking
  • Between the ages of 18-24 years old
  • Attend a college in Maryland or Oregon
  • Enrolled in college or university (at least part time)
  • Have access to a safe smart-phone or computer with internet and are comfortable downloading an app or using the internet
  • Have a safe email address

You may not qualify if:

  • Younger than 18 years of age
  • Older than 24 years of age
  • Cannot read/speak English
  • Live outside targeted states
  • No access to safe smart phone or computer with internet
  • Uncomfortable with downloading an app
  • No access to a safe email address
  • Does not report current violence from an intimate partner or having a female friend that has experienced intimate partner violence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

University of Missouri

Columbia, Missouri, 65233, United States

Location

Kaiser Foundation Research Institute

Portland, Oregon, 97239, United States

Location

Related Publications (3)

  • Bloom TL, Perrin N, Brown ML, Campbell J, Clough A, Grace KT, Laughon K, Messing J, Eden KB, Turner R, Glass N. Concerned friends of intimate partner violence survivors: results from the myPlan randomized controlled trial on college campuses. BMC Public Health. 2023 May 31;23(1):1033. doi: 10.1186/s12889-023-15918-y.

  • Glass NE, Clough A, Messing JT, Bloom T, Brown ML, Eden KB, Campbell JC, Gielen A, Laughon K, Grace KT, Turner RM, Alvarez C, Case J, Barnes-Hoyt J, Alhusen J, Hanson GC, Perrin NA. Longitudinal Impact of the myPlan App on Health and Safety Among College Women Experiencing Partner Violence. J Interpers Violence. 2022 Jul;37(13-14):NP11436-NP11459. doi: 10.1177/0886260521991880. Epub 2021 Feb 12.

  • Glass N, Clough A, Case J, Hanson G, Barnes-Hoyt J, Waterbury A, Alhusen J, Ehrensaft M, Grace KT, Perrin N. A safety app to respond to dating violence for college women and their friends: the MyPlan study randomized controlled trial protocol. BMC Public Health. 2015 Sep 8;15:871. doi: 10.1186/s12889-015-2191-6.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Nancy Glass, PhD

    Johns Hopkins University School of Nursing

    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 8, 2014

First Posted

September 10, 2014

Study Start

July 1, 2015

Primary Completion

October 1, 2017

Study Completion

February 7, 2020

Last Updated

June 2, 2020

Record last verified: 2020-06

Locations