- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236663
Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends
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:
- 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
- dissemination of the App nationally to determine the reach, adoption, implementation and maintenance of App use among university/college students.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85004
- Arizona State University
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Nursing
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Missouri
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Columbia, Missouri, United States, 65233
- University of Missouri
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Oregon
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Portland, Oregon, United States, 97239
- Kaiser Foundation Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: App Based Safety Decision Aid
Personalized App-Based Safety Decision Aid
|
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. |
Active Comparator: Control App
Usual Care Safety Plan
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in survivors' use of safety strategies on Safety Behavior Checklist at 12 months
Time Frame: Baseline, 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.
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Baseline, 12 Months
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Change from baseline in survivors' and friends' decisional conflict on Decisional Conflict Scale (DCS) immediately post intervention.
Time Frame: Baseline, immediately post intervention
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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.
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Baseline, immediately post intervention
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Change from baseline in friends' efficacy to intervene on adapted Self-efficacy to Deal with Violence Scale at 12 months
Time Frame: Baseline, 12 months
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19 times scale adapted to assess friends of survivors' confidence to intervene.
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Baseline, 12 months
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Changes from baseline in friends' supportive behaviors on Supportive Behaviors Checklist at 12 months
Time Frame: Baseline, 12 months
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Assesses supportive behaviors used to assist a friend experiencing intimate partner violence.
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Baseline, 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in survivors' drug and alcohol use on adapted Monitoring the Future Drug and Alcohol Questionnaire at 12 months.
Time Frame: Baseline, 12 months
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Baseline, 12 months
|
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Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months
Time Frame: Baseline, 12 months
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The CAS is a 30 item validated comprehensive intimate partner violence screening measure with
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Baseline, 12 months
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Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo
Time Frame: Baseline, 12 month
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Baseline, 12 month
|
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Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months
Time Frame: Baseline, 12 months
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A 20-item self report measure, designed to screen for depressive symptoms in community samples and assess the probability that an individual meets the criteria for major depressive disorder.
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Baseline, 12 months
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Changes from baseline in friends' attitudes on the Intimate Partner Violence on the Acceptance of Dating Violence Scale at 12 months
Time Frame: Baseline, 12 months
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5 item scale used to measures norms that support violence.
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Baseline, 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Glass, PhD, Johns Hopkins University School of Nursing
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NA_00054334
- 1R01HD076881-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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