Intimate Partner ViolenceNCT02236663
Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends
A study testing Personalized App-Based Safety Decision Aid in people with Intimate Partner Violence, run by Johns Hopkins University at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Personalized App-Based Safety Decision Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 649 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2015to 7 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
University of Missouri
Columbia, Missouri, 65233
Arizona State University
Phoenix, Arizona, 85004
Kaiser Foundation Research Institute
Portland, Oregon, 97239
About this study
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.
- Conditions
- Intimate Partner Violence
- Being tested
- Usual Care Safety Planing App, Personalized App-Based Safety Decision Aid
- Keywords
- Intimate Partner Violence, Dating Violence, Relationships, Safety Planning, College, Student, App
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care Safety Planing AppBehavioural
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.
Personalized App-Based Safety Decision AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| App Based Safety Decision Aid | Experimental | Personalized App-Based Safety Decision Aid Receives: Behavioral: Personalized App-Based Safety Decision Aid |
| Control App | Active comparator | Usual Care Safety Plan Receives: Behavioral: Usual Care Safety Planing App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 months
Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months
The CAS is a 30 item validated comprehensive intimate partner violence screening measure with
Measured: Baseline, 12 months
Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo
Measured: Baseline, 12 month
Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months
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.
Measured: Baseline, 12 months
Changes from baseline in friends' attitudes on the Intimate Partner Violence on the Acceptance of Dating Violence Scale at 12 months
5 item scale used to measures norms that support violence.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Arizona State University, University of Missouri-Columbia, Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Nancy Glass, PhD, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236663
- Sponsor's protocol ID
- NA_00054334
- Other IDs
- 1R01HD076881-01A1
- Status last verified
- Jun 2020
- First submitted
- 8 Sep 2014
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37259087Glass 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.
PubMed 33576291Glass 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.
PubMed 26350482
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Safety App to Respond to Dating Violence for College Women and Their Friends
- ClinicalTrials.gov ID
- NCT02236663
- Acronym / sponsor ID
- NA_00054334
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate Partner Violence, Dating Violence, Relationships, Safety Planning, College, Student, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 649 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Arizona State University, University of Missouri-Columbia, Kaiser Permanente
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App Based Safety Decision Aid | Experimental | Behavioral: Personalized App-Based Safety Decision AidPersonalized App-Based Safety Decision Aid |
| Control App | Active comparator | Behavioral: Usual Care Safety Planing AppUsual Care Safety Plan |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care Safety Planing AppThe 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. | Behavioural | Control App |
| Personalized App-Based Safety Decision AidSetting 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. | Behavioural | App Based Safety Decision Aid |
Primary outcome
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.
Change from baseline in survivors' and friends' decisional conflict on Decisional Conflict Scale (DCS) immediately post intervention.
Time frame: Baseline, 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.
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
19 times scale adapted to assess friends of survivors' confidence to intervene.
Changes from baseline in friends' supportive behaviors on Supportive Behaviors Checklist at 12 months
Time frame: Baseline, 12 months
Assesses supportive behaviors used to assist a friend experiencing intimate partner violence.
5 secondary outcomes
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
Change from baseline in survivors' abuse exposure on the Composite Abuse Scale (CAS) at 12 months
Time frame: Baseline, 12 months
Change from baseline in survivors' and friends' Decisional Conflict on Decisional Conflict Scale at 12 mo
Time frame: Baseline, 12 month
Change from baseline in survivor' depression on Center for Epidemiologic Studies Depression Scale, Revised at 12 months
Time frame: Baseline, 12 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Derived from this study: PubMed 37259087Bloom 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.
- Derived from this study: PubMed 33576291Glass 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.
- Derived from this study: PubMed 26350482Glass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Glass, PhD principal investigator
Johns Hopkins University School of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized App-Based Safety Decision Aid in people with Intimate Partner Violence, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in survivors' use of safety strategies on Safety Behavior Checklist at 12 months (time frame: Baseline, 12 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236663, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.