Intimate Partner ViolenceNCT04564261
Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
A study testing Personalized Healthy Relationship and Safety Planning Tool in people with Intimate Partner Violence, run by Johns Hopkins University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Personalized Healthy Relationship and Safety Planning Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 617 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Dec 2020to 25 Aug 2022
- 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 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
University of Missouri
Columbia, Missouri, 65233
About this study
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.
- Conditions
- Intimate Partner Violence
- Being tested
- Personalized Healthy Relationship and Safety Planning Tool, Usual Care Teen Relationship and Health Website
- Keywords
- Intimate Partner Violence, Dating Violence, Relationships, Safety Planning, Adolescent, Technology, App, Teen
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Healthy Relationship and Safety Planning ToolBehavioural
Also called myPlan Teen
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 WebsiteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| myPlan Teen Group | Experimental | Personalized Healthy Relationship and Safety Planning Tool. Receives: Behavioral: Personalized Healthy Relationship and Safety Planning Tool |
| Usual Care Teen Control Group | Active comparator | Usual Care Teen Relationships and Health Resource. Receives: Behavioral: Usual Care Teen Relationship and Health Website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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
Measured: Baseline, 3-, 6-, 12-months
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).
Measured: Baseline, 3-, 6-, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 Dec 2020
- Primary completion25 Aug 2022
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Nancy E Glass, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564261
- Sponsor's protocol ID
- IRB00241935
- Other IDs
- R01CE002979
- Status last verified
- Jul 2022
- First submitted
- 21 Sep 2020
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
- ClinicalTrials.gov ID
- NCT04564261
- Acronym / sponsor ID
- IRB00241935
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate Partner Violence, Dating Violence, Relationships, Safety Planning, Adolescent, Technology, App, Teen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, University of Missouri-Columbia
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 25 Aug 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 25 Sep 2020 (actual)
- 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myPlan Teen Group | Experimental | Behavioral: Personalized Healthy Relationship and Safety Planning ToolPersonalized Healthy Relationship and Safety Planning Tool. |
| Usual Care Teen Control Group | Active comparator | Behavioral: Usual Care Teen Relationship and Health WebsiteUsual Care Teen Relationships and Health Resource. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Personalized Healthy Relationship and Safety Planning ToolAlso: myPlan TeenThe 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. | Behavioural | myPlan Teen Group |
| Usual Care Teen Relationship and Health WebsiteThe 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. | Behavioural | Usual Care Teen Control Group |
Primary outcome
Change from baseline in safety behaviors measured by the Safety Behavior Checklist
Time frame: Baseline, 3-, 6-, 12-months
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.
Change from baseline in State of Change in Enacting Safety Behaviors
Time frame: Baseline, 3-, 6-, 12-months
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.
2 secondary outcomes
Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI)
Time frame: Baseline, 3-, 6-, 12-months
Change from baseline in survivors' depression measured by Pediatric Depressive Symptoms - Short Form 8a.
Time frame: Baseline, 3-, 6-, 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 Sep 2022.
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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 E Glass, PhD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Healthy Relationship and Safety Planning Tool in people with Intimate Partner Violence, run by Johns Hopkins University at 2 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 6 inclusion and 6 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 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 safety behaviors measured by the Safety Behavior Checklist (time frame: Baseline, 3-, 6-, 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2022.