- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564261
Examining the Effectiveness of the myPlan App to Prevent Dating Violence With Adolescents
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Nursing
-
-
Missouri
-
Columbia, Missouri, United States, 65233
- University of Missouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: myPlan Teen Group
Personalized Healthy Relationship and Safety Planning Tool.
|
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.
Other Names:
|
|
ACTIVE_COMPARATOR: Usual Care Teen Control Group
Usual Care Teen Relationships and Health Resource.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 3-, 6-, 12-months
|
|
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.
|
Baseline, 3-, 6-, 12-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in survivors' dating abuse experience measured by Conflict in Adolescent Dating Relationships Inventory (CADRI)
Time Frame: Baseline, 3-, 6-, 12-months
|
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
|
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
|
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).
|
Baseline, 3-, 6-, 12-months
|
Collaborators and Investigators
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 (ACTUAL)
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
- IRB00241935
- R01CE002979 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Intimate Partner Violence
-
Yale UniversityNational Science Foundation; Grand Challenges Canada; Weiss Foundation; World Bank... and other collaboratorsActive, not recruitingIntimate Partner Violence (IPV) | Intimate Partner Violence PreventionBangladesh
-
Uppsala UniversityNot yet recruitingIntimate Partner Violence | Resilience, Psychological | Shame | Intimate Partner Violence Against Women | Domestic AbuseSweden
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedDomestic Violence | Intimate Partner ViolenceUnited States
-
NMP Medical Research InstituteWarwick Research Services; Arsha Vidya Study Centre, Tamilnadu, IndiaCompletedDomestic Violence | Intimate Partner ViolenceIndia
-
Yale UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Active, not recruitingIntimate Partner ViolenceUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIntimate Partner ViolenceUnited States
-
Northeastern UniversityRhode Island HospitalCompleted
-
Columbia UniversityNational Institute on Drug Abuse (NIDA)Completed
-
Joanne KlevensUniversity of Michigan; The Community Health and Social Services Center, Inc.Completed
-
Karolinska InstitutetRegion Stockholm; Jane and Dan Olsson Foundation for Scientific PurposesCompletedDomestic Violence | Family Violence | Intimate-partner ViolenceSweden
Clinical Trials on Personalized Healthy Relationship and Safety Planning Tool
-
Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaCompletedViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
-
Central FITT, IncUnknown
-
University GhentUniversity Hospital, Ghent; AZ Sint-Jan AV; Algemeen Ziekenhuis Maria Middelares and other collaboratorsCompletedHealthy Volunteers | Aortic Aneurysm, AbdominalBelgium
-
University of WashingtonNational Institute of Mental Health (NIMH); Seattle Children's HospitalRecruitingSuicidal Ideation | Suicidal BehaviorUnited States
-
Ohio State UniversityMedical University of South CarolinaRecruitingSuicidal Ideation | Emotion Regulation | Treatment RefusalUnited States
-
Western University, CanadaJohns Hopkins University; University of British Columbia; Canadian Institutes... and other collaboratorsCompletedDomestic ViolenceCanada
-
New York State Psychiatric InstituteUniversity of Pennsylvania; Columbia University; University of Massachusetts,... and other collaboratorsCompleted
-
Duke UniversityCompletedType II DiabetesUnited States
-
University of PennsylvaniaNational Institute of Allergy and Infectious Diseases (NIAID); University of...Completed
-
Duke UniversityCompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus | Health Behavior | Group MeetingsUnited States