Offensive AggressionPLRNCT02080923
A Brief Intervention to Prevent Adolescent Dating Aggression Perpetration
A study testing Brief Motivational Interview in people with Offensive Aggression and Sexual Aggression, run by Boston University at 1 site in United States.
Trial summary
The proposed study is a test of the feasibility and preliminary efficacy of a brief motivational interview style intervention. The intervention will take place in the pediatric emergency department of the Boston University Medical Center by a trained interventionist and will follow an intervention manual developed by… Read more about this study
- Who is it for?
- Ages 15 to 19 years
- Conditions the study is for
- Offensive Aggression, Sexual Aggression, Dating Violence Perpetration and Victimization
- What is being tested?
- Brief Motivational Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 13 Jun 2017
- 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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- must be a patient of the Pediatric Emergency Department or adolescent outpatient center at the Boston University Medical Center
- must be 15-19 years old
- have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months
- English-speaking
Who cannot join
- patient's reason for visit to the healthcare center is an acute mental health problem
- patient is a prisoner or juvenile detainee
- patient is determined to be a potentially lethal dating abuse offender based on a lethality checklist
- patient has cognitive or psychiatric limitations that render him/her unable to complete the eligibility form independently
- currently attending a batterer intervention program
- receiving care for violent trauma victimization
- appears intoxicated or high on drugs at the time of eligibility screening, or has informed medical staff that they are
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University School of Public Health
Boston, Massachusetts, 02118
About this study
The proposed study is a test of the feasibility and preliminary efficacy of a brief motivational interview style intervention. The intervention will take place in the pediatric emergency department of the Boston University Medical Center by a trained interventionist and will follow an intervention manual developed by a team of dating abuse and brief intervention experts. The study will involve two randomized groups of youth age 15-19: one group will receive the intervention and the other will not. The study will compare changes in data from baseline to 3- and 6-month follow-up for those in both groups. Outcomes including dating abused related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization) will be assessed.
The hypothesis of this study is that youth who receive the intervention will show improvements in dating abuse related knowledge, attitudes and behavior that are maintained for 6 months, while those in the control group will show no similar change.
Read the detailed description
Emergency departments offer a unique setting through which we can reach adolescents who have perpetrated Adolescent Dating Aggression (ADA). The Project READY (Reducing Aggression in Dating Relationships for Youth) brief intervention manual and training was developed by Dr. Emily Rothman, who is a former shelter worker, batterer intervention counselor, and dating violence expert, with input from research experts in brief intervention, an expert in adolescent batterer intervention, psychologists, low-income youth of color from the Start Strong Initiative, and others, with funding from the National Institutes of Health (NIH). The READY intervention intercepts youth who utilize an urban emergency department for non-acute health care needs (e.g., cuts, sprains), provides them with tailored feedback about their relationship behavior, and uses motivational interviewing techniques and prepared worksheets to move them forward on a readiness-to-change continuum towards non-violent and respectful relationship behavior. For example, after being provided with information about acts considered unhealthy in a relationship, a participant is asked to generate a list of "pros and cons" about what he or she does to solve conflicts with partners, brainstorm alternatives that he or she would use, list reasons why the alternatives might not work in the moment, and troubleshoot those potential problems. Participants are then offered a menu of referrals and invited to select those that they would use (e.g., free mental health and substance abuse counseling, sexual health testing, gang prevention resources).
The randomized controlled trial (RCT) research study will build upon our completed small-scale feasibility pilot project, which was conducted in 2012- 13. For the proposed study, we will recruit a sample large enough to evaluate whether the intervention improves ADA-related knowledge, positively changes ADA-related attitudes and behavioral intentions, and reduces self-reported perpetration behavior after 3- and 6-month follow-up periods. The study will enroll youth ages 15-19 years old. Notably, the setting for this intervention test will be an urban pediatric emergency department that primarily serves low income youth.
- Being tested
- Brief Motivational Interview
- Keywords
- Adolescent, Adolescent Behavior, Age Factors, Courtship, Randomized Control Trial, Female, Male, Minority Groups/statistics & numerical data, Risk-Taking, Sex Factors, Sexual Behavior/statistics & numerical data, Substance-Related Disorders/epidemiology, Urban Population/statistics & numerical data, Violence/statistics & numerical data, Dating Violence, Dating Aggression, Perpetration
- Medical subject headings
- Adolescent Behavior, Courtship, Risk-Taking, Sexual Behavior, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Motivational InterviewBehavioural
The intervention is exclusively focused on Adolescent Dating Aggression and will always be delivered by a human interventionist. It is theory-based and its success as an intervention method for substance abuse and several other health-related issues is well established.
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Interview | Experimental | Health-related counseling that takes place in as little as one hour or up to a few sessions. Receives: Behavioral: Brief Motivational Interview |
| Standard Care | No intervention | Participant will receive information about dating abuse in a handout and referrals to a national domestic violence hotline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dating Aggression Perpetration
Change in the perpetration of dating aggression from baseline to follow-up.
Measured: 3 months or 6 months
Intentions to use physical violence during next partner conflict
Change in the intention to use acts of physical violence during the next conflict with a dating partner
Measured: 3 months or 6 months
Secondary outcomes (1)
Knowledge and Attitudes about Dating Aggression
Change in Knowledge and Attitudes about Dating Aggression from baseline to the three month follow-up
Measured: 3 months or 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Offensive AggressionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a brief motivational interview-style intervention. Adolescents ages 15-19 years old who visit the emergency department and screen positive for physical or sexual dating abuse perpetration participate in a \~45 minute brief intervention and receive up to three booster calls in the subsequent 6 weeks.
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Emily F Rothman, MS, ScD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080923
- Sponsor's protocol ID
- H-31501
- Other IDs
- 2013-VA-CX-0001
- Acronym
- PLR
- Status last verified
- Jun 2017
- First submitted
- 4 Mar 2014
- Last updated
- 21 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rothman EF, Stuart GL, Heeren T, Paruk J, Bair-Merritt M. The Effects of a Health Care-Based Brief Intervention on Dating Abuse Perpetration: Results of a Randomized Controlled Trial. Prev Sci. 2020 Apr;21(3):366-376. doi: 10.1007/s11121-019-01054-w.
PubMed 31643025
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention to Prevent Adolescent Dating Aggression Perpetration
- ClinicalTrials.gov ID
- NCT02080923
- Acronym / sponsor ID
- PLR / H-31501
- Keywords
- Adolescent, Adolescent Behavior, Age Factors, Courtship, Randomized Control Trial, Female, Male, Minority Groups/statistics & numerical data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- Apr 2014 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 7 Mar 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.
The proposed study is a test of the feasibility and preliminary efficacy of a brief motivational interview style intervention. The intervention will take place in the pediatric emergency department of the Boston University Medical Center by a trained interventionist and will follow an intervention manual developed by a team of dating abuse and brief intervention experts. The study will involve two randomized groups of youth age 15-19: one group will receive the intervention and the other will not. The study will compare changes in data from baseline to 3- and 6-month follow-up for those in both groups. Outcomes including dating abused related knowledge, attitudes about the use of violence to resolve conflict, and dating abuse behavior (perpetration and/or victimization) will be assessed.
The hypothesis of this study is that youth who receive the intervention will show improvements in dating abuse related knowledge, attitudes and behavior that are maintained for 6 months, while those in the control group will show no similar change.
Detailed description
Emergency departments offer a unique setting through which we can reach adolescents who have perpetrated Adolescent Dating Aggression (ADA). The Project READY (Reducing Aggression in Dating Relationships for Youth) brief intervention manual and training was developed by Dr. Emily Rothman, who is a former shelter worker, batterer intervention counselor, and dating violence expert, with input from research experts in brief intervention, an expert in adolescent batterer intervention, psychologists, low-income youth of color from the Start Strong Initiative, and others, with funding from the National Institutes of Health (NIH). The READY intervention intercepts youth who utilize an urban emergency department for non-acute health care needs (e.g., cuts, sprains), provides them with tailored feedback about their relationship behavior, and uses motivational interviewing techniques and prepared worksheets to move them forward on a readiness-to-change continuum towards non-violent and respectful relationship behavior. For example, after being provided with information about acts considered unhealthy in a relationship, a participant is asked to generate a list of "pros and cons" about what he or she does to solve conflicts with partners, brainstorm alternatives that he or she would use, list reasons why the alternatives might not work in the moment, and troubleshoot those potential problems. Participants are then offered a menu of referrals and invited to select those that they would use (e.g., free mental health and substance abuse counseling, sexual health testing, gang prevention resources).
The randomized controlled trial (RCT) research study will build upon our completed small-scale feasibility pilot project, which was conducted in 2012- 13. For the proposed study, we will recruit a sample large enough to evaluate whether the intervention improves ADA-related knowledge, positively changes ADA-related attitudes and behavioral intentions, and reduces self-reported perpetration behavior after 3- and 6-month follow-up periods. The study will enroll youth ages 15-19 years old. Notably, the setting for this intervention test will be an urban pediatric emergency department that primarily serves low income youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a brief motivational interview-style intervention. Adolescents ages 15-19 years old who visit the emergency department and screen positive for physical or sexual dating abuse perpetration participate in a ~45 minute brief intervention and receive up to three booster calls in the subsequent 6 weeks.
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Interview | Experimental | Behavioral: Brief Motivational InterviewHealth-related counseling that takes place in as little as one hour or up to a few sessions. |
| Standard Care | No intervention | –Participant will receive information about dating abuse in a handout and referrals to a national domestic violence hotline. |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- must be a patient of the Pediatric Emergency Department or adolescent outpatient center at the Boston University Medical Center
- must be 15-19 years old
- have used at least one form of physical or sexual aggression against a dating or sexual partner in the past three months
- English-speaking
Key exclusion criteria (7 listed)
- patient's reason for visit to the healthcare center is an acute mental health problem
- patient is a prisoner or juvenile detainee
- patient is determined to be a potentially lethal dating abuse offender based on a lethality checklist
- patient has cognitive or psychiatric limitations that render him/her unable to complete the eligibility form independently
- currently attending a batterer intervention program
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 |
|---|---|---|
| Brief Motivational InterviewThe intervention is exclusively focused on Adolescent Dating Aggression and will always be delivered by a human interventionist. It is theory-based and its success as an intervention method for substance abuse and several other health-related issues is well established. | Behavioural | Brief Motivational Interview |
Primary outcome
Dating Aggression Perpetration
Time frame: 3 months or 6 months
Change in the perpetration of dating aggression from baseline to follow-up.
Intentions to use physical violence during next partner conflict
Time frame: 3 months or 6 months
Change in the intention to use acts of physical violence during the next conflict with a dating partner
1 secondary outcome
Knowledge and Attitudes about Dating Aggression
Time frame: 3 months or 6 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 21 Jun 2017.
- Derived from this study: PubMed 31643025Rothman EF, Stuart GL, Heeren T, Paruk J, Bair-Merritt M. The Effects of a Health Care-Based Brief Intervention on Dating Abuse Perpetration: Results of a Randomized Controlled Trial. Prev Sci. 2020 Apr;21(3):366-376. doi: 10.1007/s11121-019-01054-w.
- Academic ProfileLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Emily F Rothman, MS, ScD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Motivational Interview in people with Offensive Aggression and Sexual Aggression, run by Boston University at 1 site 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 4 inclusion and 7 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 21 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Dating Aggression Perpetration (time frame: 3 months or 6 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?
On the ClinicalTrials.gov record for NCT02080923, which also lists 1 linked publication.
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 21 Jun 2017.