ViolenceNCT02709447
Dating Violence Prevention for Juvenile Justice Girls
A study testing Date SMART and Health Promotion in people with Violence, run by Northeastern University at 1 site in United States.
Trial summary
Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence
- What is being tested?
- Date SMART and Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 30 Sep 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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Court-involved, non-incarcerated adolescent female
- Parent/ guardian consent and teen assent
Who cannot join
- Outside of 14-18 age range
- Cognitive/ developmental delays or psychosis that would interfere with study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Family Court
Providence, Rhode Island, 02903
About this study
Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. This study will advance scientific knowledge by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence, delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated girls.
Read the detailed description
Research is urgently needed to rigorously test a skills-based intervention for dating violence prevention among juvenile justice girls. Court-involved, non-incarcerated (CINI) girls represent a particularly high-risk group for dating violence exposure. This is due to the multiple risk factors they possess that have demonstrated associations with teen dating violence outcomes in other high-risk adolescent female populations. Despite the critical need for these young women to learn strategies that offset their heightened risk for involvement in coercive romantic relationships, no such evidence-based interventions exist for this population. The goal of the current study is to establish the efficacy of Date SMART (K23MH086328), a theoretically-driven skills-based intervention, in reducing dating violence, sexual risk behavior, and delinquency among girls in the juvenile justice system. Pilot data reveal that girls randomized to the Date SMART intervention spend significantly fewer days in violent relationships compared to girls randomized to the comparison condition. They also show improvements in condom use at last sex and reductions in delinquency. Moreover, the risk profile of adolescent girls who participated in the pilot trial is remarkably similar to the profile of adolescent girls involved in the juvenile justice system. Thus, Date SMART is uniquely suited for CINI girls. Despite the promise of Date SMART, the time lag from pilot testing to efficacy testing and final dissemination activities is protracted, as researchers fail to consider questions of effectiveness early on. Hybrid designs that retain core components of efficacy trials (randomization, controlled conditions) and essential elements of effectiveness research (e.g., participant diversity; standardized training procedures, attention to cost) can reduce time to implementation in the "real world." As such, investigators plan to test the efficacy of Date SMART on dating violence, sexual risk, and delinquency among 250 court-involved, non-incarcerated girls. Investigators will also gather effectiveness data from key stakeholders to determine how best to implement the program, train staff, and predict the cost of the program within the juvenile court. CINI girls, ages 14-17 (N= 12 juveniles for Phase I Intervention Run-Through; N=250 for Phase II Randomized Control Trial [RCT] study) will be recruited from the Rhode Island Family Court and Probation Departments and randomized to either the Date SMART (active) intervention (n=125) or a Health Promotion (control) condition (n=125). In Phase I (12 juveniles will be recruited to complete the Intervention Run-Through and research assessment once to allow testing of RCT intervention and assessment procedures prior to the RCT phase. In Phase II, 250 juveniles will be recruited and randomized at baseline and then re-assessed at 3, 6, 9 and 12 month post-intervention follow-ups.
- Conditions
- Violence
- Being tested
- Date SMART, Health Promotion
- Keywords
- Intimate Partner Violence, Juvenile Delinquency, Sexual Behavior
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Date SMARTBehavioural
Skills-based, group prevention program targeting emotion regulation and interpersonal skills using a cognitive-behavioral framework.
Health PromotionBehavioural
Psycho-educational group prevention program targeting knowledge and skills only
| Study group | Role | What they receive |
|---|---|---|
| Date SMART | Experimental | Group based prevention Receives: Behavioral: Date SMART |
| Health Promotion | Active comparator | Group based prevention Receives: Behavioral: Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Dating Violence Perpetration and Victimization from Baseline to 3 months
Conflict in Adolescent Dating Relationships Inventory (CADRI) assesses abuse perpetration and victimization with a current or recent dating partner. The CADRI has strong internal consistency (total α = .83) and 2-week test retest reliability, r = .68, p < .01, as well as acceptable partner agreement (r = .64, p < .01) on the basis of 35 couples. At baseline, participants will be asked about the prevalence of DV over the lifetime and the past 3 months. For all other time points, we will assess the past 3 months.
Measured: Baseline and 3 months
Secondary outcomes (4)
Recidivism over 3 months
Juveniles' recidivism rates, description of related charges (e.g., substance-related, property) and time detained/incarcerated (all tracked by the court database) will be available to the project and assessed at baseline and follow-ups.
Measured: Baseline and 3 months
Change in Unprotected Sex Acts from Baseline to 3 months
The Adolescent Risk Behavior Assessment (ARBA) assesses type of sexual behavior, frequency of sex and condom use, number of partners and substance use preceding and/or during sex. Intentions to have sex, use condoms and get pregnant are measured within the ARBA and will be recorded.
Measured: Baseline and 3 months
Change in Delinquent Behavior from Baseline to 3 months
The National Youth Survey Self Reported Delinquency Scale will also be administered and is a self-report of delinquent acts (e.g., larceny, fighting, selling drugs, etc.), the number of times alcohol/drugs were involved in each delinquent act, and number of times the delinquent act was committed to gain access to alcohol/drugs.
Measured: Baseline and 3 months
Change in Physical and Sexual Dating Violence Perpetration from Baseline to 3 months
Timeline Follow-back Spousal Violence Interview (TLFB -SV), adapted for adolescents (and used successfully in pilot trial) assesses the number of days with a dating partner, presence of physical or sexual DV (perpetration or victimization) by day, and presence of alcohol/drug use.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2015
- Primary completion15 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies 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
- Masking
- None (open label)
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital
- Responsible party
- Sponsor
- Investigators
- Christie Rizzo, PhD, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709447
- Sponsor's protocol ID
- 500421
- Status last verified
- Mar 2020
- First submitted
- 9 Feb 2016
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dating Violence Prevention for Juvenile Justice Girls
- ClinicalTrials.gov ID
- NCT02709447
- Acronym / sponsor ID
- 500421
- Conditions
- Violence
- Keywords
- Intimate Partner Violence, Juvenile Delinquency, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital
- Study start
- Apr 2015
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 16 Mar 2016 (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.
Girls in the juvenile justice system are at high risk for dating violence exposure as well as co-occurring problems with delinquency and sexual risk taking. Despite the multitude of negative outcomes associated with dating violence, no evidence-based preventive interventions exist for juvenile justice girls. This study will advance scientific knowledge by testing the efficacy of a promising, skills-based intervention (Date SMART) on reducing dating violence, delinquency and sexual risk outcomes for a broad range of court-involved, non-incarcerated girls.
Detailed description
Research is urgently needed to rigorously test a skills-based intervention for dating violence prevention among juvenile justice girls. Court-involved, non-incarcerated (CINI) girls represent a particularly high-risk group for dating violence exposure. This is due to the multiple risk factors they possess that have demonstrated associations with teen dating violence outcomes in other high-risk adolescent female populations. Despite the critical need for these young women to learn strategies that offset their heightened risk for involvement in coercive romantic relationships, no such evidence-based interventions exist for this population. The goal of the current study is to establish the efficacy of Date SMART (K23MH086328), a theoretically-driven skills-based intervention, in reducing dating violence, sexual risk behavior, and delinquency among girls in the juvenile justice system. Pilot data reveal that girls randomized to the Date SMART intervention spend significantly fewer days in violent relationships compared to girls randomized to the comparison condition. They also show improvements in condom use at last sex and reductions in delinquency. Moreover, the risk profile of adolescent girls who participated in the pilot trial is remarkably similar to the profile of adolescent girls involved in the juvenile justice system. Thus, Date SMART is uniquely suited for CINI girls. Despite the promise of Date SMART, the time lag from pilot testing to efficacy testing and final dissemination activities is protracted, as researchers fail to consider questions of effectiveness early on. Hybrid designs that retain core components of efficacy trials (randomization, controlled conditions) and essential elements of effectiveness research (e.g., participant diversity; standardized training procedures, attention to cost) can reduce time to implementation in the "real world." As such, investigators plan to test the efficacy of Date SMART on dating violence, sexual risk, and delinquency among 250 court-involved, non-incarcerated girls. Investigators will also gather effectiveness data from key stakeholders to determine how best to implement the program, train staff, and predict the cost of the program within the juvenile court. CINI girls, ages 14-17 (N= 12 juveniles for Phase I Intervention Run-Through; N=250 for Phase II Randomized Control Trial [RCT] study) will be recruited from the Rhode Island Family Court and Probation Departments and randomized to either the Date SMART (active) intervention (n=125) or a Health Promotion (control) condition (n=125). In Phase I (12 juveniles will be recruited to complete the Intervention Run-Through and research assessment once to allow testing of RCT intervention and assessment procedures prior to the RCT phase. In Phase II, 250 juveniles will be recruited and randomized at baseline and then re-assessed at 3, 6, 9 and 12 month post-intervention follow-ups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Date SMART | Experimental | Behavioral: Date SMARTGroup based prevention |
| Health Promotion | Active comparator | Behavioral: Health PromotionGroup based prevention |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Court-involved, non-incarcerated adolescent female
- Parent/ guardian consent and teen assent
Key exclusion criteria (2 listed)
- Outside of 14-18 age range
- Cognitive/ developmental delays or psychosis that would interfere with study participation
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 |
|---|---|---|
| Date SMARTSkills-based, group prevention program targeting emotion regulation and interpersonal skills using a cognitive-behavioral framework. | Behavioural | Date SMART |
| Health PromotionPsycho-educational group prevention program targeting knowledge and skills only | Behavioural | Health Promotion |
Primary outcome
Change in Dating Violence Perpetration and Victimization from Baseline to 3 months
Time frame: Baseline and 3 months
Conflict in Adolescent Dating Relationships Inventory (CADRI) assesses abuse perpetration and victimization with a current or recent dating partner. The CADRI has strong internal consistency (total α = .83) and 2-week test retest reliability, r = .68, p < .01, as well as acceptable partner agreement (r = .64, p < .01) on the basis of 35 couples. At baseline, participants will be asked about the prevalence of DV over the lifetime and the past 3 months. For all other time points, we will assess the past 3 months.
4 secondary outcomes
Recidivism over 3 months
Time frame: Baseline and 3 months
Change in Unprotected Sex Acts from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Delinquent Behavior from Baseline to 3 months
Time frame: Baseline and 3 months
Change in Physical and Sexual Dating Violence Perpetration from Baseline to 3 months
Time frame: Baseline and 3 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 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Violence
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
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.
Christie Rizzo, PhD principal investigator
Northeastern 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 Date SMART and Health Promotion in people with Violence, run by Northeastern 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 2 inclusion and 2 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 3 Mar 2021. 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?
Change in Dating Violence Perpetration and Victimization from Baseline to 3 months (time frame: Baseline and 3 months). 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 3 Mar 2021.