- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709447
Dating Violence Prevention for Juvenile Justice Girls
March 1, 2021 updated by: Northeastern University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
253
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Rhode Island Family Court
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Court-involved, non-incarcerated adolescent female
- Parent/ guardian consent and teen assent
Exclusion Criteria:
- Outside of 14-18 age range
- Cognitive/ developmental delays or psychosis that would interfere with study participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Date SMART
Group based prevention
|
Skills-based, group prevention program targeting emotion regulation and interpersonal skills using a cognitive-behavioral framework.
|
Active Comparator: Health Promotion
Group based prevention
|
Psycho-educational group prevention program targeting knowledge and skills only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recidivism over 3 months
Time Frame: Baseline and 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.
|
Baseline and 3 months
|
Change in Unprotected Sex Acts from Baseline to 3 months
Time Frame: Baseline and 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.
|
Baseline and 3 months
|
Change in Delinquent Behavior from Baseline to 3 months
Time Frame: Baseline and 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.
|
Baseline and 3 months
|
Change in Physical and Sexual Dating Violence Perpetration from Baseline to 3 months
Time Frame: Baseline and 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.
|
Baseline and 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depression Symptoms from Baseline to 3 months
Time Frame: Baseline and 3 months
|
The Beck Depression Inventory-II (BDI-II) consists of 21 items to assess the intensity of depression.
Each item is a list of four statements in increasing severity about a symptom of depression.
|
Baseline and 3 months
|
Change in Emotion Regulation Skills from Baseline to 3 months
Time Frame: Baseline and 3 months
|
The Adolescent Self-Regulatory Inventory (ASRI) is a 33 item survey that measures adolescents' use of both functional and dysfunctional emotion regulation strategies.
|
Baseline and 3 months
|
Change in Anger Expression from Baseline to 3 months
Time Frame: Baseline and 3 months
|
The Anger Expression Scale (AES) of the State-Trait Anger Expression Inventory (STAXI-2) measures control of expressed anger and internal/external anger expression (reliability is good; α's range.73 - .84).
|
Baseline and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
September 15, 2020
Study Completion (Actual)
September 30, 2020
Study Registration Dates
First Submitted
February 9, 2016
First Submitted That Met QC Criteria
March 15, 2016
First Posted (Estimate)
March 16, 2016
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 500421
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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