Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02709447
Other study ID # 500421
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 2015
Est. completion date September 30, 2020

Study information

Verified date March 2020
Source Northeastern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 253
Est. completion date September 30, 2020
Est. primary completion date September 15, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Date SMART
Skills-based, group prevention program targeting emotion regulation and interpersonal skills using a cognitive-behavioral framework.
Health Promotion
Psycho-educational group prevention program targeting knowledge and skills only

Locations

Country Name City State
United States Rhode Island Family Court Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Northeastern University Rhode Island Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in Depression Symptoms from Baseline to 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
Other Change in Emotion Regulation Skills from Baseline to 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
Other Change in Anger Expression from Baseline to 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; a's range.73 - .84). Baseline and 3 months
Primary 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 a = .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 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. Baseline and 3 months
Secondary 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. Baseline and 3 months
Secondary 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. Baseline and 3 months
Secondary 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. Baseline and 3 months
See also
  Status Clinical Trial Phase
Completed NCT00729391 - Women-Focused HIV Prevention in the Western Cape Phase 2/Phase 3
Recruiting NCT06062732 - Face It Evaluation N/A
Withdrawn NCT03762356 - Questionnaire About Individual's Insight/Awareness of Risk of Violence
Completed NCT02506088 - Preventing Sexual Aggression Among High School Boys N/A
Completed NCT02458365 - A Stage-Based Expert System for Teen Dating Violence Prevention Phase 2
Completed NCT00527358 - Evaluation of SAFER Latinos' Program to Prevent Youth Violence Phase 2/Phase 3
Completed NCT00251212 - Tailored Teen Alcohol and Violence Prevention in the Emergency Room (ER) N/A
Completed NCT01025674 - Randomized Trial of the Positive Action Program in Chicago Schools and Extension to Grade 8 N/A
Completed NCT00164541 - An Arts-Based Initiative for the Prevention of Violence Against Women and Girls Phase 1
Recruiting NCT05706376 - An Evidence-based Family Support Program for Parents and Children in Palestine: A Theory-based Intervention N/A
Recruiting NCT06001554 - Preventing Physical and Emotional Violence by Teachers in Public Schools in Pakistan N/A
Recruiting NCT05585918 - The R-CITY Project: A Collaborative Intervention With Teachers and Youth N/A
Recruiting NCT06099262 - GenPMTO Evaluation
Recruiting NCT05595759 - Violence Against Women in Patients With Alcohol Substance Addiction Training N/A
Completed NCT05207319 - Effects of Integrated Moral Reasoning Development Intervention for Management of Violence in Schizophrenia N/A
Completed NCT03473067 - Community Level Primary Prevention of Dating and Sexual Violence in Middle Schools N/A
Completed NCT06056661 - Within My Reach (WMR) Adaptation N/A
Not yet recruiting NCT04520399 - Prediction of Violent Behavior in Patients With Schizophrenia by Multimodal Machine Learning
Not yet recruiting NCT02257944 - Assessing and Reducing Risk of Violent Re-Injury Among Victims of Urban Violence N/A
Completed NCT01770873 - A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence N/A