Juntos Program for Preventing Dating Violence

No longer recruiting at 1 trial location

Overseen By Maya Ragavan

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Unable to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a family-based program to prevent dating violence among Latine adolescents and their caregivers. The program, called Juntos, includes six weeks of in-person sessions and at-home activities designed to help families discuss dating, understand healthy relationships, and learn about cultural values and practices. Participants will either receive the Juntos intervention or a resource guide, with the option to join the intervention later. This trial is ideal for Latine caregivers and their adolescents aged 12-16 who live near Pittsburgh, Pennsylvania, and are interested in learning more about healthy relationships.

As an unphased trial, this study offers a unique opportunity for families to engage in a culturally tailored program that promotes healthy relationships.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this program is safe for participants?

Research has shown that family-based programs like Juntos are safe and generally well-received. The Juntos program is not a medication but focuses on education and support, including in-person meetings and activities for home. These programs usually pose very low risk because they don't involve taking medicine or undergoing medical procedures.

Juntos aims to improve family communication and understanding of issues related to dating violence. The main concern is ensuring everyone feels comfortable during discussions. Participants should feel supported and not pressured to share. Past programs of this nature have demonstrated that families often benefit without major issues when participating together.

This trial is in the "Not Applicable" phase, meaning it tests the program's approach rather than a new drug, suggesting fewer safety concerns compared to drug trials. Participants can expect a supportive environment that helps build knowledge and skills with minimal safety risks.

Why are researchers excited about this trial?

The Juntos program is unique because it focuses on a family-based approach to preventing dating violence by involving both caregivers and adolescents in the intervention. Unlike traditional methods that might center on individual counseling or school-based programs, Juntos includes six in-person sessions and five at-home activities that emphasize cultural values and open communication. Researchers are excited about this program because it was specifically developed by Latino caregiver-adolescent pairs, making it culturally tailored and potentially more effective for this community.

What evidence suggests that the Juntos program is effective for preventing dating violence?

Research shows that programs to prevent dating violence can help people understand and improve their attitudes about healthy relationships. For example, the Safe Dates program significantly reduced physical and sexual dating violence. Another study found that these programs can moderately decrease both the experience and perpetration of dating violence over time, especially for females. In this trial, the Juntos intervention, which involves caregivers, may enhance these effects by including families in discussions about cultural values and relationship skills. Meanwhile, the control group will receive a resource guide. Overall, these findings suggest that programs like Juntos can positively impact the prevention of dating violence among teenagers. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for Latine families with caregivers and adolescents, aiming to prevent dating violence. Participants will be randomly assigned to either the intervention or a wait-list control group.

Inclusion Criteria

I am a Hispanic or Latino/a/x/e adult, speak Spanish, live near Pittsburgh, am a caregiver for a participating child, and was born outside the US.

I am 12-16 years old, identify as Hispanic or Latino/a/x/e, speak Spanish or English, live near Pittsburgh, and have a participating parent.

Exclusion Criteria

I am unable to give consent by myself.

Does not meet inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week family-based dating violence prevention intervention called Juntos, including 6 in-person sessions and 5 at-home activities.

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up surveys conducted at 1 week and 3 months post-intervention.

3 months

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Juntos
• Resource guide

Trial Overview

The 'Juntos' program, a family-based prevention strategy against dating violence over six weeks, is being tested against a wait-list control group that receives only a resource guide.

How Is the Trial Designed?

Group I: Juntos intervention Experimental Treatment 1 Intervention

In the Juntos intervention, 24 caregiver-adolescent dyads will receive a 6 week family-based dating violence prevention intervention called Juntos. Juntos includes 6 in-person sessions and 5 at home activities and was developed by Latino caregiver-adolescent dyads. Topics include cultural values and practices, talking about dating and dating violence, rule-setting, understanding signs of healthy and unhealthy relationships, and resources for support.

Group II: Control group Active Control 1 Intervention

The control arm will resource a resource guide and can be placed on a wait list to receive the intervention after the intervention is complete

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

The 'Dat-e Adolescence' prevention program significantly reduced instances of sexual and severe physical dating violence and bullying among adolescents, as shown in a study involving 1423 participants with a mean age of 14.98.

The program's effectiveness was evaluated through a randomized controlled trial design with multiple assessments over time, indicating that such prevention programs can address various behavioral issues in adolescents by targeting shared risk and protective factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of the "Dat-e Adolescence" Prevention Program in the Reduction of Dating Violence and Bullying. Muñoz-Fernández, N., Ortega-Rivera, J., Nocentini, A., et al.[2020]

In a study involving 68 heroin-dependent subjects over 26 weeks, health data linkage revealed that a significant number of serious adverse events (SAEs) went unreported by participants, with 41.4% of hospital admissions and 67.7% of emergency department visits not documented in the trial.

The use of health data linkage resulted in a substantial increase in recorded SAEs, showing a 1.71-fold increase in hospital admissions and a 3.09-fold increase in emergency department attendances, highlighting its effectiveness in capturing missing health data in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the usefulness of health data linkage in obtaining adverse event data in a randomised controlled trial of oral and implant naltrexone in the treatment of heroin dependence. Kelty, E., Ngo, H., Hulse, G.[2013]

The Safe Dates program significantly reduced instances of physical, serious physical, and sexual dating violence among adolescents, with effects lasting up to 4 years after the intervention.

Providing a booster to the Safe Dates program did not enhance its effectiveness, suggesting that the initial program alone is sufficient for long-term impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the long-term effects of the Safe Dates program and a booster in preventing and reducing adolescent dating violence victimization and perpetration. Foshee, VA., Bauman, KE., Ennett, ST., et al.[2022]

A review of 10 randomized controlled studies on sexual, dating, and intimate partner violence prevention programs for males revealed significant variability in program content, delivery methods, and study designs, indicating a lack of standardization in this area.

Only one of the evaluated programs was effective in reducing self-reported sexual violence perpetration among men, highlighting critical gaps in understanding what strategies are truly effective for preventing violence among boys and men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluations of Prevention Programs for Sexual, Dating, and Intimate Partner Violence for Boys and Men: A Systematic Review. Graham, LM., Embry, V., Young, BR., et al.[2021]

The Safe Dates program significantly reduced reports of psychological abuse and sexual violence among adolescents, with 1700 out of 1886 participants completing follow-up questionnaires after the intervention.

The program was effective for both primary prevention (reducing initiation of dating violence among those with no prior violence) and secondary prevention (reducing further violence among those with a history of dating violence), primarily by changing attitudes towards dating violence and increasing awareness of available services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of Safe Dates, an adolescent dating violence prevention program. Foshee, VA., Bauman, KE., Arriaga, XB., et al.[2022]

The JOVEN/YOUTH program showed medium to strong effects in reducing dating violence victimization and perpetration among male Cuban American adolescents, based on a study with 82 participants over a year.

However, the intervention did not yield statistically significant effects over time, particularly for female participants, indicating a need for further research to improve its effectiveness and assess a broader demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents. Gonzalez-Guarda, RM., Guerra, JE., Cummings, AA., et al.[2021]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

The Safe Dates Project demonstrated significant reductions in psychological, moderate physical, and sexual dating violence perpetration and victimization among adolescents over four follow-up periods, indicating its effectiveness as a school-based prevention program.

The program's success was consistent across genders and racial groups, and it was linked to changes in dating violence norms and increased awareness of community services, suggesting that these factors play a crucial role in its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the effects of the dating violence prevention program "safe dates" using random coefficient regression modeling. Foshee, VA., Bauman, KE., Ennett, ST., et al.[2022]

The adapted Safe Dates curriculum significantly improved responses to anger, reduced gender stereotyping, and increased awareness of resources related to teen dating violence among 41 pregnant and/or parenting teens who participated in the program.

The study suggests that this intervention may effectively change attitudes and behaviors related to dating violence, but further research with a larger sample and control groups is needed to confirm its efficacy in reducing teen dating violence incidents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of safe dates for teen mothers. Herrman, JW., Waterhouse, JK.[2016]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

The Safe Dates program effectively changed attitudes toward teen dating violence among 21 resettled Karen refugee youth from Burma, indicating its potential for positive impact in this demographic.

The study found that the number of years living in the United States influenced the participants' attitudes, suggesting that acculturation may play a significant role in shaping views on dating violence among ethnic minority youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Teen Dating Violence Prevention Program With Karen Refugees. Ravi, KE., Black, BM., Mitschke, DB., et al.[2020]

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Juntos Program for Preventing Dating Violence

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"Our study offers strong evidence that the Fourth R program can play a vital role in reducing the recurrence of physical dating violence,” said ...