Juntos Program for Preventing Dating Violence

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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

In this trial, we will be pilot-testing a family-based dating violence prevention program for Latine caregivers and adolescents. Participants will be randomized 1:1 to receive a community-based 6 week intervention or to a wait-list control where they will receive a resource guide.

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 data supports the effectiveness of the treatment Juntos, Resource guide for preventing dating violence?

The JOVEN program, similar to Juntos, showed medium to strong effects in reducing dating violence among male Cuban American adolescents, although these effects were not statistically significant over time. Additionally, the Safe Dates program, another dating violence prevention initiative, demonstrated significant effects in reducing various forms of dating violence across multiple follow-up periods. ^{1 2 3 4 5}

Is the Juntos Program for Preventing Dating Violence safe for participants?

In studies of psychosocial treatments, including those for substance abuse, serious adverse events (SAEs) were not found to be related to the study itself, suggesting that such interventions are generally safe for participants. ^{6 7 8 9 10}

How is the Juntos treatment different from other dating violence prevention treatments?

The Juntos treatment is unique because it specifically targets Hispanic adolescents, particularly Cuban American youth, and has shown medium to strong effects on reducing dating violence victimization and perpetration among male participants. Unlike other programs, its effects were not statistically significant over time, indicating a need for further research to enhance its efficacy. ^{2 3 11 12 13}

Eligibility Criteria

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

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.

Exclusion Criteria

I am unable to give consent by myself.

Does not meet inclusion criteria

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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 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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Examining the Preliminary Efficacy of a Dating Violence Prevention Program for Hispanic Adolescents. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing the effects of the dating violence prevention program "safe dates" using random coefficient regression modeling. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An evaluation of Safe Dates, an adolescent dating violence prevention program. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluations of Prevention Programs for Sexual, Dating, and Intimate Partner Violence for Boys and Men: A Systematic Review. [2021]

6. England 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. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? [2021]

10. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Efficacy of the "Dat-e Adolescence" Prevention Program in the Reduction of Dating Violence and Bullying. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

A Pilot Study of a Teen Dating Violence Prevention Program With Karen Refugees. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

A feasibility study to assess the effectiveness of safe dates for teen mothers. [2016]