What side effects are associated with this type of intervention?

Behavioral interventions for dating abuse, such as cognitive-behavioral therapy (CBT) and other structured programs, are generally well-tolerated but can have some side effects. Common side effects include emotional distress as individuals confront and process traumatic experiences, temporary increases in anxiety or depression, and potential strain on personal relationships as dynamics change. It's important for participants to have access to supportive resources and follow-up care to manage these effects.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of dating abuse. However, related treatments for issues such as domestic violence and alcohol use often involve behavioral interventions. The Online Synchronous DV and AU Prevention Curriculum being studied is an example of such an intervention, focusing on reducing domestic violence and alcohol use through behavioral strategies. These types of interventions are crucial as they address the underlying behavioral patterns contributing to abuse and substance use.

What other types of research exist?

Promising alternatives to the Online Synchronous DV and AU Prevention Curriculum for dating abuse patients include: 1) Motivational Interview Techniques (MIT) incorporated into Perpetrators' Intervention Programs (PIPs), which have shown increased treatment adherence and motivation for change. 2) Mobile phone-based life-skills training programs like SmartCoach, which provide tailored feedback and text messages to improve self-management and resistance skills. 3) Acceptance and Commitment Therapy (ACT) based online programs focused on repetitive negative thinking, such as the DAC program, which have been rated as clear and useful for preventing emotional symptoms.

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Behavioral Intervention

PRYSHM Program for LGBTQIA+ Youth Well-Being (PRYSHM Trial)

N/A

Waitlist Available

Research Sponsored by University of Nebraska Lincoln

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 9, and week 21

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an online program called PRYSHM to help prevent dating violence and alcohol use among LGBTQ+ youth aged 15 to 18. The program addresses stress from discrimination and builds a sense of community to reduce risky behaviors. It is especially aimed at youth in rural areas who may not have access to in-person support.

Who is the study for?

This trial is for LGBTQIA2S+ youth aged 15-18 in the U.S. who are currently or recently were in a romantic relationship, can attend weekly online sessions, and have internet access. It's not for those outside this age range, full-time college students, heterosexual and cisgender individuals, or those at high risk of suicide.

What is being tested?

The PRYSHM program is being tested to prevent dating abuse and alcohol misuse among sexual and gender minority youths. Participants will join an online curriculum with weekly sessions to assess its effectiveness and acceptance.

What are the potential side effects?

Since PRYSHM is an educational intervention rather than a medical treatment, it may not have typical 'side effects,' but participants might experience emotional discomfort discussing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 9, and week 21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 9, and week 21

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 9, and week 21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Alcohol Use at Week 9 and Week 21

Change from Baseline in Drinking Intentions at Week 9 and Week 21

Change from Baseline in Intimate partner violence perpetration at Week 9 and Week 21

+4 more

Secondary study objectives

Change from Baseline in Depressive Symptoms at Week 9 and Week 21

Change from Baseline in Drug Use at Week 9 and Week 21

Change from Baseline in Experience of Negative Consequences as a Result of Alcohol Use at Week 9 and Week 21

+1 more

Other study objectives

Baseline measure in Family Rejection

Change from Baseline in Accurate Perceptions of Alcohol Use at Week 9 and Week 21

Change from Baseline in Accurate Perceptions of Dating Violence at Week 9 and Week 21

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment ConditionExperimental Treatment1 Intervention

The PRYSHM program is theoretically grounded, follows best practices for effective health behavior prevention, and includes nine, one hour sessions co-facilitated by 2 LGBTQ+ adults.

Group II: ControlActive Control1 Intervention

Check-ins/provision of resources

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Promoting Resilient Youth with Strong Hearts and Minds (PRYSHM)

2022

N/A

~310

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for dating abuse, such as the Online Synchronous DV and AU Prevention Curriculum, typically involve behavioral interventions that focus on cognitive-behavioral therapy (CBT) and motivational interviewing (MI). These treatments work by helping individuals recognize and change harmful thought patterns and behaviors, improving their coping strategies, and enhancing their motivation to change. For dating abuse patients, these mechanisms are crucial as they address both the psychological and behavioral aspects of abuse, promoting healthier relationship dynamics and reducing the risk of substance use that can exacerbate abusive behaviors.

Attrition from a male batterer treatment program: client-treatment congruence and lifestyle instability.Developing an Integrated Violence Prevention for Men and Women in Treatment for Substance Use Disorders.Motivational interviewing and intimate partner violence: a randomized trial.