U-PEACE Program for Emotional Challenges

Overseen By Jill Ehrenreich-May, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Seizures, Neurological problems, Autism, others

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

Compensation: Varies

Number of Visits: 1

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new program designed to help high school students facing emotional and academic challenges. The U-PEACE Intervention will be compared to standard services to determine which is more effective. The trial seeks high school students who often feel anxious or depressed and are interested in participating. Students under 18 will need a caregiver’s consent to join. Participants can expect involvement in the study for about 13 weeks. As an unphased trial, this study offers students the opportunity to contribute to research that could enhance support services for their peers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the U-PEACE program is safe for high school students?

Research shows that the U-PEACE program targets high school students facing emotional and academic challenges, such as depression or anxiety. Specific safety information for this program is not yet available. The trial is in a "Not Applicable" phase, indicating it explores new methods or strategies rather than testing a new drug.

As U-PEACE is a program, not a medication, it likely includes counseling or educational activities. These programs are generally considered safe, aiming to provide emotional support and teach skills, which most participants manage well. However, due to the lack of detailed data from past studies, participants should discuss any concerns or negative experiences with trial coordinators during the program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The U-PEACE intervention is unique because it focuses on addressing emotional challenges through a structured program, rather than medication or traditional therapy alone. Unlike standard treatments that often rely on pharmaceuticals or one-on-one therapy sessions, U-PEACE aims to equip participants with practical skills and strategies over a 13-week period. Researchers are excited about this approach because it empowers individuals to manage their emotional well-being actively, potentially leading to lasting improvements without the side effects associated with medications.

What evidence suggests that the U-PEACE Intervention is effective for emotional and academic challenges?

Research shows that the U-PEACE program, which participants in this trial may receive, could assist high school students facing emotional and academic challenges. Studies suggest it addresses multiple issues simultaneously, rather than focusing on a single problem. Early evaluations indicate that students in similar programs improved their emotional management and academic performance. The program teaches skills for handling emotions and stress, crucial for both emotional well-being and academic success. Although more research is needed to confirm its effectiveness, the initial results are promising. ^{1 2 6 7 8}

Who Is on the Research Team?

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

The U-PEACE trial is for high school students aged 13-18 with emotional and academic challenges. They must show signs of depression or anxiety, be enrolled at target schools, and if under 18, have caregiver consent. It's not for those unwilling to participate or with certain mental health conditions like autism or substance use disorders.

Inclusion Criteria

Individuals who are able to speak, read, and understand English

Individuals who are currently employed at the target HSs

I am willing to consent to receive services through the School Health Initiative, or if under 18, my caregiver has consented.

Exclusion Criteria

You or your caregiver have reported a history of seizures, neurological problems, autism spectrum disorder, substance use disorder, or serious mental illness like schizophrenia. You also have significant cognitive delays that would make you unsuitable for the study.

Unclear cases will be reviewed by the PI and Director of the SHI, Co-I Lisa Gwynn, D.O.

I am not a child or teenager.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the U-PEACE intervention or services as usual for approximately 13 weeks

13 weeks

Weekly group sessions

Follow-up

Participants are monitored for changes in emotional and academic challenges after the intervention

4 weeks

1-month follow-up assessment

What Are the Treatments Tested in This Trial?

Interventions

• U-PEACE Intervention

Trial Overview

This study tests the U-PEACE program aimed at supporting adolescents facing emotional and academic difficulties. Students will either receive this new intervention (U-PEACE) or stick to standard support (SAU), to see which helps more with their challenges.

How Is the Trial Designed?

Group I: U-PEACE Group Experimental Treatment 1 Intervention

Participants in this group will receive the U-PEACE intervention (study participation to last approximately 13 weeks).

Group II: Services As Usual (SAU) Group Active Control 1 Intervention

Participants in this group will receive service as usual (study participation to last approximately 13 weeks).

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Institute of Educational Sciences (IES)

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

The pilot program training for Department of Defense providers in problem-solving training (PST) significantly increased their self-efficacy in delivering the intervention, indicating that they felt more confident in their ability to help service members manage distress (p < 0.001).

Service members who participated in the PST intervention (n = 435) reported significant reductions in distress and improvements in resilience and coping skills, as evidenced by declines in Outcome Questionnaire-30 and Patient Health Questionnaire-9 scores, and increases in Brief Resilience Scale and Social Problem Solving Inventory scores (all p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military Health Provider Training and Evaluation of a Problem-Solving Intervention to Reduce Distress and Enhance Readiness Among Service Members. Cooper, DC., Bates, MJ.[2020]

The CanCope Mind (CM) intervention, an Internet-based adaptation of the Unified Protocol, significantly improved emotion regulation strategies in cancer survivors, with moderate-to-large effect sizes (SMDs from 0.44 to 0.88) observed at post-intervention and maintained at 3-month follow-up.

Compared to the lifestyle-focused control group, CM participants showed greater improvements in key areas such as beliefs about emotions, mindfulness, and cognitive reappraisal, suggesting that this targeted approach may enhance emotional functioning and well-being in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting emotional regulation using an Internet-delivered psychological intervention for cancer survivors: A randomized controlled trial. Smith, IS., Bind, MA., Weihs, KL., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12508673/

An Iteratively Adapted Transdiagnostic Prevention Program ...

The program will be known as the Unified Protocol for Transdiagnostic Treatment of Emotional and Academic Challenges in Education (U-PEACE).

2.

researchprotocols.org

researchprotocols.org/2025/1/e74080

An Iteratively Adapted Transdiagnostic Prevention Program ...

The program will be known as the Unified Protocol for Transdiagnostic Treatment of Emotional and Academic Challenges in Education (U-PEACE).

3.

withpower.com

withpower.com/trial/phase-emotions-10-2023-6030a

U-PEACE Program for Emotional Challenges

The purpose of the study is to evaluate the feasibility and effectiveness of a program for high school students with emotional and academic challenges U-PEACE ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06056674

Unified Protocol for Preventing Emotional and Academic ...

The purpose of the study is to evaluate the feasibility and effectiveness of a program for high school students with emotional and academic challenges ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40990367/

An Iteratively Adapted Transdiagnostic Prevention Program ...

Objective: This study aimed to iteratively adapt and implement the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3918896/

The Reformulation of Emotional Security Theory: The Role of ...

The objective of this paper is to describe how our reformulation of emotional security theory (EST-R) within an ethological and evolutionary framework may ...

7.

ipinst.org

ipinst.org/wp-content/uploads/2020/12/2012_Mental-Health-in-Peace-Operations.pdf

Mental Health in UN Peace Operations: Addressing Stress, ...

As a result, there is still a tremendous gap in the data on mental health in peace operations. ... Safety and Security Challenges in UN Peace.

8.

mdpi.com

mdpi.com/2227-9032/10/9/1777

The Social Support, Tracking Distress, Education, and ...

This puts them at high risk for negative mental health outcomes such as posttraumatic stress injury/disorder, compassion fatigue, and burnout [1 ...