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

72 Participants Needed

Trial Summary

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 data supports the effectiveness of the U-PEACE treatment for emotional challenges?

Research on a similar treatment, the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders, showed significant improvements in emotion regulation, PTSD symptoms, and depressive symptoms among veterans. This suggests that the U-PEACE treatment, which may share components with the Unified Protocol, could also be effective for emotional challenges. ^{1 2 3 4 5}

How is the U-PEACE treatment different from other treatments for emotional challenges?

The U-PEACE Intervention is unique because it focuses on emotional regulation and resilience, similar to the Unified Protocol for Emotional Disorders, which has shown effectiveness across various mental health conditions. Unlike standard treatments, it may incorporate elements from successful programs like FOCUS, which emphasizes family-centered support, or problem-solving training, which builds coping skills. ^{6 7 8 9 10}

What is the purpose of this trial?

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 and gaining feedback on that program.

Research Team

Jill Ehrenreich-May, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effectiveness of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Among Veterans With Posttraumatic Stress Disorder: A Pilot Study. [2019]

2. Iran pubmed.ncbi.nlm.nih.gov

Efficacy of Emotion Regulation for Patients Suffering from Chronic Obstructive Pulmonary Disease. [2019]

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

Mediating role of spirituality on the relationships between posttraumatic stress and posttraumatic growth among patients with cancer: A cross-sectional study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Targeting emotional regulation using an Internet-delivered psychological intervention for cancer survivors: A randomized controlled trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Overcoming barriers to mental health care: multimodal trauma-focused treatment approach for unaccompanied refugee minors. [2021]

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

Family-centered preventive intervention for military families: implications for implementation science. [2022]

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

Evaluation of a family-centered prevention intervention for military children and families facing wartime deployments. [2022]

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

Unified protocol for anxiety disorders in two cities of Mexico measuring gamma activity: Study protocol for a randomized controlled trial. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Early Adolescent Skills for Emotions (EASE) intervention for the treatment of psychological distress in adolescents: study protocol for randomised controlled trials in Lebanon and Jordan. [2022]

10. England 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. [2020]