Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)

NCT06056674 | Active Not Recruiting

• 1 other identifier: 20230796
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emotions

Outcome Measures

Primary Outcomes (9)

• Change in Adolescent Academic Problems Checklist (AAPC)

  Scores on each item range from 0 to 3, with higher scores indicating more academic problems.

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

• Therapeutic Alliance Scale for Children, Revised (TASC-R)

  Scores on each item range from 1 (not true) to 4 (very much true). This scale measures the perceived therapeutic alliance between child and therapist.

  Mid (approximately week 4)

• Client Satisfaction Questionnaire (CSQ)

  Total Scores range from 8 to 32, with higher scores indicating greater client satisfaction. The CSQ support used to evaluate satisfaction with a particular intervention, client self-efficacy and the likelihood of recommending the intervention to others.

  Mid (approximately week 4)

• Top Problems Assessment - Child Report as measured by Likert Scale

  The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on Likert scale from 0 (not at all a problem) to 10 (a huge problem).

  Up to 13 weeks

• Adherence to U-PEACE, as Measured by Homework Completion

  Adherence to U-PEACE will be measured by the overall number of homework assignments completed.

  At all group sessions (up to 9 weeks)

• Adherence to U-PEACE, as Measured by Session Attendance

  Adherence to U-PEACE will be measured by the overall number of sessions attended.

  At all group sessions (up to 9 weeks)

• Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)

  The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

• Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)

  GAD-7 evaluates core anxiety concerns across a 7-item self-report measure. Items are rated using a 4-point Likert scale from 0 (not at all) to 3 (nearly every day). It yields a total score and a rating of impairment

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

• Change in Patient Health Questionnaire 9-item Scale (Modified for Major Depressive Disorder in Adolescents; PHQ-9M)

  PHQ-9 evaluates core depression symptoms across 9 items. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (nearly every day)

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

Secondary Outcomes (5)

• School Achievement, as measured by attendance

  Up to approximately 13 weeks

• School Achievement, as measured by report card

  Up to approximately 13 weeks

• Change in Child Anxiety Impact Scale-Academic Subscale (CAIS-AS)

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

• Change in Affective Reactivity Scale (ARI)

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

• Change in Distress Tolerance Scale (DTS)

  At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)

Study Arms (2)

U-PEACE Group

EXPERIMENTAL

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

Behavioral: U-PEACE Intervention

Services As Usual (SAU) Group

ACTIVE COMPARATOR

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

Behavioral: SAU

Interventions

U-PEACE Intervention BEHAVIORAL

This program will involve about 13 group sessions, with each group session lasting approximately 40-50 minutes. The program session will be held about 2 times a week during the school day (e.g., lunch time) if the group meets in person, or at a pre-scheduled time every week if the group meets online via Zoom. Participants will learn how to better understand emotional experiences and use this understanding to embrace agency in challenging situations. Participants will develop skills to better deal with emotions by increasing awareness of what is happening in different settings and choose how to respond. Skill-building exercises may include mindfulness practices, flexible thinking, behavioral activation, problem-solving, and exposure activities.

U-PEACE Group

SAU BEHAVIORAL

Participants in this group will continue to receive standard of care within their school clinic.

Services As Usual (SAU) Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Youth:
• Adolescents between the ages of 13 and 18 years at the time of enrollment, who:
• display depressive symptoms above the clinical cut-off of 9 or above on the Patient Health Questionnaire-8 (PHQ-8),
• display elevated anxiety symptoms of 10 or above on the Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer et al., 2006),
• are enrolled at the target High Schools (HS),
• have expressed interest in participating in the study, and
• have a caregiver who is available to sign study consent forms (if under 18 years of age)
• Adolescents must be, or are willing to be, consented to receive services through School Health Initiative (SHI) (i.e., SHI consent). If they are under 18 years of age, their caregiver must provide consent.
• Adolescents and caregivers are able to complete all study procedures in English or Spanish.
• Teachers:
• Individuals who are 18 years or older.
• Individuals who are currently employed at the target HSs.
• Individuals who are able to speak, read, and understand English.

You may not qualify if:

• The following individuals may be excluded at any time (e.g., before consent, after being enrolled).
• Individuals who do not wish to participate in this study and/or who are not able to read and understand the consent/assent.
• Individuals with self- or caregiver-reported history of seizures, neurological problems, autism spectrum disorder, substance use disorder, or serious mental illness (e.g., schizophrenia), and any indicator of a significant cognitive delay that would make U-PEACE inappropriate (e.g., full-time special education placement)
• Individuals with current anxiety or depressive symptoms or active suicidality at levels where more intensive services (e.g., day treatment, inpatient) would be warranted (e.g., hospitalization for suicidal behavior in the last 12 months).
• Ineligible adolescents will be provided referrals to medical providers at the SHI, community agencies contracted with the Miami-Dade County Public Schools (M-DCPS) Office of Mental Health Services or emergency room settings, as appropriate.
• Unclear cases will be reviewed by the PI and Director of the SHI, Co-I Lisa Gwynn, D.O.

Sponsors & Collaborators

• University of Miami: lead
• Institute of Educational Sciences (IES): collaborator

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Related Publications (1)

• Velez CV, Campez-Pardo M, Canovas JM, Pedronzo PM, Ahn YA, Dale CF, Dale SK, Gwynn L, Jensen-Doss A, Pulgaron ER, St George SM, Ehrenreich-May J. An Iteratively Adapted Transdiagnostic Prevention Program for Diverse High School Settings (U-PEACE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 24;14:e74080. doi: 10.2196/74080.

  PMID: 40990367 DERIVED

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: October 5, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)