Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE) (NCT06056674) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)
United States72 participantsStarted 2023-10-05
Plain-language 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.
Who can participate
Age range
13 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. The following individuals may be excluded at any time (e.g., before consent, after being enrolled).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Adolescent Academic Problems Checklist (AAPC)
Timeframe: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
2
Therapeutic Alliance Scale for Children, Revised (TASC-R)
Timeframe: Mid (approximately week 4)
3
Client Satisfaction Questionnaire (CSQ)
Timeframe: Mid (approximately week 4)
4
Top Problems Assessment - Child Report as measured by Likert Scale
Timeframe: Up to 13 weeks
5
Adherence to U-PEACE, as Measured by Homework Completion
Timeframe: At all group sessions (up to 9 weeks)
6
Adherence to U-PEACE, as Measured by Session Attendance
Timeframe: At all group sessions (up to 9 weeks)
7
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
Timeframe: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
. 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.
8
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
Timeframe: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
9
Change in Patient Health Questionnaire 9-item Scale (Modified for Major Depressive Disorder in Adolescents; PHQ-9M)
Timeframe: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)