EmotionsNCT06056674
Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)
A study testing U-PEACE Intervention and SAU in people with Emotions, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Emotions
- What is being tested?
- U-PEACE Intervention and SAU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 20Show fewer
- 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.
- Youth Exclusion Criteria:
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE) Randomized Controlled 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.
- Conditions
- Emotions
- Being tested
- U-PEACE Intervention, SAU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
U-PEACE InterventionBehavioural
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.
SAUBehavioural
Participants in this group will continue to receive standard of care within their school clinic.
| Study group | Role | What they receive |
|---|---|---|
| U-PEACE Group | Experimental | Participants in this group will receive the U-PEACE intervention (study participation to last approximately 13 weeks). Receives: 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). Receives: Behavioral: SAU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adolescent Academic Problems Checklist (AAPC)
Scores on each item range from 0 to 3, with higher scores indicating more academic problems.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Attendance is defined as number of days attending school (not absent)
Measured: Up to approximately 13 weeks
School Achievement, as measured by report card
School achievement will be measured by a numeric score on each participant's school report card
Measured: Up to approximately 13 weeks
Change in Child Anxiety Impact Scale-Academic Subscale (CAIS-AS)
CAIS-AS is a youth- and caregiver-report measure that assesses the impact of anxiety on function. The Academic sub scale assesses the impact of anxiety on assignments and tests, getting to school on time, etc. Items are rated on a 4-point Likert scale from 0 (not at all) to 3 (very much), with higher scores indicating greater impact of anxiety symptoms on academics
Measured: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Change in Affective Reactivity Scale (ARI)
ARI is a 7-item youth- and caregiver-report measure of irritability. Items are rated on a 3-point Likert scale from 0 (not true) to 2 (certainly true)
Measured: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Change in Distress Tolerance Scale (DTS)
DTS is a 15-item youth report measure to evaluate emotional distress tolerance. Items are rated on a 5-point Likert scale from 1 (strongly agree) to 5 (strongly disagree)
Measured: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start5 Oct 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmotionsStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Educational Sciences (IES)
- Responsible party
- Principal investigator, Jill May Ehrenreich, University of Miami
- Investigators
- Jill Ehrenreich-May, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056674
- Sponsor's protocol ID
- 20230796
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2023
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40990367
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06056674
- Acronym / sponsor ID
- 20230796
- Conditions
- Emotions
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Institute of Educational Sciences (IES)
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| U-PEACE Group | Experimental | Behavioral: U-PEACE InterventionParticipants in this group will receive the U-PEACE intervention (study participation to last approximately 13 weeks). |
| Services As Usual (SAU) Group | Active comparator | Behavioral: SAUParticipants in this group will receive service as usual (study participation to last approximately 13 weeks). |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- Adolescents between the ages of 13 and 18 years at the time of enrollment, who:
- 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.
- Individuals who are 18 years or older.
- Individuals who are currently employed at the target HSs.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| U-PEACE InterventionThis 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. | Behavioural | U-PEACE Group |
| SAUParticipants in this group will continue to receive standard of care within their school clinic. | Behavioural | Services As Usual (SAU) Group |
Primary outcome
Change in Adolescent Academic Problems Checklist (AAPC)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Scores on each item range from 0 to 3, with higher scores indicating more academic problems.
Therapeutic Alliance Scale for Children, Revised (TASC-R)
Time frame: Mid (approximately week 4)
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.
Client Satisfaction Questionnaire (CSQ)
Time frame: Mid (approximately week 4)
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.
Top Problems Assessment - Child Report as measured by Likert Scale
Time frame: Up to 13 weeks
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).
Adherence to U-PEACE, as Measured by Homework Completion
Time frame: At all group sessions (up to 9 weeks)
Adherence to U-PEACE will be measured by the overall number of homework assignments completed.
Adherence to U-PEACE, as Measured by Session Attendance
Time frame: At all group sessions (up to 9 weeks)
Adherence to U-PEACE will be measured by the overall number of sessions attended.
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
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.
Change in Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
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
Change in Patient Health Questionnaire 9-item Scale (Modified for Major Depressive Disorder in Adolescents; PHQ-9M)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
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)
5 secondary outcomes
School Achievement, as measured by attendance
Time frame: Up to approximately 13 weeks
School Achievement, as measured by report card
Time frame: Up to approximately 13 weeks
Change in Child Anxiety Impact Scale-Academic Subscale (CAIS-AS)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Change in Affective Reactivity Scale (ARI)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Change in Distress Tolerance Scale (DTS)
Time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 40990367Velez 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.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jill Ehrenreich-May, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing U-PEACE Intervention and SAU in people with Emotions, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adolescent Academic Problems Checklist (AAPC) (time frame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056674, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.