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

Emotions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056674
• Other study ID #: 20230796
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: September 1, 2025

Study information

• Verified date: December 2023
• Source: University of Miami
• Contact: Jill Ehrenreich-May, PhD
• Phone: 3052846476
• Email: j.ehrenreich[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: September 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

Youth:

1. Adolescents between the ages of 13 and 18 years at the time of enrollment, who:

1. display depressive symptoms above the clinical cut-off of 9 or above on the Patient Health Questionnaire-8 (PHQ-8),

2. display elevated anxiety symptoms of 10 or above on the Generalized Anxiety Disorder 7-item Scale (GAD-7; Spitzer et al., 2006),

3. are enrolled at the target High Schools (HS),

4. have expressed interest in participating in the study, and

5. have a caregiver who is available to sign study consent forms (if under 18 years of age)

2. 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.

3. Adolescents and caregivers are able to complete all study procedures in English or Spanish.

Teachers:

1. Individuals who are 18 years or older.

2. Individuals who are currently employed at the target HSs.

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

Youth Exclusion Criteria:

1. The following individuals may be excluded at any time (e.g., before consent, after being enrolled).

1. Individuals who do not wish to participate in this study and/or who are not able to read and understand the consent/assent.

2. 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)

3. 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).

2. 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.

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

Related Conditions & MeSH terms

• Emotions

Intervention

Behavioral:
• U-PEACE Intervention
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.
• SAU
Participants in this group will continue to receive standard of care within their school clinic.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Institute of Educational Sciences (IES)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	School Achievement, as measured by attendance	Attendance is defined as number of days attending school (not absent)	Up to approximately 13 weeks
Secondary	School Achievement, as measured by report card	School achievement will be measured by a numeric score on each participant's school report card	Up to approximately 13 weeks
Secondary	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	At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Secondary	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)	At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Secondary	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)	At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)