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

Not Applicable

Active, not recruiting

• Conditions: Emotions
• Interventions: Behavioral: SAU; Behavioral: U-PEACE Intervention

• Registration Number: NCT06056674
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2023-10-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Services As Usual (SAU) Group	SAU	Participants in this group will receive service as usual (study participation to last approximately 13 weeks).
U-PEACE Group	U-PEACE Intervention	Participants in this group will receive the U-PEACE intervention (study participation to last approximately 13 weeks).

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	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.
Adherence to U-PEACE, as Measured by Homework Completion	At all group sessions (up to 9 weeks)	Adherence to U-PEACE will be measured by the overall number of homework assignments completed.
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)	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)	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)	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)
Change in Adolescent Academic Problems Checklist (AAPC)	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)	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.
Top Problems Assessment - Child Report as measured by Likert Scale	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 Session Attendance	At all group sessions (up to 9 weeks)	Adherence to U-PEACE will be measured by the overall number of sessions attended.

Secondary Outcome Measures

Name	Time	Method
Change in Affective Reactivity Scale (ARI)	At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)	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)
Change in Distress Tolerance Scale (DTS)	At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)	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)
School Achievement, as measured by report card	Up to approximately 13 weeks	School achievement will be measured by a numeric score on each participant's school report card
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)	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
School Achievement, as measured by attendance	Up to approximately 13 weeks	Attendance is defined as number of days attending school (not absent)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Coral Gables, Florida, United States