Clinical trial NCT06056674: Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE)
Official title: Unified Protocol for Preventing Emotional and Academic Challenges in Education (U-PEACE) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotions
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Institute of Educational Sciences (IES)
First posted: 2023-09-28
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
measure: Therapeutic Alliance Scale for Children, Revised (TASC-R)
timeFrame: Mid (approximately week 4)
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Mid (approximately week 4)
measure: Top Problems Assessment - Child Report as measured by Likert Scale
timeFrame: Up to 13 weeks
measure: Adherence to U-PEACE, as Measured by Homework Completion
timeFrame: At all group sessions (up to 9 weeks)
measure: Adherence to U-PEACE, as Measured by Session Attendance
timeFrame: At all group sessions (up to 9 weeks)
measure: 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)
measure: 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)
measure: 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)
Secondary outcomes:
measure: School Achievement, as measured by attendance
timeFrame: Up to approximately 13 weeks
measure: School Achievement, as measured by report card
timeFrame: Up to approximately 13 weeks
measure: Change in Child Anxiety Impact Scale-Academic Subscale (CAIS-AS)
timeFrame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
measure: Change in Affective Reactivity Scale (ARI)
timeFrame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
measure: Change in Distress Tolerance Scale (DTS)
timeFrame: At baseline, mid (approximately week 4), post (approximately week 9) and 1-month follow-up (approximately week 13)
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, PhD
role: PRINCIPAL_INVESTIGATOR
References: