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

University of Miami

Status: Active, not recruiting

Conditions: Emotions

Treatments: Behavioral: SAU; Behavioral: U-PEACE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06056674

20230796

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 13 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

U-PEACE Group

Experimental group

Description:

Participants in this group will receive the U-PEACE intervention (study participation to last approximately 13 weeks).

Treatment:

Behavioral: U-PEACE Intervention

Services As Usual (SAU) Group

Active Comparator group

Description:

Participants in this group will receive service as usual (study participation to last approximately 13 weeks).

Treatment:

Behavioral: SAU