Unified Protocol: Community Connections

NCT ID: NCT06038721

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-25

Study Completion Date

2028-09-25

Brief Summary

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The purpose of this study is to administer the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. The UP-C and the UP-A are cognitive-behavioral therapies to treat emotional disorders.

Detailed Description

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Conditions

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Mental Health Issue Anxiety Disorder Depressive Disorder Parenting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) in up to 15 sessions through a group format, attended over up to 24 weeks. Sessions will include parent and child strategies to manage strong emotions.

Group Type EXPERIMENTAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

Intervention Type BEHAVIORAL

The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

The participants in this group will receive the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in an individual format for up to 24 weeks.

Group Type EXPERIMENTAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

Intervention Type BEHAVIORAL

The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.

Interventions

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The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children

The UP-C is administered in-person to parents and children over the course of up to 15 weekly group sessions, which last approximately 90 minutes each.

Intervention Type BEHAVIORAL

The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

The UP-A is administered to parents and teens over the course of approximately 15-24 weekly individual sessions, which last approximately 50 minutes each. Sessions can be administered in-person or online, with at least one session occurring in person.

Intervention Type BEHAVIORAL

Other Intervention Names

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UP-C UP-A

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 7-17.
* Youth currently resides in Miami-Dade County.
* Children and their parents must be able to speak and understand English and/or Spanish sufficiently well to complete study procedures (e.g., provide their informed consent/assent, complete assessment measures and/or program materials).
* At least one parent or caregiver with whom the child is living with that can accompany the child and participate in all visits (assessment and treatment).
* Positive endorsement of elevated emotional concerns in one of a limited range of emotional disorder domains (i.e., anxiety, depression, trauma, or obsessive-compulsive symptoms, etc.) during full DIAMOND-Kid semi-structured interview, and/or elevated anxiety or depression symptoms (T-Score \> or = 65 for youth 8-17 years old; Raw score \> or = 12 for children under 8 years old) on the Revised Child Anxiety and Depression Scale - Short Form (RCADS-SF; Child or Parent Report).
* Youth with other types of comorbid conditions (e.g., tic/Tourette's disorder, eating disorders, or disruptive behavior disorders) will not be excluded, providing a clinical area of concern is regarding one of the emotional disorder domains specified and treatment within this protocol is deemed most appropriate.
* Youth and parent participation in at least one in-person session if the treatment is predominantly delivered virtually.

Exclusion Criteria

* Prior receipt of at least 8 sessions of the UP-C/A program at the Child and Adolescent Mood and Anxiety Treatment Program (CAMAT).
* Psychiatric hospitalization in the previous 6 months (i.e., due to Baker Act, psychotic symptoms, significant suicidal ideation, danger to self or others, etc.).
* Another significant problem area that takes priority for services (e.g., eating disorder, substance-use disorder, primary externalizing concerns, psychotic symptoms, etc.), as identified by family report or via DIAMOND-Kid interview.
* Inability for family to wait for the next group treatment cohort to start, family declining therapist assignment following intake, and/or family no-showing to 3 or more scheduled sessions at CAMAT (inclusive of intake assessment).
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Children's Trust, Miami FL

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Jill May Ehrenreich

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill Ehrenreich-May, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Child and Adolescent Mood and Anxiety Treatment Program

Coral Gables, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jill Ehrenreich-May, PhD

Role: CONTACT

305-284-6476

Danielle Ibarra, PsyD

Role: CONTACT

305-284-2712

Facility Contacts

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Jill Ehrenreich-May, PhD

Role: primary

References

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Ehrenreich-May, J., Kennedy, S. M., Sherman, J. A., Bilek, E. L., Buzzella, B. A., Bennett, S. M., & Barlow, D. H. (2017). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents: Therapist guide. Oxford University Press.

Reference Type BACKGROUND

Other Identifiers

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20230860

Identifier Type: -

Identifier Source: org_study_id

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