Unified Protocol: Community Connections

University of Miami

Status: Enrolling

Conditions: Parenting; Anxiety Disorder; Mental Health Issue; Depressive Disorder

Treatments: Behavioral: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children; Behavioral: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

Study type: Interventional

Funder types: Other

Identifiers

NCT06038721

20230860

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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