Recruiting

Observational Study

Sponsor:

University of Miami

Code:

NCT06038721

Conditions

Mental Health Issue

Anxiety Disorder

Depressive Disorder

Parenting

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief summary:

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.

Conditions

Mental Health Issue

Anxiety Disorder

Depressive Disorder

Parenting

Study ID

NCT06038721

Start date

Sep 25, 2023

Status verified date

Sep, 2025

Completion date

Sep 25, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

1500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

Interventions

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.

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.

Primary outcome measure

  • Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S) [ Time Frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). ]
  • Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S) [ Time Frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). ]
  • Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P) [ Time Frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). ]
  • Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C) [ Time Frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). ]
  • Change in Parental Stress Scale (PSS) as measured by Likert Scale [ Time Frame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks). ]

Central Contacts and Locations

Central contacts

Jill Ehrenreich-May, PhD

305-284-6476j.ehrenreich@miami.edu

Danielle Ibarra, PsyD

305-284-2712d.ibarra@umiami.edu

Locations

Child and Adolescent Mood and Anxiety Treatment Program

Recruiting

Coral Gables, Florida, United States, 33146

Principal Investigator:

Jill Ehrenreich-May, PhD

More Information

Sponsor

University of Miami

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Miami on 2025-09-11.