Unified Protocol: Community Connections

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Parenting; Anxiety Disorder; Mental Health Issue
• Intervention / Treatment: 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
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jill Ehrenreich-May, PhD; Phone Number: 305-284-6476; Email: j.ehrenreich@miami.edu
• Study Contact Backup: Name: Niza Tonarely-Busto, PhD; Phone Number: 305-284-2712; Email: niza.tonarely@miami.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • Child and Adolescent Mood and Anxiety Treatment Program
      • Principal Investigator: Jill Ehrenreich-May, PhD
      • Contact: Jill Ehrenreich-May, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: 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.; Other Names: UP-C
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.	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.; Other Names: UP-A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)	The Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-25) is 25-item parent-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite score ranging from 0 to 75. A score of 70 or higher indicates high severity.	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)	The Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-25) is 25-item self-reported scale measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with total composite scores ranging from 0 to 75. A score of 70 or higher indicates high severity.	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)	The Strengths and Difficulties Questionnaire (SDQ) is a 25-item parent-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.	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)	The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-reported measure assessing five domains in youth: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and pro-social behaviors. All items are rated on a 3-point scale from 0 (not true) to 2 (Certainly true). A score can be generated for each scale and all except the prosocial subscale are added together to generate a total composite difficulties score (based on 20 items). Higher total composite scores are indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behavior.	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	The Parental Stress Scale (PSS) is an 18-item measure assessing parents' feelings about their parenting role, exploring both positive (e.g., emotional benefits, personal development) and negative (e.g., demands on resources, feelings of stress) aspects on parenthood. All items are rated on 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). Items are summed with higher scores indicating higher levels of parental stress.	Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Top Problems Assessment - Parent Report as measured by Likert Scale	The Top Problems assessment is used to identify parent-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).	up to 24 weeks
Top Problems Assessment - Child Report as measured by Likert Scale	The Top Problems assessment is used to identify self-reported target problems for treatment and track changes in problem severity over time. Identified top problem statements are rated on 9-point Likert scale from 0 (not at all a problem) to 8 (a huge problem).	up to 24 weeks
Change in Clinical Global Impression, Severity Scale (CGI-S)	The CGI-S is a single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom severity.	At baseline, and up to 24 weeks
Clinical Global Impression - Improvement (CGI-I)	The CGI-I is a single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The item is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline.	At up to 24 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: The Children's Trust, Miami FL
• Investigators: Principal Investigator: Jill Ehrenreich-May, PhD, University of Miami

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 25, 2028

Study Registration Dates

• First Submitted: September 7, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: 20230860

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No