Unified Protocol: Community Connections

NCT06038721 | Recruiting

• 1 other identifier: 20230860
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Top Problems Assessment - Parent Report as measured by Likert Scale

  up to 24 weeks

• Top Problems Assessment - Child Report as measured by Likert Scale

  up to 24 weeks

• Change in Clinical Global Impression, Severity Scale (CGI-S)

  At baseline, and up to 24 weeks

• Clinical Global Impression - Improvement (CGI-I)

  At up to 24 weeks

Study Arms (2)

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

EXPERIMENTAL

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 Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents

EXPERIMENTAL

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

Interventions

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

Also known as: UP-C

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

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

Also known as: UP-A

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

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• The Children's Trust, Miami FL: collaborator

Study Sites (1)

Child and Adolescent Mood and Anxiety Treatment Program

Coral Gables, Florida, 33146, United States

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Jill Ehrenreich-May, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jill Ehrenreich-May, PhD

CONTACT

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

Danielle Ibarra, PsyD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 15, 2023
• Study Start: September 25, 2023
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 25, 2028
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)