Unified Protocol: Community Connections

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• 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).]

Secondary outcome measures (4)

• Top Problems Assessment - Parent Report as measured by Likert Scale [Time frame: up to 24 weeks]
• Top Problems Assessment - Child Report as measured by Likert Scale [Time frame: up to 24 weeks]
• Change in Clinical Global Impression, Severity Scale (CGI-S) [Time frame: At baseline, and up to 24 weeks]
• Clinical Global Impression - Improvement (CGI-I) [Time frame: At up to 24 weeks]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Child and Adolescent Mood and Anxiety Treatment Program — Coral Gables

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.

Identifiers

NCT: NCT06038721 · 20230860

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗