Clinical trial NCT06038721: Unified Protocol: Community Connections
Official title: Unified Protocol: Community Connections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health Issue
Anxiety Disorder
Depressive Disorder
Parenting
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Children's Trust, Miami FL
First posted: 2023-09-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)
timeFrame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
measure: Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
timeFrame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
measure: Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)
timeFrame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
measure: Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)
timeFrame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
measure: Change in Parental Stress Scale (PSS) as measured by Likert Scale
timeFrame: Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Secondary outcomes:
measure: Top Problems Assessment - Parent Report as measured by Likert Scale
timeFrame: up to 24 weeks
measure: Top Problems Assessment - Child Report as measured by Likert Scale
timeFrame: up to 24 weeks
measure: Change in Clinical Global Impression, Severity Scale (CGI-S)
timeFrame: At baseline, and up to 24 weeks
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: At up to 24 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Child and Adolescent Mood and Anxiety Treatment Program
state: Florida
Study officials:
affiliation: University of Miami
name: Jill Ehrenreich-May, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.