Unified Protocol: Community Connections | NCT06038721

NCT06038721

Status Module

Name	Class
The Children's Trust, Miami FL	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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)

Secondary Outcomes

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

Eligibility Module

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).

Name	Role	Phone	Extension	Email
Jill Ehrenreich-May, PhD	Contact	305-284-6476		j.ehrenreich@miami.edu
Danielle Ibarra, PsyD	Contact	305-284-2712		d.ibarra@umiami.edu

ID	Term
D001008	Anxiety Disorders
D003866	Depressive Disorder

ID	Term
D001523	Mental Disorders
D019964	Mood Disorders