Back to resultsUnified Protocol: Community Connections
Primary Purpose
Mental Health Issue, Anxiety Disorder, Depressive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
Sponsored by
About this trial
This is an interventional treatment trial for Mental Health Issue
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) 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).
Sites / Locations
- Child and Adolescent Mood and Anxiety Treatment ProgramRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
NCT ID
NCT06038721
First Posted
September 7, 2023
Last Updated
October 13, 2023
Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL
1. Study Identification
Unique Protocol Identification Number
NCT06038721
Brief Title
Unified Protocol: Community Connections
Official Title
Unified Protocol: Community Connections
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2023 (Actual)
Primary Completion Date
September 1, 2028 (Anticipated)
Study Completion Date
September 25, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Children's Trust, Miami FL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Issue, Anxiety Disorder, Depressive Disorder, Parenting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
Arm Type
Experimental
Arm Description
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.
Arm Title
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
Other Intervention Name(s)
UP-C
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
Other Intervention Name(s)
UP-A
Intervention Description
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 Measure Information:
Title
Change in Revised Children's Anxiety and Depression Scale - Parent Revised Short Version (RCADS-P-S)
Description
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.
Time Frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Title
Change in Revised Children's Anxiety and Depression Scale - Child Revised Short Version (RCADS-C-S)
Description
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.
Time Frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Title
Change in Strengths and Difficulties Questionnaire - Parent Version (SDQ-P)
Description
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.
Time Frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Title
Change in Strengths and Difficulties Questionnaire - Child Version (SDQ-C)
Description
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.
Time Frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Title
Change in Parental Stress Scale (PSS) as measured by Likert Scale
Description
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.
Time Frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).
Secondary Outcome Measure Information:
Title
Top Problems Assessment - Parent Report as measured by Likert Scale
Description
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).
Time Frame
up to 24 weeks
Title
Top Problems Assessment - Child Report as measured by Likert Scale
Description
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).
Time Frame
up to 24 weeks
Title
Change in Clinical Global Impression, Severity Scale (CGI-S)
Description
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.
Time Frame
At baseline, and up to 24 weeks
Title
Clinical Global Impression - Improvement (CGI-I)
Description
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.
Time Frame
At up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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) 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jill Ehrenreich-May, PhD
Phone
305-284-6476
Email
j.ehrenreich@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Niza Tonarely-Busto, PhD
Phone
305-284-2712
Email
niza.tonarely@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Mood and Anxiety Treatment Program
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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.
Results Reference
background
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Unified Protocol: Community Connections
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