Unified Protocol: Community Connections
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorUniversity of Miami
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
BehavioralThe 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.
The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
BehavioralThe 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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in ChildrenExperimental treatment 1 intervention
Group B: The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in AdolescentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).2
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.
Time frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).3
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.
Time frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).4
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.
Time frame
Session 1 (approximately week 1), session 8 (approximately week 8), and at the natural termination session (approximately 24 weeks).Secondary outcomes
1
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).
Time frame
up to 24 weeks2
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).
Time frame
up to 24 weeks3
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.
Time frame
At baseline, and up to 24 weeks4
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.
Time frame
At up to 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
The Children's Trust, Miami FL
Collaborator
Source ClinicalTrials.gov