NCT06038721 Unified Protocol: Community Connections
| NCT ID | NCT06038721 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Mental Health Issue |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2023-09-25 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,500 participants in total. It began in 2023-09-25 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Contact & Investigator
Jill Ehrenreich-May, PhD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT06038721 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Mental Health Issue. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06038721 currently recruiting?
Yes, NCT06038721 is actively recruiting participants. Contact the research team at j.ehrenreich@miami.edu for enrollment information.
Where is the NCT06038721 trial being conducted?
This trial is being conducted at Coral Gables, United States.
Who is sponsoring the NCT06038721 clinical trial?
NCT06038721 is sponsored by University of Miami. The principal investigator is Jill Ehrenreich-May, PhD at University of Miami. The trial plans to enroll 1,500 participants.