What this study is
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.
What's being tested
- The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children
Intervention · 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.
- The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents
Intervention · BEHAVIORAL
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.
Study details
- Sponsor
- University of Miami
- Conditions
- Mental Health Issue · Anxiety Disorder · Depressive Disorder · Parenting
- Enrolling
- 1,500 people
- Starts
- 2023-09-25
- Est. completion
- 2028-09-25
- Design
- Open-label, non-randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 7 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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).
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openChild and Adolescent Mood and Anxiety Treatment Program
Coral Gables, Florida, United States
- Jill Ehrenreich-May, PhD · Contact
- Jill Ehrenreich-May, PhD · Principal investigator
Recruiting
Study team
Sponsor
University of Miami
Study ID 20230860
Principal investigator
Jill Ehrenreich-May, PhD
University of Miami
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.