Community Connections for treating emotional disorders in youth
Unified Protocol: Community Connections
This study is testing a new therapy program for kids and teens with anxiety and depression to see if it helps them feel better, and it involves both the youth and their parents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1500 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Trial ID | NCT06038721 on ClinicalTrials.gov |
What this trial studies
This study aims to implement the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents to address mental health issues such as anxiety and depression. Participants, including youth aged 7-17 and their parents, will engage in cognitive-behavioral therapy sessions designed to treat emotional disorders. The efficacy of the treatment will be evaluated through standardized measures, questionnaires, and interviews to assess outcomes. The study is conducted in Miami-Dade County, focusing on both the youth and their caregivers.
Who should consider this trial
Good fit: Ideal candidates are children aged 7-17 living in Miami-Dade County who exhibit elevated emotional concerns and can participate with a parent or caregiver.
Not a fit: Patients who do not have elevated emotional concerns or those who cannot participate with a caregiver may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve emotional well-being and coping strategies for children and adolescents facing anxiety and depressive disorders.
How similar studies have performed: Previous studies utilizing cognitive-behavioral therapies for emotional disorders in youth have shown promising results, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Coral Gables, Florida
- Child and Adolescent Mood and Anxiety Treatment Program — Coral Gables, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Jill Ehrenreich-May, PhD — University of Miami
- Study coordinator: Jill Ehrenreich-May, PhD
- Email: j.ehrenreich@miami.edu
- Phone: 305-284-6476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.