New therapy trial aims to ease anxiety and depression in youth
NCT ID NCT06038721
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing a therapy program called the Unified Protocol for Children (UP-C) and Adolescents (UP-A) to help young people aged 7-17 with anxiety, depression, or other emotional difficulties. The program involves up to 24 sessions with a therapist, either in groups or individually, and includes parents. Researchers will measure changes in symptoms using questionnaires filled out by children and parents. The goal is to see if this therapy can reduce emotional distress and improve daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cognitive-behavioral therapy (Unified Protocol for Children and Adolescents)
- What this could lead to
- If it works, this could provide an effective therapy option to reduce anxiety and depression symptoms in children and teens.
- What could go wrong
- This is a large but early-stage study without a control group, so results may not prove the therapy is better than no treatment or other approaches. Success depends on consistent participation and follow-up.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2023
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 17 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Anxiety disorder are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Child and Adolescent Mood and Anxiety Treatment Program
RECRUITINGCoral Gables, Florida, 33146, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can two workshops and daily texts cool family fights?
- Can a few minutes online help parents keep their cool?
- Can treating Mom's ADHD help her Child's symptoms?
- One 90-Minute session may help parents steady young Kids' mental health
- Can brisk walking boost antidepressant results?
- Can a Brain-Signaling drug crack depression that resists standard treatment?