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New therapy trial aims to ease anxiety and depression in youth

NCT ID NCT06038721

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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).

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Coral Gables, Florida, 33146, United States

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