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Can talk therapy tame severe irritability in kids? new study aims to find out

NCT ID NCT07296939

Symptom relief Sponsor: Florida State University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study is testing whether cognitive behavioral therapy (CBT) can help children aged 4 to 17 who struggle with severe irritability, anxiety, or mood disorders. Researchers will track changes in irritability and overall functioning using clinician and parent reports. The goal is to understand how CBT works for these emotional and behavioral challenges.

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 (CBT)
What this could lead to
If successful, this could provide an effective, non-drug treatment option for severe irritability and emotional dysregulation in children and teens.
What could go wrong
This is an early-stage study without a control group, so results may not prove the therapy works better than no treatment. Also, CBT requires active participation and may not help everyone.

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 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jul 2027

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

4 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 4-17 years * (a) a principal diagnosis of an anxiety or mood disorder per DSM-5 criteria, OR (b) parent report of clinically impairing irritability, emotional dysregulation, and/or disruptive behavior in youth * Child and parent must be able to complete consent documents, assessments, and participate in treatment in English without a translator * At least one parent must be available and willing to participant in both phases. Exclusion Criteria: * Gross neurological, sensory, or motor impairment * History of seizure disorder, psychosis, or organic brain syndrome * Conditions requiring acute intervention, e.g., active suicidality * Non-English speaking child or parent

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Conditions

The condition(s) this trial relates to.

anxiety disorder Depression mood disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression, anxiety

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

  • Florida State University

    RECRUITING

    Tallahassee, Florida, 32304, United States

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