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Can a primary care therapy ease trauma in children?

NCT ID NCT07797400

Symptom relief Sponsor: The University of Texas Health Science Center, Houston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This study tests a stepped-care version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for children with elevated traumatic stress symptoms. The therapy is delivered in pediatric primary care, with intensity matched to each child's needs and caregiver involvement. Researchers will assess feasibility and acceptability, along with changes in trauma and anxiety symptoms. The goal is to see if this approach can reduce trauma symptoms and related mental health issues in a primary care setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A stepped-care version of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) delivered in pediatric primary care, with caregiver involvement.
What this could lead to
If it works, this could offer a practical way to deliver trauma-focused therapy in primary care, helping more children recover from trauma symptoms.
What could go wrong
This is a small early feasibility study with 30 participants, so it may not show clear benefits or generalize widely. The therapy requires caregiver participation and may not suit all families.

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 30 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 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

8 to 14 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: * able to read or understand English Exclusion Criteria: * Currently receiving mental health treatment elsewhere * Clinical exclusion criteria: 1. Evidence of active suicidality 2. Presence of psychotic symptoms Severe psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as: 1. Score ≥ 40 on the child-report measure, or 2. Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments

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Conditions

The condition(s) this trial relates to.

injury

As listed by the trial registrant

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

Trauma patients

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

  • The University of Texas Health science Center at Houston

    Houston, Texas, 77030, United States

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