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Can a simple hospital program prevent PTSD in kids and parents after injury?

NCT ID NCT06856057

Symptom relief Sponsor: Medical University of South Carolina 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial tests a program called CAARE that provides education, monitoring, and brief therapy to caregivers of young children hospitalized for a traumatic injury. The goal is to improve quality of life and reduce PTSD, depression, and behavioral problems in both children and their caregivers. The study involves 348 families randomly assigned to either the CAARE program or standard care. If successful, this approach could be used in hospitals nationwide to support families after pediatric injuries.

What this could mean

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

Active substance
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) behavioral intervention
What this could lead to
If effective, this program could provide a scalable model to help families recover emotionally and behaviorally after a child's traumatic injury, improving quality of life and access to mental health services.
What could go wrong
This is a relatively early-stage trial testing a behavioral intervention, so results may not be generalizable. The program's success depends on caregiver engagement and may not work for 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 348 people

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

Started

May 2025

Expected to finish

Aug 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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Caregivers (≥18 years old) of children hospitalized with pediatric injury * Children hospitalized with pediatric injury \<12 years old * Screen positive on the ASC-Kids (aged 6-11 years) or PDI Caregiver measure of acute distress. Exclusion Criteria: * A caregiver whose primary language is not English or Spanish * A cognitive challenge (caregiver or child) that would impair ability to consent * Presence of a self-afflicted injury * Presence of injuries resulting from caregiver abuse or neglect (these patients will follow an alternative treatment path).

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Conditions

The condition(s) this trial relates to.

depressive disorder post-traumatic stress disorder

As listed by the trial registrant

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

Child externalizing behavior Depression not otherwise specified PTSD Quality of life

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. 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

  • C.S. Mott Children's Hospital

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Memorial Hermann Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Kentucky Children's Hospital

    RECRUITING

    Lexington, Kentucky, 40536, United States

More trials for these conditions

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