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Improving Behavioral Health for Caregivers and Children After Pediatric Injury

Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CAARE, a program that uses technology to support children’s and caregivers’ emotional and behavioral health after a child’s injury. It is for children under age 12 who are in the hospital for an injury and their adult caregivers. Families are assigned by chance to CAARE or enhanced usual care that follows care guidelines.

Pediatric traumatic injury (PTI) is a public health priority, with more than 125,000 children experiencing injuries that require hospitalization each year. These children, and their caregivers, are affected in many ways that may affect quality of life, emotional and behavioral health, physical recovery, family roles and routines, and academic functioning; yet US trauma centers do not adequately address these outcomes and a scalable national model of care for these families is needed. This proposal builds on prior research from the investigative team to test a technology-assisted, stepped care behavioral health intervention for children (\<12 years) and their caregivers after PTI, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), via a hybrid type I effectiveness-implementation trial with 348 families randomly assigned to CAARE (n=174) vs. guideline-adherent enhanced usual care (EUC) (n=174).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The caregiver is at least 18 years old.
  • The child is under age 12 and is in the hospital for an injury.
  • The child ages 6–11 or the caregiver has a positive result on a study screening test for strong emotional distress.

Who can't join

  • The caregiver’s main language is not English or Spanish.
  • The caregiver or child has trouble with thinking or understanding that would limit their ability to agree to join the study.
  • The child’s injury was self-inflicted, meaning the child caused their own injury.
  • The child’s injury resulted from caregiver abuse or neglect. These children will receive a different treatment path.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (4)

CA

KY

MI

TX