Quality of LifeNCT06856057
Improving Behavioral Health for Caregivers and Children After Pediatric Injury
A study testing Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) in people with Quality of Life and PTSD, run by Medical University of South Carolina at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life, PTSD, Depression Not Otherwise Specified
- What is being tested?
- Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 May 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ebonie Powell contact
United States4 sites, 4 recruiting
- Recruiting
C.S. Mott Children's Hospital
Ann Arbor, Michigan, 48109
Peter Ehrlich, (734) 763-2072, pehrlich@med.umich.edu
- Recruiting
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Linda Ewing-Cobbs, 713-500-3873, Linda.Ewing-Cobbs@uth.tmc.edu
- Recruiting
Kentucky Children's Hospital
Lexington, Kentucky, 40536
Meghan Marsac, 859-218-9113, meghan.marsac@uky.edu
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Ryan Spurrier, 323.361.2322, rspurrier@chla.usc.edu
About this study
Official title: Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury
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).
Read the detailed description
Annually, ~8 million children receive emergency care due to injury, over 125,000 of whom experience pediatric traumatic injury (PTI) - injuries so severe that they are hospitalized, typically after motor vehicle crashes, falls, animal attacks, gunshot wounds, or being struck by a car or other object. Roughly 1 in 3 develop posttraumatic stress disorder (PTSD) and/or depression after PTI - risk factors for poor physical recovery, social and school-related impairment, and disruption of roles and routines. Moreover, \>50% of caregivers of children with PTI are highly distressed in the acute stages of recovery and themselves have high risk of PTSD and depression. This is concerning because caregivers' mental health is highly correlated with children's outcomes. Interventions that improve families' quality of life and emotional and behavioral recovery after PTI are a public health priority. However, trauma centers do not currently have best-practice interventions in place to address this need. Studies led by our team found that few Level 1 pediatric trauma centers have embedded behavioral health programs and that there is high interest in learning how to implement such programs. Many centers are eager to implement cost-efficient models of care. The 2022 American College of Surgeons guidelines explicitly recommend mental health intervention. Pediatric trauma centers therefore are ideally positioned and motivated to embed best-practice care to address the emotional and behavioral needs of children and families.
- Being tested
- Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)Behavioural
CAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm hand-off to mental health services if needed (Step 4).
| Study group | Role | What they receive |
|---|---|---|
| Enhanced usual care (EUC) | No intervention | Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI). |
| Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) | Experimental | CAARE provides bedside screening and education, digital health tools to help caregivers track and manage emotional and behavioral recovery, and timely follow-up to facilitate screening and referrals (if needed). The 4 steps are: (1) a brief bedside intervention for caregivers and children with positive acute stress risk screens designed to provide coping skills and reduce distress; (2) technology resources including (a) a text message-based tool to facilitate symptom self-monitoring and (b) an mHealth application with embedded learning, coping skills, and service locator tools; (3) a 30-day behavioral health screening, and (4) referral to evidence-based treatment for children and caregivers with positive screens. Receives: Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Measured: From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month
Change in scores in caregiver self-report of PTSD
The Abbreviated PTSD Checklist for DSM-5 (PCL-5) will be used to assess caregiver PTSD. The 20 items are rated on a scale from 0-4, with a total symptom severity score calculated by summing all item scores, resulting in a possible range of 0-80, with higher scores indicating the increase in severity of PTSD in caregivers.
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Change in scores in caregiver self-report of caregiver depression
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms.
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Change of child externalizing problems from 3 month to 12 month
The investigators will use the BASC-3 Behavioral and Emotional Screening System (BESS) to assess children's externalizing behaviors using the BESS Externalizing Problems Composite scale via self-report (ages 6-11) and caregiver proxy report (ages 2-11). The BASC-3 Behavioral and Emotional Screening System (BESS) uses a Behavioral and Emotional Risk Index (BERI) T score to indicate a student's risk level for behavioral and emotional problems. Normal risk: 60 or lower, elevated risk: 61-70, extremely elevated risk: 71 or higher
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Change in scores in child self-report and caregiver proxy-report of child PTSD
The Child and Adolescent Trauma Screen (CATS) will be used to assess child PTSD via both self report (ages 7-11) and caregiver proxy report (ages 3-11). The CATS has 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning. Ages 3-6: The total symptom score is calculated by summing up the items 1-16 (possible range = 0-48), ≥ 16 is an indication of a clinically relevant level of symptoms. Ages 7-17: The total symptom score is calculated by summing up the raw scores of items 1-20 (possible range = 0-60), ≥ 21 as indication of a clinically relevant level of symptoms
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Change in scores in child self-report (ages 6-11) of child depression
The Center for Epidemiological Studies Depression Scale for Children (CESD) is a 20-item measure assessing depression in children ages 6-17. Scores range from 0-60, with higher scores indicating higher symptoms of depression in children
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Secondary outcomes (5)
Number of caregivers with service engagement
Mental health care service engagement will be assessed using the National Health Injury Survey (NHIS) mental health service utilization items and also items assessing barriers to healthcare.
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Mean number of child missed daycare/school days due to pediatric traumatic injury
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Measured: At 3-month, 6-month, and 12-month
Change in caregiver health status
36-item Short Form Health Survey (SF-36) will be used to assess a generic indicator of caregivers' health status assessing physical health, role, social, and mental health function. Higher scores indicate more favorable health state, with scores ranging from 0-100.
Measured: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
Change in caregiver work and productivity status
A single questionnaire item asking caregivers whether they are working, laid off/looking for work, not working and not searching for employment, a student, a homemaker, volunteering, caretaking for another, retired, hospitalized or in a skilled nursing facility, in jail, disabled, or homeless.
Measured: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
Number of children with service engagement
Mental health care service engagement will be assessed using the National Health Injury Survey (NHIS) mental health service utilization items and also items assessing barriers to healthcare.
Measured: From 3-month, to 6-month, until end of treatment at 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 May 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Leigh Ridings, Medical University of South Carolina
- Investigators
- Leigh Ridings, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856057
- Sponsor's protocol ID
- Pro00138482
- Other IDs
- 1R01HD117024-01
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Life and Behavioral Health Service Access for Caregivers and Young Children After Pediatric Traumatic Injury
- ClinicalTrials.gov ID
- NCT06856057
- Acronym / sponsor ID
- Pro00138482
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 May 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Annually, ~8 million children receive emergency care due to injury, over 125,000 of whom experience pediatric traumatic injury (PTI) - injuries so severe that they are hospitalized, typically after motor vehicle crashes, falls, animal attacks, gunshot wounds, or being struck by a car or other object. Roughly 1 in 3 develop posttraumatic stress disorder (PTSD) and/or depression after PTI - risk factors for poor physical recovery, social and school-related impairment, and disruption of roles and routines. Moreover, \>50% of caregivers of children with PTI are highly distressed in the acute stages of recovery and themselves have high risk of PTSD and depression. This is concerning because caregivers' mental health is highly correlated with children's outcomes. Interventions that improve families' quality of life and emotional and behavioral recovery after PTI are a public health priority. However, trauma centers do not currently have best-practice interventions in place to address this need. Studies led by our team found that few Level 1 pediatric trauma centers have embedded behavioral health programs and that there is high interest in learning how to implement such programs. Many centers are eager to implement cost-efficient models of care. The 2022 American College of Surgeons guidelines explicitly recommend mental health intervention. Pediatric trauma centers therefore are ideally positioned and motivated to embed best-practice care to address the emotional and behavioral needs of children and families.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced usual care (EUC) | No intervention | –Educational packet includes behavioral health education for children and families after pediatric traumatic injury(PTI). |
| Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) | Experimental | Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)CAARE provides bedside screening and education, digital health tools to help caregivers track and manage emotional and behavioral recovery, and timely follow-up to facilitate screening and referrals (if needed). The 4 steps are: (1) a brief bedside intervention for caregivers and children with positive acute stress risk screens designed to provide coping skills and reduce distress; (2) technology resources including (a) a text message-based tool to facilitate symptom self-monitoring and (b) an mHealth application with embedded learning, coping skills, and service locator tools; (3) a 30-day behavioral health screening, and (4) referral to evidence-based treatment for children and caregivers with positive screens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)CAARE is a technology-enhanced stepped model of care that is designed to deliver education at the bedside to caregivers of children under age 12 years hospitalized for pediatric injury about mental health recovery after pediatric injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and reinforcement of coping skills via mHealth tools (Step 2), screen for caregivers' and children's PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm hand-off to mental health services if needed (Step 4). | Behavioural | Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) |
Primary outcome
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
Time frame: From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month
PROMIS General Life Satisfaction (Caregiver QOL) consists of 10 items that assess general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. The Pediatric Quality of Life Inventory (PEDSQL) consists of 23 items in that comprise four Generic Core Scales: Physical Functioning (8 items), Emotional Functioning (5 items), Social Functioning (5 items), and School Functioning (5 items). Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life.
Change in scores in caregiver self-report of PTSD
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
The Abbreviated PTSD Checklist for DSM-5 (PCL-5) will be used to assess caregiver PTSD. The 20 items are rated on a scale from 0-4, with a total symptom severity score calculated by summing all item scores, resulting in a possible range of 0-80, with higher scores indicating the increase in severity of PTSD in caregivers.
Change in scores in caregiver self-report of caregiver depression
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
Patient Health Questionnaire (PHQ-8) will be used to assess symptoms of caregiver depression, with scores ranging from 0-24 and higher scores indicating higher depression symptoms.
Change of child externalizing problems from 3 month to 12 month
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
The investigators will use the BASC-3 Behavioral and Emotional Screening System (BESS) to assess children's externalizing behaviors using the BESS Externalizing Problems Composite scale via self-report (ages 6-11) and caregiver proxy report (ages 2-11). The BASC-3 Behavioral and Emotional Screening System (BESS) uses a Behavioral and Emotional Risk Index (BERI) T score to indicate a student's risk level for behavioral and emotional problems. Normal risk: 60 or lower, elevated risk: 61-70, extremely elevated risk: 71 or higher
Change in scores in child self-report and caregiver proxy-report of child PTSD
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
The Child and Adolescent Trauma Screen (CATS) will be used to assess child PTSD via both self report (ages 7-11) and caregiver proxy report (ages 3-11). The CATS has 15 items measuring traumatic events, 20 items measuring DSM-5 PTSD symptoms, and 5 items measuring psychosocial functioning. Ages 3-6: The total symptom score is calculated by summing up the items 1-16 (possible range = 0-48), ≥ 16 is an indication of a clinically relevant level of symptoms. Ages 7-17: The total symptom score is calculated by summing up the raw scores of items 1-20 (possible range = 0-60), ≥ 21 as indication of a clinically relevant level of symptoms
Change in scores in child self-report (ages 6-11) of child depression
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
The Center for Epidemiological Studies Depression Scale for Children (CESD) is a 20-item measure assessing depression in children ages 6-17. Scores range from 0-60, with higher scores indicating higher symptoms of depression in children
5 secondary outcomes
Number of caregivers with service engagement
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
Mean number of child missed daycare/school days due to pediatric traumatic injury
Time frame: At 3-month, 6-month, and 12-month
Change in caregiver health status
Time frame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
Change in caregiver work and productivity status
Time frame: From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month
Number of children with service engagement
Time frame: From 3-month, to 6-month, until end of treatment at 12-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ebonie Powell contact
Leigh Ridings, Ph.D. principal investigator
Medical University of South Carolina
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) in people with Quality of Life and PTSD, run by Medical University of South Carolina at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leigh Ridings ((843) 792-5146, ridingle@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL) (time frame: From enrollment (baseline) to 3-month, to 6-month, until end of treatment at 12-month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.