Improving Behavioral Health for Caregivers and Children After Pediatric Injury

NCT06856057 | Recruiting

• 2 other identifiers: Pro001384821R01HD117024-01
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 4

Brief 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 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).

Conditions

Quality of Life; PTSD; Depression Not Otherwise Specified; Child Externalizing Behavior

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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

  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

  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

  From 3-month, to 6-month, until end of treatment at 12-month

Secondary Outcomes (5)

• Number of caregivers with service engagement

  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

  At 3-month, 6-month, and 12-month

• Change in caregiver health status

  From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month

• Change in caregiver work and productivity status

  From enrollment (baseline) to 3-month, to 6-month, to end of treatment at 12-month

• Number of children with service engagement

  From 3-month, to 6-month, until end of treatment at 12-month

Study Arms (2)

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.

Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

Interventions

Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) BEHAVIORAL

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).

Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 8-11 years) or PDI Caregiver measure of acute distress.

You may not qualify if:

• A caregiver whose primary language is not English
• 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).

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

Kentucky Children's Hospital

Lexington, Kentucky, 40536, United States

RECRUITING

C.S. Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Leigh Ridings, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leigh Ridings

CONTACT

(843) 792-5146; ridingle@musc.edu

Ebonie Powell

CONTACT

powelebo@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 4, 2025
• Study Start: May 28, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (4)