Trauma InjuryNCT04579198
Using mHealth to Improve Emotional Recovery After Pediatric Injury
A study testing Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) in people with Trauma Injury and Child, Only, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury, Child, Only, Posttraumatic Stress Disorder
- 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
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- caregivers of children who experience pediatric traumatic injury
- children younger than 12
- caregivers older than age 18.
Who cannot join
- caregiver's primary language is not English
- self-afflicted injury
- injuries resulting from caregiver abuse or neglect
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Scalable mHealth Resource to Facilitate Behavioral and Emotional Recovery After Pediatric Traumatic Injury
Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.
Read the detailed description
This project consists of three main study aims. The first aim is to finalize the CAARE model and research protocol in preparation for the open trial (Aim 2). To complete this study Aim, CAARE will first be refined guided by preliminary work led by the PI with caregivers after pediatric traumatic injury (PTI). Then, we will conduct usability testing and refine the mHealth components of CAARE with about 10 caregivers in preparation for the open trial (Aim 2). Finally, we will debug the research protocol via implementation of the full CAARE intervention with approximately 5 families prior to conducting the open trial. Aim 2, the open trial, is described in more detail in the Arms/Intervention section.
Aim 3 is to assess CAARE implementation feasibility with families, trauma center leaders, and program managers. This will be conducted through qualitative interviews with (1) ~20 caregivers who participated in the open trial - diverse with respect to race, child age, and mental health status - to assess their reactions to CAARE; (2) ~15 pediatric trauma center directors and ~15 pediatric trauma program managers to identify perceived barriers and facilitators associated with implementing CAARE in pediatric trauma centers.
- Conditions
- Trauma Injury, Child, Only, Posttraumatic Stress Disorder, Parents
- Being tested
- Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)
- Medical subject headings
- Accidental Injuries, 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
The intervention, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), consists of four components: First, all caregivers of PTI patients (ages 0-11) will be given brief education in the hospital related to children's and caregivers' emotional recovery. Second, all families will receive an in-hospital risk-reduction session. These sessions will address avoidance and trauma triggers; scheduling of pleasurable activities; and coping strategies. Third, all caregivers will receive the CAARE app-based components before discharge. The app will engage caregivers for 30 days via an automated SMS system. MHealth components of care will reinforce risk-reduction strategies. Fourth, 30 days post-discharge, a brief behavioral health screen will be completed by caregiver and child to assess need for more intensive screening by a mental health provider. Caregivers/children reporting elevated symptom levels will receive a comprehensive screening and referral process.
| Study group | Role | What they receive |
|---|---|---|
| Families receiving intervention | Experimental | Not described 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 of caregiver self-report of psychological distress
Kessler Psychological Distress Scale (K6); higher scores indicate higher distress levels; Assesses feelings of nervousness, hopelessness, restlessness/fidgetiness, depression, worthlessness, and perceived effort burden; Each question asks patients to indicate how much of the time the child experienced the emotion/behavior during the past week by responding via a 5-point Likert scale (1=All to 5=None)
Measured: 30 days; 60 days; and 90 days post-baseline
Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
Pediatric Emotional Distress Scale (PEDS; caregiver proxy report ages 2-11); 21-item parent-report measure was designed to assess and screen for elevated symptomatology in children following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.
Measured: baseline; 30 days; 60 days; and 90 days post-baseline
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: baseline; 30 days; 60 days; and 90 days post-baseline
Change in scores in child self-report and caregiver proxy-report of child Posttraumatic Stress
The Child PTSD Symptom Scale, Child and Caregiver Versions (CPSS) includes 26 items assessing PTSD diagnostic criteria and severity in youth ages 6-17. Scores range from 0-51, with higher scores indicating higher symptoms of PTSD
Measured: baseline; 30 days; 60 days; and 90 days post-baseline
Change in scores in child self-report (ages 6-11) of child depression; 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. 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: baseline; 30 days; 60 days; and 90 days post-baseline
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: 30 days post-baseline
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: 60 days post-baseline
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: 90 days post-baseline
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: Baseline, 30 days; 60 days; and 90 days post-baseline
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: Baseline, 30 days; 60 days; and 90 days post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Mar 2022
- Primary completion10 Oct 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Leigh Ridings, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579198
- Sponsor's protocol ID
- 00094279
- Other IDs
- K23HD098325
- Status last verified
- Jan 2026
- First submitted
- 1 Oct 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ridings LE, Thomsen KN, Prentice MA, Powell E, Becerra G, Mueller M, Hanson R, Streck CJ, Ehrlich P, Ewing-Cobbs L, Marsac ML, Spurrier R, Davidson T, Ruggiero KJ. Hybrid type 1 randomized controlled trial of technology-assisted stepped care behavioral health intervention for caregivers and children following pediatric traumatic injury. Contemp Clin Trials. 2026 Jul;166:108352. doi: 10.1016/j.cct.2026.108352. Epub 2026 May 23.
PubMed 42178019
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Scalable mHealth Resource to Facilitate Behavioral and Emotional Recovery After Pediatric Traumatic Injury
- ClinicalTrials.gov ID
- NCT04579198
- Acronym / sponsor ID
- 00094279
- Conditions
- Trauma Injury, Child, Only, Posttraumatic Stress Disorder, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 8 Oct 2020 (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.
Nearly 300,000 U.S. children experience injuries that require them to be hospitalized this year. These children, and their caregivers, are at high risk for emotional and behavioral problems, as well as poor quality of life. Trauma centers in the US have good outcomes for survival and physical recovery, but they typically do not have programs to address the emotional and behavioral needs of families. The purpose of this project is to develop a service that achieves this and that can serve as a good model for trauma centers to use. This project will develop, evaluate, and test CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) to address the behavioral and emotional needs of caregivers and children.
Detailed description
This project consists of three main study aims. The first aim is to finalize the CAARE model and research protocol in preparation for the open trial (Aim 2). To complete this study Aim, CAARE will first be refined guided by preliminary work led by the PI with caregivers after pediatric traumatic injury (PTI). Then, we will conduct usability testing and refine the mHealth components of CAARE with about 10 caregivers in preparation for the open trial (Aim 2). Finally, we will debug the research protocol via implementation of the full CAARE intervention with approximately 5 families prior to conducting the open trial. Aim 2, the open trial, is described in more detail in the Arms/Intervention section.
Aim 3 is to assess CAARE implementation feasibility with families, trauma center leaders, and program managers. This will be conducted through qualitative interviews with (1) ~20 caregivers who participated in the open trial - diverse with respect to race, child age, and mental health status - to assess their reactions to CAARE; (2) ~15 pediatric trauma center directors and ~15 pediatric trauma program managers to identify perceived barriers and facilitators associated with implementing CAARE in pediatric trauma centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Families receiving intervention | Experimental | Behavioral: Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- caregivers of children who experience pediatric traumatic injury
- children younger than 12
- caregivers older than age 18.
Key exclusion criteria (3 listed)
- caregiver's primary language is not English
- self-afflicted injury
- injuries resulting from caregiver abuse or neglect
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)The intervention, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), consists of four components: First, all caregivers of PTI patients (ages 0-11) will be given brief education in the hospital related to children's and caregivers' emotional recovery. Second, all families will receive an in-hospital risk-reduction session. These sessions will address avoidance and trauma triggers; scheduling of pleasurable activities; and coping strategies. Third, all caregivers will receive the CAARE app-based components before discharge. The app will engage caregivers for 30 days via an automated SMS system. MHealth components of care will reinforce risk-reduction strategies. Fourth, 30 days post-discharge, a brief behavioral health screen will be completed by caregiver and child to assess need for more intensive screening by a mental health provider. Caregivers/children reporting elevated symptom levels will receive a comprehensive screening and referral process. | Behavioural | Families receiving intervention |
Primary outcome
Change in scores of caregiver self-report of psychological distress
Time frame: 30 days; 60 days; and 90 days post-baseline
Kessler Psychological Distress Scale (K6); higher scores indicate higher distress levels; Assesses feelings of nervousness, hopelessness, restlessness/fidgetiness, depression, worthlessness, and perceived effort burden; Each question asks patients to indicate how much of the time the child experienced the emotion/behavior during the past week by responding via a 5-point Likert scale (1=All to 5=None)
Change in scores in caregiver proxy-report of child emotional distress, ages 2-11
Time frame: baseline; 30 days; 60 days; and 90 days post-baseline
Pediatric Emotional Distress Scale (PEDS; caregiver proxy report ages 2-11); 21-item parent-report measure was designed to assess and screen for elevated symptomatology in children following exposure to a stressful and/or traumatic event; The measure yields scores on the following scales: 1) Anxious/Withdrawn, 2) Fearful, and 3) Acting Out.
Change in scores in child self-report and caregiver proxy-report of child Quality of Life (QOL)
Time frame: baseline; 30 days; 60 days; and 90 days post-baseline
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 child self-report and caregiver proxy-report of child Posttraumatic Stress
Time frame: baseline; 30 days; 60 days; and 90 days post-baseline
The Child PTSD Symptom Scale, Child and Caregiver Versions (CPSS) includes 26 items assessing PTSD diagnostic criteria and severity in youth ages 6-17. Scores range from 0-51, with higher scores indicating higher symptoms of PTSD
Change in scores in child self-report (ages 6-11) of child depression; Caregiver self-report of caregiver depression
Time frame: baseline; 30 days; 60 days; and 90 days post-baseline
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. 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
Mean number of child missed daycare/school days due to pediatric traumatic injury
Time frame: 30 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Mean number of child missed daycare/school days due to pediatric traumatic injury
Time frame: 60 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Mean number of child missed daycare/school days due to pediatric traumatic injury
Time frame: 90 days post-baseline
Caregiver will report on children's number of school and/or daycare days missed due to the injury
Change in caregiver health status
Time frame: Baseline, 30 days; 60 days; and 90 days post-baseline
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.
Change in caregiver work and productivity status
Time frame: Baseline, 30 days; 60 days; and 90 days post-baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Derived from this study: PubMed 42178019Ridings LE, Thomsen KN, Prentice MA, Powell E, Becerra G, Mueller M, Hanson R, Streck CJ, Ehrlich P, Ewing-Cobbs L, Marsac ML, Spurrier R, Davidson T, Ruggiero KJ. Hybrid type 1 randomized controlled trial of technology-assisted stepped care behavioral health intervention for caregivers and children following pediatric traumatic injury. Contemp Clin Trials. 2026 Jul;166:108352. doi: 10.1016/j.cct.2026.108352. Epub 2026 May 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Trauma Injury and Child, Only, run by Medical University of South Carolina at 1 site 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 3 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: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of caregiver self-report of psychological distress (time frame: 30 days; 60 days; and 90 days post-baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579198, which also lists 1 linked publication.
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 16 Jan 2026.