Traumatic InjuryPACTSNCT06366282
Pediatric and Caregiver Traumatic Stress Intervention (PACTS)
A study testing Caregiver Counseling for Childhood Traumatic Injury in people with Traumatic Injury, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Traumatic Injury
- What is being tested?
- Caregiver Counseling for Childhood Traumatic Injury
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 31 Jul 2026
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units
- English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)
- Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.
Who cannot join
- Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.
Read the detailed description
This study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. The purpose of the PACTS Intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.
- Conditions
- Traumatic Injury
- Being tested
- Caregiver Counseling for Childhood Traumatic Injury, Standard of Care for Childhood Traumatic Injury
- Keywords
- posttraumatic stress disorder, depression, pediatric injury
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caregiver Counseling for Childhood Traumatic InjuryBehavioural
Caregiver intervention will be provided by the counseling team that includes components of trauma narrative, psychoeducation, coping strategies, and resilience-building using, for burn patients.
Standard of Care for Childhood Traumatic InjuryBehavioural
Control group receives the current standard of care provided by the counseling team
| Study group | Role | What they receive |
|---|---|---|
| Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling | Experimental | Screening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization Receives: Behavioral: Caregiver Counseling for Childhood Traumatic Injury |
| Peritraumatic Distress Inventory (PDI) Tool - Standard of Care | Active comparator | Screening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress Receives: Behavioral: Standard of Care for Childhood Traumatic Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Kessler 6 Scores
Administered to the caregiver to screen for secondary Post Traumatic Stress Disorder (PTSD) - A six-item K6 screening scale for psychological distress - a short measure of non-specific psychological distress based on questions about the level of nervousness, agitation, psychological fatigue and depression - scores range from 10-50 with higher scores meaning a severe mental disorder
Measured: From baseline to Month 3
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression
Measured: From baseline to Month 3
Change in Child and Adolescent Trauma Screen (CATS) Scores
Caregiver administered to caregiver to screen for PTSD in the child - The "Child and Adolescent Trauma Screen (CATS)" is a Diagnostic and Statistical Manual-5 (DSM-5) based checklist that includes 15 potentially traumatic events or series of events, the 20 posttraumatic stress symptoms (PTSS) and 5 impairment items. The younger child version conforms to the DSM-5 3-6 year old PTSD symptom criteria. The CATS can be administered as a self-report or as an interview. Interview may be preferable with younger children or youth with reading comprehension challenges. Scores ranging from 0-16+ with higher scores meaning more probability of Post Traumatic Stress Disorder (PTSD)
Measured: From baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start26 Nov 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic InjuryStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Childress Institute for Pediatric Trauma
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shilling, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366282
- Sponsor's protocol ID
- IRB00110030
- Acronym
- PACTS
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric and Caregiver Traumatic Stress Intervention: A Path Forward After Injury for Pediatric Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT06366282
- Acronym / sponsor ID
- PACTS / IRB00110030
- Conditions
- Traumatic Injury
- Keywords
- posttraumatic stress disorder, depression, pediatric injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Childress Institute for Pediatric Trauma
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 15 Apr 2024 (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.
The purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.
Detailed description
This study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. The purpose of the PACTS Intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling | Experimental | Behavioral: Caregiver Counseling for Childhood Traumatic InjuryScreening using Peritraumatic Distress Inventory (PDI) tool and one or more caregiver intervention during a single hospitalization |
| Peritraumatic Distress Inventory (PDI) Tool - Standard of Care | Active comparator | Behavioral: Standard of Care for Childhood Traumatic InjuryScreening using the Peritraumatic Distress Inventory (PDI) tool and standard of care related to acute stress and post-traumatic stress |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units
- English-speaking adults, with English denoted as the primary language in the electronic medical record (EMR)
- Caregiver-child dyads who screen positive with the Peritraumatic Distress Inventory (PDI) Tools will be invited to participate in the randomized controlled trial.
Key exclusion criteria (1 listed)
- Patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (AMA) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population
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 |
|---|---|---|
| Caregiver Counseling for Childhood Traumatic InjuryCaregiver intervention will be provided by the counseling team that includes components of trauma narrative, psychoeducation, coping strategies, and resilience-building using, for burn patients. | Behavioural | Peritraumatic Distress Inventory (PDI) Tool - Trauma Counseling |
| Standard of Care for Childhood Traumatic InjuryControl group receives the current standard of care provided by the counseling team | Behavioural | Peritraumatic Distress Inventory (PDI) Tool - Standard of Care |
Primary outcome
Change in Kessler 6 Scores
Time frame: From baseline to Month 3
Administered to the caregiver to screen for secondary Post Traumatic Stress Disorder (PTSD) - A six-item K6 screening scale for psychological distress - a short measure of non-specific psychological distress based on questions about the level of nervousness, agitation, psychological fatigue and depression - scores range from 10-50 with higher scores meaning a severe mental disorder
Change in Patient Health Questionnaire - 9 (PHQ-9) Scores
Time frame: From baseline to Month 3
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression
Change in Child and Adolescent Trauma Screen (CATS) Scores
Time frame: From baseline to Month 3
Caregiver administered to caregiver to screen for PTSD in the child - The "Child and Adolescent Trauma Screen (CATS)" is a Diagnostic and Statistical Manual-5 (DSM-5) based checklist that includes 15 potentially traumatic events or series of events, the 20 posttraumatic stress symptoms (PTSS) and 5 impairment items. The younger child version conforms to the DSM-5 3-6 year old PTSD symptom criteria. The CATS can be administered as a self-report or as an interview. Interview may be preferable with younger children or youth with reading comprehension challenges. Scores ranging from 0-16+ with higher scores meaning more probability of Post Traumatic Stress Disorder (PTSD)
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 13 Oct 2026.
- 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.
Elizabeth Shilling, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caregiver Counseling for Childhood Traumatic Injury in people with Traumatic Injury, run by Wake Forest University Health Sciences 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 1 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 13 Oct 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 Kessler 6 Scores (time frame: From baseline to Month 3). The study lists 3 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 13 Oct 2026.