Skip to main content

Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma



Post-traumatic stress symptoms develop in a quarter to half of injured children affecting their longer-term psychologic and physical health. Evidence-based care exists for post-traumatic stress; however, it is not readily available in some communities. We have developed an eHealth program consisting of online, interactive educational modules and telehealth therapist support based in trauma-focused cognitive behavioral therapy, the Reducing Stress after Trauma (ReSeT) program. We hypothesize that children with post-traumatic stress who participate in ReSeT will have fewer symptoms compared to the usual care control group.


This is a randomized controlled trial to test the effectiveness of the ReSeT intervention in reducing symptoms of post-traumatic stress compared to a usual care control group. One hundred and six children ages 8–17 years, who were admitted to hospital following an injury, with post-traumatic stress symptoms at 4 weeks post-injury, will be recruited and randomized from the four participating trauma centers. The outcomes compared across groups will be post-traumatic stress symptoms at 10 weeks (primary outcome) controlling for baseline symptoms and at 6 months post-randomization (secondary outcome).


ReSeT is an evidence-based program designed to reduce post-traumatic stress symptoms among injured children using an eHealth platform. Currently, the American College of Surgeons standards suggest that trauma programs identify and treat patients at high risk for mental health needs in the trauma system. If effectiveness is demonstrated, ReSeT could help increase access to evidence-based care for children with post-traumatic stress within the trauma system.

Trial registration NCT04838977. 8 April 2021.

Peer Review reports


Post-traumatic stress symptoms (PTSS) are associated with significant child and family psychological distress after injury [1,2,3]. PTSS affects children’s functioning after injury and may include psychological symptoms such as dissociation, avoidance, intrusive thoughts, hyperarousal, and irritability and physical symptoms such as sleep disturbance [4]. Between 25 and 57% of injured children develop significant PTSS [5, 6]. Thus, PTSS following pediatric injury represents a substantial health burden as 3.5 million children sought emergency department care after injury in the USA in 2020 with over 121,994 children under 17 years of age hospitalized for non-fatal injuries [7]. Risk factors for PTSS include pre-injury child adjustment problems such as anxiety, post-injury reactions to the trauma, subjective life threat and fear, low social support and parental PTSS [8,9,10,11,12]. Interestingly, injury severity itself is not associated with development of PTSS symptoms [13]. Because PTSS develops after children are discharged from the hospital, these symptoms are frequently not visible to the trauma system and, thus, may go unrecognized. A study by Newgard and colleagues examining pediatric deaths after admission to the ED for injury showed that self-harm in the year following injury was one of the leading causes of death, underscoring the need for mental health services integrated into the trauma system [14]. Thus, a screening method and a brief, effective treatment that could be delivered through the trauma system has the potential to fill a needed gap in therapy.

Evidence-based therapies for PTSS do exist. Cognitive behavioral therapy (CBT) is an evidence-based treatment that has shown greater improvement than supportive child-centered therapies for childhood anxiety and behavioral problems in general and for children with PTSS in particular [15, 16]. Evidence-based treatments such as CBT [17,18,19,20] typically include education about emotions, identifying and modifying negative thoughts and appraisals, and training in coping skills and relaxation and may include trauma exposure to reduce anxiety and fear (e.g., graded exposure, reducing avoidance) [18, 19]. Trauma-focused CBT was developed to intervene following a range of specific traumas, including interpersonal violence, accidents and injuries, or exposure to/witnessing events occurring to others [17, 21]. Trauma-focused CBT addresses trauma impact using components of CBT and recounting of the trauma narrative to address cognitive distortions and provide exposure to the child’s personal trauma experience. As children retell their experience, they apply the CBT skills that they have learned to restructure and master the response to their memories [18]. The trauma narrative provides children with tools to engage with trauma memory, organize and articulate a positive interpretation of their trauma story, and modify basic core beliefs about the world [21]. Community access to these evidence-based treatments for PTSS is limited in many regions due to families’ lack of health insurance coverage and a paucity of providers especially in more rural areas [22].

eHealth approaches may improve access and reduce barriers to care. eHealth delivers psychological therapy to children and adults with a variety of conditions including PTSD, anxiety, and traumatic brain injury with comparable efficacy to face-to-face approaches [23]. Online alone preventive treatment for PTSS has been successful in a small pilot [10]; however, therapist involvement for treatment may be associated with larger treatment effects [24]. eHealth approaches may also improve access to care especially in rural communities and reduce barriers including the stigma sometimes associated with seeking mental health care [25]. Translating existing PTSS treatments to a therapist-involved eHealth delivery system may substantially improve access to and participation in treatment without reducing efficacy. Many trauma systems, especially those with large rural catchment areas, have active telehealth programs into which an eHealth therapy program could be integrated [26], thereby improving widespread dissemination and implementation [27].

We have developed an online psychoeducational program that includes web-based psychoeducation about PTSS and elements of CBT (e.g., stress management strategies, reframing unhelpful thoughts) with sharing the trauma narrative and graded exposures to the most distressing memories of the experience. The online content is accompanied by weekly meetings with a therapist via videoconference. If successful, these methods could be integrated into trauma systems with existing telehealth programs, providing a systems-level intervention.


The goal of the current randomized controlled trial is to evaluate the Reducing Trauma After Stress (ReSeT) program. ReSeT is a therapist-involved online intervention that incorporates both elements of CBT and graded exposures for children with post-traumatic stress who have been hospitalized following an injury. ReSeT provides online education about post-traumatic stress, identifying and managing feelings, and teaches coping skills which are then used to process the exposure through the trauma narrative. Support is provided by a therapist in weekly online meetings. The goal is to improve children’s psychological outcome after a traumatic injury and give them tools to manage future challenges.

Aims and hypotheses

This study was designed to test the efficacy of ReSeT to reduce PTSS after hospitalization for an injury compared to usual care among children who have elevated symptoms of PTSS at 4 weeks post-injury. Our first aim is to compare the groups on the outcome of PTSS at 10 weeks and 6 months post-randomization as measured by the Child PTSD Scale (CPSS) [28]. Second, we will explore whether child pre-existing psychological health modifies outcomes. Third, we will examine whether there is heterogeneity of treatment effects among subgroups including those with a higher initial symptom burden compared to those with a lower symptom burden, age, and sex.

We hypothesize that children who receive the ReSeT intervention will have a clinically important and statistically significant reduction in symptoms at 10 weeks post-randomization (primary outcome), and this effect will be shown to be durable at 6 months. Finally, we expect that we will find heterogeneity of treatment effect among subgroups of children including those with a higher symptom burden, and those with higher levels of pre-existing psychological problems and with lower functioning families.

Study design

This is a multicentered randomized controlled trial with a 1:1 assignment of the intervention (ReSeT) to control (usual care) that aims to evaluate whether ReSeT is superior to usual care in reducing children’s symptom levels. The intervention lasts 8 weeks. Outcome assessment occurs 1-week post- injury (baseline or pre-injury measure), with assessment for trial entry (elevated stress) at 4 weeks post-injury. The primary study outcome is assessed at the completion of the intervention (10 weeks post-randomization) and durability of effect is assessed at 6 months post-randomization. This study was registered at (NCT04838977) 8 April 2021. Study investigators are handling all aspects of trial management including training of research coordinators, monitoring enrollment, and checking data quality. Investigators meet bi-weekly to review subject accrual, monitor processes, and discuss any potential needed protocol modifications. Data are managed by the Utah Data Coordinating Center at the University of Utah who developed and maintain the REDCap database.


Children are recruited from four level 1 pediatric trauma centers in the USA: Cincinnati Children’s Hospital and Medical Center (Cincinnati, Ohio); Children’s Memorial Hermann Hospital (Houston, Texas); Nationwide Children’s Hospital (Columbus, Ohio); and, Primary Children’s Hospital (Salt Lake City, Utah). Level 1 trauma centers are regional referral hospitals that are capable of providing all aspects of trauma care from prevention through rehabilitation. Children are recruited from the inpatient wards including the pediatric intensive care unit, the surgical unit, and the short stay units (< 23 h hospital admissions).

Participant eligibility, recruitment, enrollment and randomization


Children aged 8 to 17 years hospitalized for trauma are eligible for the study. To be included, children and at least one parent must speak English and have broadband internet availability at their home address. Children with broadband availability but without an internet subscription or computer will be provided with a tablet and internet subscription. Children may not have moderate or severe TBI, as defined by a Glasgow Coma Score of < 13 as these children may find it difficult to participate in therapy. Exclusionary criteria include pre-existing severe psychiatric problems requiring hospitalization; developmental disorders which would preclude participation in therapy; children injured by abuse or through interpersonal violence or a self-inflicted injury; children currently receiving psychotherapy; children hospitalized for over 30 days; and children injured in an event where there was a death of a family member or friend.

Recruitment and enrolment

Research coordinators screen all hospital trauma admissions daily using the electronic medical record. Families are then approached in person or by telephone to confirm eligibility and request verbal consent to participate in the study. Families who are missed are contacted by postal mail to inform them about the study. Families who agree to participate are sent a link to a REDCap (Research Electronic Data Capture) website 1 week following injury and they are asked to fill in baseline information including demographics and study outcomes to obtain baseline measures. Study measures are shown in Table 1.

Table 1 Schedule of enrolment, interventions and assessments

Parents and children are asked to complete a measure of child PTSS, the Child PTSD Scale (CPSS), at 1 week and 4 weeks post-injury [28]. The CPSS was selected as it is a well-established open source questionnaire with favorable sensitivity and specific for identifying PTSS and predicting children’s response to treatment that has been used previously in similar populations [10, 29]. To assess the child’s stress symptoms, the highest value of the parent or child’s response to each item on the CPSS are summed. If the sum is greater or equal to 11 at 4 weeks post-injury, the child is eligible for randomization. The summed value is used as parents may be unaware of children’s internalizing symptoms and children may self-report low values on some items due to avoidance as suggested by Mai and Scheeringa [30]. Families whose child has a CPSS ≥ 11 meet with the research coordinator for their site via videoconference to recheck eligibility requirements and to review the full trial information. After time to ask any remaining questions or consult with other family members, parents are asked to complete informed consent via a REDCap module and children are asked for assent. After informed consent and assent, the family is enrolled in the trial and proceeds to randomization. There are no additional consent provisions. Figure 1 shows the consort diagram from recruitment through follow-up.

Fig. 1
figure 1

ReSeT flow chart from recruitment through completion


Randomization occurs at the time of the 4-week CPSS. One hundred and six children will be randomized from the participating centers using a computer-generated random assignment sequence prepared by the study statistician and uploaded into the REDCap randomization module. Stratification will occur by site and by age group (8–11 years, 12–17 years). Randomization is conducted while the coordinator is speaking with the family via videoconference in order to enable a “warm handoff” to the therapist for families randomized to the treatment group. The randomization sequence is not visible to the research coordinators.


The ReSeT intervention includes 8 online psychoeducational sessions with each session followed by a meeting with a post-doctoral psychology fellow or a doctorate level psychology student supervised by a psychologist with expertise in trauma intervention. The psychoeducational content is delivered online from a dedicated website that has a logon for each individual. Each of the 8 sessions has 3–4 short interactive videos to help children learn the concepts being taught. Concepts are reinforced with brief homework assignments. The therapist meetings are conducted via HIPAA compliant video conferencing. Parents are asked to attend therapy sessions with children younger than age 11 years and may meet the therapist before and after the session for older children as outcomes have been shown to improve with parent involvement [31].

In the first session, the therapist goes through the online video content with the child and parent to teach them about the program and trouble shoot problems that families may have with the technology. After this initial visit, the next three sessions focus on aspects of cognitive behavioral therapy including understanding feelings, identifying helpful and unhelpful thoughts, understanding that thoughts can change outcomes, and cognitive reframing. Videos for each session engage children in learning the concepts and learning skills that they are then able to practice with the therapist and at home including belly breathing, positive imagery, cognitive reframing, and using feelings thermometers to rate the intensity of feelings and the effectiveness of stress management therapies. Videos include interactive content to engage children. Children may go to the ReSeT website to practice skills using the videos as often as they wish and are asked to rate their feelings with the feeling thermometer on the website. Sessions 5 to 7 involve telling the most stressful or scary aspects of the trauma narrative while practicing stress management techniques to allow desensitization to the trauma. The video content shows a child who was injured sharing her trauma narrative with the therapist. The videos show the child creating a hierarchy of least scary to most scary events after injury, and working through the hierarchy with therapist by using the skills that were taught in the prior sessions if she becomes stressed. In the session with the therapist, children build their own trauma narrative hierarchy by identifying and ranking the least to most scary aspects of the trauma and practicing their skills while they talk about what happened. The final session involves a wrap up and resilience plan in which children learn that stress may return and make a plan to manage it. If the parent requests or the therapist feels that the child needs ongoing care after the intervention is completed, appropriate referrals are made by the PI at each site.

Psychoeducational resources for parents are available on the website and include education about self-care for the parent, managing their own stress symptoms, positive parenting and managing child behavior, and managing sleep problems for children. Parents view these resources independently and their completion is not required.

Control subjects will receive usual care. All aspects of care are permitted during the trial, including psychological support. Families are asked whether psychological support was received outside of the ReSeT program at the 10-week and 6-month outcome assessments. Usual care was selected as the comparator as it reflects what children currently receive in the trauma system. Families who request a referral for psychological resources either during or after the completion of the study are given a referral by the site investigator.

Criteria for discontinuing the intervention

Participants are free to discontinue the intervention at any time; however, modification will not be made to the intervention.

Strategies to improve adherence

Participants are reminded to complete measures using automated REDCap reminders and text messages from the research coordinators. Participants receive a small monetary incentive for completion of trial activities.

Relevant concomitant care

While we exclude children from the trial if they are currently receiving therapy so as not to interfere with their ongoing care, all types of concomitant care are allowed during the trial including seeking therapy outside of the trial.

Data management and security

We use REDCap to support this study. REDCap is a secure, web-based, data capture tool, hosted at the University of Utah, which allows participant outcomes to be directly entered by participants. Participants and their parents enter all baseline information including private identifiers and subsequent assessments into REDCap. Study personnel enter medical information from the patients’ charts into the REDCap database. Study personnel may only view participants from their own site. REDCap is programmed with plausible ranges for entered values. The ReSeT website, where participants view the videos, is encrypted and password protected. Each family is given a unique logon and create a password. Each participant is assigned a study ID that is linked to the REDCap database and the ReSeT website. At the time of analysis, an analysis file will be created that merges de-identified information from the ReSeT website and REDCap database by study ID. Data checks are run prior to each DSMB meeting and site research coordinators are asked to source verify any missing variables; however, participants may skip questions in the assessments if they do not wish to respond. The REDCap instance is HIPAA compliant and is housed at the University of Utah’s secure, Federal Information Security Management Act compliant, Data Coordinating Center behind University firewalls.

Quality control measures

Training research assistants

Research assistants are trained on the study protocol. Training includes (1) review of the ReSeT manual; (2) use of the REDCap; (3) best practices for communications with families including how to approach families in person, by phone or by text; (4) consent procedures including practice of providing informed consent and using the REDCap consent module. Training materials are kept with updated versions stored in a Box folder accessible to all sites.

Supervision of therapists

Therapists are trained in the use of the website and delivery of therapy. They are trained through reading and discussion of the training manual, viewing video trainings, and discussions with a licensed clinical psychologist. All cases are supervised weekly by two experienced clinical psychologists who helped to develop the intervention. During supervision meetings, each aspect of the completed sessions is discussed and future sessions are planned to ensure fidelity to the manual.


This is an unblinded study as it is not feasible to blind the research coordinators, the therapists, or the participants. Participants in the treatment and control groups complete outcome measures by directly entering responses into REDCap and the analysis file is de-identified which reduces the risk of bias from unblinded study personnel. Because this study is not blinded, there are no procedures for unblinding.

Fidelity to treatment

Therapists complete a detailed fidelity checklist after each session to document that each element in the treatment manual for that session is completed. Additional documentation includes the total duration of the session, who attended, and time spent with the participant and the participant’s parent. The therapist also rates the participant’s engagement in the session using a Likert scale.

Baseline measures

Parents will be asked to complete family demographic measures including family composition, self-identified race and ethnicity, health insurance status, and income. Parents will be asked to complete measures of family functioning and parental psychological health as these may directly impact children’s recovery [32, 33]. Children complete baseline mental health questionnaires. Both children and parents separately complete a measure of post-traumatic stress reflecting the 1-week post-injury timepoint. Research coordinators will abstract injury information from the chart to include injury mechanism, injury severity score, admission unit and whether there was an operative intervention, and length of stay using a structured format. Abbreviated injury scores will be provided by each hospital’s trauma registrar [34].

Outcome evaluation

All child participants and parents will be asked to complete outcome evaluations through REDCap at 10 weeks and 6 months post-randomization. Participants randomized to the intervention will be asked to complete outcome evaluations regardless of whether they completed all 8 sessions. Table 1 displays schedule of enrolment, interventions and assessments with their timing for participants and their parents. Measures include child physical and psychological health as well as brief measures of family function and parent psychological health as these may affect either children’s likelihood of having PTSS or their response to treatment.

Study outcomes

Primary outcome

The child PTSD scale (CPSS)

The CPSS is a validated child report and parent proxy measure of PTSS [28]. The measure is comprised of 24 items. The CPSS includes 17 questions mapping on to DSM-IV symptoms of PTSD rated on a 4-point scale that indicates how frequently each symptom occurs (0 = not at all, 1 = once a week or less/once in a while, 2 = 2 to 4 times a week/half the time, 3 = 5 or more times a week/almost always). In addition, the CPSS includes seven questions regarding functional impairment. These questions are scored dichotomously as absent (0) or present (1). Scores range from 0 to 7, with higher scores indicating greater functional impairment. A composite of the parent and child CPSS will be used for the primary outcome. We will sum the highest score on each item from the parent and the child as suggested by Mai and Scheeringa for entry into the trial and as the primary outcome [30].

Secondary outcome

The secondary outcome is the composite CPSS assessed at 6 months post-randomization that will assess the durability of any treatment effect.

Potential moderators of treatment outcome: child measures

Screen child anxiety and related emotional disorders (SCARED)

SCARED is a questionnaire that screens for anxiety and emotional disorders in children [37]. The child self-report version will be used in this study, which consists of 41 items rated on a 3-point Likert scale (0 = not true or hardly ever true, 1 = somewhat true or sometimes true, 2 = very true or often true). This measure yields raw scores for anxiety disorder, panic disorder, generalized anxiety disorder, separation anxiety, social anxiety disorder, and significant school avoidance.

Patient-reported outcomes measurement information system (PROMIS)

PROMIS is a National Institutes of Health (NIH) initiative created to advance assessment of patient-reported outcomes [44]. We will use both the pediatric self-report and parent proxy short forms for the anger, anxiety, depression, psychological stress, and physical stress scales which are each eight items and the global health scale which is seven items. Additionally, the eight-item sleep disturbance questionnaire will be completed by parents.

The pediatric quality of life inventory (PedsQL 4.0)

The PedsQL is a well-validated parent-report measure consisting of 23 items that takes less than 5 min to complete [46]. The PedsQL evaluates health-related quality of life by assessing the dimensions of physical, emotional, social, and cognitive functioning in children from infancy to 18 years of life age.

Connor-Davidson resiliency scale (CD-RISC)

The CD-RISC is a self-report questionnaire to measure resilience [41]. The shorter version will be used in this study, which consist of 10 items rated on a 4-point Likert scale (0 = rarely true, 1 = sometimes true, 2 = often true, 3 = true nearly all of the time). The 10-item version has demonstrated good internal consistency and construct validity.

Traumatic events screening inventory – child report form revised (TESI-CRF-R)

The TESI-CRF-R is a well-validated measure consisting of 24 items to assess traumatic experiences among youth ages 6 to 18 years [42]. The TESI-CRF-R assess a child’s experience of a variety of potential traumatic events including current and previous injuries, hospitalizations, domestic violence, community violence, disasters, accidents, physical abuse, and sexual abuse.

Vanderbilt ADHD diagnostic rating scale (VADRS)

The VADRS is a parent-report scale with good internal consistency, factor structure, and concurrent validity for the assessment of attention-deficit hyperactivity disorder (ADHD) and externalizing difficulties [43]. We will be administering 40 items of the VADRS including the ADHD scale (18 items), ODD scale (8 items), and conduct disorder scale (14 items). The VADRS includes the 18 DSM-IV ADHD symptoms rated on a 4-point scale that indicates how frequently each ADHD symptom occurs (0 = never, 1 = occasionally, 2 = often, 3 = very often). In addition, the VADRS includes ODD and conduct disorder scales that are reliable.

Child post-traumatic cognitions inventory (CPTCI) S

The CPTCI-SF is a self-report measure of negative post-trauma cognitions [35, 36]. The CPTCI-S consists of 10 questions for self-report asking about reactions after a frightening event. Each question is ranked on a 4-point Likert scale.

Potential moderators of treatment outcome: parent and family measures

Family assessment device-general functioning scale (FAD-GF)

The FAD-GF is a 12-item sub-scale of the FAD that has demonstrated reliability and validity in assessing global family function [47].

PROMIS adult self-report

This 29-item parent self-report assesses each of the seven PROMIS domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) with 4 questions [48]. Each of the questions is ranked on a 5-point Likert scale. The last item is an 11-point rating scale that assesses pain intensity.

PTSD Checklist-DSM5 (PCL-5)

The PCL-5 is a 20-item parent self-report measure that assesses the 20 DSM-5 symptoms of PTSD [49]. Respondents rate the frequency of their PTSD symptoms over the past 2 weeks on a 4-point Likert scale (0 = not at all or only one time to 3 = 5 or more times a week/almost always). A total symptom severity score can be obtained by summing the scores for each of the items.

COVID exposure and family impact survey (CEFIS)

CEFIS is a caregiver report measure developed in March/April 2020 to measure potentially traumatic aspects of the COVID-19 epidemic as they may influence pediatric study outcomes. It consists of 25 items related to COVID-19-related events and 12 items that measure their impact. The CEFIS was registered and made available on April 22, 2020, with the National Institutes of Health Disaster Information Management Research Center. The scale was validated in 2021 and has excellent internal reliability [50].

Satisfaction surveys

Both parents and children complete brief surveys asking about their overall satisfaction with the program and whether they liked or disliked specific aspects of the program. These surveys, developed by the investigators, are for potential future modifications of the program.

Data analysis

The primary analysis is an intention to treat analysis including all patients who are randomized regardless of their adherence. We will also do an analysis of per-protocol efficacy of participants who received at least 4 of the 8 sessions and completed the 10-week post-randomization CPSS. All analysis will be performed using SAS® Software version 9.4 or later whenever possible. Other software packages, including R, STATA and StatXact®, may be used for particular specialized procedures.

Demographic variables will be summarized with descriptive statistics. Parent and child psychological health scales and subscales will be scored and described. Data will be examined for missingness and outliers. We will examine whether there are baseline differences between groups in the demographic or health scales in case randomization did not adequately balance the groups.

The purpose of the primary analysis is to test the null hypothesis that here is no difference in mean 10-week CPSS score between the CBT and usual care arms. The alternate hypothesis is that there is a difference in mean 10-week CPSS score between the CBT and usual care arms. To test our hypothesis, we will use a generalized linear regression model with an outcome of 10-week CPSS score. Generalized linear regression was chosen as many survey outcomes can be heavily skewed; this approach is flexible enough to accommodate outcomes with either a normal or non-normal distribution [51]. Covariates in the model will include an indicator for treatment group, baseline (1 month) CPSS score, time since randomization, site, and age group. The coefficient for treatment group will answer our primary efficacy question regarding whether 10-week CPSS score differs between CBT versus usual care arms. Adjustment for the baseline CPSS score provides the structure of an analysis of covariance (ANCOVA) to improve statistical power [52]. Time since randomization will be included as a continuous variable to control for a variability among timing of when patients complete the outcome in the event that these differ by group. Site and age group will be included since they were stratification variables used in the randomization protocol.

Regression diagnostics will include plotting residuals vs fitted values to assess linearity, the square root of the standardized residuals vs fitted values (i.e., “Scale-Location”) to assess variance homogeneity, qq plot to assess normality, and standardized residual vs leverage to assess for outliers. The choice of outcome model will depend on the distribution of the CPSS score, which will be visualized using a histogram and density curves stratified by treatment arm. Provided the CPSS score distribution is sufficiently symmetric, we will use a normal outcome model. If the regression assumptions are not reasonably met, we will consider alternative models such as gamma or lognormal. As a sensitivity analysis, we will repeat the above model excluding time since baseline, and also excluding any CBT subjects that had a CPSS score collected after 12 weeks.

If there is an issue with treatment adherence, we will use an instrumental variables approach to estimate treatment effects under different treatment doses. The advantage of this approach over a per-protocol analysis is that it enables us to analyze patients according to their randomized assignment.

Analysis of secondary outcome

For analysis of the 6-month CPSS time point, which will assess persistence of the treatment effect between the CBT and usual care groups, we will use restricted maximum likelihood estimation [53] under a generalized linear mixed model. We will again adjust for the same variables as described above for the main efficacy analysis, except that the outcome timepoint also will be included as binary (10 weeks vs 6 months). The primary efficacy evaluation will be performed using an interaction between the CBT versus usual care group indicator and time. We will adjust for 1 month baseline CPSS in this analysis.

Analysis of exploratory outcomes

Exploratory outcomes will examine whether subgroups differ in their response to treatment. Subgroups will include whether separate child and parent CPSS scores instead of the combined scores alters the treatment effect, whether children with a higher initial CPSS (CPSS ≥ 15) differ from those with a lower CPSS, and whether children with pre-existing depression or anxiety respond differently to treatment. Additionally, we will explore whether treatment differences are seen by age or sex. As the non-CPSS exploratory outcomes are not assessed at the 1 month time point, but they are available at 1 week after injury, we will use this 1 week time point as our baseline measure.

Missing data

Multiple imputation will be implemented for our intention to treat analysis if there is notable missingness in the 10-week CPSS, or an imbalance in missingness between treatment arms [54]. Multiple imputation is particularly useful if there are auxiliary variables that are highly correlated with both the study outcomes and risk of missingness. We will include the following auxiliary variables: child and parent measures (Table 1) and patient demographic factors. In the event that multiple imputation is used, we will generate 20 imputed data sets which contain imputed values of the primary CPSS outcome (if R is used, we will use the mice package). The imputation model will include the outcomes and all predictor variables including the randomized treatment assignment, auxiliary variables, and the baseline level of CPSS.

Power analysis and sample size

The power analysis was conducted in PASS v. 16.0.6. We assumed a correlation between CPSS at trial entry and the 10-week post-intervention CPSS of 0.55 based on prior work by the study team. We estimated a conservative effect size of 0.5 based on Kassam-Adams’ pilot of an online only PTSS preventive treatment among injured children [10]. Based on these assumptions, using an ANCOVA model, we estimate that we would have 80% power at a 0.05 significance level to detect this difference with 45 participants per group (90 total). We expect a loss to follow-up rate of up to 15%; thus, we need to enroll 53 participants per group for 106 total.

Data safety and monitoring board

A Data Safety and Monitoring Board (DSMB) will meet every 6 months via video conference to monitor the trial for accrual and retention, confidentiality of the study data, safety of participants, performance of study sites, and other factors that may affect study outcome. The DSMB consists of two psychologists who are skilled in the treatment of children with post-traumatic stress, and a statistician who is skilled in clinical trials. The DSMB is independent from the sponsor and has declared that no competing interests exist. At the first DSMB meeting, members will review the study protocol and data collection procedures. At subsequent meetings, issues discussed will include the conduct and progress of the study, including patient recruitment, data quality, general adherence, compliance with protocol, any protocol modifications, and any other logistical matters that may affect either the conduct or outcome of the study. No interim statistical analyses are planned for the trial; however, the DSMB will have access to subject accrual and aggregated data by study group at each meeting. The DSMB charter is maintained in a Box account at the University of Utah. The DSMB will provide a report after each meeting to summarize their findings and make recommendations concerning continuation, termination, or other modifications to the study.

Adverse events

The study team will collect any adverse events. All treatment and control patients have access to the study coordinator text numbers and treatment patients meet with the therapist. Any participant needing additional support will be provided referrals by the study team. Adverse events will be reported to the Institutional Review Board and to the DSMB. The DSMB will monitor the occurrence of adverse events. Serious adverse events will be reported to the DSMB within 7 days of site awareness.

Protocol amendments

The need for protocol amendments will be discussed among the investigators. If all investigators approve the amendments, the requested change will be submitted to the Institutional Review Board, the DSMB, and the National Clinical Trials website.

Dissemination policy

The investigators will have access to the all data, perform the main analyses and publish them in the peer-reviewed literature and present them at relevant meetings. We do not plan to use professional writers. Study results will be available in Families will be notified of trial results through an emailed newsletter at the trial conclusion.


This study evaluates whether the use of an eHealth educational program combined with telehealth visits with a therapist is effective to treat children with PTSS after admission to hospital following an injury. The study builds on prior work that demonstrates that TF-CBT is effective in decreasing stress symptoms and that eHealth methods work similarly to in-person counseling for children with depression and anxiety [18, 55]. Because injury severity is not a predictor for the development of post-traumatic stress symptoms [13], the population at risk is potentially much larger, extending to children who are treated and released from the emergency department following injury.

The current study focuses on the reduction of stress symptoms; however, it offers an opportunity to examine the effects of the trial on other outcomes including health-related quality of life and symptoms such as anxiety and depression. It also allows the exploration of the interaction of parents’ mental health symptoms and the family environment with children’s symptoms [56]. This may provide other targets for intervention.

If this trial is successful, it could be scaled for use within the pediatric trauma system as many trauma systems have existing telehealth capabilities designed to reach their large catchment areas. Recently, identification and treatment of patients at high risk for mental health needs within the trauma system was recommended by the American College of Surgeons as a Type II standard [57]. An eHealth program, such as ReSeT, would be especially useful for trauma programs with large rural catchments where referrals to evidence-based treatments may not be feasible. If the trial is successful, ReSeT could be extended to use these for other causes of pediatric post-traumatic stress such as natural disasters.

Trial status

Trial enrollment was started on 23 July 2021 and will be completed as of 30 November 2023. Follow-up of all study subjects will be complete as of 15 June 2024. Protocol version #3; date 3 August 2023 [3].

Availability of data and materials

A fully de-identified data (direct and indirect identifiers) containing the data that this study relies upon will be available on request 3 years after the completion of all study procedures with accompanying code for the main analysis. Because these data contain clinical information, any data or resources shared upon request will be released only after documentation (e.g., data sharing agreements) as appropriate is completed by the relevant entities. Users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, proper acknowledgement of the data resource, information provided to users will not be used for commercial purposes, and will not be redistributed to third parties.



Cognitive behavioral therapy


Connor-davidson resiliency scale


Child post-traumatic cognitions inventory short form


Child PTSD scale


Data safety and monitoring


Family assessment device-general functioning scale


Pediatric quality of life inventory


PTSD Checklist-DSM5


Patient-reported outcomes measurement information system


Post-traumatic stress disorder


Post-traumatic stress symptoms


Research electronic data capture


Screen child anxiety and related emotional disorders


Traumatic events screening inventory – child report form revised


Vanderbilt ADHD diagnostic rating scale


  1. De Young AC, Kenardy JA, Cobham VE, Kimble R. Prevalence, comorbidity and course of trauma reactions in young burn-injured children. J Child Psychol Psychiatry. 2012;53(1):56–63.

    Article  PubMed  Google Scholar 

  2. Levi RB, Drotar D, Yeates KO, Taylor HG. Posttraumatic stress symptoms in children following orthopedic or traumatic brain injury. J Clin Child Psychol. 1999;28(2):232–43.

    Article  CAS  PubMed  Google Scholar 

  3. Winston FK, Baxt C, Kassam-Adams NL, Elliott MR, Kallan MJ. Acute traumatic stress symptoms in child occupants and their parent drivers after crash involvement. Arch Pediatr Adolesc Med. 2005;159(11):1074–9.

    Article  PubMed  Google Scholar 

  4. Cohen JA, Scheeringa MS. Post-traumatic stress disorder diagnosis in children: challenges and promises. Dialogues Clin Neurosci. 2009;11(1):91–9.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Kahana SY. Posttraumatic stress in youth experiencing illnesses and injury: an exploratory meta-analysis. Traumatology. 2006;12(148).

  6. Schreier H, Ladakakos C, Morabito D, Chapman L, Knudson MM. Posttraumatic stress symptoms in children after mild to moderate pediatric trauma: a longitudinal examination of symptom prevalence, correlates, and parent-child symptom reporting. J Trauma. 2005;58(2):353–63.

    Article  PubMed  Google Scholar 

  7. Web-based Injury Statistics Query and Reporting System (WISQARS) [Internet]. National Center for Injury Prevention and Control. Centers for Disease Control and Prevention. 2021 Available from: 21 Jul 2023.

  8. Brosbe MS, Hoefling K, Faust J. Predicting posttraumatic stress following pediatric injury: a systematic review. J Pediatr Psychol. 2011;36(6):718–29.

    Article  PubMed  Google Scholar 

  9. Kassam-Adams N, Marsac ML, Hildenbrand A, Winston F. Posttraumatic stress following pediatric injury: update on diagnosis, risk factors, and intervention. JAMA Pediatr. 2013;167(12):1158–65.

    Article  PubMed  Google Scholar 

  10. Kassam-Adams N, Marsac ML, Kohser KL, Kenardy J, March S, Winston FK. Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events. J Pediatr Psychol. 2016;41(1):138–48.

    Article  PubMed  Google Scholar 

  11. Marsac ML, Donlon KA, Winston FK, Kassam-Adams N. Child coping, parent coping assistance, and post-traumatic stress following paediatric physical injury. Child Care Health Dev. 2013;39(2):171–7.

    Article  CAS  PubMed  Google Scholar 

  12. Price J, Kassam-Adams N, Alderfer MA, Christofferson J, Kazak AE. Systematic Review: A Reevaluation and Update of the Integrative (Trajectory) Model of Pediatric Medical Traumatic Stress. J Pediatr Psychol. 2016;41(1):86–97.

    Article  PubMed  Google Scholar 

  13. Trickey D, Siddaway AP, Meiser-Stedman R, Serpell L, Field AP. A meta-analysis of risk factors for post-traumatic stress disorder in children and adolescents. Clin Psychol Rev. 2012;32(2):122–38.

    Article  PubMed  Google Scholar 

  14. Newgard CD, Lin A, Goldhaber-Fiebert JD, Marin JR, Smith M, Cook JNB, Mohr NM, Zonfrillo MR, Puapong D, Papa L, et al. Association of Emergency Department Pediatric Readiness With Mortality to 1 Year Among Injured Children Treated at Trauma Centers. JAMA Surg. 2022:e217419.

  15. Silk JS, Tan PZ, Ladouceur CD, Meller S, Siegle GJ, McMakin DL, Forbes EE, Dahl RE, Kendall PC, Mannarino A, et al. A Randomized Clinical Trial Comparing Individual Cognitive Behavioral Therapy and Child-Centered Therapy for Child Anxiety Disorders. J Clin Child Adolesc Psychol. 2016:1–13.

  16. Weisz JR, Kuppens S, Ng MY, Eckshtain D, Ugueto AM, Vaughn-Coaxum R, Jensen-Doss A, Hawley KM, KrumholzMarchette LS, Chu BC, et al. What five decades of research tells us about the effects of youth psychological therapy: A multilevel meta-analysis and implications for science and practice. Am Psychol. 2017;72(2):79–117.

    Article  PubMed  Google Scholar 

  17. Cohen J, Mannarino AP. Disseminating and Implementing Trauma-focused CBT in community settings. Trauma Violence Abuse. 2008;9(4):214–26.

    Article  PubMed  Google Scholar 

  18. Cohen JA, Mannarino AP. Trauma-focused Cognitive Behavior Therapy for Traumatized Children and Families. Child Adolesc Psychiatr Clin N Am. 2015;24(3):557–70.

    Article  PubMed  PubMed Central  Google Scholar 

  19. Gillies D, Taylor F, Gray C, O’Brien L, D’Abrew N. Psychological therapies for the treatment of post-traumatic stress disorder in children and adolescents (Review). Evid Based Child Health. 2013;8(3):1004–116.

    Article  PubMed  Google Scholar 

  20. Roberts NP, Kitchiner NJ, Kenardy J, Bisson JI. Systematic review and meta-analysis of multiple-session early interventions following traumatic events. Am J Psychiatry. 2009;166(3):293–301.

    Article  PubMed  Google Scholar 

  21. Deblinger E, Mannarino AP, Cohen JA, Runyon MK, Steer RA. Trauma-focused cognitive behavioral therapy for children: impact of the trauma narrative and treatment length. Depress Anxiety. 2011;28(1):67–75.

    Article  PubMed  Google Scholar 

  22. Kolko DJ. Options for the delivery of mental health services. McInerny T, editor. Elk Grove Village, IL: American Academy of Pediatrics; 2009.

  23. Andrews G, Cuijpers P, Craske MG, McEvoy P, Titov N. Computer therapy for the anxiety and depressive disorders is effective, acceptable and practical health care: a meta-analysis. PLoS ONE. 2010;5(10): e13196.

    Article  PubMed  PubMed Central  Google Scholar 

  24. Grist R, Croker A, Denne M, Stallard P. Technology delivered interventions for depression and anxiety in children and adolescents: A systematic review and meta-analysis. Clin Child Fam Psychol Rev. 2019;22(2):147–71.

    Article  PubMed  Google Scholar 

  25. Boydell KM, Hodgins M, Pignatiello A, Teshima J, Edwards H, Willis D. Using technology to deliver mental health services to children and youth: a scoping review. J Can Acad Child Adolesc Psychiatry. 2014;23(2):87–99. PMCID: PMC4032077.

  26. Marcin JP, Schepps DE, Page KA, Struve SN, Nagrampa E, Dimand RJ. The use of telemedicine to provide pediatric critical care consultations to pediatric trauma patients admitted to a remote trauma intensive care unit: a preliminary report. Pediatr Crit Care Med. 2004;5(3):251–6.

    Article  PubMed  Google Scholar 

  27. Southam-Gerow MA, McLeod BD. Advances in Applying Treatment Integrity Research for Dissemination and Implementation Science: Introduction to Special Issue. Clin Psychol (New York). 2013;20(1):1–13.

  28. Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001;30(3):376–84.

    Article  CAS  PubMed  Google Scholar 

  29. Kassam-Adams N, Marsac ML, Garcia-Espana JF, Winston F. Evaluating predictive screening for children’s post-injury mental health: New data and a replication. Eur J Psychotraumatol. 2015;6:29313.

    Article  PubMed  Google Scholar 

  30. Mai TA, Scheeringa MS. Caregiver and child agreement on traumatic events, PTSD, internalizing, externalizing, and ADHD problems in a child welfare population. J Publ Child Welfare. 2021;15(2):251–74.

    Article  Google Scholar 

  31. Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A. Mobile Health Interventions for Improving Health Outcomes in Youth: A Meta-analysis. JAMA Pediatr. 2017;171(5):461–9.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Kassam-Adams N, Fleisher CL, Winston FK. Acute stress disorder and posttraumatic stress disorder in parents of injured children. J Trauma Stress. 2009;22(4):294–302.

    Article  PubMed  Google Scholar 

  33. Landolt MA, Ystrom E, Sennhauser FH, Gnehm HE, Vollrath ME. The mutual prospective influence of child and parental post-traumatic stress symptoms in pediatric patients. J Child Psychol Psychiatry. 2012;53(7):767–74.

    Article  PubMed  Google Scholar 

  34. Association for the Advancement of Automotive Medicine. Abbreviated Injury Scale Available from: Accessed: 25 Jul 2023.

  35. McKinnon A, Smith P, Bryant R, Salmon K, Yule W, Dalgleish T, Dixon C, Nixon RD, Meiser-Stedman R. An update on the clinical utility of the children’s post-traumatic cognitions inventory. J Trauma Stress. 2016;29(3):253–8.

    Article  PubMed  Google Scholar 

  36. Meiser-Stedman R, Smith P, Bryant R, Salmon K, Yule W, Dalgleish T, Nixon RD. Development and validation of the Child Post-Traumatic Cognitions Inventory (CPTCI). J Child Psychol Psychiatry. 2009;50(4):432–40.

    Article  PubMed  Google Scholar 

  37. Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997;36(4):545–53.

    Article  CAS  PubMed  Google Scholar 

  38. DeWalt DA, Gross HE, Gipson DS, Selewski DT, DeWitt EM, Dampier CD, Hinds PS, Huang IC, Thissen D, Varni JW. PROMIS((R)) pediatric self-report scales distinguish subgroups of children within and across six common pediatric chronic health conditions. Qual Life Res. 2015;24(9):2195–208.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Varni JW, Thissen D, Stucky BD, Liu Y, Magnus B, Quinn H, Irwin DE, DeWitt EM, Lai JS, Amtmann D, et al. PROMIS(R) Parent Proxy Report Scales for children ages 5–7 years: an item response theory analysis of differential item functioning across age groups. Qual Life Res. 2014;23(1):349–61.

    Article  PubMed  Google Scholar 

  40. Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009;18(7):873–80.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Connor KM, Davidson JR. Development of a new resilience scale: The Connor-Davidson resilience scale (CD-RISC). Depress Anxiety. 2003;18(2):76–82.

    Article  PubMed  Google Scholar 

  42. Choi KR, McCreary M, Ford JD, Rahmanian Koushkaki S, Kenan KN, Zima BT. Validation of the Traumatic Events Screening Inventory for ACEs. Pediatrics. 2019;143(4).

  43. Wolraich ML, Lambert EW, Bickman L, Simmons T, Doffing MA, Worley KA. Assessing the impact of parent and teacher agreement on diagnosing attention-deficit hyperactivity disorder. J Dev Behav Pediatr. 2004;25(1):41–7.

    Article  PubMed  Google Scholar 

  44. Forrest CB, Bevans KB, Pratiwadi R, Moon J, Teneralli RE, Minton JM, Tucker CA. Development of the PROMIS (R) pediatric global health (PGH-7) measure. Qual Life Res. 2014;23(4):1221–31.

    Article  PubMed  Google Scholar 

  45. Meltzer LJ, Forrest CB, de la Motte A, Bevans KB. Clinical Validity of the PROMIS Pediatric Sleep Measures across Populations of Children with Chronic Illnesses and Neurodevelopment Disorders. J Pediatr Psychol. 2020;45(3):319–27.

    Article  PubMed  Google Scholar 

  46. Varni JW, Seid M, Knight TS, Uzark K, Szer IS. The PedsQL 4.0 Generic Core Scales: sensitivity, responsiveness, and impact on clinical decision-making. J Behav Med. 2002;25(2):175–93.

  47. Miller IW, Bishop DS, Epstein NB, Keitner GI. The McMaster family assessment device: Reliability and validity. J Marial Fam Therapy. 1985;11:345–56.

    Article  Google Scholar 

  48. Cella D, Choi SW, Condon DM, Schalet B, Hays RD, Rothrock NE, Yount S, Cook KF, Gershon RC, Amtmann D, et al. PROMIS((R)) Adult Health Profiles: Efficient Short-Form Measures of Seven Health Domains. Value Health. 2019;22(5):537–44.

    Article  PubMed  PubMed Central  Google Scholar 

  49. Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The PTSD Checklist for DSM-5 (PCL-5). National Center for PTSD. 2013. Scale available from the National Center for PTSD at

  50. Kazak AE, Alderfer M, Enlow PT, Lewis AM, Vega G, Barakat L, Kassam-Adams N, Pai A, Canter KS, Hildenbrand AK, et al. COVID-19 Exposure and Family Impact Scales: Factor Structure and Initial Psychometrics. J Pediatr Psychol. 2021;46(5):504–13.

    Article  PubMed  Google Scholar 

  51. Nelder J, Wedderburn, R. Generalized Linear Models. Journal of the Royal Statistical Society, Series A (General). 1972;135(3):370–84.

  52. Fitzmaurice G, Laired N, Ware J. Analyzing response profiles. Applied longitudinal analysis, modeling the mean. New York, NY: Wiley; 2004.

  53. Harville DA. Maximum likelihood approaches to variance component estimation and to related problems. J Am Stat Assoc. 1977;72(358):320–38.

    Article  Google Scholar 

  54. Jakobsen JC, Gluud C, Wetterslev J, Winkel P. When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts. BMC Med Res Methodol. 2017;17(1):162.

    Article  PubMed  PubMed Central  Google Scholar 

  55. Cushing CC, Steele RG. A meta-analytic review of eHealth interventions for pediatric health promoting and maintaining behaviors. J Pediatr Psychol. 2010;35(9):937–49.

    Article  PubMed  Google Scholar 

  56. Wilcoxon LA, Meiser-Stedman R, Burgess A. Post-traumatic stress disorder in parents following their child’s single-event trauma: A meta-analysis of prevalence rates and risk factor correlates. Clin Child Fam Psychol Rev. 2021;24(4):725–43.

    Article  PubMed  PubMed Central  Google Scholar 

  57. Committee on Trauma American College of Surgeons. Resources for optimal care of the injured patient. Available from: Accessed: 26 Jul 2023.

Download references


National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health & Human Development, R24HD096350. The funder does not play a role in study design, data collection, analysis, interpretation of the data, writing of the manuscript, or decision to submit the report for publication.

Author information

Authors and Affiliations



HTK, LE-C, and SW had the original idea for the study and obtained funding together as co-principal investigators. All authors substantially contributed to the development of the study protocol, read and approved the final version, with HTK taking the lead in writing.

Corresponding author

Correspondence to Heather T. Keenan.

Ethics declarations

Ethics approval and consent to participate

Ethical approval was obtained for all four participating sites through the use of single IRB located at Cincinnati Children’s Hospital and Medical Center (CCHMC). Approved 15 March 2021. IRB ID: 2021–0084. The single IRB will undergo an administrative review by 3/14/2024 as per CCHMC policy. Written parental informed consent and child assent will be obtained from all participants in the trial. The consent form is available at

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Keenan, H.T., Wade, S.L., Miron, D. et al. Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma. Trials 24, 766 (2023).

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: