Experiencing an accident and staying in the hospital can be scary and traumatic for children. The goal of this project is to develop an online resource to help children and their parents develop effective coping skills to manage their stress. Children ages 8-17 who exhibit signs of posttraumatic stress will view 8 online modules and attend weekly videoconferencing sessions with a therapist. Parents will have 4 modules to assist them in supporting their child after the injury.
The overarching goal of this project is to provide a research and treatment resource for the management of psychological distress in children who have been hospitalized for a physical trauma. The investigators will pilot an innovative, brief e-health approach to treatment of PTSS designed to be delivered through the trauma system. The investigators will create interactive web-based psychoeducational modules that are developmentally tailored for school age children (8 to 17 years) for use with synchronous e-health therapy sessions with a trained therapist. Companion modules for parents will help parents to understand and respond to their child's PTSS. The investigators will perform a single-arm pilot trial of a brief e-health approach to treatment of PTSS (i.e., Recovery after Stress Toolkit; ReSeT). ( delete with usual care.)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
ReSeT involves online modules with parallel videoconferencing sessions. ReSeT integrates two evidence-based treatment methods: cognitive behavioral therapy coping skills (coping CBT) and direct exposure to trauma reminders through a trauma narrative.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Adherence
Adherence to the ReSeT intervention will be assessed by calculating the number of sessions participants complete out of the 8 proposed sessions.
Time frame: Feasibility will be assessed at 12 weeks post-enrollment.
Acceptability
The acceptability of the ReSeT intervention will be assessed with child and parent satisfaction surveys, and a qualitative interview with open-ended feedback about the program. The satisfaction surveys ask participants to rate their satisfaction with the program on a 4-point Likert scale (from "strongly disagree" to "strongly agree"), with higher scores indicative of greater satisfaction and acceptability. The ratio of child satisfactory responses over the total number of possible child satisfaction survey responses was calculated to measure overall child satisfaction.
Time frame: Acceptability will be assessed at 12 weeks post-enrollment.
Length of Time to Complete Sessions
The feasibility of the ReSeT intervention will be assessed with the number of weeks that it takes participants to complete the 8 sessions of the intervention. The intervention was designed to take place over a 12 week period, with sessions occurring weekly.
Time frame: This outcome will be assessed at the end of the 8 sessions of the intervention.
Child Post-traumatic Stress Symptoms (PTSS)
The Child Post-Traumatic Stress Disorder Scale (CPSS; Foa et al, 2001) is a validated child report and parent proxy measure of PTSS. The measure is comprised of 24-items. The CPSS includes 17 questions mapping on to DSM-IV symptoms of PTSD rated on a 5-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 3 times a week/half the time, 3 = 4 to 5 times a week, 4=6 or more time a week/almost always). The minimum score for PTSS symptoms is 0 and the maximum is 80. A higher score indicates greater PTSS. The change in raw score from the 17 questions mapping PTSD symptoms was calculated from change in scores at 1 week post discharge to scores at 12 weeks post randomization.
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Time frame: Child PTSS from pre-intervention (within 6 months of the injury discharge) will be compared to the child's PTSS post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Child Anxiety Symptoms
The Screen Child Anxiety and Related Emotional Disorders (SCARED; Birmaher et al., 1999) is a widely used questionnaire that screens for anxiety and emotional disorders in children. 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 measures yields raw scores for anxiety disorder, panic disorder, generalized anxiety disorder, separation anxiety, social anxiety disorder, and significant school avoidance. Total scores range from 0-82, with scores above 25 indicating the presence of clinically significant anxiety. The change in total score from 1 week post discharge to 12 weeks post randomization was then calculated to get the overall change in score.
Time frame: Child anxiety from pre-intervention (within 6 months of the injury discharge) will be compared to child anxiety post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Child Quality of Life
The Pediatric Quality of Life Inventory (PedsQL 4.0; Varni et al., 2001) is a well-validated parent- report measure consisting of 15 items that takes less than 5 minutes to complete. 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. The total quality of life scale score will be utilized. Scores range from 0-100, with higher scores indicating better health related quality of life. The Total quality of life score change from 1 week post discharge to 12 weeks post randomization was then calculated, with a greater change in total score indicating greater improvements in quality of life.
Time frame: Child quality of life from pre-intervention (within 6 months of the injury discharge) will be compared to child quality of life post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.
Child Depressive Symptoms
The Patient Reported Outcomes Measurement Information System is a National Institutes of Health (NIH) initiative created to advance assessment of patient-reported outcomes. To measure child depressive symptoms for this outcome measure, the depression subscale t score (Mean 50 with SD 10) from the child reports were pulled, and the change in t score from 1 week post discharge to 12 weeks post randomization was calculated. As this outcome measure represents a change in t score from one time point to another, there is no standard minimum and maximum value to report. A greater change in t score represents a greater decrease in depressive symptoms, which represents better outcomes. There are no clinical cut-offs, however, greater than two standard deviations above or below the mean would represent an extreme value.
Time frame: Child depressive symptoms from pre-intervention (within 6 months of the injury discharge) will be compared to child depressive symptoms post-intervention, at 12 weeks post-enrollment or until the child has finished treatment.