Online Modules to Help Children Manage Medical Stress After an Injury: Recovery After Stress Toolkit (ReSeT) Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Adherence
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ages of 8 to 17 years at time of enrollment
- •Hospitalized for trauma at one of the following sites: PICU, ward or rapid treatment/observation unit (less than 23 hours stay)
- •Both the parent and the child participating have the ability to read and speak English
- •Have broadband internet availability at their home address
- •Elevated post-traumatic stress symptoms (If the child exhibits clinically significant PTSS determined with the CPSS [Foa et al., 2001] with a score greater than or equal to 11 on the sum of the highest item by item score of parent/child report, they will be invited to participate in the pilot intervention. This methodology for using a joint score on the CPSS was informed by previous work indicating that both parents and children tend to underreport PTSS symptoms. Thus, implementing a multi-informant approach yields a more valid estimation of a child's psychopathology.)
Exclusion Criteria
- •Has sustained a moderate or severe TBI, as defined by a Glasgow Coma Score of less than 13
- •Has been diagnosed with moderate or severe intellectual disability , low functioning autism spectrum disorder, or a developmental disability (This will be determined by medical chart review and confirmed with parent report: Has the child ever been diagnosed with an intellectual or developmental disability? i.e., child must be able to talk; the rationale for this is that they may have difficulty mastering the course content)
- •Has a pre-existing severe psychiatric disorder that required prior psychiatric hospitalization (e.g., bipolar disorder, schizophrenia)
- •The mechanism of the injury was abuse or interpersonal violence
- •They are currently receiving psychotherapy
- •Has been hospitalized for their injury for over 30 days
- •No attempt will be made to recruit caregivers while their child is unstable, e.g. vitals are abnormal, there are major complications, or death may be imminent. Children with multiple injuries are eligible to participate but their caregivers will not be approached until any interventions (surgery, casting, etc.) are completed.
Arms & Interventions
Recovery after Stress Toolkit (ReSeT)
ReSeT is comprised of interactive web-based psychoeducational modules that are developmentally tailored for school age children (8-17 years) for use with synchronous e-health therapy sessions with a trained therapist.
Participants in the ReSeT treatment will complete 8 modules and therapy sessions. Parents will also have access to 4 modules During the study, children/youth will be asked to complete all eight sessions of the online treatment together with the therapist over an 8 -12 week time period (to allow for scheduling/cancellations). For younger children, parents will participate in the beginning and end of each session. Sessions will last approximately 30-60 minutes and will occur approximately every week for an anticipated 4-8 hour time commitment. Parents of older children will be permitted to review the content independently and participate in feedback sessions.
Intervention: Recovery after Stress Toolkit (ReSeT) (Behavioral)
Outcomes
Primary Outcomes
Adherence
Time Frame: Feasibility will be assessed at 12 weeks post-enrollment.
Adherence to the ReSeT intervention will be assessed by calculating the number of sessions participants complete out of the 8 proposed sessions.
Acceptability
Time Frame: Acceptability will be assessed at 12 weeks post-enrollment.
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.
Length of Time to Complete Sessions
Time Frame: This outcome will be assessed at the end of the 8 sessions of the intervention.
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.
Secondary Outcomes
- Child Quality of Life(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 Post-traumatic Stress Symptoms (PTSS)(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(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 Depressive Symptoms(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.)