N/A
N=6
Recovery After Stress Toolkit (ReSeT): Pilot Study
Post-traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04830839 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Adherence — 7.3 number of sessions completed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Recovery after Stress Toolkit (ReSeT) (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
7.3 | — |
| PRIMARY Acceptability |
50 | — |
| PRIMARY Length of Time to Complete Sessions |
65.2 | — |
| SECONDARY Child Post-traumatic Stress Symptoms (PTSS) |
-10 | — |
| SECONDARY Child Anxiety Symptoms |
-7 | — |
| SECONDARY Child Quality of Life |
9 | — |
| SECONDARY Child Depressive Symptoms |
-6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04830839). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.