Brain Injury Traumatic Mild
Conditions
Brief summary
SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.
Interventions
BEHAVIORALSelf-Monitoring Activity-restriction and Relaxation Training (SMART)
SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.
Sponsors
University of Cincinnati
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 11-18 years old * Sustained mTBI within the past week
Exclusion criteria
* Patient and/or family do not speak and read English * Patient and/or family do not have Internet access * Patient experiencing more severe brain injury (Glasgow coma score \<13) * Patient with more than one moderate extracranial injury * Patients with non-mTBI reasons for altered mental status * Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL) | From baseline to 4 weeks post-injury | The PedsQL includes 23 items measuring physical, emotional, social, and school functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form) | From baseline to 4 weeks post-injury | The CSI-S is a coping styles measure and has been used with other pediatric TBI samples. Adolescents rate how much they agree with 32-statements regarding different ways of coping with difficult situations on a 5-point Likert scale. Responses are then grouped into primary subscales reflecting eight different coping strategies (e.g., problem-solving, problem avoidance, social withdrawal, etc.). |
| Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS) | From baseline to 4 weeks post-injury | This 2-item measure will be developed by the research team based on Bandura's self-efficacy theory. Adolescents will rate their level of confidence that they are able to maintain a plan to manage their symptoms each week |
| Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) | From baseline to 4 weeks post-injury | PROMIS collects data from the adolescent participant and the parent about the impact a condition has on the adolescent's functioning. |
| Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI) | From baseline to 4 weeks post-injury | The HBI is a 20-item questionnaire which includes a variety of cognitive, somatic, emotional, and behavioral symptoms requiring parents and adolescents to rate the frequency of occurrence of each symptom over the past week on a 4-point scale, ranging from never to often. |
Countries
United States
Outcome results
None listed