An interventional study of Self-Monitoring Activity-restriction and Relaxation Training (SMART) in Brain Injury Traumatic Mild, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 11 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
Behavioral: Self-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.
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.
Time frame: From baseline to 4 weeks post-injury
Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
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.).
Time frame: From baseline to 4 weeks post-injury
Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
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
Time frame: From baseline to 4 weeks post-injury
Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS collects data from the adolescent participant and the parent about the impact a condition has on the adolescent's functioning.
Time frame: From baseline to 4 weeks post-injury
Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)
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."
Time frame: From baseline to 4 weeks post-injury
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Children's Hospital Medical Center, Cincinnati