Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program

Conditions
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Brain Injury Traumatic Mild

Intervention / Treatment
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* Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMART Intervention<br> | Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)<br>* 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.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From baseline to 4 weeks post-injury | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.). | 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 | 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. | 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. | From baseline to 4 weeks post-injury |