SMART: Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SMART Intervention
|
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.
|
| No Intervention: Usual Care
|
Outcome Measures
Primary Outcome Measures
- Change in Psychological Distress, as measured by the Strengths and Difficulties Questionnaire (SDQ) [From baseline to 4 weeks post-injury]
The SDQ is a 25-item behavioral screening questionnaire that has adolescents rate their psychological symptoms and positive attributes. The measure has been used with other pediatric-TBI populations89 and provides a measure of functioning across five domains (e.g., prosocial behavior and emotional symptoms). Both youth and their parents will complete, capturing adolescent strengths and challenges on a weekly basis.
Secondary Outcome Measures
- 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 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.
- 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."
- Change in concussion knowledge, as measured by the Concussion Questionnaire [From baseline to 4 weeks post-injury]
The concussion knowledge questionnaire will be based upon the 11-item questionnaire currently being used in the Centers for Disease Control and Prevention Head's Up Concussion Course geared at coaches.
Eligibility Criteria
Criteria
Inclusion Criteria:
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11-18 years old
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Sustained mTBI within the past week
Exclusion Criteria:
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Patient and/or family do not speak and read English
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Patient and/or family do not have Internet access
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Patient experiencing more severe brain injury (Glasgow coma score <13)
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Patient with more than one moderate extracranial injury
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Patients with non-mTBI reasons for altered mental status
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Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | United States | 45229 |
Sponsors and Collaborators
- Children's Hospital Medical Center, Cincinnati
- University of Cincinnati
Investigators
- Principal Investigator: Lynn Babcock, M.D., Children's Hospital Medical Center, Cincinnati
Study Documents (Full-Text)
More Information
Publications
None provided.- CIN001--SMART