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| Name | Class |
|---|---|
| University of Cincinnati | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMART Intervention | Experimental |
| |
| Usual Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Monitoring Activity-restriction and Relaxation Training (SMART) | Behavioral | 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. |
| 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 |
| 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.). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn Babcock, M.D. | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36565462 | Derived | Wade SL, Sidol C, Babcock L, Schmidt M, Kurowski B, Cassedy A, Zhang N. Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury. J Pediatr Psychol. 2023 Mar 20;48(3):241-253. doi: 10.1093/jpepsy/jsac086. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 7, 2023 | |
| Reset | Feb 21, 2024 | |
| Release | Mar 20, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 8, 2019 | Jan 11, 2022 |
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|
| 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 |
| Reset | Apr 8, 2026 |
| Release | Jun 15, 2026 |
| Unrelease | Jun 15, 2026 |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2023 | Feb 21, 2024 | |||
| Mar 20, 2026 | Apr 8, 2026 | |||
| Jun 15, 2026 | Jun 15, 2026 | |||
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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