Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury
NCT ID: NCT03498495
Last Updated: 2023-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2019-05-12
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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SMART Intervention
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.
Usual Care
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Sustained mTBI within the past week
Exclusion Criteria
* 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.
11 Years
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Lynn Babcock, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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CIN001--SMART
Identifier Type: -
Identifier Source: org_study_id
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