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

Brain Injury Traumatic Mild Clinical Trial

— SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03498495
• Other study ID #: CIN001--SMART
• Status: Completed
• Phase: N/A
• Start date: May 12, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: July 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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