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

Not Applicable

Completed

• Conditions: Brain Injury Traumatic Mild
• Interventions: Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)

• Registration Number: NCT03498495
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-04
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-13
• Study Start: 2019-05-12
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMART Intervention	Self-Monitoring Activity-restriction and Relaxation Training (SMART)	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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 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."

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States