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

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

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.

Study Overview

• Status: Completed
• Conditions: Brain Injury Traumatic Mild
• Intervention / Treatment: Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.).	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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Cincinnati
• Investigators: Principal Investigator: Lynn Babcock, M.D., Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2019
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: CIN001--SMART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No