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Completed

NCT Number: NCT03498495

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

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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Key information

Conditions

Brain Injury Traumatic Mild Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)

    Time frame: From baseline to 4 weeks post-injury

    The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.

Secondary outcomes

  1. Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)

    Time frame: 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.).

  2. Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)

    Time frame: 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

  3. Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

    Time frame: 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.

  4. Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)

    Time frame: 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."

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • University of Cincinnati

Registry information

Official study title

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

Acronym: SMART

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2018
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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