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

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

NCT03498495•Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

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.

Eligibility

Age

11 - 18 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Key Dates

Start Date

May 12, 2019

Primary Completion Date

August 31, 2020

Completion Date

August 31, 2020

Last Updated

July 10, 2023

Enrollment

ACTUAL participants

Conditions

Brain Injury Traumatic Mild

Interventions

Self-Monitoring Activity-restriction and Relaxation Training (SMART)

BEHAVIORAL

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

NCT05663034

Traumatic Brain InjuryInsomnia+8 more

View study

RECRUITINGNA

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

NCT05589064

Brain Injury Traumatic Mild

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

CBT-I vs. MBTI for Traumatic Brain Injury (TBI)-Related Insomnia and Post-Traumatic Stress Symptoms

Evaluation of the Impact of a Dietary and Nutritional Intervention on Persistent Post-concussive Symptoms

Longitudinal Assessment of Post-concussion Driving in Young Adults

Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport