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

Cincinnati Children's Hospital Medical Center logo

Cincinnati Children's Hospital Medical Center

Status

Completed

Conditions

Brain Injury Traumatic Mild

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03498495
CIN001--SMART

Details and patient eligibility

About

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.

Enrollment

74 patients

Sex

All

Ages

11 to 18 years old

Volunteers

No 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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

74 participants in 2 patient groups

SMART Intervention
Experimental group
Treatment:
Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)
Usual Care
No Intervention group

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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