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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03498495
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
University of Cincinnati
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Brain Injury Traumatic Mild Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program
Actual Study Start Date : May 12, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

No Intervention: Usual Care



Primary Outcome Measures :
  1. Change in Psychological Distress, as measured by the Strengths and Difficulties Questionnaire (SDQ) [ Time Frame: From baseline to 4 weeks post-injury ]
    The SDQ is a 25-item behavioral screening questionnaire that has adolescents rate their psychological symptoms and positive attributes. The measure has been used with other pediatric-TBI populations89 and provides a measure of functioning across five domains (e.g., prosocial behavior and emotional symptoms). Both youth and their parents will complete, capturing adolescent strengths and challenges on a weekly basis.


Secondary Outcome Measures :
  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 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.

  4. 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.

  5. 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."

  6. Change in concussion knowledge, as measured by the Concussion Questionnaire [ Time Frame: From baseline to 4 weeks post-injury ]
    The concussion knowledge questionnaire will be based upon the 11-item questionnaire currently being used in the Centers for Disease Control and Prevention Head's Up Concussion Course geared at coaches.



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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498495


Contacts
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Contact: Lynn Babcock, M.D. 513-250-5188 lynn.babcock@cchmc.org
Contact: Shari Wade, Ph.D 513-636-3370 shari.wade@cchmc.org

Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Lynn Babcock, M.D.    513-250-5188    lynn.babcock@cchmc.org   
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
University of Cincinnati
Investigators
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Principal Investigator: Lynn Babcock, M.D. Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03498495    
Other Study ID Numbers: CIN001--SMART
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System